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Muscle Disease Drug Development Halted

A Phase 3 study evaluating Ultragenyx Pharmaceuticals’ aceneuramic acid extended release in patients with GNE Myopathy did not achieve its primary endpoint.

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Novo Nordisk’s semaglutide beats out Trulicity

Positive results were announced from Novo Nordisk’s SUSTAIN 7 Phase III trial comparing once-weekly semaglutide against Lilly’s Trulicity for type 2 diabetes.

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Bristol-Myers Kidney Cancer Drug Flunks Study

Bristol-Myers Squibb released mixed top-line results from its Phase III CheckMate-214 clinical trial of Opdivo in combination with Yervoy for advanced or metastatic RCC.

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Lexicon Reports Additional Positive Data From Pivotal Phase 3 inTandem2 Study Of Sotagliflozin

Lexicon Pharmaceuticals Inc. announced additional positive data from the pivotal Phase 3 inTandem2 study of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor.

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Ophthotech’s Wet AMD Drug Fails to Meet Primary Endpoint in Phase III Study

Three times is not the charm. New York-based Ophthotech Corporation announced that its Fovista (pegpleranib) failed yet another Phase III clinical trial.

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Sleep may not be controlled only by the brain according to research led by Morehouse School of Medicine

A recently released study from a team led by Morehouse School of Medicine shows that the process controlling sleep may not lie totally in the brain.

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Lilly’s acute migraine drug succeeds in Phase III

Drugmaker Eli Lilly and Co. said its acute migraine drug lasmiditan succeeded in a key late-stage study, setting the stage for U.S. regulatory approval.

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U.S. scientists able to alter genes of human embryos

U.S. scientists have succeeded in altering the genes of a human embryo to correct a disease-causing mutation, making it possible to prevent the defect from being passed on to future generations.

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Merck & Co. Dealt Another Setback as Its Ace Keytruda Comes Up Short in Head and Neck Cancer Study

Merck’s vaunted PD-1 inhibitor Keytruda suffered another setback when it failed to meet endpoints in a Phase III head and neck cancer study.

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Pfizer, Merck KGaA skin cancer drug gets EMA nod for approval

(Reuters) – European regulators on Friday recommended approving Pfizer Inc and Merck KGaA’s immuno-oncology drug Bavencio to treat a rare type of skin cancer called Merkel cell carcinoma. In May, Bavencio was approved by the U.S. Food and Drug Administration to treat bladder cancer and in March to treat Merkel cell carcinoma. ( Bavencio, known […]

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EU medicines agency recommends approval of Novartis leukemia drug Rydapt

ZURICH (Reuters) – A European Medicines Agency (EMA) panel recommended on Friday approval of a new Novartis drug to be used against a tough-to-cure form of blood cancer as the Swiss drugmaker makes headway on refreshing its oncology portfolio. The EMA’s Committee for Medicinal Products for Human Use (CHMP) backed Rydapt against acute myeloid leukemia […]

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Vertex Gains $8 Billion Overnight as Cystic Fibrosis Combo Drug Wows in Trials

Vertex Pharmaceuticals announced positive efficacy data from its Phase I and Phase II studies of three different triple combination regimens for cystic fibrosis patients,

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Nektar Announces Topline Data from HAP Study for NKTR-181

NKTR-181 shows significantly less abuse potential compared to oxycodone.

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Puma Biotech Surges After the FDA Officially Approves Breast Cancer Drug

The FDA approved Puma Biotechnology’s breast cancer drug Nerlynx (neratinib).

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Gottlieb Lays Out Plans to Attract and Preserve Top Talent at the FDA

The FDA is tackling a new way to recruit top talent — talent that will fill a “substantial” number of vacant position.

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Artificial sweeteners may not be risk free

People hoping to lose a few pounds by substituting artificial sweeteners for regular sugar may end up disappointed, suggests a fresh look at past research.

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Boosts in R&D Spending Drive Biotech Innovation

Fueled by a desire for innovation and new medical breakthroughs, the biotech industry continues to enjoy substantial growth due to increased investment in R&D.

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Patient Deaths Prompt the FDA to Suspend Three of Merck & Co.’s Keytruda Trials

FDA placed a clinical hold on three trials studying Merck’s PD-1 inhibitor Keytruda in combination with products developed by Celgene following Merck’s initial reporting of several patient deaths.

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Opdivo Prevails in Phase III Melanoma Trial

Bristol-Myers Squibb announced promising interim data from its Phase III clinical trial of Opdivo 3 mg/kg compared to 10 mg/kg Yervoy in melanoma.

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AstraZeneca, Chi-Med take kidney cancer drug into final testing

AstraZeneca and Hutchison China MediTech said they had initiated a global late-stage clinical trial of the experimental drug savolitinib in a relatively rare type of kidney cancer.

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