With the completion of the Senate HELP Committee’s third and final markup on biomedical innovation legislation, a complete cures package is expected to hit the full Senate shortly. Source: Drug…

The FDA has taken two clinical investigators to task for deviating from their investigational plans. Source: Drug Industry Daily

Gaping GMP holes in Swedish contract manufacturer Apotek Produktion & Laboratorier’s processes resulted in a seven-item Form 483 following an Oct. 5 to 9, 2015 inspection. Source: Drug Industry Daily

FDA Puts Clinical Hold on Ionis Candidate BI Snags Additional Indication for Giotrif in EU FTC Frees Pfizer From 2010 Restriction Shire to Continue With Baxalta Merger Despite Treasury Inversion…

The FDA is cracking down on supplement makers for adding stimulants to their products as evidenced by seven recent warning letters. Source: Drug Industry Daily

Five companies are throwing their support behind Sequenom’s efforts to have the U.S. Supreme Court reconsider the limits of patent eligibility. Source: Drug Industry Daily

Apricus Biosciences has cut 30 percent of its workforce — including part of its executive team — following an unsuccessful Phase 2b trial evaluating fispemifene in men with secondary hypogonadism…