Both the active pharmaceutical and the formulation plants in India that Ranbaxy Laboratories planned to use to manufacture the long-delayed generic of Novartis' blood pressure drug Diovan are under FDA import alerts. But the Indian drugmaker has finessed a manufacturing workaround with the agency to make the heart drug at its Ohm Laboratories plant in New Jersey.
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.
The salary differences between top executives and the lowest-paid employees widened at 18 large Swiss companies last year, with pharma giants Roche and Novartis ranking high on the list of top offenders. That's the conclusion of a new report from Travail Suisse, an organization of trade unions.
Novartis' multiple sclerosis drug Gilenya may be able to mitigate a painful side effect of chemotherapy in cancer patients, according to a new preclinical study.
Novartis is in the process of trying to hive off its flu vaccines business after selling off the rest of its vax unit to GlaxoSmithKline. But first, it may have to deal with an Italian fraud investigation over pricing on a pair of those products.
Novartis is already under scrutiny in Italy after authorities there accused it of colluding to protect sales of eye drug Lucentis. But the Swiss pharma's situation in the country may be getting stickier, with authorities scouring its offices there for information on flu vaccine pricing.
Remember how Novartis CEO Joe Jimenez vowed to improve the Swiss drugmaker's margins? Would have been there and done that, if the company's recent spate of deals had been done last year--by 2.5 percentage points, Novartis now says.
Novartis, the industry's largest employer, is flipping units and streamlining its operation to boost margins, but the company has no plans to take its foot off the gas in R&D, keeping the pace on a $10-billion-a-year research budget with hopes of cranking out 14 blockbusters by 2018.
Manufacturing snafus have delayed copycat versions of Novartis' blood pressure drug Diovan, AstraZeneca's stomach-acid remedy Nexium and Roche's antiviral drug Valcyte.
Pfizer and Novartis have been racing to get their meningitis B vaccines to market for years. But as of Tuesday, the contest has never been closer, with both companies submitting approval applications to the FDA. Now, it's up to the agency to decide which shot gets the green light first--and first crack at the wide-open patient pool that comes with it.