Major research institutions that receive federal funding routinely fail to report human trial results to ClinicalTrials.gov, the federal transparency database, in violation of federal law. Drugmakers usually bear the brunt of scrutiny and criticism over failure to disclose, but a STAT News investigation has found that major academic research centers, teaching hospitals and not-for-profit institutions were even bigger offenders. How is everyone getting away with ignoring federal law? The feds have never enforced it.
The FDA's priority review waiver program, which gives drugmakers a waiver for expedited review of future drugs in exchange for developing a drug which treats neglected tropical diseases, allows drugmakers to get a waiver even if they didn't develop the drug--U.S. approval of a drug used for decades elsewhere in the world is good enough. The Turing Pharmaceuticals CEO wants to take advantage of that fact.
FDA repeatedly approved cancer drug Afinitor without proof it extended life | Milwaukee Journal Sentinel
The FDA has approved the Novartis cancer drug Afinitor for five indications, including for a common type of breast cancer, even though it comes with a long list of serious side-effects that occured in a high percentage of patients in clinical trials, and there has been no evidence the drug extends lives.
Returns on pharma R&D sink to lowest in five years | Financial Times
A Deloitte report finds that even though new U.S. FDA drug approvals in 2015 topped hit an 18-year high, returns on research and development have fallen to just 4.2% of spending, a five-year low. The report attributed the declining returns to lower average drug sales and increasing development costs. The changes are driving the explosion of M&A deals as drugmakers seek greater growth potential.
Google's high profile restructuring and rebranding as Alphabet includes news that it's Life Sciences division, renamed Verily, will continue to pursue health tech research partnerships. Re/code takes a look Verily's leadership and what the company has in development.