These days, research scientists, much like Rodney Dangerfield, can’t get any respect. The latest evidence of this arrived on Friday, when AstraZeneca (London) proposed to cut 3500 research and development (R&D) jobs by 2014. Read more »

The European Commission has said it will be taking a close look at patent settlements where an originator has paid off a generic competitor in return for delayed market entry of a generic drug. Only yesterday, the EC released a statement saying that it has asked certain pharmaceutical companies to submit copies of their patent settlement agreements completed between originator and generic companies between July 2008 and Dec. 31, 2009. Read more »

Friday the 13th was an unlucky day for Genzyme (Cambridge, MA). On that day, the company and the US Food and Drug Administration alerted healthcare providers that stainless steel fragments, nonlatex rubber, and fiberlike material had been found in products filled at Genzyme’s Allston Landing manufacturing facility. The enzyme-replacement products Cerezyme, Fabrazyme, Myozyme, Aldurazyme, and Thyrogen were affected. FDA advised that visual inspection and filtration of the products should reduce the risk of administering contaminated medicines to patients. Read more »

“If QbD is the ocean of knowledge, then generics are just pulling out of the driveway. We haven’t even seen the beach yet,” said Aloka Srinivasan, PhD, a team leader at the FDA Office of Generics (OGD) and a speaker at today’s keynote session of the 3rd Annual Pharmaceutical Technology Conference in Philadelphia, PA. Read more »

Last week, the Biotechnology Industry Organization (BIO) and the Generic Pharmaceutical Association (GPhA) released dueling statements about the proposal to establish an approval pathway for follow-on biologics that the Senate Committee on Health, Education, Labor, and Pensions (HELP) is considering. Are the two antagonists advancing the debate? Read more »

President Obama’s plan for lowering the cost of healthcare relies partly on ensuring that affordable generic drugs are available to patients. This strategy is not likely to be palatable to innovator companies, who have tried various ways of delaying generic drugs’ introduction to the market. Read more »

Like a snowball that gets bigger and bigger as it hurtles down the side of a mountain, generic drugs pose an increasingly large threat to branded pharmaceutical companies. Wolters Kluwer Health’s annual analysis reveals that more than 60% of all US prescriptions filled in 2008 were generics. For orally administered medicines, the percentage was even greater. In 2008, 2.4 billion prescriptions were filled for generic drugs, and only 1.4 billion for branded therapies—an unprecedented divide, according to the report.

What’s Big Pharma to do? Read more »

When faced with determined opponents, sports teams sometimes work the referees to win the game. A victory based on an interpretation of the rules is a victory nonetheless. The team of Warner Chilcott (Rockaway, NJ), Medicis Pharmaceutical (Scottsdale, AZ), Roche (Basel), and Stiefel Laboratories (Coral Gables, FL) recently used this tactic in their competition with generic drugmakers. The companies filed citizen petitions with the US Food and Drug Administration in an attempt to delay the approval of generic versions of their antibiotics. Read more »

It’s déjà vu all over again. Little more than a month after Pfizer (New York) announced that it would acquire Wyeth (Madison, NJ), Merck (Whitehouse Station, NJ) and Schering-Plough (Kenilworth, NJ) have unveiled their own merger agreement. The combined company will be called Merck and be based in Whitehouse Station, New Jersey. Schering-Plough CEO Fred Hassan will help during the merger, but Merck’s CEO Richard Clark will lead the combined company. Read more »

It’s official. The wires had been buzzing with rumors for several days, and today Pfizer (New York) announced that it would acquire Wyeth (Madison, NJ) for about $68 billion. The transaction will bolster Pfizer’s pipeline and improve its biopharmaceutical portfolio with the addition of Wyeth’s “Prevnar” pneumococcal vaccine and “Enbrel” arthritis treatment. The resulting company will be so diversified that it expects that no drug will account for more than 10% of its revenue in 2012, according to a Pfizer press release. Read more »