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UK cost agency rebuffs Sanofi cholesterol drug but backs Amgen’s

Britain’s cost watchdog has recommended that patients with high cholesterol should not get Sanofi and Regeneron’s new cholesterol-lowering injection Praluent, although Amgen’s similar drug Repatha will be available. The National Institute for Health and Care Excellence (NICE) cost watchdog said in draft guidance on Monday that Praluent’s benefits were uncertain and it was likely to […]

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Three Potential Blockbusters that Could Singlehandedly Catapult Big Pharma in 2016

Over the past few years, annual revenue growth of pharma giants Johnson & Johnson (NYSE:JNJ), Novartis (NYSE:NVS), and Bristol-Myers Squibb (NYSE:BMY) has been mostly flat to somewhat negative. Although each of these companies market dozens of products, making it hard for any one to move the needle on its own, the emergence of a multi-billion […]

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Roche expects cancer treatments to be spared U.S. pricing curbs

The U.S. Congress may intervene on how much companies can charge for some drugs following a move last year by Turing Pharmaceuticals to ratchet up the price of a treatment for deadly parasite infections by 5,000 percent, Roche’s head of pharmaceuticals said.   Roche’s Dan O’Day is convinced the oncology portfolio at the world’s biggest […]

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Obama calls for rapid Zika research as virus seen spreading

President Barack Obama on Tuesday called for the rapid development of tests, vaccines and treatments to fight the mosquito-transmitted Zika virus, which has been linked to birth defects and could spread to the United States in warmer months. U.S. health officials are stepping up efforts to study the link between Zika virus infections and birth […]

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Major drugmakers push back in U.S. price debate

With a backlash brewing over the price of medicines in the United States, drugmakers are pushing back with a new message: Most people don’t pay retail.    Top executives from Eli Lilly and Co (LLY.N), Merck & Co (MRK.N) and Biogen Inc (BIIB.O) said in interviews with Reuters this week that the media focus on retail, […]

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U.S. justices reject Johnson & Johnson unit’s anti-psychotic drug appeal

The U.S. Supreme Court on Monday declined to hear a Johnson & Johnson subsidiary’s appeal of a $124 million penalty imposed by South Carolina after a jury found the drugmaker had improperly marketed the anti-psychotic drug Risperdal and concealed its risks. The court’s decision not to hear the appeal filed by Johnson & Johnson’s Janssen […]

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Eli Lilly’s diabetes pill takes market share from J&J, Astra

Eli Lilly and Co’s new Jardiance diabetes treatment has begun stealing market share from rival drugs in its class, the company said on Tuesday, bolstered by clinical trial data showing it slashed deaths by 32 percent in patients with Type 2 diabetes. In a three-year study whose results were released last summer, Jardiance became 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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Sanofi pulls plug on MannKind inhaled insulin after poor sales

French drugmaker Sanofi is to stop selling an inhalable insulin developed by MannKind, following disappointing sales of the product since its launch in February 2015. The decision to terminate the collaboration marks a blow for the idea of delivering insulin through an inhaler, rather than by injection, and shares in U.S.-based MannKind were down around […]

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Drug approvals at 19-year high belie industry challenges

2015 was a good year for innovation in medicine with the U.S. Food and Drug Administration approving 45 novel drugs, four more than in 2014 and the most since the all-time record of 53 set in 1996. Across the Atlantic, the European Medicines Agency recommended 93 new products, including generics, up from 82 in 2014. […]

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Mylan Launches Generic Zyvox Tablets

HERTFORDSHIRE, England and PITTSBURGH, Dec. 29, 2015 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Linezolid Tablets, 600 mg, which is the generic version of Pfizer’s Zyvox® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which […]

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Celgene settles U.S. patent litigation for top seller Revlimid

Celgene Corp said it would allow for the sale of a generic version of its flagship multiple myeloma drug, Revlimid, in the United States over a year before patents covering the drug expire. The company said it would provide India-based Natco Pharma Ltd and its U.S. partner, Arrow International Limited, a unit of Allergan Plc, […]

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Bristol’s drug pricing under fire as UK agency rejects Opdivo

Bristol-Myers Squibb’s closely watched new drug Opdivo, one of the first of a new wave of cancer medicines that boost the immune system, has been rejected as too expensive for treating lung cancer by Britain’s cost watchdog. In draft guidance issued on Wednesday, the National Institute for Health and Care Excellence (NICE) said using Opdivo, […]

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AstraZeneca chases Acerta to secure next cancer drug winner

AstraZeneca said on Monday it was in talks that might lead to the acquisition of privately held biotech firm Acerta Pharma, a potential $5 billion-plus deal designed to build up its cancer drug portfolio.   “AstraZeneca confirms that it is exploring potential strategic options with Acerta Pharma BV. There can be no certainty that any […]

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Reckitt Benckiser misled consumers on Nurofen painkillers: Australian court

An Australian court ordered Reckitt Benckiser to pull several of its Nurofen pain relief products from the market, saying on Monday the British firm had misled consumers by marketing identical products for different types of pain.   The Federal Court ruled that the Nurofen Back Pain, Period Pain, Migraine Pain and Tension Headache products were […]

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Horizon Pharma plc to Acquire Crealta Holdings LLC in All Cash Acquisition

Addition of Biologic KRYSTEXXA® (pegloticase) Expands and Diversifies Horizon’s Orphan Business; Leverages Rheumatology Expertise and Infrastructure; Transaction Is Expected to Be Immediately Accretive to Adjusted EBITDA in 2016; Conference Call Today at 8 a.m. ET to Discuss Transaction DUBLIN, IRELAND–(Marketwired – Dec 11, 2015) – Horizon Pharma plc (NASDAQ: HZNP), a biopharmaceutical company focused on […]

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UK cost agency endorses Novartis heart drug for some patients

Novartis’s big new drug hope Entresto has been recommended for use in some patients with heart failure by Britain’s cost agency NICE, which said on Friday it believed the treatment was a cost-effective option.   Entresto has a list price of 1,194 pounds ($1,809) a year in Britain, or less than half the price of […]

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Sales and Marketing: IMS projects narrowing use gap, slowing med spend growth over next five years

More than half of the world’s population will live in countries where medicine use will exceed one dose per person per day by 2020, up from 31 percent in 2005, as the “medicine use gap” between developed and pharmerging markets narrows, according to research by the IMS Institute for Healthcare Informatics.

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Senate panel focuses on toll of Valeant, Turing drug price spikes

A pediatric doctor in Alabama had to scramble to find a less expensive supply of a lifesaving drug to treat an infant who was suffering from a parasitic infection.   In Utah, a hospital has been forced to change the way it stocks a drug critical to treating heart patients after the cost skyrocketed from […]

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Trial for Bayer’s Xarelto under scrutiny over defective device

European and U.S. drug regulators are looking into whether a defective blood clotting test device affected a trial involving Bayer’s top-selling anti-clotting drug Xarelto, hitting the German drugmaker’s shares. The study compared Xarelto, also known as rivaroxaban, with older drug warfarin for preventing strokes in patients with a type of irregular heartbeat common among the […]

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