On the heels of FDA's rejection of the AcelRx New Drug Application for sublingually delivered postoperative pain killer Zalviso, CEO Richard King expounded on the "optical system errors" of the opioid drug's handheld, preprogrammed delivery device during a July 28 conference call with investors.
FDA's May 28 approval of Natesto, the first nasally delivered testosterone gel for hypogonadism, came just in time for Canada's Trimel Pharmaceuticals, which had just $18 million left on hand at the beginning of the year.
AstraZeneca has won FDA approval for its new prescription strength fish oil therapy for artery-clogging fats, but don't look for it to help much in its nascent effort to convince investors that its bright prospects should make them steer clear of Pfizer's takeover pitch. This drug is headed into a crowded field that now includes a low-priced generic competitor.
After a quick march through the clinic, Novartis has won early FDA approval for the new "breakthrough" lung cancer drug ceritinib (or LDK378), which will now be launched as Zykadia.
The wave of new drug approvals that had been building at the FDA has broken. According to the official tally of new drug and biologics approvals at the agency, the biopharma industry registered only 27 OKs for new entities in 2013--a sharp plunge from 2012's high of 39 that once again raises big questions about the productivity and sustainability of the world's multibillion-dollar R&D business.
The FDA has come through with an early approval of the BTK drug ibrutinib, a likely new cancer blockbuster from Pharmacyclics (and Johnson & Johnson.
So far this year the FDA has approved 27 new drugs, fewer than last year's total. But a greater focus on real medical breakthroughs will make this year's crop far more valuable than the harvest of 2012, according to EP Vantage.
Despite fewer drug approvals overall compared to last year, this year will have turned out a new crop of blockbusters whose combined revenues 5 years out are forecast to reach $18.7 billion, besting last year's record of $16.4 billion in projected sales, according to a report released today by EP Vantage.
Just hours after Bayer laid out some ambitious plans to accelerate development of a new wave of cancer and cardiovascular therapies, the FDA came through with a key new approval of riociguat--to be sold as Adempas--for a devastating lung disease.
So what happens at the FDA in the event of a government shutdown next Tuesday? For now, the agency isn't saying, referring reporters to an OMB statement guiding government agencies to prepare to execute "an orderly shutdown."