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Vertex Pharma receives subpoena from Department of Justice

Vertex Pharmaceuticals Inc said it received a subpoena from the U.S. Department of Justice in the third quarter related to its marketed medicines, seeking documents related primarily to its “good laboratory practices” in a bioanalytical lab. Good laboratory practices are rules that govern non-clinical safety studies, ensuring quality, integrity and reliability of data. Bioanalytical labs […]

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Basketball players may be at heightened risk of lung clots

(Reuters Health) – Basketball players could be at heightened risk for dangerous blood clots that travel to the lungs, according to a small Spanish study. But the results – calculated from only six cases of so-called pulmonary embolism in U.S. and European players – need to be replicated in larger studies, the authors caution. “We […]

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Hospitals to pay $250 million for cardiac device coverage violations: DOJ

Hundreds of U.S. hospitals will pay a total of more than $250 million stemming from allegations that they implanted cardiac devices in Medicare patients in violation of coverage requirements, the U.S. Justice Department said on Friday. The 457 hospitals are from 43 states, the Justice Department said. The settlement involves a type of device that […]

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Regeneron Announces EU Approval of EYLEA (aflibercept) Injection for the Treatment of Visual Impairment Secondary to Myopic Choroidal Neovascularization

TARRYTOWN, N.Y., Oct. 30, 2015 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that Bayer HealthCare has received European approval for EYLEA® (aflibercept) Injection for the treatment of visual impairment due to myopic choroidal neovascularization (myopic CNV). Myopic CNV is an eye disease associated with high degrees of myopia (near-sightedness) and frequently affects people […]

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AbbVie projects double-digit annual earnings growth through 2020

AbbVie Inc (ABBV.N) reported higher quarterly sales and net income on Friday and forecast double-digit growth of earnings per share through 2020, putting the drugmaker in line to beat Wall Street’s current expectations. AbbVie, which was spun out of Abbott Laboratories in 2013, expects revenue of $37 billion in 2020, which is $5 billion more […]

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Sanofi Walks Away from a $613 Million Multiple Sclerosis Pact with Glenmark Pharma

PARIS – After experimental multiple sclerosis drug vatelizumab failed to meet its primary endpoints in a mid-stage trial, Sanofi AG (SNY) said it has dropped plans to develop the drug with India-based Glenmark Pharmaceuticals.   During a second-quarter results analysis with media members, Glenmark revealed that Sanofi was terminating the development agreement for vatelizumab, also […]

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Allergan’s Warner Chilcott Coughs Up $125 Million to Settle Kickback Charges, Former Exec Arrested in Boston

The former president of an Irish drug company was arrested in Boston this morning on charges of conspiring to pay kickbacks to physicians, as his company settled allegations of fraud for $125 million. The U.S. Justice Department said in a release that 57-year-old W. Carl Reichel, the former president of Dublin-based Warner Chilcott, has been […]

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Novartis, Juno face production hurdles for new blood cancer drugs

As drugmakers including Novartis, Juno Therapeutics and Kite Pharma race to launch what may be the most effective treatments ever seen for leukemia and other blood cancers, they are grappling with how to make them widely available in a reliable and cost-efficient way.   The new therapies, known as CAR T cells, are made by […]

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FDA approves new Novartis dual combination bronchodilator Utibron Neohaler for patients with chronic obstructive pulmonary disease

– Utibron Neohaler (indacaterol/glycopyrrolate) demonstrated superior and sustained improvements in lung function compared to either of its single bronchodilator components as well as placebo, and improved lung function compared to placebo at 5 minutes after the first dose and throughout the dosing interval.1 It does not replace the use of a rescue inhaler – Utibron […]

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Intouch Solutions moves NYC office, expands

NEW YORK CITY (OCTOBER 29, 2015) — Intouch Solutions, a marketing agency serving the pharmaceutical industry, has moved their New York offices to 469 Seventh Avenue in Midtown Manhattan. The move comes in response to rapid expansion at Intouch Solutions fueled by the acquisition of a number of major new clients. Employee count in the […]

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Survey: Pharma wants promotional content management systems, but silos abound

Veeva Systems released its 2015 Promotional Content Management System survey, and found that while many in the pharma industry want end-to-end systems to keep track of and disseminate the flood of promotional digital materials being generated, the industry’s capabilities to do so are hampered at this time by a number of factors. Med Ad News […]

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You probably have herpes, the WHO says

Two-thirds of the world’s population under 50 have the highly infectious herpes virus that causes cold sores around the mouth, the World Health Organization said on Wednesday, in its first estimate of global prevalence of the disease. More than 3.7 billion people under the age of 50 suffer from the herpes simplex virus type 1 […]

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Arcturus Therapeutics Stands to Collect Up to $1.66 Billion from Rare Disease Pact with Ultragenyx

Novato, Calif.-based Ultragenyx Pharmaceutical Inc. (RARE), announced today that it has inked a research and collaboration deal with San Diego-based Arcturus Therapeutics, Inc.   The two companies will work to identify and develop messenger RNA (mRNA) therapeutics for rare disease targets utilizing Arcturus’ UNA Oligomer chemistry and LUNAR nanoparticle delivery program. Ultragenyx will pay Arcturus […]

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Rumors Confirmed, Pfizer and Allergan In Talks to Merge

After months of speculation on who Pfizer Inc. (PFE) will attempt to buy are now officially over — sort of. It has been confirmed that Pfizer Inc. and Allergan Plc (AGN), according to the Wall Street Journal, are discussing a potential merger. The two companies have declined to comment.   Analysts have been speculating on […]

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Valeant’s ambitious plan for its contact lens business

Valeant Pharmaceuticals International has pursued a plan in recent months to dominate the market for specialty contact lenses, according to two people familiar with the company’s approach and some of the company’s communications with its customers.   The Canadian drugmaker’s goal, spelled out to key employees and demonstrated through its actions, has been to acquire […]

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FDA expands use of Bristol-Myers’ cancer drug Yervoy

The U.S. Food and Drug Administration expanded the use of Bristol-Myers Squibb Co’s skin cancer drug, Yervoy, as an additional therapy for patients with late-stage melanoma. This approval extends Yervoy’s use to patients with stage III melanoma, who have a high risk of recurrence after surgery, the agency said on Wednesday. Due to the potential […]

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Amgen profit beats Street, issues conservative 2016 forecast

Amgen Inc (AMGN.O) on Wednesday reported much higher-than-expected third-quarter profit, helped by a 30-percent spike in revenue from the rheumatoid arthritis drug Enbrel due to price increases and inventory stocking. The world’s largest biotechnology company raised its full-year earnings forecast on the back of the strong quarter, and issued its first 2016 projections for adjusted […]

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Fred Kinch Launches Healthcare Advertising Agency

Industry veteran Fred Kinch has launched a new healthcare communications agency this month. Mr. Kinch previously served as Managing Partner and Executive Creative Director at New York-based healthcare ad agency AgencyRx. Kinch Advertising LLC is a full-service, mission-built, independent healthcare advertising agency located in Midtown Manhattan. The agency is primarily focused on creating promotions and […]

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Sanofi U.S. recalls Auvi-Q injections for severe allergy

French drugmaker Sanofi SA said it was voluntarily recalling all its Auvi-Q injections in the United States to treat patients with severe allergic reactions. The company said on Wednesday its U.S. unit was recalling the injections as they could potentially deliver an inaccurate dose. Auvi-Q is designed to treat anaphylaxis, a potentially fatal allergic reaction, […]

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Baxter International Brings Aboard Former Covidien Head as Chairman, CEO

DEERFIELD, Ill. – Baxter International tapped José (Joe) Almeida as the company’s new chairman and chief executive officer effective Jan. 1, 2016, the company announced Wednesday.   Almeida, the former president and CEO of Covidien, will take over the Baxter helm when current CEO Robert Parkinson Jr. retires. Almeida, a native of Brazil, will start […]

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