Onyx goes on the auction block after confirming Amgen’s $8.7B bid

John Carroll FierceBiotech News

FDA Takes Action Against 9,600 Online Pharmacies

barbara.lempert FDA takes action to protect consumers from dangerous medicines sold by illegal online pharmacies International Operation Pangea VI combats online sale and ...

Mallinckrodt Pharmaceuticals Declares Its Independence — Again

barbara.lempert ST. LOUIS, June 28, 2013 (ST. LOUIS POST DISPATCH)–In his offices overlooking Mallinckrodt Pharmaceuticals’ sprawling campus in Hazelwood, chief executive ...

GSK receives positive CHMP opinions for Tafinlar

barbara.lempert Regulatory Update – GSK receives positive CHMP opinions for Tafinlar® (dabrafenib) and Tyverb® (lapatinib) LONDON, June 28, 2013 – Today, GlaxoSmithKline ...

Dendreon Receives Positive Opinion for Provenge

barbara.lempert Dendreon Receives Positive Opinion for PROVENGE® in the European Union SEATTLE–(BUSINESS WIRE)– June 28, 2013–Dendreon Corporation (Nasdaq: DNDN) ...

Genzyme Receives Positive CHMP Opinion for Lemtrada

barbara.lempert Genzyme Receives Positive CHMP Opinion for LEMTRADA™ (alemtuzumab) in Europe– CHMP also Recommends NAS Designation for AUBAGIO® (teriflunomide) Following Positive ...

Hospira’s Inflectra the first biosimilar monoclonal antibody to receive positive opinion from EMA’s CHMP for rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis

barbara.lempert Hospira’s Inflectra™ (infliximab) the first biosimilar monoclonal antibody to receive positive opinion from EMA’s CHMP for rheumatoid arthritis, inflammatory ...

FDA Rejects Xarelto sNDA

barbara.lempert FDA Issues Complete Response Letter for XARELTO® (rivaroxaban) to Reduce the Risk of Stent Thrombosis in Patients with Acute Coronary Syndrome RARITAN, N.J., ...

A Watershed For Biosimliars: EU Recommends Copies Of Remicade

esilverman In a defining moment for the advent of biosimilars, European regulators have recommended two versions of the Remicade blockbuster injectable treatment, marking the ...

MiMedx Receives Additional EpiFix Medicare Reimbursement Coverage

barbara.lempert EPIFIX® NOW APPROVED FOR COVERAGE BY SIX OF THE NINE MEDICARE CONTRACTORS MARIETTA, Ga., June 28, 2013 /PRNewswire/ — MiMedx Group, Inc.  (NASDAQ: MDXG), an ...

Regeneron Announces First Recipients of Annual Regeneron Prize for Creative Innovation

barbara.lempert New National Prize Recognizes Talented Early-Career Scientists Poised to Make Important Contributions to Scientific Discovery TARRYTOWN, N.Y., June 27, 2013 /PRNewswire/ ...

A Senate Bill To Limit Antibiotics In Food-Producing Animals

esilverman In the latest effort to combat the spread of superbugs that are resistant to antibiotics, a bill was introduced in the US Senate that would direct the FDA to prohibit ...
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