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Janssen Announces SVR12 Rates with Twelve Weeks of Treatment with All-Oral, Once-Daily Regimen of Simeprevir Plus Sofosbuvir in Genotype 1 HCV Patients With and Without Cirrhosis

CORK, Ireland, April 23, 2015 /PRNewswire/ — Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), today announced results for its hepatitis C treatment simeprevir at The International Liver Congress™ 2015 of the European Association for the Study of the Liver (EASL) in Vienna. Late-breaking results from the Phase 3 […]

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Hyperemesis gravidarum tied to children’s neurological problems

A woman holds her stomach at the last stages of her pregnancy in Bordeaux April 28, 2010. Reuters/Regis Duvignau (Reuters Health) – Children born to women who suffered severe nausea and vomiting during pregnancy are more likely to be diagnosed with neurological developmental disorders, according to a small U.S. study. Compared to children of women […]

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FDA grants priority review to Boehringer’s blood clotting agent

  <span class=”articleLocatio n”>(Reuters) – Boehringer Ingelheim Pharmaceuticals Inc said its emergency blood clotting agent was granted a priority review status by the U.S. Food and Drug Administration, accelerating the regulatory process by four months. The drug, idarucizumab is specifically being tested to reverse the blood thinning effects of Pradaxa, the privately held company said […]

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CymaBay Therapeutics Announces the Initiation of a Phase 2 Study of MBX-8025 in Patients With Homozygous Familial Hypercholesterolemia

NEWARK, CA–(Marketwired – April 23, 2015) – CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company developing therapies to treat metabolic diseases with high unmet medical need, today announced the initiation of a Phase 2 study of MBX-8025 in patients with homozygous familial hypercholesterolemia (HoFH). MBX-8025 is an orally administered potent and selective peroxisome proliferator-activated receptor […]

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Insys Therapeutics Commences Dosing in Phase 1/2 Safety and Pharmacokinetic Study of Cannabidiol Oral Solution in Pediatric Epilepsy Patients

PHOENIX, AZ–(Marketwired – Apr 23, 2015) – Insys Therapeutics, Inc. (NASDAQ: INSY) (“Insys” or “the Company”) today announced that it has commenced dosing of pediatric epilepsy patients in a Phase 1/2 safety and pharmacokinetic (PK) study in pediatric subjects with treatment-resistant seizures. The clinical trial will evaluate multiple ascending doses of Insys’ pharmaceutical cannabidiol (CBD) […]

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Helix BioPharma Corp. Provides an Update on the U.S. Study of L-DOS47

AURORA, ON–(Marketwired – Apr 22, 2015) –  Helix BioPharma Corp. (TSX: HBP) (FRANKFURT: HBP) NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRES OR DISSEMINATION IN THE UNITED STATES First Patient Dosed and Three Clinical Sites Initiated Helix BioPharma Corp. (TSX: HBP) (FRANKFURT: HBP), a biopharmaceutical company developing innovative drug candidates for the prevention and treatment of […]

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FDA Accepts Filing of BETACONNECT for Relapsing-Remitting Multiple Sclerosis Patients Taking BETASERON (interferon beta-1b)

WHIPPANY, N.J., April 22, 2015 /PRNewswire/ — Bayer is pleased to announce today that the U.S. Food and Drug Administration (FDA) has accepted the filing for Bayer’s supplemental Biologics License Application (sBLA) for BETACONNECT TM (proposed name), another delivery option for BETASERON® (interferon beta-1b), a treatment for relapsing-remitting multiple sclerosis. “This filing underscores Bayer’s continued, longstanding […]

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Roche more confident in beating Alzheimer’s after Biogen data

(Reuters) – Swiss drugmaker Roche has “renewed confidence” that drugs targeting potentially brain-destroying plaque can fight Alzheimer’s disease, following promising results with a product from a rival. Pharmaceuticals head Daniel O’Day said on Wednesday Roche would look again at prospects for two of its experimental Alzheimer’s drugs, both of which suffered setbacks in 2014, in […]

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Extreme ‘morning sickness’ tied to children’s neurological problems

(Reuters Health) – The children born to women who suffered severe nausea and vomiting during pregnancy are more likely to be diagnosed with neurological developmental disorders, according to a small U.S. study. Compared to children of women without such severe morning sickness – formally known as hyperemesis gravidarum – children who were exposed to the […]

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Isis Pharmaceuticals Reports Positive Data From ISIS-TTR Rx in Patients With TTR Amyloidosis

CARLSBAD, Calif., April 22, 2015 /PRNewswire/ — Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today positive data from an ongoing open-label extension (OLE) study of ISIS-TTRRx in patients with familial amyloid polyneuropathy (FAP).  FAP patients completing the ongoing Phase 3 study are eligible to enroll in this OLE study in which all patients receive ISIS-TTRRx.  An […]

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