News

Gilead's Sovaldi triumph puts major hurt on payers' bottom lines

Hepatitis C wonder-drug Sovaldi is still selling at breakneck pace. And at this rate, it could break some insurers. At $84,000 per 12-week treatment course, Sovaldi's quick uptake is threatening payers' earnings, analysts say--and the drug's stellar efficacy profile leaves them with few options.

Supreme Court to hear Teva's Copaxone appeal

The Supreme Court has agreed to hear an appeal of a lower court's decision to invalidate Teva's Copaxone patent, which if restored will shield the drug until September 2015. The decision may, in the least, leave competitors wary of proceeding with generics, giving Teva more time to convert patients to a new, long-acting version of the treatment.

Sanofi taps outcomes exec for new C-level job as 'patient officer'

Last week, Johnson & Johnson chalked up a Big Pharma first by hiring a chief design officer. This week, the groundbreaker is Sanofi. The job? Chief Patient Officer.

Pfizer gets FDA green light for Nexium OTC launch as AZ braces for competition

AstraZeneca has been pulling out all the stops in trying to preserve blockbuster Nexium's revenues for as long as it can. Now, the FDA has approved an over-the-counter version of the drug--but thanks to a 2012 agreement, those sales are on their way to Pfizer.

GSK building up R&D, manufacturing and goodwill in Africa

Lots of drugmakers see Africa as a market that over time can produce some substantial business. But GlaxoSmithKline is not just manufacturing and selling drugs there. It is going one better with a new "open lab" R&D facility to let African researchers work on the drugs needed by Africans for noncommunicable diseases.

Biogen hemophilia nod puts Baxter's to-be-spun-off biopharma unit on notice

Biogen Idec now has FDA approval for Alprolix, the first in a new wave of long-acting hemophilia treatments on their way to market. For Biogen, the thumbs-up is an opportunity to grab market share with a hemophilia B product that works three times as long as current clotting factors. But what will the ensuing market battle mean for Baxter?

FTC aiming for $1B pay-for-delay patent settlement this year

The Federal Trade Commission is so fed up with "pay-for-delay" pharma deals, that it's hoping to reach a $1 billion settlement in at least one pharma antitrust case this year. That's the word from Deborah Feinstein, director of the FTC's Bureau of Competition, who revealed the agency's aims at a recent meeting of the American Bar Association's Section of Antitrust Law in Washington, D.C.

Massachusetts bans Zogenix's controversial new painkiller Zohydro

While congressional reps and activists flog the FDA for approving the powerful new painkiller Zohydro, Massachusetts Gov. Deval Patrick is taking a more direct approach. Patrick says he's banning Zohydro from his state until Zogenix develops an abuse-deterrent version.

GSK buys full control of consumer unit in Indonesia

Indonesia is one of the rapidly growing markets that drugmakers are trying to tap to boost sales, and GlaxoSmithKline is upping its bet. The U.K.-based drugmaker said today it will buy full control of its consumer health unit there.

Critics knock JAMA study linking testosterone drugs to cardio risks

A study the FDA has cited as a reason to investigate the cardiovascular safety of testosterone drugs has come under heavy fire from critics. Physicians and researchers are calling for the November paper's retraction, citing at least two corrections that they say compromise its credibility.

Bayer keeps cheap Nexavar copy from being exported from India

Chalk up a win for Bayer KGaA in its running battle in India over a compulsory license granted to Natco to produce a cheap knock-off of its cancer drug Nexavar. The drug is being sold in India but a high court there says that is as far as the Indian drugmaker can go with it for now.

Regeneron clears roadblock for new plant in Irish tax haven

Regeneron will continue forth with its €220 million plans to revamp a former Dell plant in Ireland now that an interest group has pulled its appeal, making room to flesh out its product line beyond blazing eye treatment Eylea.

UPDATED: Hospira puts shareholder lawsuit behind it with $60M settlement

Hospira is getting past quality issues that for several years dominated its attention and undermined its revenues. Now it has unburdened itself of litigation that came along with it.

Roche nabs European approval for time-saving formulation of Rituxan

Pharma companies sometimes try to extend the lives of drugs by developing new formulations or follow-on products before their patent expires. Swiss pharma giant Roche scored a victory today when European regulators approved a subcutaneous version of its cancer drug Rituxan, known as MabThera overseas.

GlaxoSmithKline pulls all U.S. alli supplies, launches product-tampering probe

GlaxoSmithKline is recalling supplies of its OTC weight-loss drug alli in light of reports from U.S. consumers who found the wrong drug when they opened their bottles.

GlaxoSmithKline's diabetes contender albiglutide nabs EU approval

European officials gave a green light to GlaxoSmithKline's once-weekly diabetes drug Eperzan (albiglutide). The GLP-1 drug is awaiting FDA approval, with a decision expected next month.

New NICE evals could green-light more drugs, but only at 'the very best price'

The U.K.'s cost watchdog is changing up the way it evaluates drugs. The National Institute for Health and Care Excellence (NICE) will be zooming out to look at the bigger picture when assessing therapies, which could result in more positive recommendations--something drugmakers have been dreaming of for years.

Merck, GlaxoSmithKline halt copay help for Obamacare patients

Merck and GlaxoSmithKline have nixed their copay assistance for Obamacare patients. The two companies say they fear subsidizing patients' drug purchases will run afoul of federal anti-kickbacks law. But many other top drugmakers- including Novartis, Sanofi and Eli Lilly--will keep their copay cards and discounts, at least for now.

Drugmakers agree to new FDA rules restricting antibiotic use in livestock

In December, the FDA asked animal health companies to voluntarily stop using antibiotics to promote growth of meatier cows, pigs, and other livestock. Now, the agency says 25 companies have signed on to its new guidelines, including Eli Lilly's Elanco, Novartis' animal health unit, and Zoetis.

Baxter to spin off its $6B biopharma business in industry's latest split-up

The pharma split-up movement is spreading. Baxter International says it will spin off its biopharma business into a separate company, leaving its $9 billion medical products business to venture on under the Baxter name.