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CP Wire Articles

                 
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He... read more

Tue, 04/24/18 - 07:50 pm
CP Staff

Pfizer received a Complete Response Letter from the FDA on 4/23/18 highlighting the need for additional technical information. Though this is a setback for Pfizer's Herceptin biosimilar program,... read more

Tue, 04/24/18 - 07:43 pm
CP Staff

  • ADPKD, the fourth leading cause of end-stage renal disease,1,2 is a progressively debilitating genetic disease characterized by the development of fluid-filled cysts in the kidneys3... read more
Tue, 04/24/18 - 06:59 pm
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GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) announced on 4/24/18 that the US Food and Drug Administration (FDA) has approved an expanded indication for Trelegy Ellipta (... read more

Tue, 04/24/18 - 02:26 pm
CP Staff

Celgene Corporation (NASDAQ:CELG) announced  on 4/24/18 additional phase III data analyses evaluating the efficacy and safety of ozanimod, a novel, oral, selective sphingosine 1-phosphate 1 (S1P1... read more

Tue, 04/24/18 - 09:25 am
CP Staff

Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company discovering and developing Pentarins as a new class of potent and selective cancer medicines, announced on 4/24/18 that it... read more

Tue, 04/24/18 - 09:02 am
CP Staff

Surface Oncology announced on 4/23/18 the closing of its initial public offering of 7,200,000 shares of common stock at a public offering price of $15.00 per share. The gross proceeds from the... read more

Mon, 04/23/18 - 08:20 pm
CP Staff

Patients with relapsing remitting multiple sclerosis (RRMS) who received Sanofi Genzyme’s Lemtrada (alemtuzumab) experienced effects of treatment on disease activity that were maintained over... read more

Mon, 04/23/18 - 07:56 pm
CP Staff

NuProbe Global will commercialize the Harvard Wyss Institute's DNA nanotechnology-based variant-detecting method as a fast, low-cost and multiplexed molecular diagnostic for different disease... read more

Mon, 04/23/18 - 04:41 pm
CP Staff

GENFIT announced on 4/23/18 that the Data Safety Monitoring Board (DSMB) issued a new positive recommendation for the continuation of the RESOLVE-IT Phase 3 trial evaluating elafibranor in NASH... read more

Mon, 04/23/18 - 10:00 am
CP Staff

Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), announced on 4/23/18 that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending... read more

Mon, 04/23/18 - 09:36 am
CP Staff

Pfizer Inc. (NYSE:PFE) announced on 4/23/18  that it received a Complete Response Letter (CRL) from the FDA in response to the Biologics License Application for the company’s proposed trastuzumab... read more

Mon, 04/23/18 - 09:20 am
CP Staff

Pfizer Inc. (NYSE: PFE) today announced that Trumenba (Meningococcal Group B Vaccine) received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for active... read more

Mon, 04/23/18 - 09:03 am
CP Staff

Fresenius SE ended its pending acquisition of Akorn over a probe that found problems with product development and data. Fresenius issued a statement that said it's decision was based on a number... read more

Sun, 04/22/18 - 11:15 pm
CP Staff

Bellicum announced on 4/20/18 the closing of its previously announced underwritten public offering of 9,200,000 shares of its common stock, including 1,200,000 shares sold pursuant to the... read more

Sat, 04/21/18 - 12:48 pm
CP Staff


Chemoimmunotherapy is a promising technology in the fight against cancer. Researchers at the University of Michigan Rogel Cancer Center have designed a new delivery system – a drug hidden in a... read more

Fri, 04/20/18 - 12:35 pm
CP Staff


Helsinn Group announced on 4/20/18 that the U.S. Food and Drug Administration (FDA) has approved the intravenous formulation of Akynzeo (NEPA, a fixed antiemetic combination of fosnetupitant,... read more

Fri, 04/20/18 - 10:00 am
CP Staff

Vaxart announced on 4/20/18 that it received notification from Daiichi Sankyo Co., Ltd, that sales of Inavir, a single inhaled dose product licensed in Japan to prevent or treat influenza... read more

Fri, 04/20/18 - 09:15 am
CP Staff

Veloxis Pharmaceuticals A/S announced on 4/19/18 that the U.S. Food & Drug Administration (FDA) has accepted for standard review the Company’s supplemental New Drug Application (sNDA) which... read more

Thu, 04/19/18 - 11:31 pm
CP Staff

Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) on 4/19/18 announced the pricing of its previously announced underwritten public offering of 16,000,000 shares of its common stock, offered at a price of... read more

Thu, 04/19/18 - 09:35 pm
CP Staff

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