Wednesday, 30 April 2008
FDA asks for cash
The director of the US FDA’s Center for Drug Evaluation and Research, Janet Woodcock, has told the House Energy and Commerce subcommittee on oversight and investigations that the FDA would need $225m - 20 times more than its current foreign inspection budget - in additional funding to inspect the 3300 foreign drug-making plants as frequently as it reviews plants in the US.
Los Angeles Times
Dr Reddy's buys US facility
Continuing the moves of Indian companies acquiring western manufacturing facilities, Dr Reddy's has acquired the Shreveport, Louisiana, custom manufacturing plant from BASF. GV Prasad, Dr Reddy's Vice Chairman and CEO, said the purchase was "an infrastructure play to support our North American generics business".
Money Control
SOCMA criticises call for US-REACH
Jim DeLisi, president of Fanwood Chemical, representing SOCMA told a US Senate Environment and Public Works Committee hearing that "an American REACH would not only hamper innovation but would reverse progress made over many years by federal regulators and the chemical industry to appropriately manage risk”. The committee chair, Senator Barbara Boxer has called for US chemical producers to be responsible for proving their products are safe before entering the market.
ICIS
Tuesday, 29 April 2008
Angel's Estonian deal
Angel Biotechnology will provide biomanufacturing services for EPhaG AS. Angel will support the production of four products over the next three years, for which it will get royalty payments for five years on the sale of the first three products. EPhaG will make a £1m investment in Angel.
Hemscott
Sunday, 27 April 2008
FDA calls on pharma to oversee quality
Janet Woodcock, director of the US FDA’s Center for Drug Evaluation and Research, told the Senate Education, Labor, Health and Pensions Committee that the increasing number of ingredients sourced from overseas makes it almost impossible for the agency to ensure the safety of all drugs sold in the US. Woodcock said responsibility also lay with the pharma companies ensuring their ingredients reached quality standards.
PharmaLot
Saturday, 26 April 2008
Friday, 25 April 2008
Archimica sells plant, completes turnaround
Archimica has sold its Puerto Rico 5-fluorouracil plant to Teva. The sale completes the company's turnaround to multi-purpose facilities for manufacturing intermediates and APIs.
Archimica
Thursday, 24 April 2008
Wednesday, 23 April 2008
Record quarter for SAFC
SAFC saw record quarterly sales of $157.5m in Q1 2008 a growth of 18.2%. The company reported continued strong demand from pharmaceutical customers in the US and improved demand from biotech customers worldwide. Booked orders are at an all time high for SAFC.
PR Newswire
Tuesday, 22 April 2008
FDA weak on foreign inspections
The US Government Accountability Office has criticised the FDA for not conducting enough inspections of manufacturing facilities outside the country. in 2007 the FDA inspected 30 inspections this year it plans to conduct 50. However there are 3200 foreign drug firms listed by the FDA.
Associated Press
Pfizer to cut more manufacturing
Pfizer will close or sell 13 more manufacturing facilities as it cuts its number of production plants to 44 by the end of 2009. CFO Frank D'Amelio, was implementing an outsourcing programme.
In-Pharma Technologist
Evonik confirms bidders
Evonik ceo Werner Mueller has confirmed the four parties interested in acquiring the 25% stake the company is selling. They are Blackstone Group, Kohlberg Kravis Roberts, Bain Capital and CVC Capital Partners. Binding offers are expected by June.
Bloomberg
Previously on FINE
Indian companies shopping for CMOs
Indian life sciences companies are seeking acquisitions in the US and Europe in the chemistry and custom synthesis space.
Financial Express
Saturday, 19 April 2008
Friday, 18 April 2008
Origin labels for drugs proposed
Democrats on the US House Energy and Commerce Committee have proposed county of origin labels for drugs. The labels would have to identify the source of the active ingredient and its place of manufacture.
Associated Press