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Valeant profit beats estimates as U.S. sales stay strong

Drugmaker Valeant Pharmaceuticals International Inc (VRX.TO) (VRX.N) reported a better-than-expected quarterly profit, helped by strength in its dermatology business in the United States. The company also raised its earnings and revenue forecast for the year to reflect sales of recently acquired Salix Pharmaceuticals’ irritable bowel syndrome drug, Xifaxan. The U.S. Food and Drug Administration approved […]

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Abbott profit beats estimates on higher sales of generics

Abbott Laboratories Inc reported a slightly better-than-expected quarterly profit, helped by higher sales of its branded generics. Sales at Abbott’s three largest businesses – nutritional products, diagnostic products and pharmaceutical products – rose in the second quarter, helping the company reaffirm its full-year profit forecast. The acquisition of Chile’s CFR Pharmaceuticals S.A. in September helped […]

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Celgene Strikes Again, Extends Epizyme Pact By Three Years in Deal Worth $620 Million

Cambridge, Mass.-based Epizyme, Inc. (EPZM), announced today that it amended its agreement with Celgene Corporation for at least three more years. The original agreement, signed three years ago, was for EPZ-6438 (tazemetostat) for the treatment of non-Hodgkin lymphoma patients and patients with INI1-deficient solid tumors, and EPZ-5676 (pinometostat), an inhibitor of DOT1L for the treatment […]

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Novartis wins early U.S. approval for major new heart drug

Novartis AG on Tuesday won U.S. approval for its keenly awaited new heart failure drug Entresto earlier than expected, boosting hopes for a medicine tipped by analysts to reap billions of dollars in annual sales. The Swiss drugmaker had previously said U.S. approval was likely in August. The U.S. Food and Drug Administration said in […]

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Vertex’s $259,000 Cystic Fibrosis Drug Approved

The U.S. Food and Drug Administration approved Vertex Pharmaceutical Inc.’s cystic-fibrosis drug Orkambi, which could treat as many as 8,500 patients in the U. S. — but at a whopping annual wholesale cost of $259,000 per patient. The drug, a twice-daily oral tablet for patients 12 years and older, expands the company’s reach in the […]

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Exclusive: Hospira wins French biosimilar drug tender at 45 percent discount

A major French hospital group has chosen a cheap copycat version of a top-selling drug for treating its patients with rheumatoid arthritis, Crohn’s disease and psoriasis in a victory for a new type of medicine known as biosimilars.    In a document seen by Reuters, the central purchasing agency for the Assistance Publique – Hôpitaux de […]

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Genentech’s Ocrelizumab Wows in Late Stages and Eyes $18 Billion MS Market

South San Francisco, Calif.-based Genentech (RHHBY) announced today that its clinical studies of ocrelizumab compared to interferon beta-1a (Rebif) in relapsing multiple sclerosis (MS) met their primary and major secondary endpoints.   Two Phase III studies are being conducted, OPERA I and OPERA II. The primary endpoint of both studies was annualized protocol-defined relapse rate […]

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Vertex Poised to Become Profitable Following Expected FDA Approval of Orkambi

June 30, 2015By Alex Keown and Riley McDermid, BioSpace.com Breaking News Staff BOSTON – Vertex Pharmaceuticals (VRTX) is anxiously waiting for regulatory approval of its newest cystic fibrosis medication Orkambi, a treatment which is widely expected to have a broad impact on the cystic fibrosis market – and a treatment widely expected to sharply boost […]

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EXCLUSIVE: Knives Are Out for Biotech, As Bears Snag Options for Bubble Burst

New market data is showing a renewed and ravenous demand for options tied to declines in an exchange-traded fund tracking biotech companies, according to Bloomberg data, which hit the highest level in three years last week. Biotech is continuing its scorching pace of growth, with the NASDAQ Biotechnology Index (NBI) up more than 25 percent […]

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Synergy Pharma Becomes an Attractive Takeover Target After Drug Wows in Phase III Study

Will good news and a stock surge mean Synergy Pharmaceuticals is soon to be a target for acquisition? Some analysts think so. Synergy Pharmaceuticals (SGYP) announced the top-line results from the first of two pivotal Phase III clinical trials studying two different plecanatide treatment doses in adult chronic idiopathic constipation (CIC). Plecanatide is being studied […]

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