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.
After getting the FDA's OK for cell-culture vaccine Flucelvax back in November 2012, Novartis now has a U.S. facility licensed by the agency to produce it. The drugmaker's Holly Springs, NC, plant is now the country's first pandemic-ready site with the regulator's green light to make cell-culture flu vaccines, it said Monday.
After Japanese authorities arrested an ex-Novartis employee Wednesday, prosecutors raided the company's Tokyo office to continue their probe into data manipulation. The move comes six months after Japan's health ministry first filed a complaint to prosecutors alleging that the company used exaggerated advertising to market the blood pressure drug Diovan.
Japanese police brought in Nobuo Shiraishi, a former Novartis worker linked to discredited studies of the company's blood pressure drug Diovan. Shiraishi is suspected of violating the country's pharma laws by providing false data to researchers, Tokyo prosecutors said in a statement.