Does federal law shield the makers of vaccines from product-liability lawsuits? Last week, the US Supreme Court began considering this question, which is the heart of a lawsuit against Wyeth, now a part of Pfizer (New York). Read more »

Pharmaceutical manufacturers are always chasing the twin goals of greater efficiency and reduced costs, regardless of whether the economy is doing well or badly. Each of these goals can be elusive, and achieving both at once even more so. That’s why news about a promising method for producing paclitaxel caught my attention. Read more »

The global recession is still prompting a lot of belt tightening. Patients and healthcare payers are looking for ways to cut costs, and drugmakers are trying to boost their manufacturing efficiencies. Developing countries naturally are feeling the squeeze more keenly. Budget constraints in those nations could keep patients from receiving necessary vaccines, which often are produced from recombinant proteins in a multistep process that is complicated and expensive. Read more »

Now it’s official. Rumors about sanofi-aventis’s (Paris) desire to purchase Genzyme (Cambridge, MA) have stirred speculation for weeks. The French drugmaker laid its cards on the table on Sunday by publishing its offer letter to Henri Termeer, Genzyme’s CEO. Sanofi proposed to pay $69 in cash per Genzyme share, or a total of about $18.5 billion, to acquire the biologics manufacturer. On Friday, Genzyme shares closed at $67.62.

Termeer’s response came this morning. It can be summed up in two words: nothing doing. Read more »

Have you ever allowed yourself what you thought was ample time to drive somewhere, only to be delayed by a construction crew that was repairing the roads? Obviously, things don’t always work out as we plan them. Judging by its latest announcement about its facility ameliorations, Genzyme (Cambridge, MA) must have learned this lesson, too. Read more »

As Congress prepares to go into summer recess and begin the legislative season again after Labor Day, a subject that has been of ongoing concern for the pharmaceutical and fine-chemical industries has resurfaced: drug safety by reforming regulatory oversight for foreign drug-manufacturing facilities and related issues. The bill, the Drug Safety and Accountability Act of 2010, introduced this week by Sen. Michael Bennet (D-CO), raises again the issue on how best to oversee an increasingly global pharmaceutical supply chain. Read more »

Publicity about substandard or contaminated products usually lights a fire under pharmaceutical companies, which then race to address their compliance problems. But a new US Food and Drug Administration inspection report shows that, despite a stream of product recalls and a Congressional investigation, Johnson & Johnson (J&J, New Brunswick, NJ) has not gotten its house in order yet. And the company’s latest problems conceivably could make things hot for one of its partners. Read more »

The Wall Street Journal reported yesterday that some of McNeil Consumer Healthcare’s recalled infants’ Tylenol contained as much as 24% more acetaminophen than it should have, according to a letter the company sent to physicians and poison-control personnel. McNeil’s letter stated that the samples containing the 24% increase did not reach the public, but that the company could not be sure “all the individual bottles were within specification or that 24% would have been the maximum,” according to WSJ. Read more »

This morning I read about a public–private collaboration that reflects many of the latest trends in the drug industry today. The project began when the University of Pittsburgh Medical Center (UPMC) created the 21st Century Biodefense (21CB) initiative to enhance the nation’s biosecurity. Robert J. Cindrich, who is leading the initiative, said in a press release that the project’s goal was to foster advances in vaccine development and manufacturing. Battelle (Columbus, OH), a research and development organization, IBM (Armonk, NY), Merck (Whitehouse Station, NJ), and GE Healthcare (Waukesha, WI) have all joined the collaboration so far. Read more »

These days, mandatory furloughs and staff cuts have employees in all industries nervously glancing over their shoulders. The pharmaceutical industry is no exception. Last week, Merck (Whitehouse Station, NJ) revealed plans to reduce its workforce by 15% by the end of 2012. Read more »