News

Eliquis scores DVT/PE recommendation in Europe

Right now, Eliquis, the new-age clot-fighter from Pfizer and Bristol-Myers Squibb, is in third place in a three-horse race. But as it tries to catch up to rivals Pradaxa and Xarelto--not to mention the $3-billion-per-year sales forecasts analysts slapped on it in its early days--a new recommendation for expanded use in Europe should give it a boost.

UPDATED: Sanofi's Lantus empire imperiled as EU recommends Lilly, Boehringer biosimilar

Sanofi's Lantus is not only the best-selling diabetes drug in the world; it is one of the best selling drugs in the world with $7.6 billion in 2013 revenues. But the foundation for this juggernaut is starting to crack. The EU Friday recommended approval a biosimilar of Lantus developed by Eli Lilly and Boehringer Ingelheim.

EU backs Roche's Avastin for hard-to-treat ovarian cancer

The EU Committee for Medicinal Products for Human Use (CHMP) handed down a positive ruling on Roche's blockbuster Avastin, recommending that the European Commission approve the drug for use in women with ovarian cancer that's resistant to platinum-based chemotherapy. 

UPDATED: Ranbaxy's generic of Novartis blockbuster Diovan approved for launch

The long-delayed and highly anticipated launch of generic Diovan is on the way, which is a bummer for Novartis and a huge boost for Indian drugmaker Ranbaxy Laboratories. It is also validation for the decision by Sun Pharmaceutical's owner, billionaire Dilip Shanghvi, who struck a $3.2 billion deal to buy Ranbaxy despite its years of FDA entanglements over quality issues.

Sanofi tiptoes toward selling some older products

Back in April, Sanofi was said to be considering some spring cleaning, weighing a sale of older products to make room for the bolt-on deals CEO Chris Viehbacher wants to make. Sanofi appears to be heading down that path; the pharma giant is in the "very early stages" of weighing a sale of its older meds, Reuters sources say.

Republicans back generic industry's fight against FDA labeling rule

Two Republican lawmakers are supporting the generic industry's fight against the FDA's proposed rule on product labeling.

Eli Lilly's anti-takeover superpower? A shield forged by Indiana lawmakers

Eli Lilly & Co. won't be needing pepper spray to fend off unwanted suitors. That's not because it lacks charm or offers few attractive assets, Bernstein analyst Tim Anderson says. A quirk in Indiana law protects the drugmaker from hostile takeovers.

Biogen MS blockbuster Tecfidera earns high marks for safety

Biogen's multiple sclerosis drug Tecfidera has racked up $1.38 billion in sales since its launch last April, and now the company can claim another feather in the drug's cap: It has the best safety profile of any of its peers. That's the conclusion of a new report out from AdverseEvents, which analyzes side-effects data filed with the FDA.

Reuters: Valeant supporter Paulson grabs 6 million-plus Allergan shares

Tuesday, Valeant CEO J. Michael Pearson said his company was close to luring the 25% of Allergan investors it needs to call a special meeting, where it believes it can shake up Allergan's board and dismantle its poison pill defense to make way for a takeover. And now, the Canadian pharma may have just picked up some more support.

After 4-year Benicar review, FDA slaps aside heart-risk worries

After four years of sifting data, the FDA says it found "no clear evidence" that Daiichi Sankyo's blockbuster blood pressure drug increased the risk of heart attack. But the agency will require new safety-related data on Benicar's official label.

Valeant CEO claims Allergan investors support a buyout vote

Valeant can't make a deal for Allergan if it doesn't get shareholder support for a special meeting. That's where it hopes to overturn Allergan's board and its poison pill defense. But if you ask Valeant CEO J. Michael Pearson, his company is well on its way toward that goal.

A new excuse for pharma to avoid the Twitterverse, thanks to the FDA

Any brand managers eager to jump into Twitter as soon as the FDA gave the go-ahead? No such luck. Last week's social media guidance on risk disclosures may have cleared up some of the regulatory fog, but in this case, clarity isn't a positive.

J&J, GSK meds join Sovaldi, Tecfidera in blockbuster-to-be crowd

New drug approvals may have dropped from 2012's high of 43 to 35 last year. But that doesn't mean 2013's crop lacks superstars.

GSK expects to meet flu vaccine demand but even short interruptions can be costly

GlaxoSmithKline, responding to an FDA warning letter sent to the plant that produces its FluLaval and other influenza vaccines for the U.S. and Canada, said it expects to be on track to produce more than 30 million doses for the upcoming flu season. But the experience of other drugmakers suggests that even a small hiccup in producing a vaccine for a crucial cycle can be significant to a drugmaker's top and bottom lines.

Novo Nordisk exec: We'll double sales within 10 years

This has not been a great year for Denmark's Novo Nordisk ($NVO) so far--the diabetes drugmaker failed to post double-digit sales growth in first quarter for the first time in four years. But the company believes its 2014 performance is just a temporary blip.

AbbVie can argue for a Shire buy, but price is the thing--and $51B might do it

Monday, Shire laid out its justification for staying independent, eager to ward off circling suitors. Now, AbbVie, which has already made three passes at the Irish drugmaker, has laid out its own case for a takeover.

Affymax, once a promising biotech, is dissolving

Affymax, which 18 months ago appeared poised for big things, is dissolving the company and will pay shareholders pennies for the shares that traded at $27 a share before patient deaths led it to pulled its Omontys anemia drug from the market.

R&D spending rebounds big in 2013

Pharma companies have taken some heat for their R&D productivity levels as of late, but drug developers and investors may recently have seen some of their faith restored.

Big Pharma ceding sales--and share--to up-and-coming drugmakers

Good news for drugmakers: Sales will grow more than 5% through 2020. More good news: Patent cliffs will be more like "rolling hills" in the years to come, thanks to the preponderance of biologic meds. Even more good news: Last year's crop of new drugs is the strongest in years, judging by the blockbuster-level expectations for most of them.

Struggling Endo grabs generics maker DAVA for up to $600M

Endo, in a world of financial hurt, has been turning to M&A lately to ease the pain. Its latest move: a deal for New Jersey generics maker DAVA Pharmaceuticals worth up to $600 million.