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Alcoholism drug can wake up dormant HIV to be killed, study finds

Scientists seeking a cure for the AIDS virus have made an unexpected discovery with a drug designed to combat alcoholism which they say could be a critical part of a strategy to “wake up” and then kill dormant HIV hiding in the body. The drug, branded as Antabuse but also sold as a generic called […]

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FDA approves J&J drug for advanced multiple myeloma

U.S. regulators have approved an experimental treatment from Johnson & Johnson that may offer hope to multiple myeloma patients who have run out of other options against the blood cancer. The U.S. Food and Drug Administration on Monday said it had approved Darzalex (daratumumab) for patients who had already undergone at least three prior standard […]

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Dassault Systèmes Launches Three Industry Solution Experiences for Life Sciences

Pharmaceutical and Biotechnology Companies Can Now Digitally Transform Therapeutic Innovation   VELIZY-VILLACOUBLAY, France — November 16, 2015 — Dassault Systèmes (Euronext Paris: #13065, DSY.PA), the 3DEXPERIENCE Company, world leader in 3D design software, 3D Digital Mock Up and Product Lifecycle Management (PLM) solutions, today announced the launch of three industry solution experiences for life sciences, […]

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FDA approves Baxalta’s drug for rare bleeding disorder

The U.S. Food and Drug Administration said on Friday it approved Baxalta Inc’s drug for use in patients with a type of rare bleeding disorder. The drug, Adynovate, was approved to control and reduce the frequency of bleeding episodes in patients with Hemophilia A, the agency said in a statement. Data from a late-stage study, […]

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U.S. approves AstraZeneca’s potential $3 billion lung cancer pill

A new lung cancer pill from AstraZeneca, designed for patients whose disease has worsened after treatment with other therapies, was approved by U.S. regulators on Friday, in a boost for the British drugmaker.   Tagrisso, also known as AZD9291, is one of several cancer medicines AstraZeneca hopes will rebuild its sales following patent losses on […]

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Roche Exiting Four Manufacturing Sites in Europe and the U.S.,1,200 Jobs Impacted

November 12, 2015By Alex Keown, BioSpace.com Breaking News Staff   BASEL, Switzerland – Roche (RHHBY) will vacate four manufacturing sites in the United States and Europe, displacing approximately 1,200 employees as part of a restructuring effort for the manufacturing of its small molecule products, the company announced Thursday. The move comes as Swiss-based Roche addresses […]

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U.S. FDA approves Gilead’s hepatitis C drug for expanded use

Drugmaker Gilead Sciences Inc said on Thursday the U.S. Food and Drug Administration had approved the expanded use of its blockbuster hepatitis C drug, Harvoni.   The drug can now be used to treat patients with subtypes of chronic hepatitis C virus (HCV) and patients who are co-infected with Human Immunodeficiency Virus (HIV), Gilead said […]

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Pacific trade deal could limit affordable drugs: world health chief

A massive trade pact between 12 Pacific rim countries could limit the availability of affordable medicines, the head of the World Health Organization said on Thursday, joining a heated debate on the impact of the deal.   Margaret Chan told a conference there were “some very serious concerns” about the Trans-Pacific Partnership (TPP), a central […]

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Novartis, Roche find ‘outcome-based’ drug pricing an elusive dream

News that Novartis’s heart drug Entresto cuts the risk of re-hospitalization might have helped Chief Executive Joe Jimenez realize his ambition of getting insurers to pay more for treatments when they cut overall medical costs. Instead Jimenez and Severin Schwan, CEO of cross-town rival Roche, have been forced to concede that insurance companies, especially in […]

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Clinical Trial Results Disclosure by Large Biopharmaceutical Companies Falls Below Legal and Ethical Standards, Study Published in BMJ Open Shows

Study Conducted by Bioethics International Debuts Good Pharma Scorecard – an Integrity Ranking for the Healthcare Industry   NEW YORK, Nov. 12, 2015 /PRNewswire/ — Bioethics International, a not-for-profit organization focused on the ethics and governance of how medicines are researched, developed, marketed and made accessible to patients around the world, today announced the publication of […]

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Portola reversal agent for Xarelto succeeds in late stage trial

A drug developed by Portola Pharmaceuticals to rapidly reverse the effect of new blood thinning agents in cases of major bleeding or other emergencies proved highly effective in a late stage study, according to data presented on Wednesday that should help make the case for its approval. Portola’s andexanet alfa reversed the anticoagulant effect of […]

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Alnylam, Medicines Co cholesterol drug effective for six months: study

An experimental cholesterol fighter being developed by Alnylam Pharmaceuticals and The Medicines Co slashed levels of bad LDL cholesterol and remained effective for six months, according to data from a small, early stage study. The drug, called ALN-PCSsc, cut LDL by more than 50 percent in the 69-subject study presented at the American Heart Association […]

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LEO Pharma to Acquire Global Dermatology Portfolio from Astellas

BALLERUP, Denmark , Nov. 11, 2015 /CNW/ – LEO Pharma A/S, a global healthcare company dedicated to helping people achieve healthy skin, and Japanese pharmaceutical company Astellas Pharma Inc. today announced that they have entered into an Asset Purchase Agreement under which Astellas will transfer its global dermatology business to LEO Pharma for € 675 […]

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Daiichi Sankyo and Plexxikon Announce FDA Approval of Cobimetinib in Combination with Zelboraf (vemurafenib) in Advanced Melanoma

– Combination of cobimetinib and Zelboraf reduced risk of disease worsening or death by half compared to Zelboraf alone – Daiichi Sankyo, Inc. to co-promote cobimetinib in combination with Zelboraf along with Genentech and Exelixis – New co-promote agreement along with pipeline of innovative oncology compounds demonstrate Daiichi Sankyo’s commitment to oncology   PARSIPPANY, N.J. […]

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FDA approves Roche’s Cotellic for combination skin cancer therapy

The U.S. Food and Drug Administration on Tuesday approved Swiss drugmaker Roche’s Cotellic to be used in combination with the company’s Zelboraf drug to treat BRAF V600 mutation-positive advanced melanoma.   Roche is counting on the addition of Cotellic to help it revive flagging sales of five-year-old Zelboraf, which dropped 25 percent during the first […]

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U.S. court imposes temporary sales ban on Dr Reddy’s generic Nexium

Dr Reddy’s Laboratories Ltd, India’s second-largest drugmaker by sales, said on Tuesday it had been temporarily barred by a U.S. court from selling its generic form of blockbuster heartburn drug Nexium in the United States. The order was passed by the U.S. district court of Delaware after AstraZeneca, the maker of Nexium, moved a motion […]

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AstraZeneca lupus drug impresses in mid-stage trial

AstraZeneca’s experimental lupus drug anifrolumab significantly cut disease activity in a mid-stage clinical trial, boosting hopes for a medicine the company believes could become a $1 billion-a-year seller. The drugmaker said on Tuesday that the new treatment was more effective than another drug, sifalimumab, that it had also been testing in lupus. It has therefore […]

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Intensive blood pressure lowering cuts heart failure, death: study

Lowering blood pressure below a commonly used target dramatically reduced heart failure and risk of death in adults aged 50 and older in a large U.S. government-sponsored study, results that could lead to a change in treatment guidelines and medical practice.   The data presented on Monday had some potentially troubling side effects that researchers […]

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Lilly diabetes drug cuts heart failure death, hospitalization: study

Eli Lilly’s new diabetes drug Jardiance significantly cut the risk of heart-related death and hospitalization for heart failure in patients with type 2 diabetes who are at high risk for serious heart problems, according to data from a large study presented on Monday. The 3-year trial of more than 7,000 patients caused a sensation in […]

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U.S. top court allows Apotex to pursue generic version of Daiichi drug

The U.S. Supreme Court on Monday rejected appeals by Daiichi Sankyo Inc and Mylan Pharmaceuticals Inc seeking to stop Apotex Inc from trying to introduce a generic version of Benicar, a drug for treating hypertension. The justices declined to review an April ruling by the U.S. Court of Appeals for the Federal Circuit in favor […]

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