News

Adventrx, Hyaluron, MedImmune, Novartis, More

Lyon, France (Apr. 17)-Sanofi Pasteur, the vaccine division of the Sanofi-Aventis Group, announced that the US Food and Drug Administration has licensed its H5N1 vaccine, making it the first avian-influenza vaccine for humans in the United States.

Billerica, MA (Apr. 13)-Millipore Corporation has become the first company to integrate radio frequency identification (RFID) technology with the filtration products used to manufacture biopharmaceutical drugs.

Toronto (Apr. 17)-Patheon, Inc. plans to restructure its current network of six pharmaceutical manufacturing facilities in southern Ontario, Canada as part of its strategy to focus on manufacturing prescription pharmaceutical products and to improve its profitability.

Chalfont St. Giles, UK (Apr. 16)-GE Healthcare, a unit of General Electric, acquired Wave Biotech LLC, a supplier of disposable manufacturing technologies and processing equipment for the biopharmaceutical industry.

Rockville, MD (Apr. 5)-The US Food and Drug Administration concluded its reinspection of Wyeth?s manufacturing facility in Guayama, Puerto Rico. Conditions at the Guayama facility prompted a Warning Letter in May 2006.

Abbott, Cardinal, Illumina, more

Washington, DC (Apr. 5)-The Pharmaceutical Research and Manufacturers of America joined the debate on follow-on biologics when senior vice-president Caroline Loew issued a statement recommending caution.

London (Mar. 29)-GlaxoSmithKline (GSK) plans to invest EUR 250 million ($334 million) at its production site at Currabinny, County Cork, Ireland over the next five years, according to a release issued by the Irish Development Agency (IDA Ireland, Dublin).

Washington, DC (Apr. 3)-The Synthetic Organic Chemical Manufacturers Association (SOCMA) adopted a policy on Inherently Safer Technology (IST) at its March meeting.

Singapore (Mar. 29)-The contract manufacturing organization Lonza Group (Basel, Switzerland) and Bio*One Capital (Singapore) broke ground for their large-scale commercial mammalian cell-culture manufacturing facility at Tuas Biomedical Park in Singapore.

Thousand Oaks, CA (Apr. 3)-Amgen, Inc. has provided a new schedule for the completion of a new manufacturing facility in County Cork, Ireland.

Vetter, AAI, Merck, Eli Lilly, More

Brussels, Belgium (Mar. 22)-The European Commission?s (EC) Directorate-General for Enterprise and Industry (Brussels, Belgium) is asking manufacturers, distributors, and users of human-pharmaceutical excipients to participate in an online questionnaire on the effect of various policy options. Responses will be used to prepare a directive on good manufacturing practices (GMPs) for certain excipients.

Washington, DC (Apr. 2)-The US Department of Homeland Security released an interim final rule that imposes federal security regulations for high-risk chemical facilities.

Rockville, MD (Mar. 1)-The number of US Food and Drug Administration inspections of biologic and drug-manufacturing facilities declined to 4237 in fiscal 2006, according to a report by the Office of Regulatory Affairs.

Inaccuracies in Chapter ‹1072› of the current USP 29 reveal problems in USP's revision and proofreading process.

BIO Raises Concerns About Studies on Follow-On Biologics; Green Chemistry Reduces Costs and Waste; Novel Polymer–DNA Delivery System; WHO Stresses Lack of Capacity for Pandemic Flu Vaccine; EGA Concerned About Regulatory Workload in Approving Generics

Mishaps in packaging labels serve as a reminder: the recall is in the details.

To effectively grow in the biotech industry, companies must develop multiphase plans that focus on regulation and efficiency.

Indian pharmaceutical machine manufacturers (IPMMs) are exceptional among their foreign counterparts. Historically similar to the Chinese with regard to copycat practices, patent infringements, and substandard quality, the IPMMs have made great strides in innovation and collaboration to break free from the shackles of this paradigm.

Agawam, MA (Mar. 26)-Contract manufacturing and testing laboratory Microtest signed a manufacturing deal with Antisoma to produce AS1411, a new drug being developed for the treatment of various cancers.

South San Francisco, CA (Mar. 28)-Genentech, Inc. announced plans to invest $140 million in 1000-liter manufacturing facility in Singapore.

Washington, DC (Mar. 26)-The congressional Committee on Oversight and Government Reform held a hearing to evaluate the cost of biotech drugs as well as strategies for establishing an approval process for the US Food and Drug Administration approval of generic versions of these drugs.

Midland, MI (Mar. 21)-The Dow Chemical Company formed an alliance with Colorcon, Inc. for the global marketing, sales, technical service and development, and distribution of Dow pharmaceutical excipient products for use in controlled-release applications.

Improving performance at an active pharmaceutical ingredient manufacturing plant involves an integrated approach that incorporates methods for optimizing total production management, quality control and assurance, and inventory management. The authors analyze results from a recent benchmarking study to evaluate the critical success factors in high-performing API manufacturing plants.

Rockville, MD (Mar. 23)-The US Food and Drug Administration has submitted to Congress its final proposals for reauthorizing the fourth Prescription Drug User Fee Act (PDUFA IV), which will follow the expiration of the current user-fee on September 30, 2007.

Aventrx, ImmBio, Eli Lilly, more

Berlin and Basel, Switzerland (Mar. 26)-Bayer Schering Pharma AG and Novartis reached an agreement over multiple sclerosis therapy ?Betaseron.?

Cobra, InterMune, Pall, More