Thursday, 27 November 2008

Calls for FDA overhaul

In the run up to the change of President in the US, former FDA officials, members of Congress, watchdog groups and various government reports are suggesting the Agency requires an infusion of strong leadership, money, technology and personnel, and perhaps a major restructuring.
Washington Post

Profit rise at Matthey

Johnson Matthey's Fine Chemicals & Catalysts Division’s saw its operating profit rise 5% to £32.4m. The Macfarlan Smith API and intermediate business achieved good sales growth in specialist opiates, despite a rise in manufacturing costs. The Pharmaceutical Materials and Services API manufacturing business had reduced income from amphetamine salts.
Johnson Matthey

RFCL-Mallinckrodt Baker deal delayed because of valuation problems

Indian Stock Daily

Three contracts for Eden

Eden Biodesign has signed three contracts worth a total of £2.97m for development and cGMP manufacturing services. Two of the contracts are with new clients, one in Asia and one in Europe, the other is for a new therapeutic with an existing UK client.
Eden Biodesign

Gedeon Richter has licensed DSM Biologics and Crucell's PER.C6 biopharmaceutical production platform


Dishman Pharma thinks it could see a 30% growth in revenues in its 2008-2009 year

Business Standard

PacificGMP will manufacture Actinium's HuM195 monoclonal antibody for a Phase I/II clinical trial

Pacific GMP

BASF to idle 80 plants reduce production in 100 more


Wednesday, 19 November 2008

FDA opens China office

The FDA has opened its first overseas office - in Beijing, China - as part of its strategy to ensure the safety of drugs and food products imported into the US. The FDA will also open offices in Shanghai and Guangzhou in China as well as in India, Latin America and Europe. The FDA will have eight staff in its China offices. These will include inspectors and senior technical experts on regulation, policy, food, medicines and medical devices who will work with their Chinese counterparts to build capacity and offer their experiences and expertise.
Associated Press

Deretil in management buy-out

The management of DSM Deretil has reached an agreement with DSM for a management buy-out of the business. Deretil will continue to focus on its core business of producing side-chains for API manufacturing. FInancial details of the buy-out have not been revealed.

Tuesday, 18 November 2008

Codexis licenses in enzyme technology

Codexis has licensed Dyadic International's C1 expression system for large-scale production of enzymes in fields including pharmaceutical intermediate production. Codexis will make a $10m upfront payment provided that certain performance criteria are satisfied.

BioReliance will produce investigational quantities of Provecs Medical's Immunalon

Business Wire

Wacker Biotech has extended the licensing agreement with MorphoSys for its prokaryotic secretion technology for antibody manufacture


Recipharm moves into biologics manufacturing

Recipharm's biotech subsidiary, Recipharm Biotech, has acquired AstraZeneca's biotech manufacturing facility in Södertälje, Sweden. AstraZeneca has entered a supply arrangement with Recipharm for Phase I and Phase II material for one of its development projects and will hold a significant minority stake in the new company.

BASF has acquired 94.55% of Ciba shares


Jubilant Organosys has acquired TrialStat ClinicalAnalytics for C$750,000

India Infoline

Thursday, 13 November 2008

Delays for Dishman

Dishman has slowed its plans to develop two special economic zones in Bavla. The company said the development could be delayed by six months. In addition the completion of construction of Dishman's manufacturing unit in China has been delayed has delayed until early next year. Dishman's oncology bulk drugs unit in Gujarat is expected to come on stream in the first quarter 2009.

Thursday, 6 November 2008

Cambrex expects market softening

Cambrex saw a small increase in sales in the third quarter. Steven Klosk, Cambrex President and ceo, said "the market for early stage clinical development projects is softening. This is especially true of emerging biotech companies and our large pharma customers in Europe." Klosk attributed this to cost containment programs and a continuous review of R&D pipeline by big pharma and smaller companies focusing on fewer projects.
Cambrex is nearing completion of its new mid-scale API manufacturing facility at its Swedish operation, which is expected to be on line in early 2009. The company has started production in a portion of its state of the art API finishing facility in Milan, Italy, with the remainder in the later stages of validation. The new high potency development center in Charles City, Iowa, is also now fully operational. Klosk said these facilities position the company well for future growth.
Seeking Alpha

Lonza completes expansion

Lonza has completed the biologics manufacturing capacity expansion at its Portsmouth, NH, site. The $300m, 33,000m2 expansion brings reactor capacity at the site to 93,000L. Lonza wil also increase its workforce by more than 300 employees.
New Hampshire Union Leader