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
