News

J&J, Medivir get EU nod for their hep C drug Olysio

The horse race for oral treatments of chronic hepatitis C entered another turn today as the European Union recommended approval of Olysio, the Johnson & Johnson and Medivir entry in the high-stakes derby, Bloomberg reports.

Novartis' vaccine unit gets a badly needed booster from the U.K.

The U.K.'s Joint Committee on Vaccination and Immunization (JCVI) is revising its stance on Novartis' meningitis B vaccine Bexsero. The jab, originally left off Britain's routine vaccination schedule, has gained the JCVI's nod, supplying a needed boost for the Swiss company's flailing vaccine unit.

J&J's Velcade cleared by U.K. for first-line myeloma treatment in about-face

The U.K.'s National Institute for Health and Care Excellence has come around on Johnson & Johnson's Velcade as a first-line treatment for the blood cancer multiple myeloma. It approved the drug for the new use today, four months after initially saying it was unconvinced the benefits of the drug outweighed its costs.

Wockhardt plants cited by Indian regulators

In a move that seems to heed FDA Commissioner Margaret Hamburg's call to expect higher standards from their drugmakers, state drug regulators in India have taken action against two Wockhardt plants that the U.S. FDA banned months ago.

Novo CEO sees improved picture for Tresiba in U.S. market

Last year's FDA delay on Novo Nordisk's Tresiba was a major setback for the long-acting insulin that analysts said would severely dampen its earnings potential. But in the ever-changing pharma landscape, a new development has Novo CEO Lars Rebien Sørensen thinking the company may still get Tresiba to the U.S. market ahead of any significant competition.

Arkansas court boots $1.2B J&J verdict on technical grounds

In defending the largest state-level decision ever won against Johnson & Johnson for its Risperdal marketing, the state of Arkansas said the New-Jersey based company didn't properly communicate the antipsychotic's risks and marketed it for off-label use. In its appeal, J&J said it didn't commit fraud or harm the state's Medicaid program. But Arkansas' Supreme Court had something entirely different to say when it overturned the $1.2 billion judgment Thursday.

Merck to have Cipla make cut-rate version of an HIV drug

India's Cipla has been aggressive about taking aim at Western meds it thinks are too expensive for the Indian market, sometimes targeting those that have seen their patents pushed aside by compulsory licenses. But drugmaker Merck has a new deal with Cipla that might help it sidestep that issue.

J&J blazes a new pharma trail with industry's first designer-in-chief

Johnson & Johnson has designs on a brand-new way of thinking about products. The company is hiring a chief design officer, The Wall Street Journal reports, to create drugs and consumer products that look good, work well, and--it hopes--sell better.

New heart-disease guidelines could mean 12.8M new statin patients, NEJM study finds

New statin-use guidelines divided cardiologists when they were rolled out in November, because they would put millions more patients in line for the drugs. Now, new research estimating their impact puts the number of eligible statin patients even higher than some originally thought.

AstraZeneca unveils direct-to-patient Nexium delivery to fend off generic rivals

AstraZeneca is staring down the barrel of its Nexium patent loss, but it's doing its best to dodge the bullet. In a bid to keep patients hooked on the branded version of that purple pill, the company will sell Nexium to them directly--and at a discount.

Pay-for-delay: Is cash the only antitrust test that matters in patent settlements?

Patent settlements between drugmakers and generic manufacturers have drawn even more scrutiny since the U.S. Supreme Court ruled last summer that the Federal Trade Commission has a right to challenge them. At issue are "pay-for-delay" deals, in which manufacturers of branded drugs pay generics challengers to refrain from launching copies until an agreed-upon date.

Valeant's CEO, a crackerjack cost-cutter, seeks more 'fat' companies to buy

Back in January, Valeant Pharmaceuticals' CEO J. Michael Pearson couldn't say how he intended to reach his lofty goal of cracking the list of top 5 drugmakers worldwide. Now, he's offering new details about his acquisition blueprints, and they include deals in ophthalmology, dermatology and dentistry.

Horizon Pharma grabs Vidara and will head to tax-advantaged Ireland

Yet another U.S. drugmaker is headed to Ireland to enjoy the tax benefits. Horizon Pharma is doing a reverse merger with Vidara Therapeutics International in a deal that it says speeds its path to profitability. And where is Vidara based? Dublin.

Should gastro specialist Salix snap up Furiex and its IBS drug candidate?

Should Salix Pharmaceuticals snap up its North Carolina neighbor Furiex Pharmaceuticals? The latter's bowel drug could slide right in to Salix's business, analysts said. And Furiex is scouting around for a potential buyer, Bloomberg reports.

Contrary to popular belief, side-effect reports on new meds keep a steady pace, study finds

Side-effect reports to the FDA are a contentious subject. Despite a series of efforts to improve adverse-event reporting, numbers from the agency's database tend to be quoted with an accompanying list of disclaimers. But is the Federal Adverse Event Reporting System more reliable than we think?

Medivation, Astellas ask FDA to approve Xtandi for pre-chemo prostate cancer use

Astellas and Medivation today said they are asking the FDA for approval for Xtandi to be used on patients with metastatic castration-resistant prostate cancer who have not received chemotherapy.

Don't bet on a home-run drug launch, even for power-hitting drugs

Two-thirds of new drugs fall short of expectations their first year on the market and continue to fall short after that. But McKinsey & Co. consultants found that good launches are very, very good. What makes the difference? The consulting firm took a close look at 60 different drug launches to find out.

Roche breast cancer drugs Perjeta, Kadcyla are built for speed, report finds

Roche's new set of HER2-positive breast cancer drugs are making it big with oncologists.

Tamiflu study funded by Roche shows lives saved in pandemic

Governments around the world have been stockpiling Roche's Tamiflu to protect their citizens in the event of a flu pandemic--a practice that has been questioned by critics who say there's not enough evidence the drug works. Now, Roche has fresh data showing Tamiflu saved lives during the H1N1 swine flu outbreak of 2009.

Add 3 more biotechs to the IPO list: Agile, Aldeyra and GlobeImmune

Three more biotechs are aiming for IPOs amid a frenzy of public offerings in the industry. Agile Therapeutics, Aldeyra Therapeutics and GlobeImmune are hoping to raise a combined $132 million.