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…
EMA Proposes Revisions to Module V of GVPs on Risk Management Systems
The European Medicines Agency has begun a public consultation on planned revisions to Module V of the good pharmacovigilance practices on risk management systems, which clarifies what risk management plans…
Celltrion’s Remicade Biosimilar Gets Adcomm Backing for 6 Indications
An FDA advisory committee gave South Korea’s Celltrion’s biosimilar candidate for Remicade a strong show of support Feb. 9, backing its approval for six indications. Source: International Pharmaceutical Regulatory Monitor
France’s ANSM Dings Chinese Drugmaker Over 10 GMP Concerns Cited at Plant
Heparin is back in the news, after France’s National Agency for Medicines and Health Products Safety issued a GMP noncompliance statement to China’s Dongying Tiandong Pharmaceutical, which manufactures the active…
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…