In 2015, the FDA by its own account approved 45 new drugs, the largest one-year tally since 1996, which wrapped up with a record 53 regulatory OKs. Now, here's the full list of new drugs approved by the FDA in 2015, in chronological order.
There's not going to be a beyond-the-pill revolution in 2016. Frankly, pharma doesn't yet have the technology to move beyond pushing products to delivering outcomes. But drugmakers are teaming up with major technology players in deals that marry Big Data record-sifting with cutting-edge patient-monitoring gadgetry, and that's the kind of infrastructure necessary for big moves beyond the pill.
With one biosim already on the U.S. market, and more poised for a 2016 liftoff, next year will give drugmakers and payers a taste of the biosim contest to come.
Novartis will shed another manufacturing unit as it continues its efforts to improve earnings by getting more efficient. This time, it will sell an Alcon unit to Swedish contract manufacturer Recipharm but has swung a deal to buy and continue to market the eye meds made there.
Earlier this year, U.S. regulators updated the label of Novartis' multiple sclerosis pill, Gilenya, to reflect cases of serious brain infections linked to the treatment. And now, its counterparts across the pond are following suit.
Novartis has signed up as the strategic pharma investor in Seventure Partners' microbiome fund, blasting the VC shop past its initial fundraising target in the process. With €160 million ($176 million) to play with, Seventure now plans to back 25 microbiome companies, most of which will be based in Europe.
Novartis has stepped in to back Paris-based Seventure Partners' biotech fund focused exclusively on the emerging field of the microbiome as well as nutrition, bringing its fund to $176 million.
AbbVie, questing to justify its colossal buyout of Pharmacyclics, came away among the winners of the weekend's American Society of Hematology meeting, while the recently IPO'd Global Blood Therapeutics ran into mixed results with its sickle cell therapy and Celgene doubled down on immuno-oncology.
Novartis, leading a pack of companies developing genetically engineered T cells to fight cancer, unveiled more promising data on its Phase II treatment as it wends toward an FDA filing.
Sun Pharma said today that the FDA has approved its generic of Novartis' top-selling drug, cancer pill Gleevec, and that it will launch its version in two months, beginning Feb. 1.