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Biotech 2016: Now Starts the Hangover

January 27, 2016By Karl Thiel for   Not that you need to be reminded of this, but… For the stock market, this has been the worst kickoff ever to a new year. And for biotech, it has been much, much worse. The Nasdaq Biotech Index plummeted over 17 percent in the first eight trading […]

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Actelion receives Canada approval for Uptravi

Actelion Ltd (ATLN.VX), Europe’s biggest biotech firm, said on Tuesday that Health Canada had granted a notice of compliance for Uptravi, a new pulmonary arterial hypertension medicine.   The approval is “a major milestone”, Chief Executive Jean-Paul Clozel said in a statement, adding that the company is working to make the drug available to patients […]

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FDA gives full approval to Amgen blood cancer drug

The U.S. Food and Drug Administration said on Thursday it has approved Amgen Inc’s cancer drug Kyprolis in combination with certain other therapies to treat patients with multiple myeloma. The agency also approved the drug as a single agent for patients with relapsed or refractory multiple myeloma who have received one or more previous treatments. […]

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U.S. Food and Drug Administration Approves Humulin® R U-500 KwikPen®

INDIANAPOLIS, Jan. 21, 2016 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company’s (NYSE: LLY) Humulin® R U-500 KwikPen®(insulin human injection) 500 units/mL, a pre-filled device containing Humulin R U-500, a highly concentrated formulation of insulin. Humulin R U-500 is the only FDA-approved insulin that is five-times more concentrated than […]

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Samsung Bioepis’ Enbrel drug copy gets EU approval

Samsung Bioepis Co Ltd said on Sunday it had received European Commission approval for its copy of the blockbuster biotech arthritis drug Enbrel. The drug, known scientifically as etanercept, will be sold in Europe by U.S. biotechnology group Biogen and rolled out gradually across all 28 European Union member states as well as Norway, Iceland […]

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Novartis receives two new FDA approvals for Cosentyx® (secukinumab) to treat patients with ankylosing spondylitis and psoriatic arthritis

EAST HANOVER, N.J., Jan. 15, 2016 /PRNewswire/ — Novartis announced today that the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for two new indications – the treatment of adult patients with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA). AS and PsA are both life-long, painful and debilitating inflammatory diseases that affect […]

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FDA clears Olympus duodenoscope with design modifications

The U.S. Food and Drug Administration on Friday cleared Japan’s Olympus Corp’s duodenoscope with changes to the device’s design and labeling intended to help reduce the risk of bacterial infections. Olympus will voluntarily recall its original model being used in health care facilities to fix them as quickly as possible, the regulator said. ( The […]

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Actelion sees Uptravi price of $160,000-170,000/patient

Swiss drug company Actelion expects an average annual per-patient price for its new pulmonary arterial hypertension medicine in the United States of $160,000 to $170,000, before rebates, Chief Operating Officer Otto Schwarz told analysts on Tuesday.   The drug, Uptravi, won approval from the U.S. Food and Drug Administration last month and went on sale […]

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AstraZeneca gets U.S. approval for gout drug Zurampic

U.S. health regulators on Tuesday approved AstraZeneca’s drug Zurampic to treat a condition associated with gout to be used in combination with another type of drug that reduces production of uric acid in the body. Zurampic, known chemically as lesinurad, works by helping the kidneys to excrete uric acid. Gout is a painful form of […]

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Actelion’s Uptravi Received FDA Approval, to Enter U.S. Market in January

December 22, 2015By Mark Terry, Breaking News Staff   Allschwil, Switzerland-based Actelion (ALIOF.PK) announced today that its drug Uptravi (selexipag) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of pulmonary arterial hypertension (PAH). The company has plans to launch the drug in January 2016, and will be hosting […]

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