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.
Novartis' Bexsero, approved in 34 countries, was the world's first marketed vaccine to protect against the deadly meningitis B. And now, it's one step closer to becoming the first in the U.S.--that is, if a Pfizer candidate doesn't beat it to the finish line.
Both Pfizer and Novartis have picked up the FDA's much-coveted breakthrough-therapy designation for their meningitis B vaccines, and now the rivals have chosen the same day to submit their injections for approval, leaving it up to regulators which will hit the market first.
Novartis' $1 billion influenza vaccine manufacturing plant in Holly Springs, NC, has just become the first pandemic-ready site FDA-approved to make cell-culture influenza vaccines. Now it needs to find a buyer for the facility.
Australian survivors of the deadly meningococcal B strain are mounting pressure on the country's Pharmaceutical Benefits Advisory Committee to include Novartis' Bexsero, the only approved vaccine for the disease, on its national immunization plan when it meets next month.