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
Friday, 29 February 2008
FDA needs more funds
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
Wednesday, 27 February 2008
FDA needs budget boost
FDA Commissioner Andrew von Eschenbach says critics of the agency have a point: it needs more money than budgeted and requires a revamped organisation to better oversee drug safety and other issues.
Wall Street Journal
Evonik plans IPO and sale
Further to reports earlier this week about the future of Evonik, RAG-Stiftung reportedly plans to sell 25% of Evonik to a financial investor, float 50% in an IPO and retain 25%. RAG plans to approach Permira, BC Partners, KKR, Bain Capital and Blackstone. David Blitzer, senior managing director at Blackstone, said Blackstone may be interested in acquiring a stake in Evonik.
Forbes
Hemscott
Shasun signs Merck deal
Shasun Chemicals has licensed its Buchwald cross-coupling technology to Merck & Co for API manufacture. Shasun will receive upfront payments from Merck and expects contractual rights from Merck if products are commercialised.
Hindu Business Line
Tuesday, 26 February 2008
Arch looks to Europe
Arch Pharmalabs is looking for European acquisitions following the opening of its new manufacturing facility in Gurgaon, India. The new $12.5m facility, which will manufacture APIs for the US and European markets, includes four manufacturing plants and a pilot plant. Arch expects the facility to be inspected by the US FDA in the first half of 2008. Ajit Kamath, Arch's managing director,, said the company is also looking to acquiring a medium sized firm in Europe with sales of $100m.
Business Standard
Monday, 25 February 2008
New powers for FDA proposed
The US FDA could receive new authority over drug imports from overseas. The proposals would give the FDA to address criminal conduct overseas that may affect US consumers. However, questions remain over how the new powers would be funded or whether the FDA would have enough staff to carry them out.
Wall Street Journal
Sunday, 24 February 2008
Evonik postpones IPO seeks buyer
Evonik Industries AG has put its IPO on hold and is thought to have seeking an out-right buyer. The company has spoken with financial investors from southeast Asia, Dubai and the US.
Forbes
Saturday, 23 February 2008
Friday, 22 February 2008
Call for inspections law change
Key congressmen, John Dingell, chairman of the Committee on Energy and Commerce, and Bart Stupak, chairman of the Subcommittee on Oversight and Investigations, are looking at changes in law that will prohibit the marketing of any drug from a plant that has not been properly inspected.
Committee on Energy and Commerce
Thursday, 21 February 2008
BASF sees higher fine chems earnings
The fine chemicals business at BASF saw higher earnings in 2007 following recent restructuring measures. However, the company said it believes the full potential of its custom synthesis business has not been fully exploited and that development work with customers will further contribute to earnings in 2008. The company as a whole saw sales rise 10% to €58bn and earnings rise to €7.6bn in 2007.
BASF
Wednesday, 20 February 2008
Tuesday, 19 February 2008
FDA inspected wrong plant
The Chinese plant implicated in supplying the API in heparin was not inspected by the FDA. Instead, the agency mistakenly inspected a plant with a similar name.
Washington Post
Friday, 15 February 2008
Call for FDA head to resign
A member of the US House Energy and Commerce Committee has called for the resignation of FDA chief Andrew von Eschenbach. The call follows revelations that the FDA had not inspected the Chinese manufacturing facility which is believed to have produced the irregular heparin.
New York Times
Los Angeles Times
Record for Cambrex
Cambrex completed a record number of projects in 2007 - 85, said James Mack, company Chairman, President, and Chief Executive Officer. The company also has a growing number of projects in its pipeline.
Cambrex
Thursday, 14 February 2008
AZ spins off GI research
Further to earlier reports, AstraZeneca has spun off its Swedish gastrointestinal research unit into a standalone company: Albireo Pharma. AstraZeneca will own a minority stake in the new company, which is financed by Nomura Phase4 Ventures, TVM Capital and Scottish Widows Investment Partnership.
Wall Street Journal
DSM to buy and sell
DSM is seeking acquisitions in the $0.5-1bn range to bolster its life sciences and materials businesses. The company also plans strategic divestments, said chief executive officer, Feike Sijbesma.
Forbes
SAFC grows in 2007
Sigma-Aldrich reported strong growth -over 19% - for its SAFC business in 2007, with organic growth of 7%. SAFC said strong demand from pharmaceutical customers in the US also continued. Overall Sigma-Aldrich reported annual sales over $2bn.
Sigma-Aldrich
Wednesday, 13 February 2008
Flat year at DSM
DSM's Pharmaceutical Products business unit saw flat sales in 2007. The unit compensated for the expiration of contracts from Roche while increasing innovation.
DSM
Tuesday, 12 February 2008
AstraZeneca may spin off GI research
As a further sign that all may not be well in Big Pharma, AstraZeneca is believed to be looking at options for its Sweden-based GI business. The favoured option is thought to be a venture capital backed spin off company.
The Times
Monday, 11 February 2008
Friday, 8 February 2008
Cambridge Major adds capacity
Cambridge Major Laboratories is planning a $30m project to expand API manufacturing capacity and offer other clinical development services. The facility will add up to 5 tonnes capacity in Germantown, Wisconsin.
OutSourcing Pharma
Thursday, 7 February 2008
3i buys Alpharma API biz
3i is purchasing Alpharma's API business for $395m. Alpharma will invest in its pharmaceutical and animal health divisions. Private equity group, 3i, sees continued growth in serving the generics business built by Alpharma.
In-Pharma Technologist
Wednesday, 6 February 2008
Tuesday, 5 February 2008
Budget increase for FDA
President George Bush has requested a 5.7% increase in the FDA budget. The figure falls short of what many have been asking for in the wake of much criticism of the speed and quality of FDA procedures.
Reuters
Monday, 4 February 2008
Papers: Give the FDA money and people
Two major American newspapers have called for the US Congress to sufficiently fund the FDA. The papers believe that a lack of funds and enough trained staff is at the heart of the FDA's recent problems.
Boston Globe
New York Times
More Indian plants for AMRI
AMRI has acquired a manufacturing plant from FineKem Laboratories in Aurangabad, India. The plant adds pilot-scale capacity and generic heart drug isosorbide mononitrate to AMRI's portfolio.
Forbes
Saturday, 2 February 2008
Friday, 1 February 2008
CiVentiChem adds pilot plant in India
CiVentiChem is investing $8m in a new pilot facility in India. The 5000m2 facility is being build at its Indus Biosciences subsidiary in Hyderabad.
CiVentiChem