Tuesday, 30 December 2008
FDA approvals up in 2008
The FDA will approve 21 drugs in 2008, up from 18 last year. However, the agency has missed its targets for 15 other products.
Washington Post
Dow-Rohm & Haas merger under threat
The $15.4bn merger between Dow Chemical and Rohm & Haas is under threat following the collapse of Dow's deal with Kuwait. Shares in both companies dropped.
Bloomberg
Dishman breaks ground for SEZ, plans JVs
Dishman has broken ground for its Pharma, Fine Chemicals and Engineering Special Economic Zone (SEZ) on a 300 acre site near Bavla-Bagodara. The $205m investment is due to be operational in 2010 and is expected to provide employment to 50,000 people. Dishman plans to use 40% of the site in joint manufacturing ventures with global pharma companies.
Desh Gujarat
Economic Times
CMC Biologics delays expansion
CMC Biologics has postponed its previously announced plans to expand its Bothwell manufacturing facility.
In-Pharma Technologist
Albemarle aims for $40m savings
In response to falling demand, Albemarle is planning a series of measures to achieve $40m in annualised cost savings in 2009. The company plans to achieve the savings by accelerating its cost reduction programs and resizing its business footprint.
Forbes
Dishman changes financing plans
Dishman Pharmaceuticals has failed to raise $30m from the World Bank’s International Finance Corporation. The company will now use non-convertible bonds to fund its aggressive expansion plans.
Economic Times
Thursday, 18 December 2008
Good year for Ampac, sees future growth
American Pacific's Ampac Fine Chemicals business saw revenues increase 19% to $124.2m in the year ended 30 September 2008 primarily driven by increased volume for anti-viral products. The company sees a decline in demand in 2009 but believes the pharmaceutical fine chemicals market will continue to present growth opportunities in the longer term as the pharmaceutical industry continues to outsource. Ampac expects to meet its growth in the segment through strategic acquisitions and to a lesser extent investment in our facilities.
American Pacific
Cefic groups welcome API inspection programme
Cefic's European Fine Chemicals Group and Active Pharmaceutical Ingredients Committee have welcomes the establishment of an International Cooperative API Inspection Programme. The programme is designed to coordinate inspection resources from Europe, USA, and Australia in higher risk countries - especially in Asia - and aims to prevent counterfeit APIs reaching patients.
EFCG
Thursday, 11 December 2008
Hovione buys Pfizer plant
Hovione has acquired Pfizer's Loughbeg, Ireland, API manufacturing facility. Following the deal is due to be completed by April 2009, Hovione will provide manufacturing for Pfizer. The facility will employ 70-80 staff - a reduction of about 150 on current levels. Over the next two years Hovione will transfer products from its Loures, Portugal site and validating processes for new compounds in expectation of drug approval.
RTE
Actavis' Bulgarian MBO
Actavis will sell its Razgrad, Bulgaria, production company to the management. The facility will then be used for contract manufacturing generic APIs.
In-pharma Technologist
Dow cuts back
Mirroring the recent actions by BASF and DuPont, Dow Chemical is to close 20 plants and idle 180 more. In addition the company will make 5000 redundancies, some of which will come through sell-offs.
Bloomberg
Thursday, 4 December 2008
DSM wins NicOx deal, Archimica loses out
NicOx has selected DSM to manufacture the API for its potential blockbuster, Naproxcinod, which has completed its phase III trials. The API will be produced in DSM's Linz, Austria, facility. As a result of the agreement with DSM, NicOx has ended its API supply agreement with Archimica.
Reuters
Monday, 1 December 2008
Management buy-out for Seal Sands site
The Evonik fine chemicals custom manufacturing site at Seal Sands, UK, has been acquired by the site’s management. In future the site will operate as an independent limited company - Fine Organics - and will continue to manufacture products for Evonik.
The Chemical Engineer
Thursday, 27 November 2008
Calls for FDA overhaul
In the run up to the change of President in the US, former FDA officials, members of Congress, watchdog groups and various government reports are suggesting the Agency requires an infusion of strong leadership, money, technology and personnel, and perhaps a major restructuring.
Washington Post
Profit rise at Matthey
Johnson Matthey's Fine Chemicals & Catalysts Division’s saw its operating profit rise 5% to £32.4m. The Macfarlan Smith API and intermediate business achieved good sales growth in specialist opiates, despite a rise in manufacturing costs. The Pharmaceutical Materials and Services API manufacturing business had reduced income from amphetamine salts.
Johnson Matthey
Three contracts for Eden
Eden Biodesign has signed three contracts worth a total of £2.97m for development and cGMP manufacturing services. Two of the contracts are with new clients, one in Asia and one in Europe, the other is for a new therapeutic with an existing UK client.
Eden Biodesign
Wednesday, 19 November 2008
FDA opens China office
The FDA has opened its first overseas office - in Beijing, China - as part of its strategy to ensure the safety of drugs and food products imported into the US. The FDA will also open offices in Shanghai and Guangzhou in China as well as in India, Latin America and Europe. The FDA will have eight staff in its China offices. These will include inspectors and senior technical experts on regulation, policy, food, medicines and medical devices who will work with their Chinese counterparts to build capacity and offer their experiences and expertise.
Associated Press
Deretil in management buy-out
The management of DSM Deretil has reached an agreement with DSM for a management buy-out of the business. Deretil will continue to focus on its core business of producing side-chains for API manufacturing. FInancial details of the buy-out have not been revealed.
DSM
Tuesday, 18 November 2008
Codexis licenses in enzyme technology
Codexis has licensed Dyadic International's C1 expression system for large-scale production of enzymes in fields including pharmaceutical intermediate production. Codexis will make a $10m upfront payment provided that certain performance criteria are satisfied.
Codexis
Recipharm moves into biologics manufacturing
Recipharm's biotech subsidiary, Recipharm Biotech, has acquired AstraZeneca's biotech manufacturing facility in Södertälje, Sweden. AstraZeneca has entered a supply arrangement with Recipharm for Phase I and Phase II material for one of its development projects and will hold a significant minority stake in the new company.
Recipharm
Thursday, 13 November 2008
Delays for Dishman
Dishman has slowed its plans to develop two special economic zones in Bavla. The company said the development could be delayed by six months. In addition the completion of construction of Dishman's manufacturing unit in China has been delayed has delayed until early next year. Dishman's oncology bulk drugs unit in Gujarat is expected to come on stream in the first quarter 2009.
Reuters
Tuesday, 11 November 2008
Thursday, 6 November 2008
Cambrex expects market softening
Cambrex saw a small increase in sales in the third quarter. Steven Klosk, Cambrex President and ceo, said "the market for early stage clinical development projects is softening. This is especially true of emerging biotech companies and our large pharma customers in Europe." Klosk attributed this to cost containment programs and a continuous review of R&D pipeline by big pharma and smaller companies focusing on fewer projects.
Cambrex is nearing completion of its new mid-scale API manufacturing facility at its Swedish operation, which is expected to be on line in early 2009. The company has started production in a portion of its state of the art API finishing facility in Milan, Italy, with the remainder in the later stages of validation. The new high potency development center in Charles City, Iowa, is also now fully operational. Klosk said these facilities position the company well for future growth.
Seeking Alpha
Lonza completes expansion
Lonza has completed the biologics manufacturing capacity expansion at its Portsmouth, NH, site. The $300m, 33,000m2 expansion brings reactor capacity at the site to 93,000L. Lonza wil also increase its workforce by more than 300 employees.
New Hampshire Union Leader
Tuesday, 4 November 2008
Thursday, 30 October 2008
Shasun to close Scottish plant
Shasun Chemicals & Drugs Ltd will close its Annan, Scotland, facility by March 2009. The facility, run by UK subsidiary Shasun Pharma Solutions Ltd, was acquired from Rhodia in 2006.
Financial Express
Wednesday, 29 October 2008
AMRI expands in India
Albany Molecular Research has expanded its Aurangabad, India, manufacturing facility with the addition of a 1000L non-GMP multipurpose pilot plant. The company said the plant will be used to produce starting materials and intermediates for its manufacturing facilities in the US and reduce the company’s reliance on third-party resource providers.
Albany Business Review
Biotech woes hit Lonza
The financing difficulties currently facing small and start-up biotech companies are hitting Lonza. The company warned it may miss its mid-term earnings target in 2008 and may not be able to offset weaker economic growth in the second half. The company expects the macroeconomic challenges to continue in 2009.
Reuters
Dishman takes loan
Dishman Pharmaceuticals and Chemicals Ltd is funding expansion projects through a loan from the International Finance Corp. Dishman will use the loan to build new facilities at its Bavla manufacturing site, invest around $10m to establish a manufacturing facility in Shanghai, China, and invest in overseas subsidiaries and joint ventures.
Sindh Today
Piramal sees Indian growth
Nicholas Piramal's custom manufacturing business has seen strong growth, 11%, in the first half of its 2009 year. Revenues from its Indian facilities grew 55% to Rs1.5bn.
Nicholas Piramal
SAFC sees decline
SAFC Pharma, the fine chemicals business of Sigma-Aldrich saw a decline during Q3 as a result of spending cutbacks in the pharmaceutical sector. Kirk Richter, Sigma-Aldrich's Treasurer and Investor Relations executive, said that "customers have either deferred committed orders or not repeated the business we've enjoyed in the past". He did remain optimistic going forward.
Seeking Alpha
Borgas: Consolidation and closures required
Stefan Borgas, ceo of Lonza, believes that there is 60% overcapacity in pharmaceutical manufacturing for chemical ingredients with a highly fragmented industry. Borgas believes that some niche capabilities may offer protection, but ultimately there needs to be consolidation in the sector along with plant closures and modern, more efficient plants being built. He also warned that the biologics manufacturing sector could follow the same "sinful path" towards fragmentation and overcapacity.
In-Pharma Technologist
Thursday, 23 October 2008
FDA inspection rate is slow
The US Congress has revealed that FDA oversight of foreign plants producing pharmaceutical products for the US market leaves a lot to be desired. The investigation revealed that at current rates it will take 13 years to inspect the 3,249 plants currently providing products. The FDA takes about 2 years to inspect the 3,000 plants in the US.
Associated Press
Tuesday, 21 October 2008
FDA outlines overseas plans
FDA Commissioner Andrew von Eschenbach has laid out further details of the Agency's plans to establish more overseas offices during the next year. The first of these will open in China before the end of 2008. The FDA plans to have 60 regulators world-wide over the next year, with a particular focus on India, Latin America and the Middle East in addition to China.
Wall Street Journal
Thursday, 16 October 2008
Tuesday, 14 October 2008
Country of origin labeling proposed
The US Senate is considering a bill that will require the country-of-origin of APIs and excipients to be labeled on finished prescription and OTC products. The bill is different from the proposal in the draft of the US FDA Globalization Act as it includes excipients.
In-Pharma Technologist
New funds for Reaxa
Reaxa has completed a rights issue underwritten by its institutional investors, EV and YFM Private Equity. Reaxa will use the funds for sales and marketing expansion and for commercial scale production of its scavenger and EnCat catalyst ranges.
Reaxa
Friday, 10 October 2008
EFIG launches excipients project
The European Fine Chemicals Group (EFCG) and IPEC Europe have formed a European Pharmaceutical Excipients Certification Project to develop advocacy and stakeholder management in Europe for manufacturers and distributors of pharmaceutical excipients. EFCG also welcomed recent announcements and actions taken by the regulatory authorities on both sides of the Atlantic and in Japan to stem the flow of sub-standard and counterfeit APIs and medicines in the wake of the heparin disaster earlier this year. Finally, EFCG set out its implementation plan for a worldwide "Voluntary Guidelines for ISO-regulated Fine Chemical Manufacturers", which is a proposed set of minimum requirements for global manufacturers of non-pharma fine chemical intermediates and active ingredients.
EFCG
EFCG
EFCG
Almac offers solid state services
Almac has added a Solid State Chemistry business to its pharmaceutical operations. Based in Craigavon, Northern Ireland, the team specialises in solid form characterisation, screening and selection, in addition to crystallization process development.
Almac
CPhI Innovation award winners
Novozymes Biopolymer won the Gold award at the 2008 CPhI Innovation Awards for its HyaCare hyaluronic acid process. Pierre Fabre Medicament won the silver award for its Formulplex "green" formulation process and Dr Reddy's precatalyst fabrication technology the bronze.
CPhI
Thursday, 9 October 2008
Ferro sells fine chems unit
Ferro Corporation has sold its fine chemicals business to Arsenal Capital Partners for $66m. Following the deal, which is expected to close by the end of the year, the business will be renames Novolyte Technologies.
RTT News
Friday, 3 October 2008
Wednesday, 1 October 2008
SAFC commissions HPAPI facility
SAFC Pharma has commissioned a high-potency API conjugates suite at its St Louis site to support oncology drug development. The suite will accommodate early-stage clinical supplies with the capability to expand production up to commercial-scale.
Pharmaceutical Online
Aptuit streamlines early stage drug development
Aptuit has launched a new programme to speed the early stages of drug discovery. Indigo aims to support development from discovery through to proof-of-concept and includes API manufacturing, toxicology, metabolism/pharmacokinetics, clinical supplies and regulatory application.
Aptuit
SAFC increases API capacity by 15%
SAFC Pharma has begun operation of a new reactor at its Arklow, Ireland, site. The 6000L reactor, which is part of a $4m project, increases SAFC's API production capacity by 15%. SAFC is also carrying out two further enhavcements in Arklow: a $2.25m pilot-scale filter dryer due for commission in Q32009; and a $1.8m expansion of warehouse capacity due for completion in 2009.
Sigma_Aldrich
Monday, 29 September 2008
CMC Biologics to expand capacity
CMC Biologics will expand capacity at its Bothell, WA, contract manufacturing facility five-fold as part of a $35m expansion plan. CMC expects the project to be completed by mid-2010.
Seattle Times
Piramal launches clinical trial supplies and acquires CRO
Piramal Healthcare has launched a clinical trials supply service from its Morpeth, UK, facility. The company has also acquired a Romanian clinical trials management company, Tangent Data s.r.l., which will be integrated into its contract manufacturing business.
Piramal Healthcare
Excelsyn upgrades Holywell
Excelsyn has added Fauske adiabatic and TSU calorimetry equipment at its Holywell, Wales, site and is now able to conduct stability testing in-house. Excelsyn has also added laboratory-scale hydrogenation capability. These additions are part of the recently completed initial phase of its three-year expansion and upgrade programme at Holywell.
Excelsyn
Thursday, 25 September 2008
Wednesday, 24 September 2008
Pfizer to use sonocrystallisation
Pfizer will use Prosonix's Prosonitron reactor and sonocrystallisation technology in its API production at its manufacturing facilities in Ireland. Prosonix claims the technology allows the control of many aspects of complex pharmaceutical crystallisation processes, including control of crystal size, shape, and purity, the selective production of polymorphs, enhancing both manufacturing productivity and ultimate formulation performance of drug product.
In-Pharma Technologist
Monday, 22 September 2008
RohnerChem to scale up EnCat
RohnerChem is to scale up Reaxa's EnCat technology. The companies have previously worked on initial screening and process development for the encapsulated catalysts.
In-Pharma Technologist
Thursday, 18 September 2008
Wednesday, 17 September 2008
Pharmatek opens high potency facility
Pharmatek has opened its 1800m2 highly-potent and cytotoxic facility in San Diego. The new development includes analytical and formulation development laboratories and cGMP manufacturing suites.
Pharmatek
Tuesday, 16 September 2008
DSM-LibraGen amine technology deal
DSM and LibraGen will co-develop new omega-transaminases for production of chiral amines. LibraGen will use its enzyme discovery and development to identify enzymes to convert ketones to optically pure amines. DSM will produce the enzyme using its fermentation capabilities and PluGbug expression platform.
LibraGen
Significant growth in Excelsyn sales
Excelsyn saw like-for-like sales increase 43.5% to $28m for its year ended 31 May. The company attributed the growth to an acceleration in volume demand and customer numbers for its pharma synthesis business and continuing growth in outsourcing of development and manufacturing services. Excelsyn ceo Ian Shott said the company's strategy, introduced in January, was delivering a significant upturn in business.
Excelsyn
Thursday, 11 September 2008
Lonza expects more outsourcing, plans acquisitions
Lonza CFO Toralf Haag has said the company expects to benefit from the pharma industry's continuing trend towards more outsourcing. He also said the company has CHF1.5bn-2bn ($1.3bn-$1.8bn) available for acquisitions in the next year.
The Guardian
Tuesday, 9 September 2008
FDA revises cGMP guidelines
The FDA has amended its cGMP requirements for finished pharmaceuticals. This amendments concern aseptic processing, verification of performance of
operations by a second individual, and the use of asbestos filters. The FDA said it changes were to "modernise or clarify some of the requirements as well as to harmonize them with other FDA regulations and international cGMP standards". The amendments which are the first phase of an incremental approach to modifying the cGMP regulations will be effective from 8 December 2008.
FDA
Sunday, 7 September 2008
SOCMA plans for "Last 100 days"
SOCMA intends to ensure that legislation key for the success for its members does not fall by the wayside during the last 100 days of the Bush Administration. SOCMA will be meeting regulatory agencies overseeing unfinished business to urge completion of its priority issues as well as ensuring that the McCain and Obama campaigns are aware of these issues.
SOCMA
SAFC confirms HP-API expansion plans
Sigma-Aldrich has confirmed plans for a $30m expansion of its SAFC high potency API facility in Madison, Wisconsin. SAFC has purchased 15 acres of land in Verona, Wisconsin, for the 4500m2 facility, which will include development laboratories, a 150L mini-processing plant and two large-scale cGMP manufacturing suites with reactors up to 4000L. Construction is expected to be completed by end-2009.
In-Pharma Technologist
Dishman plans Carbogen Amcis IPO
both acquired by Solutia in 2000. Solutia rebranded the businesses as Solutia Pharmaceutical Services before formally merging them into a single legal entity: Carbogen Amcis in 2006. Dishman acquired Carbogen Amcis from Solutia in May 2006 and has made a number of investments in the business over the past two years.
Sify Business
Tuesday, 2 September 2008
Sunday, 31 August 2008
Dishman builds Carbogen Amcis facility
Dishman is building the biggest oncology and high potency drugs facility in Asia at its Bavla plant. The Rs500m ($11m) facility is being commissioned by Dishman's Carbogen Amcis subsidiary, which will also operate the facility. In addition, Dishman Pharmaceuticals is investing Rs5bn ($115m) in two special economic zones near Bavla. The chemicals and pharmaceutical zone is expected to house 50 facilities and the engineering zone 100 facilities. Work on the zones will start before the end of the year.
Business Standard
Financial Express
Wednesday, 27 August 2008
CNOOC to establish fine chemicals park
CNOOC, the China National Offshore Oil Corp, as part of its current strategy to expand beyond its traditional upstream businesses will construct a fine chemical industrial park in the Shenzen special economic zone bordering Hong Kong. CNOOC has signed a memorandum of understanding with the government of Shenzhen city to jointly develop the park.
Trading Markets
Tuesday, 26 August 2008
Codexis expands Arch deal
Codexis has expanded its three-yeas strategic collaboration with Arch Pharmalabs. Codexis' Indian subsidiary will offer multiple pharmaceutical intermediates and APIs made with its biocatalytic processes, including intermediates used to manufacture generic atorvastatin (Lipitor), as well as the API itself.
Codexis
Dishman looks to $200m manufacturing contracts and acquisition
Dishman Pharma is currently in talks for $100-200m for its contract research and manufacturing business. Managing director, JR Vyas, puts this down to pharma companies exiting API manufacturing. Dishman is seeking an Asian acquisition to establish Carbogen Amcis as a full-service oncology package provider.
Money Control
Thursday, 21 August 2008
Jubilant invests in North America
Jubilant Organosys is integrating its North American operations. Jubilant will align Canadian Draxis Health with US subsidiary Hollister-Stier. Jubilant has also initiated a $20m capacity expansion programme.
Business Standard
Tuesday, 19 August 2008
Thursday, 14 August 2008
Tuesday, 12 August 2008
Sunday, 10 August 2008
SAFC to expand HP-API capabilities
SAFC Global is to expand its high potency API manufacturing capabilities with a new 4500m2 plant in the Verona Technology Park in Wisconsin. SAFC expects to close the deal for its $30m facility on 15 Aug. The company plans to break ground in October, complete construction in 2009 with a production starting in early 2010.
Verona Press
Thursday, 7 August 2008
API challenge for Cambrex
Despite Q2 sales rising 5% to $66.2m, Cambrex said its marginon sales decreased to 29.9% from 37.9% of sales. Cambrex said its lower sales of generic APIs were partially offset by higher custom manufacturing revenues. The company put the decrease in margins down to an unfavorable product mix, lower pricing on its largest API, and higher costs associated with the validation of the new API finishing facility in Milan, Italy.
Cambrex
Wednesday, 6 August 2008
New Institute aims to improve fine chemical processes
University of Leeds, UK, will link its research capacity with commercial needs for the fine chemical sector through its new Institute of Process Research and Development. The iPRD includes teams from the University’s School of Chemistry and School of Process, Environmental and Materials Engineering. The new institute, which is funded by industry as well as public funds, aims to develop production processes with greater efficiency and lower impact.
iPRD
NME approvals down in H1 2008
The FDA has approved only six NMEs in the first half of the year. In H1 2007 the agency approved seven. The approval level is usually similar in the second half of the year, which could mean this year is one of the wort for approvals.
In Vivo
Thursday, 31 July 2008
Wednesday, 30 July 2008
Call for FDA overhaul
A leading member of the US House of Representatives and a leading Congressman have called for a major overhaul of the nation's drug regulator. Representative John Dingell and Senator Chuck Grassley say there should be a taller wall between the agency and the industry it regulates. In addition they have called for the FDA to be given the authority to recall drugs, to impose significant fines on drug companies for safety violations and to inspect generic-drug makers before approving a new product. In addition, they want the next president to appoint a tough FDA commissioner completely independent from the industry. It is unlikely that any changes will happen before the elections in November, but next year may see significant changes to the FDA.
Wall Street Journal
Sunday, 27 July 2008
Lonza predicts weaker H2, expands Hopkinton site
Lonza reported a 83% rise in first-half net profit boosted by the sale of its stake in Polynt SpA. However the company said underlying performance was "on track despite currency and raw material challenges". Lonza ceo Stefan Borgas said the company will have a "weaker" second half than the first as a number of biopharmaceuticals customers have postponed projects until next year. Lonza is adding a state-of-the-art, high-titer 2000L microbial fermentation manufacturing train in Hopkinton, MA. The plant, which is due onstream in March 2009, will meet customer demand for mid-scale microbial manufacturing.
Reuters
Bloomberg
Lonza
SAFC record sales, expects slower growth
Sigma-Aldrich's SAFC fine chemicals division reported 11% growth in Q2 and sales of $170.4m - a third successive quarter with a sales record for the company. However, the company has reduced its growth expectations from 8-9% to 5-6% as a result of "recent economic and industry conditions and discussions with customers". The company is still looking at acquisitions that may further enhance growth.
Sigma-Aldrich
Tuesday, 22 July 2008
FDA to send workers overseas by end 2009
The US FDA expects to station employees in in China, India, Europe and Latin America to improve the safety of exports of food and drugs by the end of 2009. Workers will be stationed in the Middle East at a later date.
Bloomberg
Q2 sales rise for Albemarle's fine chemicals
Albemarle saw a 15% increase, to $151.9m, in net sales for its fine chemicals business in Q2. The company attributed the rise to higher volumes and improved pricing. However income for the sector declined $1.8m to $24.5m.
Albemarle
Sunday, 20 July 2008
Thursday, 17 July 2008
Tuesday, 15 July 2008
Ranbaxy faces US probe over quality
Federal prosecutors in the US claim Ranbaxy has misled the US government about the quality of its generic medicines and are seeking access to documents from the Indian company. Ranbaxy says the allegations are baseless.
Business Week
Economic Times
Sunday, 13 July 2008
Lonza in development deal with Novartis
Lonza has entered a strategic partnership with Novartis for the scale up development and production of its pipeline of biotechnology drugs. Under the long-term partnership each product will have a specific development agreement. Lonza will provide process development and manufacturing capabilities from its R&D centre in Slough, UK, and manufacturing capacity in the US, Spain and Singapore.
Smart Money
Ranbaxy Fine Chemicals eyes US acquisition
ICICI Ventures is planning to support its Ranbaxy Fine Chemicals Ltd company in the acquisition of the fine chemicals division of Mallinckrodt Baker. The $400m deal will treble the size of RFCL.
NDTV
Thursday, 10 July 2008
Inspectors collaborate
The US, Europe and Australia will share data from manufacturing facility inspections to cover a wider territory and more facilities than they could alone. The pilot programme will concentrate on inspecting facilities in countries such as China and India.
Associated Press
Penn acquired by Minakem
The assets of Penn Specialty Chemicals have been acquired by PennAkem, a wholly-owned subsidiary of the French Minakem Group. The acquisition makes PennAkem the preeminent supplier of furfural and furan derivatives.
Minakem
Rentschler to expand biomanufacturing and exit pharma
Rentschler will invest €14m to expant the biomanufacturing capbilities at its Laupheim site. At the same time it has sold its pharmaceutical manufacturing business to Riemser Arzneimittel, which will expand its contract manufacturing business with the acquisition.
Rentschler
Aquapharm in Dr Reddy's licensing deals
Aquapharm Biodiscovery has signed a new license agreement with Dr Reddy's and has extended an existing deal. The original deal was signed with Dowpharma, which was acquired by Dr Reddy's earlier this year, in 2006. The agreement covers the use of selected strains from Aquapharm's library of novel marine micro-organisms to generate commercial biocatalysts for the manufacture of pharmaceutical intermediates.
Aquapharm
Tuesday, 8 July 2008
Sunday, 6 July 2008
World Bank group invests in Hikal
Hikal has received a $15m equity investment from International Finance Corporation, part of the World Bank group. Hikal said it plans to use the capital to expand its manufacturing and R&D facilities in Jigani, Panoli and Taloja.
Money Control
Thursday, 3 July 2008
Wednesday, 2 July 2008
Lonza commits to stem cells
Lonza will produce clinical trial and commercial supplies of Osiris Therapeutics' adult stem cell therapy, Prochymal. Lonza will build new facilities in Walkersville, including the first commercial-scale allogeneic cGMP manufacturing facility and capacity to manufacture cGMP grade cell culture media for therapeutic applications.
Forbes
Monday, 30 June 2008
Plethico plans to cut CMO business
Plethico Pharmaceutical is looking at trimming its Contract Research and Manufacturing Services (CRAMS) business as low margins are being further squeezed out due to higher inflation and surging crude oil prices.
Economic Times
Emcure inaugurates plants
Indian manufacturer, Emcure Pharmaceuticals, has inaugurated its commercial oncology products manufacturing plant in Hinjewadi. In addition, Emcure's Gennova Biopharmaceuticals subsidiary has inaugurated its trial-scale malaria vaccine manufacturing facility.
Economic Times
Sunday, 29 June 2008
Thursday, 26 June 2008
Wednesday, 25 June 2008
FDA funding approved
The US House Agriculture subcommittee has approved funding of $2.1bn for the FDA in 2009 - $282m more than the agency originally requested.
Health Imaging
Avid joins PER-C6 network
Avid Biosciences will be the pre-approved contract manufacturer for licensees of DSM and Crucell's PER.C6 cell line located in the western US.
RTT News
DHS notifies high risk facilities
The US Department of Homeland Security (DHS) is informing the owners that 7000 chemical facilities have been designated as "high risk" in the face of terrorism attack. SOCMA has welcomes the DHS action to secure chemical facilities according to risk under its Chemical Facility Anti-Terrorism Act Standards.
HS Today
Monday, 23 June 2008
Thursday, 19 June 2008
CEFIC and DSM criticise EU API measures
CEFIC and DSM have said the European Commission's proposals for tackling counterfeit APIs do not go far enough. Responding to the public consultation both parties believe APIs in medicines destined for the EU market must comply with GMP and that there are concerns over some APIs originating from India and China.
In-Pharma Technologist
Dishman builds in China
Dishman Pharmaceuticals has invested $10m in an API and intermediates facility in Shanghai, China. The facility which is due onstream early in 2009 will support Dishman's contract manufacturing business.
Sify
Monday, 16 June 2008
FDA considers outsourcing inspections
The US FDA is looking to outsource the inspection of pharmaceutical manufacturing facilities. However, there are concerns after the relative failure of a similar system used for medical devices.
San Diego Union-Tribune
Further production boost for PER-C6
DSM And Crucell have further enhanced the productivity of their PER-C6 human cell line. Just three months after announcing the cells could produce 15g/l they have announced that they can achieve production levels of 27g/l.
Reuters
Thursday, 12 June 2008
Daiichi to acquire Ranbaxy stake
Japanese pharmaceutical company Daiichi Sankyo will acquire a controlling stake in Indian generics manufacturer Ranbaxy for $4.6bn. Analysts believe the deal may start a string of western takeovers in the Indian pharmaceutical sector. Ranbaxy is believed to have talked to other companies including Takeda, GlaxoSmithKline and Pfizer. Sources suggest Pfizer may bid for a further stake in Ranbaxy.
AFP
Times of India
Business Standard
pecter slams Administration over FDA cash
Just days after the Bush Administration called on he US Congress to authorise an additional $275m for the FDA, Senator Arlen Specter has criticised the timing in the Administration Request. Specter believes the FDA needs the money asap, but the Administration request would deliver the money in March or April 2009. Specter is highly critical in his letter to Secretary Leavitt.
Wall Street Journal
Arch buys into Benzochem
Arch Pharmalabs has acquired 70% of Benzochem Lifesciences for around $23m. Benzochem specialises in manufacturing oncology products.
In-Pharma Technologist
Administration asks for more cash for FDA
US Health and Human Services Secretary Michael Leavitt has asked Congress to give the FDA an additional $275 million in next year’s budget to enhance the safety of food and medical products.
New York Times
Matthey takes stake in Dr Reddy's subsidiary
Johnson Matthey is to buy a 49% stake in Macred India, the subsidiary of Dr Reddy's dedicated to the manufacture of narcotic drugs from opium.
Economic Times
Thursday, 5 June 2008
Central Glass acquires Girindus business
Girindus has sold its Halle-Kuensebeck, Germany, process development, upscaling, cGMP production of active pharmaceutical ingredients as well as the fine chemical business and all related analytical activities to Central Glass Germany.
Girindus
CVC wins Evonik race, IPO planned
CVC Capital Partners has won the race to acquire a stake in Evonik. The private equity house has acquired a 25.01% stake in the German industrial Group for €2.4bn. Wilhelm Bonse-Geuking, CEO of Evonik's parent company, the RAG Foundation, said that RAG plans to IPO Evonik after mid-2010 and before 2013.
CVC
Bloomberg
Hemscott
Tuesday, 3 June 2008
CVC expected to win Evonik race
As the Evonik decision day draws closer, it has been revealed that RAG now plans to sell a 25.01% stake in Evonik, giving the buyer a veto vote. Reports suggest that CVC Capital Partners is the winning bidder. CVC is set to pay €2.4bn for the stake, beating bids from Bain Capital, Blackstone Group and Kohlberg Kravis Roberts.
iii
Reuters
Sunday, 1 June 2008
Evonik decision due 11 June
Evonik's parent company RAG will decide on 11 June which of the four interested financial buyers will get the 25% stake in the company. Sources suggest the workers union liked the presentations from KKR.
Forbes
Thursday, 29 May 2008
Wednesday, 28 May 2008
Safety concerns slow FDA approvals
Janet Woodcock, director of the US FDA's Center for Drug Evaluation and Research, has said that a new focus on drug safety is delaying the approval of some medicines. She said the Agency's hiring programme would help offset the delays.
Reuters
Tuesday, 27 May 2008
FDA awaits China approval
The US FDA is awaiting approval from the Chinese Ministry of Foreign Affairs before it can establish offices in China. The FDA plans to open offices in Beijing, Shanghai and Guangzhou.
Associated Press
Chemtura for sale?
Private equity firms Blackstone Group and Apollo Management LP are said to be in talks to acquire Chemtura. Chemtura is currently reviewing strategic alternatives that could include divestitures, acquisitions or a sale.
Forbes
Monday, 26 May 2008
Saturday, 24 May 2008
Friday, 23 May 2008
Thursday, 22 May 2008
Dr Reddy's reveals Dowpharma and BASF costs
Dr Reddy's spent $38m on BASF's Shreveport manufacturing plant and $34m on Dowpharma's UK assets in Mirfield and Cambridge. The figures were revealed as the company revealed that its full year 2007-2008 profit fell almost 50% to $117m.
The Hindu
Wednesday, 21 May 2008
SOCMA certifies facilities
SOCMA has certified the first five facilities to complete the required steps of its Chemstewards programme review cycle. The five facilities, which completed the requirements a year ahead of schedule are: Synthetech in Albany, Oregon; Noramco in Athens, Georgia; Noramco in Wilmington, Delaware; Siegfried USA in New Jersey and ESCO Company in Muskegon, Michigan.
SOCMA
Tuesday, 20 May 2008
FDA to get subpoena powers?
Congressman Bart Stupak hopes that FDA chief Andrew von Eschenbach will seek subpoena power as part of the impending drug importation bill. The power will allow the FDA to demand certain documents from regulated companies.
Wall Street Journal
Sill four for Evonik
Four potential buyers are still lined up for the acquisition of a 25% stake in Evonik. KKR, Blackstone Group, Bain Capital and CVC Capital Partners are awaiting a decision by Evonik owner RAg on which two will go forward to the negotiation stage.
Forbes
Monday, 19 May 2008
Saturday, 17 May 2008
FDA confirms China plans, will ban exporters
On a trip to China the head of the US Health Secretary, Michael Leavitt, conformed that the FDA will open offices in China. The FDA will station 10 staff at three offices across the country. Leavitt also said the FDA plans similar offices in India. In addition, Leavitt said the US plans to ban Chinese companies that don't meet certification requirements form exporting goods to the US.
China Daily
Wall Street Journal
Chemie Uetikon launches biotech division
BioUetikon, the biotech custom manufacturing division of Chemie Uetikon, has been launched in Ireland. BioUetikon, a spin-out from Dublin City University funded by Chemie + Papier Holding, Chemie Uetikon's parent company, will offer manufacturing services to the biopharmaceutical, medical device and related industries.
Pharmaceutical Technology
Thursday, 15 May 2008
FDA NME approvals at all time low rate
Although the US FDA has approved 29 new drug applications in the first four months of 2008 - the highest level since 2000 - it has only approved three NMEs, equalling the record low level.
Pharmalot
Wednesday, 14 May 2008
Major expansion
Cambridge Major Laboratories plans to build North America's most advanced API facility at its Germantown, WI, headquarters. The 12,000m2 facility will include multiple GMP manufacturing suites capable of producing multi-tonne quantities of API. The company said the facility, which is scheduled for August 2009, is required to meet its large and growing pipeline of late developmental and commercial API’s.
The initial build will house six manufacturing suites with reactors up to 7500L with complete isolation and containment and vessels for hydrogenation and cryogenic reactions. Additional manufacturing suites up to 15 000L can be accommodated in the facility if needs arise.
Small Business Times
Image from Business Wire
FDA asks for cash
Andrew von Eschenbach, the US FDA Commissioner, has asked Congress for an additional $275m above the previously proposed budget. von Eschenbach's request includes a detailed spending plan which includes opening new foreign offices, increasing inspections and constructing new databases to track drug hazards.
New York Times
Tuesday, 13 May 2008
Albemarle plans fine chems acquisitions
Albemarle's fine chemicals business unit will focus on targeting the pharmaceutical market, said Ron Gardner, vice-president fine chemicals, speaking at the company's Vision 2010 investor meeting. Gardner said the company plans to develop its API and pharmaceutical intermediates businesses. The company also plans to build its capabilities first in Europe and then in India to be nearer to some of its customers and potential customers. The business is already expanding its R&D capabilities in Asia with teams in India and China.
The company is also building its brand image in the sector by working with its customer to publicise the relationships it develops. Albemarle's current pharma pipeline has 38 projects in preclinical development, 51 in phase I, 14 in phase II and 20 in phase III - the most it has ever had in pIII. Gardner said its pipeline was worth more than $100m in sales.
Acquisition will form part of the company's plan to grow the business, said Gardner. The company plans to acquire businesses that deliver $250m in sales to take the fine chemical business unit sales to $1bn by 2010.
As for competition in the arena from China, Gardner said the company was seeing customers that were hesitant to take business to China. In addition he sees the economic environment changing such that Western manufacturers are seen as relatively more attractive as china becomes relatively less competitive.
Albemarle presentation
Biopharma CMO market grows
The global biopharmaceutical CMO market grew 14% to $2.4bn in 2007, according to a report from HighTech Business Decision. For 2008, the market is expected to grow a similar amount.
Contract Pharma
Friday, 9 May 2008
Thursday, 8 May 2008
Agilent expands nucleic acid capacity, buys Dow technology
Agilent Technologies is expanding nucleic acid API manufacturing capacity at its Boulder, Colorado, facility. Additionally, Agilent has purchased the assets of Dowpharma's Nucleic Acid Medicines business, the second disposal by Dowpharma in the same number of weeks. In Boulder Agilent is adding large-scale nucleic acid synthesis, purification and drying capacity. The new capacity is due on stream by the end of 2008.
Agilent
Dishman expands API capacity
Dishman Pharmaceuticals and Chemicals has commissioned three API facilities for contract manufacturing. The $37.5m facilities are in Bavla, India. Dishman plans to commission a fourth facility dedicated to the production of cytotoxic compounds by the end the year.
India PR Wire
Wednesday, 7 May 2008
Dr Reddy's plans more acquisitions
GV Prasad, executive vice-chairman and CEO of Dr Reddy’s Laboratories, said the company plans to acquire more small companies globally rather than one large deal to push sales in overseas markets. It is looking at acquisitions including custom pharma services in the US and other markets.
Economic Times
Anu's to invest in plants
Anu's Laboratories plans to use the proceeds of its forthcoming IPO to build an API manufacturing plant and a pilot plant for contract research and manufacturing in Vishakhapatnam, India.
Economic Times
Tuesday, 6 May 2008
AMRI sees sales rise, completes high potency facility
Revenue for Q1 rose 11% to $53.6m for AMRI. Discovery, development and small-scale manufacturing saw strong growth, but large-scale manufacturing saw a sales decline. In addition, AMRI has completes its new state-of-the-art 150m2 non-GMP High Potency development laboratory suite at its Albany, NY, facility.
AMRI
Friday, 2 May 2008
FDA Director back-tracks
The director of the US FDA's Center for Drug Evaluation and Research, Janet Woodcock, refused to support Democrat proposals for tougher regulations on imported drugs and new fees on drug makers. Despite earlier comments that the FDA needs an additional $225m to inspect all foreign manufacturing facilities Woodcock refused to specify how much the agency needs.
Wall Street Journal
Thursday, 1 May 2008
Wednesday, 30 April 2008
FDA asks for cash
The director of the US FDA’s Center for Drug Evaluation and Research, Janet Woodcock, has told the House Energy and Commerce subcommittee on oversight and investigations that the FDA would need $225m - 20 times more than its current foreign inspection budget - in additional funding to inspect the 3300 foreign drug-making plants as frequently as it reviews plants in the US.
Los Angeles Times
Dr Reddy's buys US facility
Continuing the moves of Indian companies acquiring western manufacturing facilities, Dr Reddy's has acquired the Shreveport, Louisiana, custom manufacturing plant from BASF. GV Prasad, Dr Reddy's Vice Chairman and CEO, said the purchase was "an infrastructure play to support our North American generics business".
Money Control
SOCMA criticises call for US-REACH
Jim DeLisi, president of Fanwood Chemical, representing SOCMA told a US Senate Environment and Public Works Committee hearing that "an American REACH would not only hamper innovation but would reverse progress made over many years by federal regulators and the chemical industry to appropriately manage risk”. The committee chair, Senator Barbara Boxer has called for US chemical producers to be responsible for proving their products are safe before entering the market.
ICIS
Tuesday, 29 April 2008
Angel's Estonian deal
Angel Biotechnology will provide biomanufacturing services for EPhaG AS. Angel will support the production of four products over the next three years, for which it will get royalty payments for five years on the sale of the first three products. EPhaG will make a £1m investment in Angel.
Hemscott
Sunday, 27 April 2008
FDA calls on pharma to oversee quality
Janet Woodcock, director of the US FDA’s Center for Drug Evaluation and Research, told the Senate Education, Labor, Health and Pensions Committee that the increasing number of ingredients sourced from overseas makes it almost impossible for the agency to ensure the safety of all drugs sold in the US. Woodcock said responsibility also lay with the pharma companies ensuring their ingredients reached quality standards.
PharmaLot
Saturday, 26 April 2008
Friday, 25 April 2008
Archimica sells plant, completes turnaround
Archimica has sold its Puerto Rico 5-fluorouracil plant to Teva. The sale completes the company's turnaround to multi-purpose facilities for manufacturing intermediates and APIs.
Archimica
Thursday, 24 April 2008
Wednesday, 23 April 2008
Record quarter for SAFC
SAFC saw record quarterly sales of $157.5m in Q1 2008 a growth of 18.2%. The company reported continued strong demand from pharmaceutical customers in the US and improved demand from biotech customers worldwide. Booked orders are at an all time high for SAFC.
PR Newswire
Tuesday, 22 April 2008
FDA weak on foreign inspections
The US Government Accountability Office has criticised the FDA for not conducting enough inspections of manufacturing facilities outside the country. in 2007 the FDA inspected 30 inspections this year it plans to conduct 50. However there are 3200 foreign drug firms listed by the FDA.
Associated Press
Pfizer to cut more manufacturing
Pfizer will close or sell 13 more manufacturing facilities as it cuts its number of production plants to 44 by the end of 2009. CFO Frank D'Amelio, was implementing an outsourcing programme.
In-Pharma Technologist
Evonik confirms bidders
Indian companies shopping for CMOs
Indian life sciences companies are seeking acquisitions in the US and Europe in the chemistry and custom synthesis space.
Financial Express
Saturday, 19 April 2008
Friday, 18 April 2008
Origin labels for drugs proposed
Democrats on the US House Energy and Commerce Committee have proposed county of origin labels for drugs. The labels would have to identify the source of the active ingredient and its place of manufacture.
Associated Press
Wednesday, 16 April 2008
Senators: FDA underfunded
Following a US Senate Appropriations Committee hearing, Senators from both parties said the FDA needed more funding than proposed by President George Bush.
New York Times
AZ to outsource all manufacturing
AstraZeneca chief executive David Brennan said the company plans to outsource all API manufacturing within a decade. AZ has piloted the outsourcing of API for Seroquel and is will extend outsourcing to low-cost third-party manufacturers, especially in India and China.
Financial Times
Tuesday, 15 April 2008
FDA to open China office in May
The US FDA is to open three offices in China by October, the first beginning operations next month. Agency Commissioner Andrew von Eschenbach said it eventually hopes to open offices in India, Europe, the Middle East and South America.
Wall Street Journal
Monday, 14 April 2008
Codexis files for IPO
Codexis hope to raise around $100m in an IPO underwritten by Credit Suisse Securities, Goldman Sachs, Piper Jaffray, RBC Capital Markets and Thomas Weisel Partners. Codexis did not reveal the offer price or number of shares to be sold in its submission to the SEC. Last year Codexis had sales of $25.3m but made an overall loss of $39m. Since it was founded as a spin out from Maxygen, Codexis has accumulated a deficit of $94.2m.
Forbes
Saturday, 12 April 2008
Evonik plans chemicals acquisitions
Klaus Engel head of Evonik's chemicals division said the company is ready to make acquisitions again. The Degussa division has a budget of about €2.5bn for expansion in China, South America and Europe over the next three years.
Hemscott
Thursday, 10 April 2008
Actavis buys in China
Actavis has purchased a 90% of Zhejiang Chiral Medicine Chemicals. The purchase of the Hangzhou-based API manufacturer is designed to help reduce costs.
In-Pharma technologist
Wednesday, 9 April 2008
Tuesday, 8 April 2008
Overhaul coming for FDA
Congressional Quarterly reports that John Dingell, who heads the House Energy and Commerce Committee, is planning a fundamental overhaul plan that is likely to form the model for a Democratic or Republican White House following the US elections later this year. Dingell plans more full time inspectors in the developing world, adding country of origin labeling and levying new user fees on manufacturers to finance spot checks at overseas drug plants and at US points of entry.
PharmaLot
Monday, 7 April 2008
FDA to hire
The FDA plans to hire more safety evaluators, epidemiologists, regulatory project managers and experts in risk management and medication errors to enhance its postmarket drug-safety activities.
FDA News
Saturday, 5 April 2008
Jubilant buys Draxis
Jubilant Organosys is to purchase Draxis Health for $225m. Jubilant said the deal gives it "an entry into the attractive, regulated, high growth and high margin radiopharmaceutical business".
Reuters
Friday, 4 April 2008
Carbogen adds high potency in India
Carbogen Amcis' Indian subsidiary will open a high potency facility on the Bavla site of its parent company, Dishman Pharmaceuticals & Chemicals Ltd. The 4300m3 facility, which is expected to be operational by Q1 2009, will include four segregated high potency cells with reactor sizes ranging from 630L to 1600L and a number of contained development laboratories.
Carbogen Amcis
Thursday, 3 April 2008
Schering-Plough to cut manufacturing
Playing its part in the wave of cut backs in the pharma sector, Schering-Plough plans to reduce its head count by 10% and its number of manufacturing plants.
Wall Street Journal
Evonik bidders named
Insiders say that Blackstone Group, Kohlberg Kravis Roberts, Bain Capital and CVC are the preferred bidders for a stake in Evonik. They are each believed to have bid €2bn.
Reuters
Lonza to expand nicotinate capacity
Lonza will expand its manufacturing capacity for nicotinates by 40% over the next three years to meet demand. The first phase of the SFr50m investment is due on-stream in 2010 with full operation in 2011.
Forbes
Wednesday, 2 April 2008
Evonik field down to four
RAG has ruled out an IPO for part of its Evonik business for the time being. It plans to sell a 25% stake this year, with a further 50% stake sold between 2010 and 2012. Reports suggest there are four potential buyers for the current stake, one of which is Blackstone Group.
The Guardian
CNN
Tuesday, 1 April 2008
Dowpharma sells UK assets
Dowpharma has sold its small molecules facilities in Mirfield and Cambridge, both in the UK, to Dr Reddy's. Although the actual transaction cost was not revealed, G V Prasad, vice-chairman and ceo of Dr Reddy's, said the cost was slightly above the business's $25m revenue. The acquisition will include the relevant business, customer contracts, associated products, process technology, intellectual property, trademarks as well as the transfer of the facilities. Dr Reddy’s will also have a non-exclusive license to Dow’s Pfenex Expression Technology for biocatalysis development.
Bloomberg
Money Control
Thursday, 27 March 2008
FDA may fail
FDA commissioner Andrew von Eschenbach said the agency may fail to protect the health of Americans as funding has not kept pace with responsibilities. He said the FDA's regulatory role has expanded and its workforce has been overextended. He said that in order that the FDA remains the "the world's gold standard as a regulatory agency" it needs to be "stronger, bigger and better".
Bloomberg
Acquisitions for Lonza?
Lonza shareholders are advising ceo Stefan Borgas to look at larger acquisitions to expand in life sciences including drug ingredients and nutritional additives, rather than return cash to investors. Borgas said the company will have a "much tougher" time reaching profit targets this year because of rising raw-material costs and a sliding dollar.
Bloomberg
Wednesday, 26 March 2008
FDA plans to reduce drug development costs
Janet Woodcock, the recently reappointed head of the FDA Centre for Drug Evaluation and Research said the FDA would unveil proposals this autumn on reducing drug development costs by standardising the format and content of clinical trial data.
Financial Times
Saturday, 22 March 2008
Cambrex customer recalls product
A customer of Cambrex has recalled a product for which Cambrex currently supplies the API. However, Cmabrex said the recall is not linked to its performance as the manufacturer of the API. The recall will affect its finances for 2008, said Cambrex.
Forbes
Friday, 21 March 2008
Avecia sells vaccines
Avecia has sold its vaccines business to PharmAthene for $20m. Avecia will also be eligible for $20m in milestone payments. The business will remain in the UK.
Baltimore Buisiness Journal
Wednesday, 19 March 2008
Tuesday, 18 March 2008
Eleven now interested in Evonik
The German press is reporting that 11 companies are interested in the 25% stake in Evonik that is up for sale. Apollo Management, Bain Capital, BC Partners, Blackstone Group, Carlyle, Cerberus, CVC, Kohlberg Kravis Roberts, One Equity Partners, Permira and TPG are said to have contacted Evonik.
Reuters
Biotech offsets fine chemicals decline for Wacker
Wacker's fine chemicals business matched 2006 sales in 2007. The company said higher sales of biotech products offset its declining business in custom fine chemicals and catalog products.
Wacker
New projects boost Siegfried profits
Siegfried Holding saw full-year net profit rise 54% to SFR49.7m. Siegfried put the rise down to acquiring 20 new API projects and 'increased interest of pharmaceutical research firms'.
Forbes
Monday, 17 March 2008
GMP not required for excipients
A European Commission report suggests that introducing GMP for pharmaceutical excipients is unlikely to bring benefits, despite industry warnings of safety issues. The European Fine Chemicals Group (EFCG) has called for mandatory GMP to level the playing field among manufacturers of pharmaceutical excipients and bring the sector into line with other aspects of the pharmaceutical production process.
In-Pharma Technologist
More money proposed for FDA
The US Senate has passed a budget resolution to give the FDA an additional $375m over this year. “Congress has a responsibility to close the glaring gaps in food and drug safety that have begun to overwhelm the FDA,” said Senator Edward Kennedy, Democrat of Massachusetts, who pushed for the new financing.
New York Times
Good 2007 for Evonik, still looking for sale
Evonik saw sales rise 2% to €14.4bn and EBIT rises 14% to €1.3bn. The Chemicals business benefited from higher demand, an improvement in selling prices, lower depreciation and the recent restructuring. The company is still looking either to sell shares in an IPO or for a trade sale of a stake.
Evonik
Reuters
Sunday, 16 March 2008
FDA increases China staff
The FDA plans to strengthen its regulatory presence in China. The agency will establish eight permanent positions at US diplomatic posts and will also hire five Chinese nations.
Chicago Tribune
Thursday, 13 March 2008
Hikal invests in manufacturing
Hikal is establishing manufacturing units in Bangalore, to supply pharmaceutical products for Pfizer and Alpharma, and a pharmaceutical intermediate manufacturing facility near Mumbai. In addition, it is setting up a pharmaceutical and crop protection R&D centre in Pune and a crop protection active ingredients facility in Navi Mumbai. Total investment is approximately $50m.
Business Standard
RFCL on European shopping spree
RFCL Ltd is close to acquiring a European fine chemicals company. The former Ranbaxy Fine Chemical Ltd has recently closed the acquisition of a European animal healthcare company. RFCL expects the fine chemicals deal to be confirmed in April.
Domain B
Wednesday, 12 March 2008
Nicholas Piramal seeks Euro/US acquisition
Nicholas Piramal India is seeking acquisition opportunities in the US and in Europe to expand the customer base and technology range of its contract manufacturing business. An acquisition in the US is most likely said group chairman Ajay Piramal. Additionally, the company will rebrand its contract manufacturing business as Pharma Solutions.
Economic Times
Analyst: Fewer NME approvals expected in 2008
Investment analyst, Jim Kumpel of Friedman Billings Ramsey, says NME approvals are “on pace with a miserable 2007". Through the first two months of this year, the FDA has approved only one NME, which is the same rate as 2007.
Pharmalot
Tuesday, 11 March 2008
Lanxess sets criteria for acquisitions
Lanxess ceo Axel Heitman said the company will continue to look for acquisition targets to bolster growth. However, it has outlined three possible scenarios for acquisition targets: the acquisition of individual small or medium-sized operations; the acquisition of chemical businesses to broaden the portfolio; or the acquisition of companies or part of companies with potential that has not yet been fully realised.
Forbes
EMEA expects record year
The European Medicines Agency (EMEA) expects a record number of applications for market approval in 2008, according to its annual report. The Agency expects to surpass the record number of positive opinions issued in 2007.
Pharma Times
Monday, 10 March 2008
Sunday, 9 March 2008
Friday, 7 March 2008
SOCMA opposes IST legislation
Joe Acker, president of the Synthetic Organic Chemical Manufacturers Association (SOCMA), said his trade group is “stridently opposed to the merits of mandating inherently safer technology under the guise of site security”. Acker's comments follow the approval by the House Committee on Homeland Security approved the “Chemical Facility Anti-Terrorism Act of 2008" which includes the inherently safer technology (IST) reporting requirement.
ICIS
Thursday, 6 March 2008
Evonik acquires in China
Evonik has acquired the remaining 49% of its former joint venture Degussa Lynchem Co. Ltd., Dalian, China, from the Chinese shareholders Yuncai Wang and Jingkun Wang. Degussa Lynchem has become a wholly owned subsidiary of Evonik.
Degussa
Hovione invests in China
Hovione has purchased 75% of Hisyn Pharmaceutical Co. Limited, based in Zhejiang. Hovione said the acquisition provides it with significant additional drug substance manufacturing production capacity and strengthens its 20 year presence in China. The acquisition includes development labs and a 22,000m2 API) plant, which will now produce Hovione's two largest volume products.
PR Newswire
Merck invests in research centre
Merck KGaA will spend €47m on a new research centre at its Darmstadt headquarters. The centre will bring together the research activities of the liquid crystal and performance and life science chemicals businesses. Construction will begin in June and inauguration is planned for the end of 2009.
CNN
Eden in manufacturing deal with Stealthyx
Eden Biodesign will produce Stealthyx Therapeutics' lead therapeutic candidate. Stealthyx is evaluating for treatment of a range of inflammatory diseases including rheumatoid arthritis.
Eden Biodesign
Wednesday, 5 March 2008
Tuesday, 4 March 2008
Monday, 3 March 2008
Sunday, 2 March 2008
Friday, 29 February 2008
FDA needs more funds
The Leaders of the US Committee on Energy and Commerce have said that the FDA needs an injection of funds seven times that proposed by President Bush in his budget.
Committee on Energy and Commerce
Thursday, 28 February 2008
China says: buyer beware
China's State Food and Drug Administration (SFDA) said that the ultimate responsibility for imported drug ingredients lies with the importing country.
Lab Technologist
Cobra in SARS protein deal
Cobra Biomanufacturing will carry out downstream processing for a protein from the SARS virus for an undisclosed pharmaceutical company. The protein will be manufactured by the pharma partner and will be used in phase I trails.
Cobra
