The FDA has issued a warning letter to Merck & Co. regarding several manufacturing deficiencies at its main vaccine plant in West Point, PA. The letter states that the FDA found "significant objectionable conditions" in the manufacture of vaccines and drug ingredients during repeated inspections from Nov. 26th to Jan. 17th. The FDA's warning letter was issued because Merck's response to the FDA report sent after the inspections was considered to be "inadequate to address the serious deviations noted."
   
The same plant recalled two vaccines in December, PedvaxHIB, to prevent Haemophilus influenza type B, and Comvax, a combination vaccine for Haemophilus B and hepatitis B, after sterility problems were discovered.
   
According to the letter, the company didn't thoroughly investigate when vaccine batches failed to meet specifications, even if batches had been distributed, and some combination measles-mumps-rubella shots that failed "visual inspection for critical defects" were distributed anyway. The letter also said the plant didn't have written procedures, tests or other lab controls to ensure "identity, strength, quality, and purity" of products. However, according to the FDA, the issues identified are not likely to affect the safety of the vaccines made at the facility or their availability.
   
"We're committed to working with the FDA to ensure that all these issues are addressed to their full satisfaction," said Amy Rose, a Merck spokeswoman. "We are confident in the quality, effectiveness and safety of our medicines and vaccines," she said. Merck will be submitting additional information to the FDA and will discuss the information in a meeting, which is requested in the warning letter.  

GlaxoSmithKline has made several changes to its corporate executive management team. The appointments will take effect on May 22 when Andrew Witty officially assumes the role of chief executive officer.
   
Mr. Witty remarked, "It is clear that our industry is facing a rapidly changing environment. Demand for innovative medicines and healthcare products continues to grow, however we are also presented with increasing challenges, such as cost containment, regulatory pressures and generic competition."
   
He emphasized the need for GSK's business regions to drive sales growth, and announced new operational structures to expand and improve the company's capability, particularly in emerging markets and in Asia.
  
"Emerging markets, such as Brazil, Russia, India, China and the Middle East, are significant growth drivers of the future. They are already contributing close to 25% of today's market growth and are forecast to grow even faster in the future, around triple the rate of western countries. It is essential that we have an operating structure that is dynamic and responsive to the opportunities in these markets," said Mr. Witty. "I am therefore creating a new Emerging Markets region which will ensure that we devote the focus required to build on our excellent foundations in those markets and truly establish ourselves as a trusted, long-term partner, one that is actively working to address the specific healthcare needs in those countries," he said.
   
A new Asia Pacific region will also be created, which includes Japan and Australia. As part of the changes to business regions, GSK has realigned markets in North America (combining the U.S., Canadian and Puerto Rican businesses) and has established new operational areas in Europe in an effort to maximize opportunities for growth.
   
The company's new corporate executive team includes: Julian Heslop, chief financial officer; Moncef Slaoui, chairman, R&D; Chris Viehbacher, president, North American Pharmaceuticals; Simon Bicknell, senior vice president, company secretary and compliance officer; John Clarke, president, Consumer Healthcare; Marc Dunoyer, president, Asia Pacific; Eddie Gray, president, Pharmaceuticals Europe; Abbas Hussain, president, Emerging Markets; Duncan Learmouth, senior vice president, Corporate Communications & Global Community Partnerships; Bill Louv, chief information officer; Dan Phelan, chief of staff; David Pulman, president, Global Manufacturing & Supply; David Redfern, chief strategy officer; Jean Stephenne, president and general manager, Biologicals; Claire Thomas, senior vice president, Human Resources, senior vice president and general counsel.  

Robert R. Ruffolo, Jr., Ph.D. will retire as president, Wyeth Research and senior vice president, Wyeth, later this year. He will be succeeded by Mikael Dohlsten, M.D., Ph.D.
   
Dr. Ruffolo joined Wyeth in November 2000 and has been responsible for all pharmaceutical R&D for the company, including discovery, drug safety and metabolism, chemical and pharmaceutical development, clinical R&D and research operations.
   
"Bob Ruffolo has been the driving force of our R&D progress, establishing Wyeth as one of the research leaders in the pharmaceutical industry," said Bernard Poussot, Wyeth's president and chief executive officer. "His legacy will be our pipeline, recognized as one of the industry's most innovative. Bob has helped position our company for future growth through robust research and development programs in oncology, women's health, vaccines, inflammation, cardiovascular and metabolic diseases and neuroscience -- led by our multi-platform effort in Alzheimer's."
   
Dr. Ruffolo's work has been recognized throughout his 31-year career in the pharma industry with a number of prestigious awards including: The Pharmaceutical Research and Manufacturers of America's (PhRMA) 2008 Discoverer's Award for his efforts in the discovery and development of Coreg while at GlaxoSmithKline; the 2006 Scrip Award for Management Team of the Year for The Wyeth R&D Executive Team (RADEX)—formed and chaired by Dr. Ruffolo; and the George B. Koelle Award for Scientific Excellence.
    
Dr. Dohlsten was previously executive vice president within Pharmaceutical R&D/Medicine at Boehringer Ingelheim. He was responsible for leading the company's pharmaceutical research in the U.S., Canada, Germany, Italy, Austria and Japan, with major programs in seven therapeutic areas including: respiratory, inflammation/immunology, oncology, virology, cardiovascular, metabolism and CNS. He was also a member of the corporate management team responsible for reviewing all worldwide development projects and licensing opportunities. Prior to joining Boehringer, Dr. Dohlsten spent more than 15 years in various leadership roles in pharmaceutical research including positions with AstraZeneca and Pharmacia & Upjohn.
   
"We look forward to Dr. Dohlsten's leadership as we work together to continue our success at Wyeth Research," said Mr. Poussot. "His experience with industry in a broad range of therapeutic areas, and his vision going forward, match well with our scientific objectives. We know Mikael's global experience and perspective will be an inspiration to Wyeth's outstanding research teams."

In a busy week for Dr. Reddy’s Laboratories, the company has completed its acquisition of The Dow Chemical Company’s Dowpharma Small Molecules Business along with its Mirfield and Cambridge, UK sites. Financial terms of the transaction were not disclosed.
   
The acquisition includes the relevant business, customer contracts, associated products, process technology, intellectual property and trademarks, as well as the transfer of the Mirfield and Cambridge facilities. Employees directly related to the business at each site will become part of Dr Reddy’s. Dr. Reddy’s will also have a non-exclusive license to Dow’s Pfenex Expression Technology for biocatalysis development.

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