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.

Lonza reclassified as life sciences and biotechnology company


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.

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

Genmab addresses manufacturing need

In-Pharma Technologist

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

Jubilant Organosys has signed manufacturing contracts worth $92m

Equity Bulls

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.

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.

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.

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.

Saltigo has officially inaugurated its state-of-the-art multi-purpose unit for the production of APIs and intermediates


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.

Financial sources pour cold water on rumoured BASF-Albemarle deal


Wednesday, 13 February 2008

Chiral product supplier Celtic Catalysts won the "Rising Star Award” at the BIA Scotland Thistle Bioscience Forum

Alpha Galileo

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.

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

Friday, 8 February 2008

DSM Pharmaceuticals will manufacture commercial drug supply for APT Pharmaceuticals at its Greenville, NC, facility


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

American Pacific Fine Chemicals sees increased revenues in Q1 2008

American Pacific

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

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.

Laureate Pharma will manufacture Arius Research's Trop-2 IgG1 humanized antibody

Laureate Pharma

Carbogen Amcis will perform pre-clinical process development and cGMP manufacture of Aim Therapeutics' AIM-102 asthma candidate

Aim Therapeutics

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

Rumour: BASF interested in acquiring Albemarle

Seeking Alpha

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.

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.

Jubliant Organosys attributes 40% profit rise to custom manufacturing

Business Standard

Albemarle will manufacture the API for Anthera Pharmaceuticals phase III clinical trial of Varespladib