FDA Drug Shortage Strategy: Enforcement Discretion, Patient Public Relations Rapid approval of a new, preservative-free generic methotrexate and permission to import an unapproved version of doxorubicin touted at press conference as FDA emphasizes the success of administrative efforts.
Gene Therapy Firm AMT Forced To Go Private, Backed By Forbion Amsterdam Molecular Therapeutics plans to be acquired by a newly formed private company, uniQure, and to delist from Euronext.
J&J Taps Gorsky To Be Its Next CEO Alex Gorsky was one of two internal candidates who had been vying for the position, which will become available as William Weldon yields the position on April 26.
China To Further Squeeze Distribution Margins And Limit Drug Markups In Hospitals The National People's Congress and Chinese Peoples' Political Consultative Conference will bring in March a variety of new policies and regulations that will impact the industry.
Supreme Court Abstains From Drugs: Will Not Review J&J Vs. Abbott; Takes No Action On Gene Patents The high court denied J&J's request for review of a Federal Circuit decision that overturned a $1.67 billion jury verdict against Abbott's Humira; it made no decision on ACLU's petition for review of Myriad Genetics' BRCA gene patents.
Somewhat Late To The HCV Race, Novartis Licenses NS5A Inhibitor From Enanta The Phase I-ready compound joins alisporivir, a cyclophilin inhibitor licensed from Debiopharm in 2010, in Novartis' rather slight portfolio of HCV candidates.
FDA Questions CV Events, Small Database Heading Into Eklira Advisory Committee Persistent cardiovascular events across the clinical trials for Forest Laboratories Inc.'s Eklira may not represent a definite safety signal, according to FDA, but there is enough concern that an advisory committee will be asked for input on its significance. Forest wants approval of Eklira (aclidinium bromide) for long-term maintenance treatment of bronchospasm from chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
FDA Panel Will Weigh Northera's Short-Term Benefit Vs. Lack Of Durable Effect, Safety Concerns At its Feb. 23 review of Chelsea Therapeutics' investigational orthostatic hypotension drug droxidopa, FDA's Cardiovascular and Renal Drugs Advisory Committee will be asked to discuss sufficiency of the short-term efficacy data, clinical meaningfulness of the effect size and safety issues, including Japanese post-marketing reports of neuroleptic malignant syndrome.
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