What should we make of the heavy, some would say unhealthy, concentration of drug R&D in certain hot categories like oncology and inflammation?
At Merck, the already giant-sized hope that its cancer immunotherapy program for the PD-1 drug MK-3475 represents just swelled significantly in importance. Just ahead of its 2013 earnings report Wednesday, the pharma giant announced plans to tie up with a trio of major league biopharma partners to launch a whole new slate of combination studies that could significantly extend its reach in the oncology market.
One of Pfizer's top late-stage prospects is its cancer drug palbociclib, an oral inhibitor of cyclin-dependent kinases (CDK) 4 and 6 that the FDA put in its first group of therapies awarded their "breakthrough" drug designation. But Pfizer is not the only Big Pharma company to view the CDK 4/6 pathway as a likely goldmine in oncology. Novartis has now started a slate of Phase I studies of LEE011, which its researchers are touting as a best-in-class contender.
Over the past two years Bayer has snagged an impressive string of key approvals for cancer and cardiovascular drugs--a much better record than many of its larger Big Pharma rivals. And today the pharma player is rolling out its slate of the next top drug prospects being groomed for late-stage pipeline work.
Researchers have posted early-stage data demonstrating that Roche's PD-L1 drug MPDL3280A--which takes the blinders off the immune system to spur an attack on cancer--scored a hopeful 26% response rate among a small group of non-small cell lung cancer patients who smoked.
In the deal AstraZeneca is paying Merck $50 million upfront and a slate of undisclosed milestones to bring in MK-1775, a WEE1 inhibitor that Merck took up because of its potential to spur repeated cell division, offering a new way to destroy cancer cells.
Silicon Valley Bank has been crunching the numbers on biotech launches and M&A deals reaching back 8 years, concluding that there's been a recent shift in the disease focus of companies getting funded in Series A rounds, while M&A deals surged over the past two years as upfront payments dwindled.
Shares of Array BioPharma took a nasty dive Wednesday evening after Amgen pulled the plug on an ambitious four-year-old partnership to develop new Type 2 diabetes drugs. The company said it will have to ax 50 workers--20% of its staff--in response.
Ensemble Therapeutics is putting its discovery engine to work on ultrarare diseases. The Cambridge, MA-based biotech will explore its rapidly growing library of 10 million macrocycles to see what it can whip up for Alexion's pipeline.
The agency is offering developers essentially an open door at the FDA to any program that qualifies, urging on R&D teams with quick responses and help adapting trials and hurrying the review process with an aim to getting more "transformative" drugs to the market faster.