Merck may soon be the next Big Pharma to step into the Ebola vaccine arena.
In August, Sanofi's Genzyme won the FDA's blessing to take brand-new orphan drug Cerdelga into the U.S. Gaucher disease market, where the company hoped the pill could show up older, intravenous treatments. And now, it could be on its way to the same opportunity in the EU.
How low should LDL go? That is the debate that continues among heart doctors since the American Heart Association upended statin prescribing guidelines last year, and Merck's Zetia is now in the middle of the muddle.
Boehringer Ingelheim's Ofev and Roche's Esbriet became the first two U.S.-approved treatments for idiopathic pulmonary fibrosis when the FDA green-lighted them on the same day last month. And while Roche has the lead with Esbriet in Europe, Boehringer is now one step closer to leveling the playing field on the continent.
The FDA has faced a firestorm of criticism since approving Zogenix's superstrength painkiller Zohydro last year, drawing outcry from lawmakers and industry groups concerned with the drug's all-hydrocodone formula. Now, discontent could swell even further as the agency signs off on Purdue Pharma's opioid treatment Hysingla for chronic pain.
It was Sanofi's first public event without ex-CEO Chris Viehbacher. But the French drugmaker's investor day didn't bring much in the way of surprise. As expected, Sanofi Chairman Serge Weinberg talked up the launches expected for next year and beyond, all $38 billion worth.
The U.K. and Novartis have been negotiating for months now on a fair price for the Swiss pharma's meningitis B shot, Bexsero, which the country plans to add to its childhood vaccination schedule. So what's the holdup?
Which old meds hold their own with fast-growing Sovaldi, Tecfidera, and Xarelto? Try Humira and Revlimid
According to FirstWord Pharma, over the past four quarters, the 50 biggest-growing drugs delivered an absolute sales increase of $31 billion to their makers. While the top 5 slots on FWP's list are filled with a who's who of recent, high-powered launches, AbbVie stalwart Humira is right up there with the new rollouts--and the list holds a few surprises lower down, too.
France threatened to tax hepatitis C drugmakers if they insisted on charging nosebleed prices. Apparently, the arm-twisting worked: The French government says it has cut a deal with Gilead Sciences to get Sovaldi at the lowest price in Europe.
Ranbaxy Laboratories suffered a stinging setback in its battle to keep copies of AstraZeneca's blood pressure med Nexium and Roche's antiviral Valcyte off the market, as a U.S. court denied its request for a temporary restraining order against companies producing generic versions of the drugs.
What happens when the worst of the pharma patent cliff passes and new drug approvals surge? A big leap in drug spending. After a sluggish 5 years or so, global outlay on pharma products will jump by up to 30%--or $335 billion--by 2018, according to a new report from the IMS Institute of Healthcare Informatics.
Companies may want to invite other members of the office to the marketing party--and send specialized reps to offer a few favors.
Novartis hasn't been shy about digital. The Swiss drugmaker has rolled out app after app to help patients track their symptoms and stay on their drugs. But CEO Joe Jimenez says the company is about to do a lot more than that.
Those fast-and-furious rumors about Chris Viehbacher's impending ouster at Sanofi? The new round of chatter about Viehbacher's replacement is almost as intense. Bloomberg has a list of healthcare execs said to be up for the job, and they span a who's who of Big Pharma companies.
More than 500 Pennsylvania-based Shire workers are shipping up to Boston in a move CEO Flemming Ornskov says will "streamline operations and drive further efficiencies."
The safety message on Boehringer Ingelheim's key product, Pradaxa, has been mixed. But the German drugmaker has rolled out some new studies that show its effectiveness, as well as some promising data about the antidote being developed to treat serious bleeding in Pradaxa patients.
The U.K.'s cost-effectiveness gatekeepers have flip-flopped on Novartis' Xolair before, withdrawing support for the drug in 2012 before expanding its approval for asthma the following year. Now, the National Institute for Health and Clinical is asking the drugmaker to pony up more information about the product before recommending it to treat chronic spontaneous urticarial (CSU), or psoriasis.
Open up the floodgates: Gilead's hep C wonder-cocktail, Harvoni, has won approval in Europe.
Ranbaxy Laboratories has filed a federal lawsuit trying to reverse the FDA's decision to cancel its approvals to make generics of AstraZeneca's blockbuster Nexium and Roche's Valcyte.
Big Pharma earned gold stars in 2014, as the industry's top drugmakers did more to get their meds to patients in the world's poorest countries. But despite recent progress, companies still have room to grow in R&D and distribution, the Index notes.