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CP Wire Articles

Vaxart is a clinical stage biopharmaceutical company that seems to hold a great deal of promise. They are developing several oral tablet vaccines with the most promising being a vaccine for... read more

Wed, 04/25/18 - 01:59 pm
CP Staff
  • AVXS-101, has potential to be first-ever one-time gene replacement therapy for spinal muscular atrophy (SMA), a disease which results in early death or lifelong disability with considerable... read more
Wed, 04/25/18 - 09:46 am
CP Staff

In June of 2017, OrphoMed announced that they had closed a $39 Million series A round to accelerate development of their lead candidate, ORP-101, IBS-D. On 4/25/18 they announced that the FDA has... read more

Wed, 04/25/18 - 09:18 am
CP Staff
  • In SELECT-SUNRISE study, upadacitinib met the primary endpoint of ACR20 (An ACR20 score means that a person's RA has improved by 20%) across all doses (7.5 mg, 15 mg, 30 mg, once-daily) at... read more
Wed, 04/25/18 - 09:07 am
CP Staff

Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), announced on 4/24/18 that new twelve-month data from its PROMISE 1 Phase 3 clinical trial in episodic migraine patients. The data demonstrated that... read more

Tue, 04/24/18 - 11:52 pm
CP Staff

Mirati Therapeutics, Inc. (Nasdaq: MRTX) (the Company or Mirati), On 4/24/18 provided a progress update on its lead development programs and announced updated, positive clinical trial data for... read more

Tue, 04/24/18 - 11:17 pm
CP Staff

                 
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 kidneys... 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

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