News

MedImmune, Inc. (Gaitherburg, MD) reports that US Food and Drug Administration (Rockville, MD) has approved the company's supplemental biologics license application to use reverse genetics technology to construct new vaccine strains to produce seasonal influenza vaccines.

Biopharmaceutical company Lipoxen PLC (London, UK) has developed a Hepatitis E vaccine using its novel vaccine delivery technology "ImuXen," which the company claims to be easy to manufacture. According to the company, the proprietary liposomal formulation method delivers vaccine materials to the immune system in a manner designed to emulate the response of a natural encounter with the infection agent.

From RFID and pedigrees to PAT and process understanding, industry professionals are eying the growing gap between ambitious high-level guidance and current practice, and wondering how they can bridge this new space and keep in compliance with the untested rules.

A cleverly developed patent portfolio can block or minimize competition long past a patent's 20-year lifespan.

Pharmaceutical Science & Technology News

My audit host clearly knew and lied about the planned changes.

We can learn a lot about today's regulatory environment as a whole if we take it all in.

China is on the rise as a center for pharmaceutical R&D, but companies are still getting their footing for operating in China and the services industry has some maturing to do.

The creation in the Paris Region of a multidisciplinary Institute of Technology will bring together the best researchers in world, innovative SMEs and the research centres of large industrial groups.

Although it has recently been surpassed by Mexico in terms of value, the Brazilian pharmaceutical market remains of key importance to companies establishing themselves in Latin America. The Brazilian government has focused heavily on improving the healthcare system and this should lead to long-term benefits for its citizens. The Ministry of Health has also attempted to decentralize the management of the healthcare system to more regional and local levels. This has been necessary to account for the different healthcare priorities in different parts of the country.

Last week, the Generic Pharmaceutical Association (GPhA Arlington, VA) praised a proposal by the Senate Agricultural Appropriations Subcommittee that, if approved, would provide $10 million in additional funding for the US Food and Drug Administration?s (Rockville, MD) Office of Generic Drugs.

Baxa Corporation, Eli Lilly, PLIVA, SkyePharma, Wyeth

The US Food and Drug Administration (Rockville, MD) is restructuring its Office of Regulatory Affairs (ORA) into two offices.

The US Food and Drug Administration (Rockville, MD) approved the first generic versions of "Zocor" (simvastatin), the anticholesterol drug by Merck & Co., Inc. (Whitehouse Station, NJ).

On June 15, 2006, the US Food and Drug Evaluation?s Center for Drug Evaluation and Research (Rockville, MD) issued a 7-page warning letter to Ranbaxy Laboratories (Himachal Pradesh, India) for violations to US current good manufacturing practices.

Pfizer, Inc. (New York, NY) reports the United Kingdom's Court of Appeal has upheld the exclusivity of the main patent covering atorvastatin, the active ingredient in "Lipitor."

Johnson & Johnson Company (New Brunswick, NJ) agreed to buy the consumer healthcare business of Pfizer, Inc. (New York, NY) for $16.6 billion in cash.

Coinciding with the 100th anniversary of the US Food and Drug Administration (Rockville, MD), Representative Henry A. Waxman (D-CA) released a statement this week expressing his concern over ?an agency that is adrift and floundering.?

Pfizer, Inc. (New York, NY) will phase out manufacturing operations in Groton, Connecticut, eliminating roughly 300 jobs.

This week, the US Food and Drug Administration (Rockville, MD) posted a Warning Letter issued May 31 by its New Jersey District Office (Parsippany, NJ) to Neil Laboratories (East Windsor, NJ) for CGMP deviations.

Drug development opportunities, specification development, and new vaccine technologies were highlighted at the AAPS National Biotechnolgy Conference in Boston this week. More than 1100 attendees from 19 countries participated in the event.

Pall Corporation (East Hills, NY) reported strong sales growth in its biopharmaceuticals business in the fiscal third quarter (ending April 30, 2006) and announced plans for a company-wide cost-savings program.

Microsoft Corporation (Redmond, WA) announced the winners of the Microsoft Pharmaceuticals and Life Sciences Innovation Awards 2006 at this year?s meeting of the Drug Information Association in Philadelphia, Pennsylvania. A four-person panel of industry experts selected winners for the innovative use of Microsoft products in pharmaceutical and life sciences business processes and practices.

Avant, Barr, BASF, Degussa, Laureate Pharma, Millennnium Pharmaceuticals, Northfield Labs

Alpharma, Bayer, MicroTest, NexMed, Penwest

Preformulation represents an early-stage opportunity to facilitate the eventual movement of a drug substance into a commercial product. Strategies to optimize the preformulation process were outlined by Harry Brittain, institute director for the Center for Pharmaceutical Physics (Milford, NJ). He spoke at the PharmTech Annual Event in Somerset, New Jersey this week.

The ongoing battle between Bayer AG (Leverkusen, Germany) and Merck KGaA (Darmstadt, Germany) in their respective quests to acquire Schering AG (Berlin, Germany) was resolved this week, with Merck KGaA agreeing to sell its 21.8% stake in Schering to Bayer.

NPIL Pharma, a subsidiary of Nicholas Piramal India Limited (Mumbai, India) has agreed to acquire the Morpeth, Northumberland, UK, manufacturing facility of Pfizer Inc. (New York, NY).

GlaxoSmithKline PLC (GSK, London, UK) will invest more than GBP102 million ($188 million) over the next four years in a vaccine manufacturing plant in Singapore.

This week?s PharmTech Annual Event (www.pharmtechevent.com) in Somerset, New Jersey, targeted approaches to improving drug development and quality through optimizing processes, managing risk, and controlling variations in manufacturing operations.