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".

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.

Wednesday, 26 March 2008

Rhodia to dismantle Organics business

In-Pharma Technologist

WC Heraeus will manufacture picoplatin for Poniard Pharmaceuticals

San Francisco Business Times

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.

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

Tuesday, 18 March 2008

China's State Food and Drug Administration now governed by the Ministry of Health

Chemistry World

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.

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.

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'.

Monday, 17 March 2008

Goodwin Biotechnology to manufacture antibody for Q Therapeutics

Goodwin Biotechnology

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.

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

CMC ICOS will develop a production cell line for Raven’s RAV18 monoclonal antibody

CMC Biologics

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

Cobra Biomanufacturing has received R&D tax credit approval from the French Ministry for Higher Education and Research

Cobra Biomanufacturing

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

Asian competition forces Rhodia to close last paracetamol plant in Europe


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.

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.

Woodcock reappointed to head CDER

Wall Street Journal

DSM, Crucell see 15gl-1 yield with PER.C6


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

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.

Thursday, 6 March 2008

Link Technologies opens new kilo-scale facilities

Link Technologies

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.

10 bidders lined up for Evonik


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.

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

Tuesday, 4 March 2008