Sunday, 27 December 2009

Ampac Fine Chemicals revenues decline

Ampac Fine Chemicals revenues declined 23% in the year ended 30 September 2009. Ampac said the decline in revenues could be attributed to declines in core product revenues from anti-viral products of 30%, central nervous system products of 14%, and oncology products of 13%.
Seeking Alpha

DSM BioSolutions will manufacture “MS1819” lipase for Laboratoires Mayoly Spindler at its Capua, Italy facility


Cobra recommends Recipharm offer

Cobra Biomanufacturing recommends that its shareholders accept the offer from Recipharm to acquire the outstanding shares. The company said it no longer has sufficient working capital to continue and that its current financing facility runs out in January 2010.

DSM to reorganise Pharma Chemicals in Venlo

DSM will lay off 35 jobs at its Venlo, Netherlands, site in 2010 as part of a reorganisation of its Pharma Chemicals business. DSM plans to introduce a 'lean and mean' manufacturing model and is examining all the activities at Venlo. Activities that do not meet the minimum requirement will be phased out or transferred to the Linz, Austria, site. DSM puts the reorganisation down to "limited demand from pharmaceutical companies, delay in approvals and the loss of some large contracts" which have lead to increasing cost pressure.

Thursday, 17 December 2009

Angel Biotechnology has signed a £0.5m phase II clinicla trial GMP manufacturing contract with a UK biotech company


Avecia biologics business snapped up by Merck

Merck's UK affiliate Merck Sharp & Dohme will acquire the biologics business of Avecia for an undisclosed sum. Merck will acquire Avecia's assets in Billingham, UK. The deal does not include Avecia's US-based oligonucleotide business. Merck will honour Avecia's contracts and will discuss future manufacturing needs with customers after the transaction is closed. John McCubbins, senior vice president, Biologics and Therapeutic Protein Operations, Merck Manufacturing Division, said the deal provides Merck with "an operational facility staffed by an experienced workforce that is highly skilled in a broad portfolio of bioprocess systems."

The US FDA has opend an office in Mexico City


The Bio-Process Systems Alliance (BPSA) has become an affiliate of Socma

Pharmaceutical Business Review

Wednesday, 16 December 2009

Recipharm to acquire Cobra

Recipharm has made a mandatory offer for the outstanding shares in Cobra Biomanufacturing following its acquisition of 43.87% of the company for £437,625. The offer values Cobra at almost £1m. Cobra has said it expects Recipharm to make a loan to Cobra so it can meet its working capital requirements during the integration of the two businesses. Cobra had announced it was in sales talks last month.
Proactive Investors

Teva is looking to deepen its biosimilars tie-up with Lonza


Tuesday, 15 December 2009

Lonza will provide development services and cGMP manufacturing for Femta Pharmaceuticals' FM101 high affinity monoclonal antibody


Pfenex licenses technology to Merck

Pfenex, the new spinout from Dow Chemical, has licenced its Pseudomonas fluorescens biomanufacturing technology to Merck for production of proteins for an undisclosed vaccine product. Pfenex will receive $52m in upfront and milestone payments and is entitled to royalty payments on any product sales derived from the agreement.

Sunday, 13 December 2009

French newspaper, Les Echos, reports that SNPE is in talks to sell Isochem to German private equity house, Aurelius

Les Echos

Pentagon Chemicals has received a £2m investment from the UK's Capital for Enterprise fund

Private Equity Wire

Archimica sells site; begins investment programme

Erredue has acquired Archimica's Isso, Italy, manufacturing facility. In addition Archimica has started an capital investment programme with a €2.5m capacity expansion for API production at its Origgio, Italy, site. The company will also make investments in its other manufacturing sites.

Dishman invests in Saudi Arabia and India

Dishman Pharmaceuticals and Chemicals and three Saudi Arabian partners, have established a joint venture to manufacture APIs in Saudi Arabia. Dishman has invested $9m for a 30% stake in CAD. The Arab Company for Drug Industries and Medical Appliances (ACDIMA) has a 15% stake, Spimaco 20% and Capital Advisory Group 25%. The facility is due on line towards the end of 2010.
Dishman is also investing $32m in four contract manufacturing plants at its SEZ and another $32m in expanding its Bavla facility.
Business Standard

Dottikon sales fall

H1 sales for Dottikon fell 42% to CHF45.3m. The company put this down to the elimination of redundant product lines and delayed commissioning of new apparatus groups. During the period Dottikon brought on-stream the expansion of its medium scale API separator capacity and large scale corrosion-resistant glass-lined steel and Hastelloy multipurpose reactor, low-temperature, and API separator capacity.

Wednesday, 9 December 2009

Halocarbon received FDA approval to supply sevoflurane for the veterinary inhalation anaesthetic market


Dow spins out biomanufacturing technology

Dow Chemical has spun out its Pseudomonas fluorescens-based Pfenex Expression Technology for producing recombinant proteins into a new company called Pfenex Inc. The Dow Venture Capital group will retain a "significant minority share" in the new company alongside Signet Healthcare Partners. San Diego, CA-based Pfenex will focus on the human health applications of the technology.

Thursday, 3 December 2009

Cambrex's Charles City, Iowa, facility has received a GMP certificate from the MHRA


Socma names Sloan new president and ceo

Lawrence Sloan will replace Joseph Acker as President and ceo of Socma on 10 February 2010. Sloan previously served as President of the Adhesive and Sealant Council (ASC), a trade association representing the adhesive and sealant industry. Sloan started his career at Air Products & Chemicals in and later worked for Nalco Chemical Company.

RL Fine Chemicals is investing almost $1m in a formulation R&D unit

Pharma Biz

Avecia customer, Dyax has received FDA approval of its recombinant protein DX-88 for use in hereditary angioedemia

Contract Pharma

Teva will use Codexis biocatalysis technology to manufacture three generic products


Zach System receives FDA warning letter for failing to take action after shipping potentially contaminated products

FDA News

Dishman adds HPAPI lab in Netherlands

Dishman Netherlands has opened its high containment cGMP laboratory in Veenendaal, The Netherlands. The laboratory includes dedicated clean rooms with the capability to scale up to 1kg. Dishman expects an FDA compliance audit in H1 2010.
Outsourcing Pharma

Thursday, 26 November 2009

Johnson Matthey's fine chemicals business saw a 22% rise in sales in its H1


The UK's EPSRC and BBSRC research councils will invest £9m in bioprocessing research with support from industry


Lonza will provide process development and manufacture for Micromet’s blinatumomab


AZ to out source all API manufacturing

AstraZeneca plans to outsource 100% of its API manufacturing within seven years, it told analysts at a recent briefing. The company currently outsources about 80% of its API manufacturing with three preferred suppliers in Europe and suppliers in India. The additional outsourcing is expected to come from India where the cost base is lower, said Executive Vice President for Operations, David Smith, although the company expects to introduce greater quality control and supplier audits.

Angel Biotechnology has arranged a £4m financing facility with Trafalgar Capital Advisors

Angel Bio

Tuesday, 17 November 2009

Agencies failing to monitor API quality

Guy Villax, board member of the European Fine Chemicals Group, has once again raised the subject of API quality. Speaking at the AAPS meeting earlier this month Villax said that enforcement of API quality is in "disarray" and that regulatory agencies were failing to properly police the supply chain.
In-Pharma Technologist

Evonik sees 16% rise in chemicals earnings as sales fall


Tuesday, 10 November 2009

Synthetech reports 22% revenue growth in the quarter ended 30 September

Portland Business Journal

Reaxa has received £146,000 from the UK NorthWest Development Agency to further develop its Nickel EnCat catalysts


Hovione will move most of its manufactuiring to China from Europe in the medium term, according to company CEO, Guy Villax

Macau Hub

Jubilant to expand, sell

Jubilant Organosys plans to spend $54m on capacity expansion plans in the current year. Most of the money will be spent on debottlenecking and a small amount on R&D. In addition the company expects to have sold its performance polymers business by end March 2010.
Business Standard

Sunday, 8 November 2009

Althea Technologies has added customised formulation development to biopharmaceutical services


DSM Pharmaceutical Products will provide process development, scale up and commercial scale manufacturing for Galenix's drug delivery technologies


Lonza will manufacture ProChon Biotech's fibroblast growth factor at its Hopkinton, MA, facility


Carbogen Amcis restructures

Carbogen Amcis plans to restructure its Swiss operations. Early phase services will be consolidated at the company's Aarau site, while the Hunzenschwil site will focus on new technologies, such as micro-reactors and crystallisation. Late phase and high potency services at the Bubendorf facility, will be expanded, due to increased market demand. The changes would result in the loss of up to 40 positions.
Carbogen Amcis has seen a significant increase in the number and rate of progress associated with later phase projects, but there has been a substantial decline in the number of early phase projects being generated.
Dishman Pharma, Carbogen Amcis' parent company saw 2Q revenue decrease 12% mainly due to a disappointing quarter at Carbogen Amcis.
Carbogen Amcis
Money Control

Cambrex sees 3Q sales rise

Cambrex 3Q sales rose 2.3% to $57.8m. The company said the rise was primarily due to higher volumes of an API that utilises its polymeric drug delivery technology but was partially offset by lower sales of two APIs manufactured under long-term supply agreements.

Lonza has acquired Algonomics NV to add integrated immunogenicity prediction services for the development of biotherapeutics


3Q sales in DSM's Pharma business unit decreased 25% on weak demand, delay in approvals and loss of some contracts


Thursday, 29 October 2009

Lonza to cut jobs, costs

Lonza will cut about 450 jobs and reduce costs by CHF60-80m. Chief executive, Stefan Borgas, said the cuts come as a result of cancellations and postponements in large-scale biopharmaceutical custom manufacturing, an 18 month delay of a lead customer project in cell therapy due to clinical disappointments and continued low order level for Lonza's Exclusive Synthesis due to key customers reducing net working capital. The company's share price fell around 20% on the news.
Last week, Lonza withdrew its $460m bid for Patheon after the major shareholder, JLL, refused to talk. Borgas said the company is still looking for value creating add-on acquisitions. Lonza is looking to enlarge its life sciences business technology portfolio, strengthen its offering for life-science researchers including CRO services; strengthen the CMO value chain by entering finished dosage form development and manufacturing; and add niche portfolio products to the nutrition business.

Wednesday, 28 October 2009

Evonik sells AlzChem group to BluO private equity fund


Excelsyn shows full year sales of £11.7m a 16% rise on 2008

Manufacturing Chemist

Lanxess CEO says Saltigo not for sale


Stronger quarter for SAFC

SAFC showed a 4.8% increase increase in Q3 organic sales helped by sales of H1N1 vaccine adjuvants to pharma companies. Rakesh Sachdev, Senior Vice President and Chief Financial Officer, said sales were also helped by 'new customer facilities coming online, new financing becoming available at both biotech and virtual pharmaceutical companies and our customer’s efforts to push early stage clinical trials in response to indications of moderate economic improvements'.
Jai Nagarkatti, Chairman, President and Chief Executive Officer, said 'we delivered a fair amount of what was booked at June 30th, in the third quarter, but our order book remains above 25% higher than what it was at the end of 2008'.
Seeking Alpha

Thursday, 22 October 2009

PacificGMP will perform cGMP cell bank development and manufacturing of ArmaGen Technologies antibody fusion protein for phase I trials

PR Newswire

Jubilant plans fundraising and disposals

At its investors conference Jubilant Organosys announced plans to raise Rs5bn ($107m) in funds. In addition the company plans to sell its application polymers division and consumer products division and then change its name to Jubilant Life Sciences.
My Iris

Lonza acquires stake in German biotech, Cilian

Lonza has made an investment in Cilian. The deal gives Lonza right of first refusal for the commercial production of products and access to Cilian's ciliates system for the production of therapeutic proteins and nutritional ingredients. Lonza will transfer a number of patents and patent applications in tis field to Cilian in return for newly issued shares in Cilian.

Hovione has purchased manufacturing equipment from Acusphere's Tewksbury, MA, facility for $2.5m


Lonza will provide microbial fermentation, process optimization, technical and regulatory support for Alnara Pharmaceuticals' lead product liprotamase


Tuesday, 20 October 2009

Lonza withdraws Patheon bid, looks elsewhere for formulation

Lonza has withdrawn its $460m bid for Patheon after the major shareholder, JLL, refused to talk. Lonza said it was looking at other opportunities to add formulation capabilities to its portfolio, which it believes fits with its current growth strategy.

Sunday, 18 October 2009

Pfizer has completed its acquisition of Wyeth


Lifeline plans acquisitions

Lifeline Industries is planning to complete two acquisitions before the end of the year. Lifeline is in talks to buy Erica's assets for around Rs1.35bn ($29.3m) and hopes to close the deal by the end of this year. The company is also in talks for a second acquisition valued between Rs1.75bn-Rs2.0bn.
Business Standard

Wednesday, 14 October 2009

Eden Biodesign will manufacture Biotecnol's Cardiotrophin-1 for phase I clinical trials

Business Wire

Evonik expands US API capabilities

Evonik has purchased Eli Lilly's Tippecanoe, IN, manufacturing facility to strengthen its API production capabilities in the US. Financial terms for the deal, which is expected to close by the end of the year, have not been disclosed. In addition, Evonik has entered into a nine-year API production deal with Lilly.

Reaxa will establish an Indian subsidiary for scale-up manufacturing of its catalyst products

In-Pharma Technologist

Tuesday, 13 October 2009

Lonza and BioWa have unveiled a new host cell line for manufacturing recombinant antibodies


SAFC completes expansion

SAFC Pharma has completed the $12m expansion of its Carlsbad, CA, facility. The company has added two fully segregated state-of-the-art viral product manufacturing suites to expand its services for late phase and commercial clients. In addition SAFC Pharma has installed an Oxford Diffraction SuperNova single crystal X-ray diffraction system at its Pharmorphix Solid State Research Laboratories in Cambridge, UK.
Sigma Aldrich
Sigma Aldrich

Lonza has acquired the preclinical cell and molecular biology assets of Simbiosys Biowares India

Wall Street Journal

Monday, 12 October 2009

Arch Pharmalabs will use Orochem Technologies SMB to manufacture an API for an unnamed US innovator

Business Wire

Angel signs £1.2m deal with Materia Medica

Angel Biotechnology has signed a fourth deal with Materia Medica for the GMP manufacture of antibodies. Angel said that 90% of the £1.2m would be invoiced over the next 18 months.
Angel Bio

Carbogen Amcis has entered a partnership with NextPharma Technologies to reduce product development times for customers


Wednesday, 7 October 2009

CIA highlights chemical industry to opposition party

The UK Chemical Industries Association has challenged the Conservative opposition to recognise the part manufacturing industries, such as the chemical industry, can play in helping the UK meet economic and green goals.

Monday, 21 September 2009

Cobra takes loans to address shortfall

Cobra Biomanufacturing has taken a £180,000 loan from Sultan Scientific and a £50,000 loan from its biggest shareholder to fund its working capital shortfall.

Friday, 18 September 2009

Angel sales increase in H1

Angel Biotechnology reported stronger revenues in H1 2009 compared to 2008. Revenues grew 25% and the company signed contracts worth £2.2m in the half year ended 30 June. However, losses for the six-months also increased.

Codexis closes German site

Codexis has closed its Jülich, Germany, site as part of a move to streamline its supply chain efficiency. The company said it would continue to supply its inventory through a soon-to-be-launched e-store. Codexis acquired the Jülich site as part of its 2005 purchase of Jülich Fine Chemicals.

Novasep's Le Mans, France, HPAI facility gains SafeBridge certification

PR Newswire

PCAS sees first half sales decline 18%


Monday, 14 September 2009

Phoenix rises from Shasun

Phoenix Chemicals has purchased the Annan, Scotland, facility from Shasun. Shasun closed the facility in March. Phoenix said the former GlaxoSmithKline facility will expand its capabilities to manufacturing scale and plans to offer jobs to former site workers
Annandale Observer

Dishman looks to expand overseas

Dishman is expanding its contract research and manufacturing operations into Japan and the US. Dishman cfo, VVS Murthy, said the company is eyeing contracts in the US market and expects them to materialise in the financial year 2010-11.
DNA India

Informex 2010 registration is now open


Aesica will provide production and packaging for a number of Amdipharm products

In-Pharma Technologist

Angel Biotechnology will manufacture a second-generation formulation of ReNeuron’s lead CTX stem cell line for pre-clinical and clinical applications


Socma President, Joe Acker, to retire in December


Thursday, 3 September 2009

Almac founder establishes research charity

Almac founder Sir Allen McClay has established the McClay Foundation to fund research and commercial innovation in the field of healthcare and allied technologies. Almac will become the engine to generate funds for the foundation from the profits of its research and global sales.
Belfast Newsletter

Wednesday, 2 September 2009

Chinese FDA to introduce new GMP guidelines

China Financial Daily

SynCo in Japan deal

SynCo Bio Partners will provide process development and manufacturing for an unnamed Japanese company. SynCo will assist its client with in-house process development prior to transfer, scale-up and GMP manufacture for Phase I clinical trials in Amsterdam.

Indian appeals court decision will allow CMOs in India to claim tax credit on their advertising spend

Outsourcing Pharma

FDA expected to require manufacturing info in applications

The US FDA is expected to require more manufacturing site information on drug product applications. Edwin Rivera-Martinez, the FDA's chief of the international compliance in CDER’s manufacturing division said the rule is designed to cut down on unneeded FDA inspections and erroneous information about manufacturing sites by requiring sponsors to list establishments and locations involved in manufacturing drug products. Rivera-Martinez also said the agency will double its overseas inspections of facilities for GMP compliance this year from 50 to 100.
FDA News
FDA News

Lonza sells Singapore plant to Roche

Roche subsidiary Genentech has picked up its option to purchase a biologics manufacturing plant from Lonza. The facility will be merged with Genentech's existing facility in Singapore. Lonza will receive $290m and up to $70m in milestone payments.
In-pharma Technologist

Tuesday, 1 September 2009

Patheon continues to explore Lonza bid

Patheon's independent directors are continuing to examine Lonza's bid for the company. The Lonza offer, which is a 77% premium over that of JLL is conditional on being able to secure two-thirds of Patheon's shares.

Cobra struggles with cash; passes MHRA inspection

Despite an order book worth £10m Cobra Biomanufacturing's ability to continue as a going concern remains dependent on thecompany delivering contract signatures and converting these contracts into revenue and cash receipts. The company said trading conditions have resulted in a delay in the achievement of some contract signatures. Cobra has completed a successful cGMP audit by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) at its facility based at Keele.
Small Cap News

Thursday, 27 August 2009

Cobra Biomanufacturing will provide development services for an Adenovirus based product for a European biotech company


Archimica and Chemic cooperate to scale manufacturing

Chemic Laboratories and Archimica Group have formed an API development and manufacturing cooperation. Archimica will scale DEA controlled and other API to commercial scale after Chemic Laboratories have developed and produced the first quantities.
Mass Bio

Cambrex Milan manufacturing facility receives FDA warning letter


BASF ceo says company not immune to takeover, cost would be $100m


Perrigo has acquired 85% of Verdants Drugs and Fine Chemicals for $12m

Business Standard

Lonza reiterates Patheon bid

Lonza reiterated its bid for Patheon as JLL allowed its offer to expire. JLL holds 57% of Patheon. Lonza has bid $3.55/share for the company and will only proceed with an offer if it can secure 67%.
Wall Street Journal

JLL rejects Lonza bid for Patheon

JLL, the majority stakeholder in Patheon, has rejected Lonza's $460m offer for the Canadian company. JLL currently holds 57% of Patheon.
PR Newswire

Lonza makes offer for Patheon

Lonza has made a non-binding offer to acquire Patheon. Lonza has offered $3.55/share valuing Patheon at $460m. Lonza ceo Stefan Borgas said Lonza was looking to expand its offering to cover more of the manufacturing supply chain and Patheon's finished dosage manufacturing capability would fill a gap. He added that Patheon was one of several opportunities in the area that lonza had been following over the last couple of years.

Thursday, 13 August 2009

FDA expands access to experimental drugs

The US FDA has will allow greater access to experimental drugs for seriously ill patients. Under the new rules drugmakers will be able to provide experimental medicines to patients with no other options.

Wednesday, 12 August 2009

Problems at FDA

The US Department of Health and Human Services is investigating Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, for conflict-of-interest during a drug approval. In addition, Daniel Schultz, head of the FDA's device regulation division, has resigned from the agency.
Wall Street Journal
Wall Street Journal

PCAS and Nanosyn form jv

PCAS-Nanosyn, a joint venture between PCAS and Nanosyn, will operate a cGMP kilolab in Santa Rosa, CA. Christian Moretti, chairman of PCAS, said the jv allows PCAS to offer preclinical and clinical trial API synthetic capabilities nearer to its clients in the US.

Tuesday, 11 August 2009

Emergent BioSolutions is acquiring a manufacturing facility, from a CMO, in Maryland for production of its anthrax vaccine

Seeking Alpha

FDA to get tougher, faster

FDA Commissioner, Margaret Hamburg, has said the Agency will enforce its regulations in a faster and more aggressive way. Among the processes being introduced the FDA will streamline the warning letter process.
Washington Post

Reaxa has received ISO 9001:2008 accreditation for its catalyst and scavenger manufacturing


Informex looking for 2012 location

Informex is asking potential delegates where they would like the 2012 event to be held. The choices are Charlotte, Houston, Miami Beach, Philadelphia and San Diego. The 2010 event will be held in San Francisco and the 2011 event in Charlotte, NC.
Visit LinkedIn to vote

Wednesday, 5 August 2009

Ampac's fine chemicals saw Q3 revenues decrease due to a change in customer demand for CNS products


Dishman plans Carbogen Amcis changes

R Vyas, MD of Dishman Pharma said the company is looking at making some drastic changes to improve the EBDITA margins in Carbogen Amcis following the appointment of Nick Green as president of the company's CRAM activities.
Money Control

Cambrex reports sales rise

Excluding the impact of currency sales at Cambrex rose 2%. The company attributed the rise to the timing of orders related to two APIs manufactured under long-term supply agreements and an API that incorporates its polymeric drug delivery technology. However Cambrex said this was partially offset by lower sales of generic APIs and feed additives.

DSM expects pharma business improvement by year end

Profits for DSM's pharma business fell from €37m to €14m in the first half of the year. The company put this down to lower business activities in its custom manufacturing business at DSM Pharmaceutical Products, related to de-stocking, delay in approvals and the loss of some larger contracts, and weak market conditions for DSM Anti-Infectives. The company expects the year-end results to be 'substantially lower than last year due to lower prices at Anti-Infectives and challenges to fill the pipeline at DSM Pharmaceutical Products'. DSM said it expects the the results of the Pharmaceutical Products business to be better towards the end of the year.

Monday, 3 August 2009

DSM Pharmaceuticals has received SafeBridge certification for the potent sterile fill-finish production area in Greenville, NC


Cherokee Pharmaceuticals will supply DuPont with a new fermentation product

Cherokee Pharma

Dishman to expand pharma SEZ

As a result in the downturn in the engineering sector, Dishman has cancelled its engineering special economic zone near Ahmedabad, India. Instead, the company will merge the land with its ongoing pharma SEZ project.
Economic Times

Hovione sees rapid sales growth

Hovione's sales for the year ended 31 March 2009 grew 21%, compared to 2008, to $125.5m. Hovione put the growth down to a significant investment in particle design technologies and in new production lines, both at Hisyn, China and at Hovione Portugal.

Meridian Life Science has completed construction and validation for its Memphis, TN, cGMP biopharmaceutical facility

Outsourcing Pharma

Aesica plans a £5m investment in its R&D centre in Cramlington, UK

NE Business

Lonza has launched a fixed-price service for manufacturing up to 1g of microbially derived biopharmaceuticals


Tuesday, 28 July 2009

PacificGMP will provide development and manufacturing services for the University of Southern California


SAFC orders boosted by H1N1

Sales at Sigma-Aldrich's fine chemicals business, SAFC, declined 14% in Q2 2009. The company said sales improved in Q2 against Q1, but were weak compared to 2008. The SAFC saw increased booked orders for future delivery, rising 19% in Q2 to an all-time high, some of which are for H1N1 related products. The company expects SAFC to make a modest overall contribution to its low single-digit organic growth expectations for 2009.
Seeking Alpha

Albemarle sees fine chemicals income decline 80%

Albemarle's Fine Chemicals business saw sales decline 32% to $104m in Q2 2009, and income decline from $24.5m to $5.2m. The company attributed the declines to reduced sales and production volumes but is encouraged by a strong new product pipeline for the second half of the year.

Thursday, 23 July 2009

Cambridge Major to open new API facility

Cambridge Major Laboratories will inaugurate its new API plant in Gemantown, WI, next week. The facility, which will become operational during August, will allow the company to provide large scale production for its customers.
Milwaukee and Southeastern Wisconsin Business News

Tuesday, 21 July 2009

Almac receives MHRA licence for GMP radiolabeling service


Fine chems first quarter positive for Johnson Matthey

Johnson Matthey says its Fine Chemicals Division was well ahead of last year in the first quarter. The company said demand has been less affected by the recession than some other business units and it has generated income from the generic version of Adderal XR, launched in April.
Easy Bourse

Lonza consolidates custom manufacturing operations

Lonza has brought its fine chemical and biopharmaceutical custom manufacturing operations together into a single business unit. The Lonza Custom Manufacturing unit is designed to help the company's sales and marketing activities.
Easy Bourse

The Informex USA show has been rebranded into two segments: Informex Pharma and Informex Specialty


SynCo Bio Partners has increased its capacity through addition to quality team

SynCo Bio Partners

Sunday, 19 July 2009

The Food and Drug Administration hopes to build closer ties with the European Medicines Agency


Lonza is being investigated by the Swiss stock exchange over possible breaches in its reporting obligations

Mondo Visione

Lonza will manufacture LFB's anti-RhD antibody


Senate committee vote on biosimilars

The US Senate Health, Education, Labor and Pensions Committee has approved an amendment that would provide innovative biologic drugs with 12 years protection from competition by biosimilar products.
Wall Street Journal

Sunday, 5 July 2009

Wednesday, 1 July 2009

Lonza in contract dispute with Altus

Altus Pharmaceuticals has terminated a supply agreement with Lonza citing an alleged breach in the manufacture and supply of key ingredients. The move follows Lonza suing Altus over accusations that the contract was terminated in violation of certain covenants.
Boston Business Journal

Hovione's API plant in Macau has passed an FDA pre-approval inspection

Pharmaceutical Technology Europe

Cobra Biomanufacturing saw revenues rise 62%, margins rise 46% and losses fall in the six months ended 31 March 2009


Tuesday, 23 June 2009

EFCG and AIME introduce manufacturing guidelines

Cefic's European Fine Chemicals Group (EFCG) and the Agrochemical & Intermediates Manufacturers in Europe (AIME) have launched a set of voluntary guidelines for manufacturers in the non-GMP, ISO-regulated fine chemicals industry. The guidelines set out minimum requirements to help promote the highest level of risk management in the manufacturing of non-GMP intermediates, active ingredients and end products.

OctoPlus has started production in its new GMP manufacturing facility in Leiden, the Netherlands


Nick Green has been appointed as president of Dishman Contract Research and Manufacturing Services

Economic Times

AMRI has completed construction of its chemistry R&D facility in Budapest, Hungary


Monday, 22 June 2009

Helsinn plans Swiss expansion; completes Irish sale

Helsinn is planning to expand its development and manufacturing facilities at its Biasca, Switzerland, site. The expansion will build on the €5m investment in recent years. In addition, Helsinn has sold its Mulhuddart, Ireland facility to Milan, Italy, based Medinco C.F.M. Group.

Sunday, 21 June 2009

Socma has joined the RX-360 drug supply chain security and quality consortium


Biologics to dominate pharma sales by 2014

Six of the 10 top selling drugs will be biologics by 2014, demonstrating the increasing dominance of biologic products, especially those for cancer treatment says EvaluatePharma. In 2000 only one of the top 10 was a biologic product.

Eden Biodesign and Selexis will jointly jointly offer their complementary biologics manufacturing services

Eden Biodesign

European Commission reverses plan to introduce GMP for excipients


Monday, 15 June 2009

Excelsyn ceo Ian Shott awarded CBE for services to chemical engineering

The Chemical Engineer

BioOutsource will provide bio-safety testing Angel Biotechnology


Boehringer and Kemwell collaborate on Indian biologics facility

Boehringer Ingelheim is working with Kemwell Pharma on a new biologics custom manufacturing facility in Bangalore, India. Boehringer will provide process technology and its BI-HEX expression system.
In-Pharma Technologist

US Senate passes Bill to give FDA control of tobacco regulation

Wall Street Journal

Thursday, 11 June 2009

Angel reduces losses, sees positive future

Angel Biotechnology reported a pre-tax loss of almost £1.1m in 2008 as revenues rose 8% to £952,926. The company sees better prospects for 2009 and 2010 as it has recently signed three major contracts, with a value of £2.2m and its prospective new business pipeline is the best it has seen to date.
RTT News

Monday, 8 June 2009

Synthetech reports boost in earnings, gloomy outlook

Synthetech saw its earnings rise from $113,000 to $657,000 in its fourth quarter. However the company said the biopharmaceuticals market is showing some weakness, the difficult financing environment could impair drug development projects and that some major pharmaceutical companies are reducing their outsourcing expenses.
Portland Business Journal

Corden PharmaChem to close Cork facility

Corden PharmaChem is to close its Little Island, Cork, Ireland, facility later this year. The company has blamed the current API market conditions, limited potential for the development and commercialisation of new products, the scale of the plant and the significant capital investment necessary for it.
Irish Examiner

Cambrex regains compliance with NYSE listing requirements


Johnson Matthey sees fine chemicals growth

In its year ended 31 March Johnson Matthey saw sales for its Fine Chemicals and Catalysts division grow 15% mostly due to favourable exchange rates. The division's Fine Chemicals businesses, Macfarlan Smith, Pharmaceutical Materials and Services and Research Chemicals which will report as a separate unit next year, contributed £220 (36%) of the division's revenue and 68% of the operating profit. Matthey reported that sales of some products were strong, but manufacturing costs, particularly the cost of energy, rose and that revenue from contract research was adversely affected by the lack of venture capital funding for a number of our smaller customers.
Manufacturing Chemist

Johnson Matthey receives grant for CHP installation at New Jersey facility

Globe St

Dishman expects is Chinese operation to start production in August

DNA India

Tuesday, 2 June 2009

Strem Chemicals has received ChemStewards certification from SOCMA


SAFC Pharma's St Louis HPAPI conjugates facility receives SafeBridge certification


SAFC in supply chain deal with Cherokee

Cherokee Pharmaceuticals will provide analytical testing, storage, packaging and distribution services for raw materials sourced by SAFC as part of a partnership agreement. The partnership will combine SAFC's global sourcing and production capabilities and with Cherokee's analytical laboratories, large-scale cGMP manufacturing, warehousing and distribution facilities.
In-Pharma Technologist

IDT Biologika has established an office in Virginia to serve US customers

Manufacturing Chemist

Lonza negotiating Genome Valley agreement

Further to previous reports Lonza said it is currently negotiating with the Andhra Pradesh Industrial Infrastructure Corporation Ltd for the acquisition or lease of 30 acres of land in Genome Valley. Lonza plans to establish an R&D and manufacturing facility on the site.

Thursday, 28 May 2009

Wacker expands cyclodextrin capacity

Wacker has expanded its cyclodextrin facility in Eddyville, IA. The $21m investment has boosted capacity for alpha and beta cyclodextrins by 50% and doubling capacity for gamma cyclodextrin, with the new facility capable of producing 7500 tonne/year of cyclodextrin.
In-Pharma Technologist

Wacker boosts biologics

Wacker is boosting biologics production capacity at its Jena site. Following the completion of a process development and quality control facility in December 2008 a further extension will double the production area and add a downstream purification site. The new facility is expected to be on-stream by 2010

Lonza will use its proprietary microreactor technology to produce both clinical trials and large-scale commercial materials for an un-named big pharma


Emerson Process Management will provide engineering and design services and digital automation systems for Lonza's biopharma plant in Singapore

Manufacturing Chemist

Lonza invests in India

Lonza will invest $150m in a two-stage project in Genome valley, Hyderabad, India. The first phase of the development, which is due to be operational in 2011-2013, is for R&D labs for 100 people, a small-scale multi-purpose manufacturing plant for biopharmaceuticals, and a small-scale bio-therapeutic media manufacturing plant. The second phase of the development, which is due to be operational in 2014-2015 includes expanded media manufacturing capacity for bio-therapeutic media, additional R&D lab capacity for biologics for 200 researchers, and expanded large-scale manufacturing plant for biopharmaceuticals.
Fierce Biotech

Sunday, 24 May 2009

Hovione invests in R&D unit

Hovione will invest €2m ($3m) in a new R&D unit in Lisbon. The facility, which will be the base for the company's drug R&D efforts, will focus on the design, development and characterisation of nano- and micro-particles for novel delivery applications.
Outsourcing Pharma

The number of peptides in clinical studies has doubled in the last decade

Tufts CSDD

Tuesday, 19 May 2009

The US Senate has confirmed Margaret Hamburg as FDA Commissioner

Wall Street Journal

Americal Pacific Fine Chemicals saw revenues decline 9% in its Q2 2009


Lonza will manufacture a subset of Morphotek's antibody pipeline including lead candidate farletuzumab

Morning Star

Avecia Biotechnology will manufacture Giuliani SpA's oligonucleotide therapeutic for Crohn's disease

MMD Newswire

Lonza expands in Singapore

Lonza is investing CHF30m ($27.03m) in a new cell therapy manufacturing facility in Singapore. Construction will commence next year and production by mid-2011.

Minakem acquires API plant

Minakem has acquired AstraZeneca's multi-purpose APIs plant in Dunkirk. In addition Minakem has a greed a long term contract to supply AstraZeneca with Budesonide, Omeprazole and Esomeprazole. The multipurpose plant is dedicated to the production of corticosteroids.
Contract Pharma

Thursday, 14 May 2009

Lonza and Teva have received EU approval for their biosimilars jv


Eden Biodesign successfully completes second MHRA audit at Liverpool facility

Eden Biodesign

Avecia Biologics Tees Valley manufacturing facility has received a Manufacturer’s Licence from the MHRA


Avecia launches antibody fragment toolkit

Avecia Biologics has launched a toolkit of technologies for producing antibody fragment therapeutics. The toolkit combines Avecia's high yield microbial expression system with downstream technologies for purification, refold and PEGylation.

Sunday, 10 May 2009

Obama wants extra $300m for FDA

US President Barack Obama has called on Congress to authorise and addtional $300m in to boost the FDA budget from $2.06bn in 2009 to $2.35bn in 2010. The President said the budget should strengthen inspections and increase the number of generic drugs on the US market.
Wall Street Journal

CombinatoRx files against Aptuit

CombinatoRx has filed a lawsuit against Aptuit. CombinatoRx alleges that "Aptuit caused harm by willfully ignoring warnings and failing to correct or disclose deficient practices that did not comply with European Union Good Manufacturing Practices as identified by UK regulatory authorities during planned inspections of Aptuit’s manufacturing facility in Kansas City, Missouri". The suit relates to the terminated agreement to manufacture Synavive (CRx-102) for a clinical trial.

Althea Technologies has opened its new state-of-the-art, commercial-scale cGMP manufacturing facility in San Diego, CA


Pharma declines for Saltigo

Lanxess' Saltigo business unit saw "robust" performance in Q1. The unit was less affected by declining demand from customer industries than in Lanxess' other business units. However Saltigo did see some decline in its pharmaceutical intermediates business due to product launch delays.

Wednesday, 6 May 2009

Dow Chemical plans to issue shares worth $1.63bn to fund Rohm & Haas acquisition

Associated Press

Jubilant Organosys in neuroscience drug discovery collaboration with AstraZeneca

Morning Star

Cambrex sales decline

Cambrex reported a sales decline of 2.8% in Q1 2009. The company said that excluding currency impacts sales increased 8.7% primarily due to long standing orders of two APIs, higher volumes of controlled substances and slightly higher custom development revenues. However, the company saw lower sales of generic APIs.

Tuesday, 28 April 2009

Senators want FDA to inspect more foreign plants

US Senators Chuck Grassley and Edward Kennedy have introduced a Bill to require the FDA to inspect more foreign drug manufacturing plants. The Senators say the FDA would get fees for conducting drug plant inspections.
Policy and Medicine

DSM pharma sales decline, profit rises

DSM's pharmaceutical facing business saw first quarter sales decline 5% to €197m, however profit for the business unit rose 3% to €11m. DSM attributed the sales decline to the disposal of a business unit at the end of 2008.

Albemarle sees sales decline

Albemarle saw sales in its fine chemicals business fall 18% to $120.8m in Q1 2009. The company attributed the decline to reduced sales in its bromine franchise.
RTT News

Sunday, 26 April 2009

SAFC sees sales decline

Sigma Aldrich saw sales for its SAFC fine chemicals business unit decline 5% against last year in Q1. The company saw a decline in orders from pharmaceutical customers during the quarter, but has a strong forward-orders book. SAFC has continued with three key expansion projects: to expand capacity for cGMP fermentation in Israel and new high-potence API capacity in Madison, WI, both of which are due onstream early in 2010, and a new viral products facility in Carlsbad, CA, which is due onstream soon.
Seeking Alpha

Thursday, 23 April 2009

Lonza on target; opens 2000L facility

Lonza has confirmed it is on track to meet its 2009 financial goals. Chief executive, Stefan Borgas, said the company saw robust underlying demand in life science markets remains and an increased outsourcing in biopharma as well as in chemical APIs, but that Lonza was feeling the effect of customer supply chain optimisation.
In addition, Lonza has started-up its high-titre 2000L microbial manufacturing train in Hopkinton, MA. The train is complemented by a highly flexible purification area. Lonza has also revamped the entire Hopkinton site infrastructure.

PharmEng to close plant

PharmEng will not be able to file its annual audited financial statements by the filing deadline of April 30, 2009. The company will also close its Sydney, Nova Scotia manufacturing facility effective May 8, 2009.
Market Wire

Wednesday, 22 April 2009

The US Senate Finance Committee has approved Kathleen Sebelius nomination as secretary of health and human services

Associated Press

Mixed reception for UK Budget

The UK Chemical Industries Association said the UK Budget "will be a major disappointment to chemical and pharmaceutical businesses across the UK". Chief Executive, Steve Elliott is "particularly angry that existing money has not been redirected to help temporary lay-offs and short time working".
Elliott also welcomed the £750m Strategic Investment Fund to support emerging technologies and high tech manufacturing. This fund was also cautiously welcomed by the BioIndustry Association, which said "it is essential that the fund is now implemented rapidly" to ensure that companies in the sector can benefit.
Chemical Industries Association
BioIndustry Association

Hovione opens Ireland plant

Hovione has opened the API manufacturing site in Cork, Ireland, which it agreed to acquire from Pfizer in December 2008. Hovione will continue to perform some manufacturing for Pfizer, which has manufactured Lipitor at the site for more than 10 years. However, the facility will mostly be used to address Hovione's own production needs.

The US Senate Finance Committee has approved Kathleen Sebelius nomination as secretary of health and human services

Wall Street Journal

Tuesday, 21 April 2009

Excelsyn wins Queen's Award

Excelsyn has won the Queen’s Award for Enterprise 2009, in the International Trade category, in recognition of a near-trebling of its export earnings, which now account for 82% of sales.
Daily Post

AMRI relocates Bothell, WA, R&D laboratory - new facility has space for expansion


CIA calls for UK Government to re-skill chemical workers during recession


Thursday, 9 April 2009

BASF has completed its acquisition of Ciba


CIA and ICC sign MoU

The Chemical Industries Association and Indian Chemical Council have signed a memorandum of understanding to encourage the development of trade between the UK and India.

DSM selected as Shire's manufacturing partner following close of Maryland plant


Monday, 6 April 2009

Shire closes plant outsources manufacturing

UK pharma company Shire is phase out manufacturing at its Owings Mills, MD, facility over the next three years. Shire plans to outsource the manufacturing to a North Carolina-based manufacturer as the company moves away from in-house manufacturing.
Baltimore Sun

BASF-Ciba acquisition approved by US and Chinese authorities


Piramal Healthcare relocates custom manufacturing

Piramal Healthcare has closed its API contract manufacturing facility in Huddersfield, UK. Piramal will move the manufacturing jobs to its Morpeth, UK, and Ennore and Ahmedabad, India sites. The move will cost &3163;10m but the company expects to see profits in its custom manufacturing business improve by 6-8% by 2010-11.
Business Standard

Thursday, 2 April 2009

Dow Chemical completes Rohm & Haas acquisition

Wall Street Journal

Lonza’s antibody drug conjugate facility in Visp, Switzerland has received a SafeBridge “Potent Compound Safety Certification"


SOCMA changes name

SOCMA has changed its name to the Society of Chemical Manufacturers and Affiliates. Previously known as the Synthetic Organic Chemical Manufacturers Association, SOCMA believes the change formally broadens the scope of its activity to reflect service to the batch, custom and specialty chemical industry. Following changes to its charter all categories of SOCMA membership are now available to companies involved in batch, custom and specialty rather than just synthetic organic chemical manufacturing.
Pharmaceutical Business Review

Shasun has closed its Annan, Scotland, manufacturing plant

In-Pharma Technologist

Johnson Matthey to close Irish plant

Johnson Matthey plans to close its fine chemical manufacturing facility in Ireland and consolidate manufacturing of prostaglandin products at its US facility. The company said that in the quarter to the end of March its Fine Chemicals & Catalysts Division's sales excluding precious metals were ahead of the same period last year helped by favourable exchange translation and that good sales of active pharmaceutical ingredients offset some weakness in catalysts and chemicals.

Tuesday, 24 March 2009

Consortium wins manufacturing technology grant

A consortium of US and UK companies has been awarded an $11m phase 2 contract by the US Defense Threat Reduction Agency (DTRA) - Joint Science and Technology Office, Transformational Medical Technologies Initiative (TMTI), to develop technology for accelerated monoclonal antibody and vaccine manufacturing. The consortium combines Xcellerex’s microbial process development and single-use manufacturing technologies with Dowpharma’s Pfenex expression technology, deltaDOT’s analytical technology and BioPharm Services' systems integration, data management/process economics, and simulated event modeling technology. The consortium won a phase 1 grant in July 2007 (FINE Newsletter, 19 July 2007).
Boston Globe

Pharma industry calls for FDA food-drug split

Associated Press

Cobra Biomanufacturing reaches agreement with customer over contract variation


Sunday, 22 March 2009

Chemtura files for bankruptcy protection


DSM to establish JVs in China

DSM has taken a 10% stake in North China Pharmaceutical Group Corporation Ltd and the two companies are establishing three joint ventures: one for vitamin C and two for anti-infective APIs and intermediates. DSM will hold a 51% share in the two anti-infectives joint ventures.

Thursday, 19 March 2009

Almac has "topped-off" it new headquaters site in Pennsylvania


Wacker expects fine chemicals growth in 2009

Wacker's fine chemicals business saw sales fall 13% in 2008, despite higher sales of its biotech products. The company put this down to consolidation and reducing the number of catalogue products it makes. The company expects overall business to fall in 2009, but believes the fine chemicals unit will see growth.
Wacker Chemie

Onyx Scientific, Cyprotex Discovery and Glytech will jointly offer drug metabolite identification and synthesis services


Tuesday, 17 March 2009

Novasep to build HPAI facility

Novasep will develop an R&D-phase pilot facility for highly potent active ingredients (HPAIs) as part of a consortium funded by the French government to develop innovative cancer therapies.
Business Wire

Obama announces FDA picks

President Obama has finally announced his picks to head the FDA. The President has nominated Margaret Hamburg as FDA Commissioner and Joshua Sharfstein as deputy commissioner. Hamburg will face a congressional approval committee.

Wednesday, 11 March 2009

Obama settles on FDA choices

Wall Street Journal

Dow and Rohm & Haas settle merger disagreement


Ampac Fine Chemicals has inaugurated its kilogram scale cGMP batch/continuous processing development facility

Contract Pharma

Lonza speeds biologics development timeline

Lonza has developed a cell line construction process that reduces the time taken from DNA sequence to cGMP material to 14 months. The customer-tailored cell line construction process uses rapid methods for generating clonal cell lines and chemically defined, non-animal origin components.
Bio Valley

Monday, 9 March 2009

Dow back in talks with Rohm & Haas


UKTI seeks companies for ChemSpec Europe

UK Trade and Investment is seeking up to 14 companies for a stand share at ChemSpec Europe in Barcelona. The companies must be of UK origin and offer UK origin products and services within the fine and speciality chemical industry.
For more information contact UKTI

Merck to acquire Schering Plough for $41.1bn

New York Times

DSM and Roquette are to commercialise a bio-based succinic acid production process


Penn Pharmaceuticals has launched a £12m, 5-year expansion programme at its Tredegar, Wales, site

Outsourcing Pharma

US Senators propose clamp down on unsafe drug imports

A bi-partisan group of US Senators has introduced a Bill that will limit imports of drugs into the US. The Bill - The Pharmaceutical Market Access and Drug Safety Act - will only allow drugs - and drug ingredients - to be imported from FDA-inspected plants.
Domain B

Thursday, 5 March 2009

Lonza to manufacture TcL Pharma antibody

TcL Pharma has chosen Lonza to manufacture its lead monoclonal antibody. Lonza will provide strain development using its XS Microbial Expression Technologies through to cGMP manufacture of Phase I clinical material.
Manufacturing Chemist

RFCL-Mallinkrodt Baker deal off

RFCL has called off plans to acquire Mallinckrodt Baker. The two companies failed to agree a common valuatio, analysts expected the deal to be worth $325-350m.
Economic Times

Dow considers selling assets to fund Rohm & Haas deal


Tuesday, 3 March 2009

Novacta and CML partner for chiral processes

Novacta Biosystems and Cambridge Major Laboratories will collaborate to develop new manufacturing routes to chiral pharmaceutical intermediates. Novacta will develop biocatalytic approaches to target chiral intermediates which Cambridge Major will scale-up at its facility in the Netherlands.
In-Pharma Technologist

India to be top five pharma hub

The Indian Government is planning to make the country one of the top five global pharmaceutical innovation hubs within four years. It aims to invest $1bn as part of its Vision 2020 - half of which will be public funds half from industry.
Pharma Times

Sunday, 1 March 2009

Lonza leases 2200m2 space in Hopkinton, MA

Metro West Daily News

Ranbaxy lab falsifies data

US News

Fine Organics plans 5% sales growth

Financial Times

Lonza to manufacture Opsona antibody

Lonza will provide process development and cGMP manufacturing services for preclinical and Phase 1 studies of Opsona Therapeutics monoclonal antibody OPN- 305, using its GS Gene Expression System.
Morning Star

Thursday, 26 February 2009

US budget to strengthen FDA

The first budget from US President Obama's Administration will support the FDA's efforts to ensure imported drugs are safe and effective and to establish a new regulatory pathway to approve generic biologics. In addition the FDA will receive a substantial funding increase to strengthen its food and drug safety efforts.
Wall Street Journal

Sanofi-Aventis is believed to be leading the race to acquire Piramal Healthcare

Economic Times

BASF expects further earnings drop in 2009


Tuesday, 24 February 2009

UKTI seeks companies for CPhI stand

UK Trade and Investment is seeking 11 companies for a stand share at CPhI Worlwide in Madrid. The companies must be of UK origin and offer UK origin (or UK high value added) products and services to the pharmaceutical manufacturing industry.
For more information contact UKTI

Wednesday, 18 February 2009

DSM sees stable year for pharma

DSM saw stable full year organic sales in its Pharma cluster in 2008. Sales and profitability in its Pharmaceutical Products business unit were negatively impacted by the phasing-out of contracts related to the Roche Vitamins acquisition, insourcing by large pharma houses and delays in the commercial development of new products.

Arques Industries has sold Rohner to BluO


International Chemical Investors Group has acquired Miteni from Mitsubishi


Monday, 16 February 2009

CMO sector to show 10% growth in 2008

The pharmaceutical contract manufacturing sector is predicted to exceed $30bn in 2008 - a growth of 10%, according to market research publishers, Kalorama. Biomanufacturing and secondary manufacturing are the two fastest growing sectors as they are often not core competencies of pharmaceutical and biotech drug developers.
In-pharma Technologist

Thursday, 12 February 2009

Wednesday, 11 February 2009

SAFC sees flat year in 2008

Sigma-Aldrich saw sales of its SAFC fine chemicals business grow 5.25% to $623.5m in 2008. The company said that 2% of the growth was due to currency effects, 0.7% to acquisitions and 2.5% due to organic growth. The company saw a decline in 2008 in services for small molecule projects with large pharma companies, however SAFC believes it is well positioned to take advantage of the move from small molecule to large molecule drugs.

Tuesday, 3 February 2009

Obama promises 'complete review' of FDA

USA Today

Pharma changes to continue

Further to Pfizer's proposed acquisition of Wyeth announced last week, several other major pharma companies are expected to see significant changes. GlaxoSmithKline is expected to cut at least 6000 jobs worldwide. Sanofi-Aventis is believed to have approximately $26bn for acquisitions. Roche has lowered its offer for Genentech, appealing directly to the company's shareholders.
The Times
Financial Times
Financial Times

Eden Biodesign and Oxford Expression Technologies will co-market each others capabilities for manufacturing biopharmaceuticals

Eden Biodesign

Sunday, 1 February 2009

Zach System plans job cuts and restructuring at former PPG site

Usine Nouvelle

Neuland moves into peptides

Neuland Laboratories is making a two-step move into peptide contract manufacturing. Firstly it will establish a non-GMP facility for synthesis of peptides both for generic API and contract research opportunities. The second phase will add commercial scale GMP contract manufacturing for both generic and innovator companies.
Outsourcing Pharma

APC adds capacity

American Peptide is expanding its GMP peptide manufacturing facility in Vista, California. The first phase of the expansion will add four purification suites, including HPLC columns and tray lyophilisers, and will commence operation in April 2009. The second phase will include two large-scale synthesis suites, with 1000L and 2000L solution phase reactors and 26L and 500L SPPS for solid phase synthesis, with completion expected in Q2.
Outsourcing Pharma

Thursday, 29 January 2009

SAFC Pharma has commenced operations at its 700m2 biologics laboratory in Carlsbad, CA


Excelsyn reports strong sales; strengthens capabilities

Excelsyn's sales in its H1 2008/2009 were $10.98m. President and CEO Ian Shott said that progress has continued in the third quarted and it is "on track to more than double our EBITDA for FY 2008-09 – moving up to 16% from the 7% delivered in FY 2007/08".
Excelsyn has recently strengthened its capabilities at the Holywell, North Wales facility with the addition calorimetry equipment and a laboratory hydrogenation capability. The company has also completed the initial phase of its three-year expansion and upgrade programme at Holywell.

Socma sees weaker outlook for 2009

Socma President, Joe Acker, persented the results of Socma's fifth busienss outlook survey at Informex 2009. The survey showed that overall outlook for the chemical industry has weakened in the 2008 reporting cycle with fewer companies reporting an increase in sales and more of them report actual declining sales. This trend is expected to continue in 2009.
Despite the less positive outlook, companies reported planned investments in R&D remain comparable to the last two years.

Tuesday, 27 January 2009

Albemarle sees record fine chemicals income

The Fine Chemicals business of Albemarle saw a 23% increase in sales in Q4 2008 to $161.3m. The company said the rise was due to "increased volume and pricing from fine chemistry services and improved pricing from our bromine portfolio". The company's Fine Chemicals segment reported a record income for the year.

Pfizer to close five manufacturing plants

Pfizer is to reduce its number of manufacturing facilities from 46 to 41. The company will assess where its capabilities overlap with those of Wyeth, which the company is in the process of acquiring, before deciding which plants will close.
In-Pharma Technologist

Lonza reports strong year

Lonza reported a net income rise of 39% to CHF419m in 2008. Stafan Borgas, Lonza CEO, said the company saw solid demand overall and an increased trend towards outsourcing. The company's Exclusive Synthesis saw strong sales growth especially in samll molecules. The Biopharmaceuticals business was stable despite some project postponements. Borgas said the company was looking for some small to mid-sized acquisitions for its bioscience business in 2009 and that it was in advanced negotiations for a number of new custom manufacturing deals.
Easy Bourse

Rohm and Haas sues Dow to force takeover


Monday, 26 January 2009

Cytovance Biologics will develop a process for and manufacture Selexys Pharmaceutical's Chron's disease candidate

Business Wire

Pfizer confirms Wyeth bid

The worst kept secret in pharma has been confirmed. Pfizer is to pay $68bn to acquire Wyeth. The deal will be financed through $22.5bn in bank loans combined with stock and cash, of which Pfizer has roughly $26bn.
New York Times

Saltigo expands US site

Saltigo has doubled the capacity of its cGMP pilot plant and added a second kilolab at its Redmond, WA, site. Site Manager Timothy Fitzpatrick said the company has also installed a low temperature unit in the pilot plant.

Wyeth has withdrawn from its negotiations to acquire Crucell


Sunday, 25 January 2009

Dow wins FTC approval for Rohm and Haas takeover

Financial Times

Pfizer to buy Wyeth

Further consolidation may be coming to the pharma sector as rumours spread that Pfizer is looking to acquire Wyeth for $60bn. The news comes shortly after Pfizer announced another swathe of redundancies.
New York Times

Lonza starts-up Nansha API plant

Production has started at Lonza's new large-scale facility in Nansha, China. Lonza CEO Stefan Borgas said "this $200m investment enables Lonza to continue addressing the needs of our expanding worldwide customer base by adding manufacturing capacity, expanding our R&D services, and increasing flexibility.” The fully cGMP-compliant large-scale production facility is a six–train, multipurpose API manufacturing complex and complements the small-scale plant which started operations in September 2007.
Manufacturing Chemist

Thursday, 22 January 2009

Tuesday, 20 January 2009

Lonza in biosimilars deal with Teva

Lonza will commence its partnership with Teva to develop, manufacture and market biosimilar medicines in the first quarter of 2009. Stefan Borgas, Lonza’s Chief Executive Officer said Lonza's capabilities in the area of biologics manufacturing will add value to this joint venture to produce the copycat products

Angel Biotechnology saw its share price rise as ReNeuron announced stem cell clinical trials

The Times

Ranbaxy considers purchase of US manufacturing facilities

Financial Times

Prosonix will use its ultrasonic particle engineering technology to produce generic inhaled medicines for Aeropharm


Cel-Sci to support drug development programme through contract manufacturing

Outsourcing Pharma

Thursday, 15 January 2009

BayBio calls for California’s leaders to promote biomanufacturing in the state

In-Pharma Technologist

Lonza invests $26m in 4100m2 Walkersville expansion

Frederick News Post

FDA launches safety pilot programme

The FDA is seeking 100 companies to participate in its Secure Supply Chain pilot programme, which aims to improve the safety of drugs and active drug ingredients produced outside the US. Applicants must show they maintain control over the drug products from the time of manufacture through entry into the country.
Fierce Biotech

Wednesday, 14 January 2009

Agencies launch inspection sharing programme

The European, American and Australian regulatory agencies are looking at sharing inspection duties to best use resources. The European Medicines Agency (EMEA), FDA, and the Therapeutic Goods Association (TGA) have commenced an 18-month pilot programme.
In-pharma Technologist

Jubilant Organosys and BioLeap have started a drug discovery partnership

Economic Times

Sunday, 11 January 2009

SOCMA reveals "First 100 days" priorities

SOCMA has made its legislative priorities known for the first 100 days of the new Congress. The three key areas the trade association seeks action on are: the FDA’s inspection process of foreign drug-manufacturing facilities, security at chemical facilities, and chemical testing and risk management.
Pharmaceutical Technology

Sanofi-Aventis refuses to confirm links to Crucell


FDA opens Costa Rica office

Outsourcing Pharma

Sunday, 4 January 2009

FDA approvals in 2008 highest for three years

The FDA approved 24 new, or first-of-a-kind, drugs in 2008. The agency approved 18 drugs in 2007, 22 in 2006 and 20 in 2005. However, the agency has missed its targets for a number of other products.

Rhodia closes last paracetamol plant in Europe