News

What is the meaning of the Avandia vote?

After two days of deliberation, we saw a mixed vote on Avandia. Twelve members voted to take off the market, while 17 recommended changing the label to various degrees. Three voted that the drug

12 panel members recommend Avandia withdrawal

The votes are in, and it isn't good news for GlaxoSmithKline's (NYSE: GSK) Avandia (rosiglitazone). Twelve members of an FDA panel voted to recommend market withdrawal; 10 others voted for continued

Big change in market-access strategies, execs say

What's the biggest change for today's pharma executive? Market access strategies, according to a survey by Cegedim Dendrite. Forty percent cited it as the part of their business undergoing the

If Avandia falls, which diabetes meds fill the gap?

We won't have an indication of Avandia's future until this afternoon's advisory panel vote. And we won't know for sure until FDA itself makes its decision. But analysts tend to think that if Avandia

Lilly reps tout blood test to boost Effient

The clotbuster Effient is one of Eli Lilly's (NYSE: LLY) great new hopes, but the drug's early sales haven't exactly been overwhelming. As the New York Times points out, the first three quarters'

Marching orders for PhRMA's new top exec

Bloggers and industry types have taken notice of John Castellani's (photo) new role as PhRMA's chief, and they're lining up to give him some unsolicited advice. The In Vivo blog welcomed guest

GSK settles bulk of Avandia suits for $460M

As GlaxoSmithKline (NYSE: GSK) defended Avandia before an FDA advisory panel yesterday, its lawyers were making sure that defense doesn't move to a courtroom--in some 10,000 lawsuits, that is. The

Fund sues Pfizer board over off-label marketing

A union pension fund is suing Pfizer (NYSE: PFE) and its board, alleging that directors ignored signs that the drugmaker was playing fast and loose with off-label marketing. The fund blames the

How Novartis Vaccines turned fear into function

To hear Novartis Vaccines & Diagnostics' head of technical ops tell it, fear was the enemy when Novartis swept into its newly acquired vaccine company, Chiron. And conquering that fear was what

Lilly plans cuts in manufacturing, quality control

Eli Lilly plans to cut 170 manufacturing and quality-control jobs this year, most of them in Indianapolis, as part of its ongoing downsizing efforts. Report | Report

PhRMA hands reins to Roundtable chief

The drug industry in the U.S. has a new lead lobbyist. PhRMA has chosen John Castellani (photo) as its new president and CEO, beginning in September. He replaces Billy Tauzin, who stepped down last

Will FDA experts get last-minute Avandia documents?

You know what today is: FDA's expert advisors are meeting to determine the fate of GlaxoSmithKline's diabetes remedy Avandia. The agency delivered 700 pages of documents for the committee's perusal

California court resurrects price-fixing case

Thanks to the California Supreme Court, Big Pharma has to fight a price-fixing suit dismissed by a lower court two years ago. The suit claims that the drugmakers--Pfizer, GlaxoSmithKline,

Live from FDA: Nissen speaks on Avandia

GAITHERSBURG, MD -- Today is the day--the long awaited joint meeting of the FDA's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees to discuss the

Genzyme plots big growth at Framingham plant

Genzyme (NASDAQ: GENZ) isn't letting a little manufacturing crisis get in the way of its ambitious long-term growth plans. The big biotech outfit has blueprinted a massive 757,000-square-foot

Investors look to Q2 results for E.U. impact

With European governments cutting prices left and right, investors are worried. Just how worried they are--and should be--will grow clearer over the next few weeks as Big Pharma starts reporting Q2

GSK withheld Avandia data, contends ex-FDA staffer

As the FDA's expert advisors prepare to hear arguments over the safety of GlaxoSmithKline's (NYSE: GSK) diabetes drug Avandia, one former agency staffer is preparing to testify in a liability suit

PhRMA not interested in free-sample limits

Is the U.S. pharma trade group falling behind on code-of-conduct rules? PhRMA is concerned enough about Europe's new standards of behavior to issue a statement defending its own approach. The

Children's drug consumers sue J&J for fraud

Consumers are accusing Johnson & Johnson (NYSE: JNJ) of fraud and racketeering in a lawsuit stemming from its recent children's drug recall. The buyers of those recalled meds are demanding cash

IOM report could weigh on Avandia trial

Should drugmakers really conduct clinical trials when potential safety problems arise with a marketed drug? That's the question FDA Commissioner Margaret Hamburg asked the experts at the Institute of