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.
The FDA has given Tesaro a green light to start marketing rolapitant to help prevent some of the common side effects of chemotherapy. And now Tesaro will wage a David-vs.-Goliath battle for market share with a dominant Merck.
U.S.-based biotech Tesaro has in-licensed rights to its candidate to treat nausea in chemotherapy victims to China's Jiangsu Hengrui Medicine as it looks ahead to a pending review decision by the U.S. FDA.
Rolapitant, Tesaro's experimental therapy for preventing some nasty side effects of chemo, has hit all the primary and secondary goals, helping boost the company's stock today and leaving it on track to deliver an NDA to the FDA in the next few months.
Tesaro is making a move into the hot cancer immunotherapy field, paying $17 million upfront and offering milestones worth hundreds of millions more to work with AnaptysBio on a portfolio of antibodies that could be used in combination with its own pipeline drugs. And while one of the targets is PD-1, a popular subject in a field now dominated by Bristol-Myers Squibb and Merck, a pair of less familiar targets is also included in the package.
Tesaro touted positive results for the primary endpoints laid out for the late-stage program it had underway for its top cancer drug prospect rolapitant, but investors soured on the drug after it failed to score secondary goals and drove the biotech's shares down by a hefty 22% this morning.
With key results expected from its lead cancer program this year, the cancer drug specialist Tesaro has stocked its coffers with $91.2 million from a public stock offering.
After taking a beating in previous years, biotech has been hot sector on Wall Street this year. The Nasdaq Biotech Index has shot up 30% this year compared with 15% growth in the broader market. And the fact that this year's total number of biotech IPOs already matches that of 2011 indicates that there could be a growing appetite for these types of investments. But there's no indication that we're on the verge of, or will ever, return to the go-go years of the 1990s when biotechs more easily went public at lofty values. Here's the full report >>
GlobeImmune is hoping to ride the new wave of enthusiasm over immunotherapies to a successful IPO designed to raise up to $69 million.
Just two years after getting started, the experienced cancer pros at Tesaro have pulled off a successful IPO.