Briefs
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…
FDA Accuses 7 Firms of Adding Stimulants to Supplements
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
Drugmakers Back Sequenom’s Stance on Patent Eligibility
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 Terminates Fispemifene Clinical Program, Cuts Workforce
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…
Mylan Announces Intentions to Buy Sweden’s Meda for $7.2B
Generics giant Mylan N.V. has struck a tentative deal to purchase Swedish drugmaker Meda AB for $7.2 billion in cash and stock. Source: International Pharmaceutical Regulatory Monitor
EMA Issues Positive Recommendations for 6 Drugs to European Commission
Six new drugs have scored wins at the European Medicines Agency, scooping up recommendations for marketing authorization from the Committee for Medicinal Products for Human Use. Source: International Pharmaceutical Regulatory…
Trade Deal Signing Sets the Stage for New Biologics Exclusivity Policy
With 12 nations signing off on the Trans-Pacific Partnership, the clock has started on ratification of the treaty providing up to eight years of exclusivity for biologics. Source: International Pharmaceutical…
NHS England Plans to Investigate Alleged Staff Ties to Drugmakers
An NHS England spokesperson confirmed Feb. 18 that the agency will investigate whether more than 130 NHS staff involved in assessing drugs were also paid as consultants by drugmakers. Source:…
EMA Spells Out Disclosure Policy for Clinical Data Set for Publication
Drugmakers submitting anonymized clinical data in applications to the EMA must keep up on technology advances that could put that data at risk for re-identification. Source: International Pharmaceutical Regulatory Monitor
Warning Letter Hits India’s Ipca Labs on Allegations of Data Manipulation
The FDA has slammed yet another Indian drugmaker for data integrity issues. This time it rebuked Ipca Laboratories for data falsification at three of the company’s manufacturing facilities. Source: International…