Sunday, 1 March 2009
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
Wednesday, 25 February 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
Thursday, 19 February 2009
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.
DSM
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.
Sigma-Aldrich
Monday, 9 February 2009
Thursday, 5 February 2009
Tuesday, 3 February 2009
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
Sunday, 1 February 2009
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
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.
Excelsyn
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.
Socma
Wednesday, 28 January 2009
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.
Forbes
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.
Reuters
Easy Bourse
Monday, 26 January 2009
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.
Lanxess
Sunday, 25 January 2009
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
Science not politics for FDA
Acting FDA Commissioner, Frank Torti, has promised that the agency will make its regulatory decisions based on science rather than politics. He admitted that the job would be difficult as the Agency awaits a permanent leader, but said that it should work efficiently and base decisions on the laws that govern food and drugs.
FDA
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
Reuters
Thursday, 15 January 2009
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
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
Thursday, 8 January 2009
Tuesday, 6 January 2009
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.
CNN
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
