The biggest winners–and losers–in the 2015 race for new drug approvals
Let’s start with the good news. 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. The new generational high, easily lapping last year’s list of 41 approvals, marks a new peak following a surge by the R&D side of the business, which continues to recover from a lengthy period of marked weakness. The FDA has helped, proving more than willing to come through with faster approvals, particularly in oncology. And the science around drug development has improved markedly as our understanding of the genetic drivers of disease continues to make real progress. Read more |Â Subscribe to FierceBiotech
Former Valeant CFO Schiller to step in for hospitalized CEO Pearson
Last week, Valeant CEO J. Michael Pearson, in the hospital with severe pneumonia, took a medical leave of absence. And now, the company is putting a new chief in his place. Former Valeant CFO and board member Howard Schiller will step in for Pearson on an interim basis, effective immediately, Valeant said Wednesday morning. Robert Ingram, the company’s lead independent director, will serve as interim chairman. Read more | Subscribe to FiercePharma
Theranos jumps the gun on innovation, pushes proprietary tech without proof: WSJ
Theranos is no stranger to criticism, facing overwhelming pushback the past few months after articles called its proprietary testing technology into question. But problems with the company’s testing methods date back much further, as a new report shows that Theranos often jumped the gun when it came to innovation, spooking investors, employees and potential partners. Read more |Subscribe to FierceMedicalDevices
Japan’s push on innovative drugs gets a budget boost
Japan’s cabinet gave the nod to a draft of next year’s budget in a Christmas Eve meeting that saw the Ministry of Health, Labor and Welfare (MHLW) get funds outlined in September to promote development of innovative drugs and medical devices–and paves the way for compassionate clinical trial approvals. The effort will receive Â¥82.5 billion ($690 million) for the fiscal year starting April 1, according to a ministry spokesman, as part of other spending outlines that included Â¥126.5 billion, up by 1.3%, for the Japan Agency for Medical Research and Development related to overall R&D in healthcare. Read more |Subscribe to FiercePharmaAsia
Leave A Comment