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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. (bit.ly/2vIbPPG) 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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Alder’s migraine drug data disappoints

Alder BioPharmaceuticals’ late-stage study data on its experimental treatment to prevent episodic migraine fell short of investors’ expectation.

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Merck’s cholesterol drug clears main goal in late-stage study

Merck & Co. Inc. said its experimental cholesterol drug met the main goal of reducing coronary heart diseases in a late-stage study, sending the company’s shares up 2.4 percent in premarket trading.

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New Roche hemophilia drug prevents bleeds

The investigational hemophilia drug emicizumab cut the bleed rate by 87% in patients with resistance to standard therapy versus those receiving another treatment.

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Investors Relieved as Seattle Genetics Pulls Out Win for Phase III Lymphoma Trial

Seattle Genetics and Takeda Pharmaceutical Company announced positive results from the Phase III ECHELON-1 clinical trial in previously untreated advanced classical Hodgkin lymphoma.

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GSK presents positive revaccination study results

Shingrix induced a strong immune response in older adults previously been vaccinated against shingles with the currently available live-attenuated zoster vaccine.

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Clovis Oncology Ovarian Cancer Trial Dazzles

Clovis Oncology announced topline results from a confirmatory Phase III ARIEL3 trial of Rubraca (ruparib) in platinum-sensitive ovarian cancer.

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Seattle Genetics Halts Phase III Leukemia Study

Seattle Genetics halted all clinical trials of its vadastuximab talirine due to higher incidents of death associated with the treatment for AML patients.

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Exercise may stave off postpartum depression

Physical activity during and after pregnancy improves psychological wellbeing and may protect against postpartum depression, according to a new analysis.

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