News

Testosterone elevating drugs free of heart attack risk, study says

A new study of 24,000 Medicare patients found there is no heart attack risk associated with testosterone drugs and they even provided some protection in men judged most likely to suffer one.

Canada gives GSK 30 days to get its vaccine plant in order

GlaxoSmithKline is under pressure from not one, but two regulatory bodies to get problems under control at a flu vaccine plant in Canada. After the FDA handed the company a warning letter late last month, Health Canada now says the pharma giant has a month to lay out a plan for resolving issues there.

EU approves GSK's Mekinist and Novartis will reap the rewards

GlaxoSmithKline has notched another approval for its novel melanoma med Mekinist, and Novartis gets to celebrate. The drug, which the EU has approved for use there, is among those GSK is selling to the Swiss drugmaker in a $16 billion deal.

U.K. fund manager Neil Woodford bets big on AstraZeneca

Plenty of AstraZeneca fans voiced their support for a standalone company when Pfizer tried to take the drugmaker over earlier this year. But actions speak louder than words, and now one vocal advocate is putting his money where his mouth is.

U.S. voices concern over closed trial of American linked to GSK scandal

Until now, the widening soap opera that has left GlaxoSmithKline facing bribery charges in China seemed to be Britain's problem. But now the United States is stepping in, as China moves to try an American in a secret courtroom procedure starting August 7.

Teva trots out genetics in new petition against Copaxone copies

Teva just won't give up on delaying generic Copaxone. Its latest tactic: filing a citizen petition with the FDA to once again push for full-scale, placebo-controlled clinical trials for all copies of its multiple sclerosis med.

AbbVie chief quietly touts his Shire deal to shareholders, signaling a new bid

After three failed bids for Ireland's Shire, AbbVie CEO Richard Gonzalez may be considering upping his bid. But first, he's making his case to major to Shire shareholders, urging them to put the heat on the company to come to the bargaining table.

Pfizer yanks 220,000 Pristiq bottles on pill mix-up

For the second time in recent months, Pfizer is recalling hundreds of thousands of bottles of a drug when one was found to contain the wrong tablet.

PBMs join chorus of support for easy names on biosimilar drugs

The FDA is getting an earful from another group intent on saving money on biotech drugs. A coalition of pharmacies, health insurers, unions and pension plans asked the agency to allow biosimilar drugs to carry the same generic names as the drugs they copy. Easy to substitute the biosim for the brand, easier to cut biotech drug spending.

Why do vaccines cost so much? Ask Pfizer about Prevnar 13

We're accustomed to the fact that U.S. payers shell out more for drugs and vaccines than payers in other countries that have cost-conscious government gatekeepers. But a new analysis by The New York Times shows that, in the vaccines market, pricing is even more schizophrenic than that.

China chooses closed trial for investigator linked to GSK bribery scandal

China's arrest of British private investigator Peter Humphrey and his American wife Yu Yingzeng last summer was a shock to the pharmaceutical community, as Humphrey's firm, ChinaWhys, had long provided assistance to drug companies trying to navigate that country's complicated business environment. Now it looks as if the two are going to be tried privately--in a closed-trial procedure that China normally reserves for cases involving national security or state secrets.

Going beyond Pfizer: Animal health news publication to launch Monday

The editors at FiercePharma in the last 18 months have found ourselves writing a fair number of stories about animal health operations. Many of the companies we cover have animal health units and the success, or lack thereof, for those is a big deal for these companies and their investors.

Study: Med students cozy with pharma reps more likely to dole out branded drugs

Doctors aren't the only ones to fall prey to free lunches and fuzzy promotional talks. Medical students who spend more time with& pharma reps are more likely to dole out brand-name products, and less likely to rely on evidence when choosing which drugs to use, Medscape reports.

Zogenix puts Zohydro 2.0 into high gear, aiming to beat Purdue, Teva

Zogenix knows it needs to step on the gas. If the company doesn't develop an abuse-resistant version of its controversial-and-powerful painkiller Zohydro--and quickly--another drugmaker will speed past.

Rottapharm founders price IPO valuing company at up to $2.46 billion

Two years ago, Rottapharm's founding family gave up on selling a big stake in the company. Word was, the offers didn't quite measure up to the asking price--and the Rovati family wanted to keep more power than buyers were willing to give. Now, the Italian drugmaker is planning an IPO that would value the company at €1.45 billion to €1.8 billion, or up to $2.46 billion.

Bayer likes all the brands it got from Merck, Coppertone and Dr. Scholl's included

Should Bayer sell some of the consumer brands it's buying from Merck in a $14 billion deal? Analysts say a few of them--Coppertone sun products, for instance--don't quite fit with Bayer's product lineup. Buyers appear to be knocking. But Bayer says it will keep those brands, thank you very much.

Not for sale, says new Actavis CEO. We're buying instead

After serving as Bausch & Lomb's chief exec for just 5 months, incoming Actavis CEO Brent Saunders wants to keep his new job for awhile. So forget selling the company, fast-growing and attractive as it may be, Saunders is more interested in buying.

Takeda COO Weber's reset plans include acquisitions, market expansion

Takeda's board swept aside concerns over having the company run by a non-Japanese executive, setting up Frenchman Christophe Weber to carry out the plans he believes are needed to turn around the faltering drugmaker.

France aims to save big bucks by subbing unapproved Avastin for eye drug Lucentis

In June, the Italian government said it would pay for Roche's cancer drug Avastin to be used to treat a blinding eye disease, in place of the company's far more expensive eye drug Lucentis. Now, France is following Italy's lead.

Amgen scores FDA's 'breakthrough' nod for prospective leukemia therapy

Amgen nabbed a breakthrough designation for its mid-stage blood cancer drug blinatumomab.