Gilead Sciences purchased a priority review voucher, its third in four years, from Sarepta Therapeutics for $125 million. Source: Drug Industry Daily

The FDA issued Form 483s to two international API makers, citing recordkeeping failures and incomplete labeling. Source: Drug Industry Daily

Australia’s Therapeutic Goods Administration is proposing to ease the requirements for access to unapproved drugs. Source: Drug Industry Daily

Pediatric clinical trials protocols should be designed with input from stakeholders, according to the Clinical Trials Transformation Initiative on antibacterial drugs. Source: Drug Industry Daily

New Jersey federal judges validated patents on Sunovion Pharmaceuticals’ schizophrenia drug Latuda and Helsinn’s nausea therapy Aloxi, dealing a blow to sponsors looking to launch generic versions of the drugs. Source:…

Celgene will pay $198.5 million to settle a case alleging the company failed to pay royalties on patents covering the multiple myeloma drugs Revlimid and Pomalyst/Imnovid. Source: Drug Industry Daily

Asked if she would push for negotiating drug prices under Medicare as the next CMS administrator, Seema Verma told a Senate committee she couldn’t give a simple “yes or no…

In observance of Presidents’ Day, Drug Industry Daily will not be published Monday, Feb. 20. The next issue will be published Tuesday, Feb. 21. Source: Drug Industry Daily

CDER published a summary of the populations that participated in clinical trials of the 67 novel drugs approved over the past two years. Source: Drug Industry Daily

Pfizer and Flynn Pharma have appealed a £84.2 million (US $112.5 million) fine from UK’s Competitions and Market Authority over the price of the anti-epilepsy phenytoin sodium capsules, contending the agency…