Published by Erik Greb on November 9, 2009
under Biotech, Manufacturing, North America News, Regulation, Trends
After much ado, the US House of Representatives passed a healthcare-reform bill this weekend. Drugmakers and commentators are understandably eager to parse the bill to find out what it would mean for the pharmaceutical and biopharmaceutical industries. So what’s the verdict? Read more »
Published by Erik Greb on November 2, 2009
under Latin & South America News, Manufacturing, Regulation
The pharmaceutical and biopharmaceutical industries have jealously guarded their intellectual property for years. Companies routinely use patents to prevent competitors from making generic versions of their drugs. When pipelines have weakened, companies have developed new formulations or delivery methods to extend patent protection for their established drugs. The economic crisis has only sharpened this reflex.
That’s why news from Ecuador made me do a doubletake. Read more »
Published by Erik Greb on August 10, 2009
under Biotech, Manufacturing, North America News, R&D, Regulation
Last Thursday, the Biotechnology Industry Organization (BIO) weighed in on a patent issue that will soon be before the Supreme Court. In an amicus brief, BIO argued that the Court should overturn Bilski v. Doll, a decision of the US Court of Appeals for the Federal Circuit. The case involved Bernard L. Bilski’s method for hedging risks in commodities trading. Read more »
Published by Erik Greb on June 8, 2009
under Manufacturing, North America News, Regulation, Trends
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 »
Published by Erik Greb on March 23, 2009
under Formulation, Manufacturing, Products, R&D, Regulation
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 »
Published by Erik Greb on January 26, 2009
under Manufacturing, North America News, R&D
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 »
Published by Erik Greb on December 8, 2008
under Europe News, Manufacturing, R&D, Regulation
Last 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 »
Published by Erik Greb on September 8, 2008
under Manufacturing, Regulation, Trends
Americans are focused on the election in November, but it bears mentioning that voting is not the only way to participate in democracy. Expressing your opinion about an issue to legislators and other public officials can be an effective way to get them to take your side.
The Brazilian Patent Office’s decision last week about a Gilead (Foster City, CA) drug might be an example of the power of public opposition. Read more »
« Previous Page