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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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Novo Nordisk diabetes drug fails to help heart failure: study

The Novo Nordisk diabetes drug Victoza failed to improve clinical stability or delay death in patients suffering from advanced heart failure, researchers reported at a medical meeting on Sunday. The injectable drug, known chemically as liraglutide, was tested in 300 patients with and without type 2 diabetes who had advanced heart failure and a recent […]

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FDA panel backs Merck & Co. drug to reverse muscle relaxant effect

Merck & Co’s drug to reverse the effects of muscle relaxants used in surgery is safe and effective enough to warrant approval, an independent panel to the U.S. Food and Drug Administration said. The drug, which goes by the chemical name of sugammadex, has repeatedly been rejected by the FDA due to concerns about potentially […]

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Allergan CEO Saunders warms up to drug discovery

Brenton Saunders, the whiz-kid pharmaceutical executive with a reputation for being wary of the costs of early-stage drug development, says he’s open to new ideas from outside and is now warming up to investing in drug discovery if it makes sense for his company. That could ease concern that if Allergan Inc’s “friendly” talks with […]

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FDA approves Gilead Sciences’ HIV drug cocktail

Gilead Sciences Inc said the U.S. Food and Drug Administration had approved its HIV drug cocktail, Genvoya, to treat patients aged 12 and above. Genvoya, a combination tablet approved as a complete regimen, is designed to treat previously untreated patients weighing at least 35 kilograms (77 pounds), the FDA said on Thursday. (1.usa.gov/1RYxl7t) The drug […]

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Gilead’s Blockbuster Sovaldi Linked to Slower Heartbeats and Puts Patients at Risk of Passing Out

NEW YORK – A team of French doctors reported Gilead Sciences, Inc. (GILD)’s blockbuster hepatitis C drug Sovaldi can cause abnormally slower heart rates in patients taking the medication. The slower heartbeats can cause patients to pass out, the doctors said in a letter to The New England Journal of Medicine. According to the French […]

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China launches pilot scheme to ease drug approvals

China has launched a three-year pilot scheme to loosen approvals for new drugs, the country’s food and drug regulator said on Thursday, as Beijing looks to help stimulate innovation in the country’s pharmaceutical sector. The trial, set to take place in 10 regions, will allow research and development bodies to seek drug approvals, which are […]

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AstraZeneca, Teva reach deal with states in Medicaid pricing case

Drugmakers AstraZeneca Plc and Cephalon, a unit of Teva Pharmaceutical Industries Ltd, reached a multistate accord on Wednesday over civil charges they overbilled state Medicaid programs, the New York Attorney General announced. The settlement with the states comes after the U.S. Justice Department settled parallel civil charges with both companies in July. The $54 million […]

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U.S. Senate panel probing Valeant, Turing over drug costs

A U.S. Senate panel on Wednesday launched a bipartisan probe into pharmaceutical drug pricing, seeking documents from four drugmakers including Valeant Pharmaceuticals and Turing Pharmaceuticals, two companies embroiled in controversy over price hikes on lifesaving drugs.   The Senate’s Special Committee on Aging also requested information from Retrophin Inc and Rodelis Therapeutics, according to a […]

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Novo weighs options before crucial Victoza heart study data

Novo Nordisk is considering options ahead of key heart safety data for its diabetes drug Victoza and could run a further clinical study if necessary, the Danish company’s research head said on Wednesday. The outcome of Novo’s current cardiovascular trial, known as LEADER, has become critical following the unprecedented success of Eli Lilly and Boehringer Ingelheim’s […]

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Branded drugs help Botox-maker Allergan beat profit estimates

Botox-maker Allergan Plc, which is in talks to be bought by Pfizer Inc, reported a better-than-expected quarterly profit on strong sales of high-margin branded drugs, its biggest business. Shares of Allergan, created from the merger of Actavis and Allergan, rose 1.4 percent to $313.50 in premarket trading on Wednesday. The Actavis-Allergan merger brought signature drugs […]

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OECD warns high-priced drugs are stretching health budgets

Specialty medicines for which pharmaceutical companies demand high prices are straining wealthy nations’ health budgets, the OECD said on Wednesday, with drugs accounting for some 20 percent of all health spending. Across the 33 OECD countries, pharmaceutical spending reached $800 billion in 2013, and new drugs and rising demand are likely to continue to push […]

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GSK aims to file up to 20 new drugs for approval by 2020

GlaxoSmithKline said on Tuesday it could file up to 20 new drugs for regulatory approval before 2020 as it seeks to revitalize a portfolio hit by falling sales of best-selling inhaled lung treatment Advair.   Seven of these products may reach the market before the end of decade, it added. Britain’s biggest drugmaker is trying […]

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GSK and Merck to Study Immunotherapy Combination as Potential Cancer Treatment

Phase I first-in-human study to evaluate GSK’s OX40 agonist GSK3174998 as monotherapy and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab)     LONDON & KENILWORTH, N.J.–(BUSINESS WIRE)–GSK and Merck, known as MSD outside the US and Canada, today announced the initiation of a phase I clinical trial designed to evaluate GSK’s investigational immunotherapy GSK3174998 […]

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