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Amgen Fights Fire with Fire in the Biosimilars Market

Thousand Oaks, Calif.-based Amgen (AMGN), faced with generic and biosimilars competition as its blockbusters lose patent protection, is fighting back on a number of fronts.   On Oct. 2, 2015, Novartis (NVS) announced that the U.S. Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) for its proposed biosimilar to Amgen’s Enbrel […]

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Express Scripts sees $750 million in spending on new cholesterol drugs

Express Scripts Holding Co, the largest manager of prescription drug plans for U.S. employers and health plans, said it has reached deals to cover two costly new cholesterol drugs and expects to spend no more than $750 million on them next year. The injected drugs – Repatha from Amgen Inc and Praluent from partners Regeneron […]

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FDA puts clinical hold on Advaxis cancer drug

Advaxis Inc said the U.S. Food and Drug Administration has put on hold the mid-stage trials of its experimental cancer drug after a patient died, sending its shares down 27 percent in extended trading yesterday. The clinical hold on the drug, axalimogene filolisbac, was issued after Advaxis submitted a safety report to the FDA, the […]

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Microsoft unveils new smartphones, tablet and fitness tracker

Microsoft Corp unveiled on Tuesday a new line of Lumia smartphones, a new Surface Pro tablet and an updated version of its wearable fitness tracker, Microsoft Band, that will run on Windows 10, its latest operating system. Windows 10, launched in July, is part of Microsoft’s push to win a bigger share of the market […]

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AmerisourceBergen to buy PharMEDium for $2.58 billion

Drug distributor AmerisourceBergen Corp agreed to buy PharMEDium Healthcare Holdings Inc for $2.58 billion from private equity firm Clayton, Dubilier & Rice, expanding its business of supplying compounded drugs to hospitals. Compounding is a process in which pharma products are diluted to create doses that are not sold commercially. Increased regulatory oversight following a fungal […]

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Novartis’ Alcon to Add 300 Jobs in $250 Million Atlanta Expansion for Contact Lens Manufacturing

ATLANTA – Alcon (ACL), a division of Novartis (NVS), is investing $250 million into an expansion of its Atlanta-area facility that will add more than 300 jobs, the Atlanta Business Chronicle reported this morning. The expansion will allow Alcon to focus on the manufacturing and development of contact lenses, including Dailies, AquaComfort Plus, Dailies Total1 […]

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Arena Stock Jumps as CEO and Co-Founder Resigns at Request of the Board

San Diego-based Arena Pharmaceuticals (ARNA) announced today that its president and chief executive officer, Jack Lief, will retire, as well as stepping down from the company’s board of directors. The announcement says that Lief’s retirement is “at the request of the Board of Directors.” His interim replacement will be Harry Hixson, a current board member. […]

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Roche says data shows Cotellic combination therapy effective

Swiss drugmaker Roche said final survival data from a Phase III clinical trial showed the Cotellic drug used in combination with Zelboraf helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live significantly longer compared to Zelboraf alone.   Ongoing monitoring did not identify any new safety signals. Long-term safety data was expected later […]

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FDA asks duodenoscopes makers to study success of cleaning guide

The U.S. Food and Drug Administration has ordered three Japanese manufacturers of duodenoscopes to conduct studies to evaluate how the devices are being used, as part of its effort to prevent the transmission of infections through the device. Duodenoscopes are flexible, lighted tubes inserted down the throat to drain fluids from blocked pancreatic and biliary […]

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Alkermes’ schizophrenia drug Aristada gets FDA nod

The U.S. Food and Drug Administration on Monday approved Alkermes Plc’s longer-acting injectable version of blockbuster schizophrenia pill Abilify, making the treatment available in two doses. Abilify, developed by Japanese drugmaker Otsuka Pharmaceuticals and sold in the United States by Bristol-Myers Squibb Co, is already facing generic competition. Alkermes’ injectable version, Aristada, is expected to […]

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