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FDA approves Bristol-Myers drug combination for skin cancer

The U.S. Food and Drug Administration approved Bristol-Myers Squibb Co’s immunotherapy drug combination to treat a form of skin cancer, setting the tone for other companies developing similar cocktails. This is the first time the FDA has approved a combination of two immuno-oncology drugs, Bristol-Myers said on Thursday, adding that the treatment will be available […]

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Esperion Stock Plummets as Updates on ETC-1002 Proves Not Enough for Investors

ANN ARBOR, Mich. — Esperion Therapeutics, Inc. (ESPR)’s stock plummeted nearly 35 percent this morning after the company announced it will separately assess patients with statin intolerance following Phase II results. Esperion said it plans to conduct multiple Phase III clinical trials to “separately evaluate patients with statin intolerance, as well as patients who are […]

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Merck’s once-weekly diabetes drug approved in Japan

Merck & Co said its Type 2 diabetes drug had been approved in Japan, marking the first approval for the once-weekly drug. The drug, omarigliptin, belongs to the same class of drugs as Merck’s bestseller Januvia, which is to be taken once a day. Both drugs are aimed at lowering blood sugar levels. Januvia had […]

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Sun Pharma Group Stocks Dip on U.S. FDA Denial for its Epilepsy Drug

The U.S. Food and Drug Administration has revoked an approval issued in March to India’s Sun Pharma Advanced Research Company Ltd (SPARC) to launch a drug for seizures, citing manufacturing quality problems at its production site. The move comes as a setback to SPARC, the research arm of India’s largest drugmaker, Sun Pharmaceutical Industries Ltd. […]

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Novo shares jump ahead of its largest ever drug launch

Shares in Novo Nordisk (NOVOb.CO) rose as much as 5 percent on Monday after the U.S. Food and Drug Administration (FDA) approved the diabetes drug Tresiba, allowing the Danish drugmaker to prepare its largest ever drug launch.   The FDA’s decision late on Friday came two years after it had rejected the long-acting form of […]

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Regeneron and Sanofi Announce Approval of Praluent (alirocumab) for the Treatment of Hypercholesterolemia in the European Union

Praluent will be available in both a 75 mg and 150 mg dose for self-administration every two weeks   TARRYTOWN, N.Y. and PARIS, Sept. 28, 2015 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) has granted marketing authorization for Praluent® (alirocumab) for the treatment of bad cholesterol, known as […]

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Taiho Oncology Inc. Announces FDA Approval of LONSURF (trifluridine and tipiracil) for Refractory Metastatic Colorectal Cancer (mCRC)

LONSURF represents the first FDA-approved product for Taiho Oncology, setting the stage for the company’s oncology pipeline   PRINCETON, N.J., Sept. 22, 2015 /PRNewswire/ — Taiho Oncology, Inc. (U.S.), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), today announced that the U.S. Food and Drug Administration (FDA) approved LONSURF® (trifluridine and tipiracil), formerly known as […]

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‘Breakthrough’ drug may not mean what you think

(Reuters Health) – What the Food and Drug Administration calls a ‘breakthrough’ drug is often not the same as what a layperson would call a breakthrough, a new study shows. The FDA uses the term more often, and for smaller advances, than people use it colloquially, and this may lead patients to have unwarranted confidence […]

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Allergan gets FDA nod for new antipsychotic

Allergan Plc said on Thursday the U.S. Food and Drug Administration approved its new antipsychotic drug to treat bipolar disorder and schizophrenia. The drug, Vraylar, carries a boxed warning on increased risk of death associated with its use in older people with dementia-related psychosis, the FDA said on its website. Vraylar was approved after showing […]

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Novo Nordisk A/S’s Victoza Beats Sanofi’s Lixisenatide in Head-to-Head Study, Company Says

STOCKHOLM – Novo Nordisk (NVO) reported today that its type 2 diabetes treatment Victoza in combination with metformin, proved superior in reducing HbA1c than Sanofi’s lixisenatide in combination with metformin.   Novo’s stock jumped slightly this morning to a price of $56.37, up from its opening $55.94 per share. In the head-to-head trial, which surveyed […]

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