PharmTech Conference Coverage: QbD and Generics Face a Slow Road Ahead, but Traffic is Moving in the Right Direction

Angie Drakulich PharmTech editor“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 »

Same Fight, Different Day

Erik Greb PharmTech editorLast 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 »

Don’t Delay Affordable Healthcare

Erik Greb PharmTech editorPresident 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 »

The Gathering Storm of Generics

Erik Greb PharmTech editorLike 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 »

Innovators Attempt a Technical Knockout

Erik Greb PharmTech editorWhen 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 »

The Other New Jersey Giants

Erik Greb PharmTech editorIt’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 »

Pfizer & Wyeth: When the Going Gets Tough, the Big Get Bigger

Erik Greb PharmTech editorIt’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 »

If You Can’t Beat ‘Em, Buy ‘Em.

Erik Greb PharmTech editorInnovator companies are constantly looking for ways to compete with generic-drug manufacturers. The former have tried to improve or reformulate their products and to extend patent protection. But sufficiently big innovator companies have another option: they can buy their generic competitors. Read more »

How Do We Preserve Competition and Innovation?

Erik Greb PharmTech editorLast week, the European Commission (EC) published a preliminary report that described how the makers of branded pharmaceuticals delay the introduction of competing generic medicines. Industry associations for originator companies and generics manufacturers in Europe were quick to weigh in on the report. Now a UK judge has joined the debate. Read more »

Born under a Bad Sign

Erik Greb PharmTech editor

I’m not an astrologist, but sometimes you have to wonder whether plans were hatched under a bad sign. It certainly seems that way for “Vytorin,” a cholesterol-lowering drug that combines simvastatin and “Zetia.” The drug, introduced by Merck and Schering-Plough, has suffered damaging revelations. Read more »

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