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GSK President’s “Eight Terrifying Words” Face Systemic Challenges in U.S.

February 17, 2016 By Alex Keown, BioSpace.com Breaking News Staff   CHICAGO — “The days of unfettered pricing are long gone.” Those are eight of the most terrifying words pharmaceutical drugmakers could ever hear, Sean Williams, an analyst with the Motley Fool wrote this morning. The words were said by GlaxoSmithKline (GSK)’s U.S. president Jack […]

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Catalyst Pharmaceuticals Tanks on FDA Refuse-to-File Letter

Catalyst Pharmaceuticals Receives “Refusal to File” Letter From the FDA on Its NDA for Firdapse   CORAL GABLES, Fla., Feb. 17, 2016 (GLOBE NEWSWIRE) — Catalyst Pharmaceuticals, Inc. (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced that the Company has received a “Refusal to […]

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AstraZeneca wins FDA breakthrough status for key cancer drug

The U.S. Food and Drug Administration has granted breakthrough therapy designation to AstraZeneca’s biggest new drug hope ‍durvalumab as a treatment in bladder cancer, the drugmaker said on Wednesday.   The experimental medicine is a so-called PD-L1 therapy that fights cancer by boosting the immune system. Breakthrough therapy designation expedites the development and review of […]

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Flexion’s pain drug succeeds in study, shares soar

Flexion Therapeutics Inc’s pain drug was found to be effective in a late-stage study, taking the company one step closer to its first ever U.S. marketing approval. Flexion’s shares jumped about 38 percent in extended trading on Tuesday as the announcement revived hopes for the drug, which is touted to rake in peak U.S. sales […]

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Stryker expands ambulance services with Physio-Control buy

Medical device maker Stryker Corp said it would buy Physio-Control International Inc for $1.28 billion in cash to expand its emergency medical services business and raised its full-year earnings forecast for the second time this month. Stryker has been on the look out for deals. The company earlier this month inked a deal with medical […]

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FDA expands use of Gilead’s liver drug to rare subset of patients

The U.S. Food and Drug Administration has expanded the use of Gilead Sciences Inc’s blockbuster drug Harvoni to some hepatitis C patients in the advanced stage of cirrhosis, including those who have undergone liver transplant. Chronic hepatitis C patients often develop scarring and poor liver function also known as cirrhosis, which can lead to complications […]

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Genes, bugs and radiation: WHO backs new weapons in Zika fight

Countries battling the Zika virus should consider new ways to curb disease-carrying mosquitoes, including testing the release of genetically modified insects and bacteria that stop their eggs hatching, the World Health Organization said on Tuesday. “Given the magnitude of the Zika crisis, WHO encourages affected countries and their partners to boost the use of both […]

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Pfizer unit to pay $784.6 mln in Medicaid rebate settlement

Pfizer Inc said its Wyeth unit has agreed to pay $784.6 million to settle cases related to the calculation of Medicaid rebates for a gastric drug between 2001 and 2006. The claims alleged that Wyeth’s calculation of rebates for Protonix violated the Federal Civil False Claims Act and other laws before the company was bought […]

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FDA Spurns Merck & Co.’s Cardiovascular Claims for Zetia, Vytorin

February 16, 2016 By Alex Keown, BioSpace.com Breaking News Staff   KENNILWORTH, N.J. – The U.S. Food and Drug Administration rejected Merck (MRK)’s cardiovascular claims for its cholesterol-reducing drugs Zetia and Vytorin, the company announced this morning. The FDA sent Merck a complete response letter regarding the company’s new drug application for the reduction of […]

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Phase 3 Study Demonstrates Aranesp (Darbepoetin Alfa) Reduces Red Blood Cell Transfusions In Patients With Myelodysplastic Syndrome (MDS)

First Phase 3 Data From Placebo-Controlled Study With an Erythropoiesis-Stimulating Agent (ESA) in Anemic Patients With MDS Study Met Primary Endpoint and Key Secondary Endpoint of Erythroid Response   THOUSAND OAKS, Calif., Feb. 15, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the randomized, double-blind, placebo-controlled Phase 3 Aranesp® (darbepoetin alfa) ARCADE trial met its primary […]

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Gastric reflux drugs may be tied to dementia risk

Reuters Health – Repeated use of a certain class of drugs for gastric reflux or peptic ulcers was linked with a higher risk for dementia among patients in Germany, researchers say. The drugs, known as proton pump inhibitors (PPIs), include lansoprazole (Prevacid), esomeprazole (Nexium), and omeprazole (Prilosec), all manufactured by AstraZeneca. The current study can […]

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FCB Health renamed FCB Heart during Heart Failure Awareness Week

  FCB is not just talking about their commitment to health and wellbeing – they are staking their name on it. During Heart Failure Awareness Week (February 14-20), FCB Health has changed its name to FCB Heart. Beyond just changing the name and logo, the awareness campaign consist of signs, posters, and activities to help […]

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Bomb Threat Forces Evacuation at Medtronic Plant

Employees were evacuated from a facility that makes products for Medtronic’s Covidien business after a bomb threat was discovered at the Wabasha, Minn., plant. The Post Bulletin reports on the incident, which followed the discovery on Thursday of a hand-written note taped to a restroom wall. The note said there was a bomb in the […]

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Theranos Files Plans with U.S. Regulators to Fix All Serious Deficiencies at Bay Area Lab

PALO ALTO, Calif. – Theranos submitted a plan of correction to the U.S. Centers for Medicare & Medicaid Services to address deficiencies regulators found at the embattled blood-testing company’s Newark, Calif. lab, Bloomberg reported this morning. The company has maintained that approximately 95 percent of its laboratory work is performed at its Arizona facilities. But, […]

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Russia reports first case of person infected with Zika virus

Russia’s consumer safety watchdog said on Monday the country had registered its first case of a person infected with the Zika virus, an unnamed female who had been on holiday in the Dominican Republic.   Rospotrebnadzor, the watchdog, said in a statement that the condition of the person was satisfactory and that her family members […]

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China to consolidate drug market, promote traditional medicines

China plans to consolidate its huge and fragmented drug market and will support a greater role for traditional Chinese medicines (TCM), the central government said in a statement on Sunday following a meeting of the State Council.   China will also strengthen safety controls and traceability of domestic drugs, the statement said, part of an […]

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Bristol-Myers shares could rise 25 percent on cancer drug: Barron’s

Shares of Bristol-Myers Squibb could rise 25 percent within a year because of its cancer-fighting drug Opdivo, which some analysts see generating $8 billion to $9 billion in annual sales in five years, Barron’s said in its latest edition. The drug’s success in thwarting a number of cancers, including lung, melanoma, renal cell carcinoma, and […]

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TrialScope: Upcoming U.S. And EU Clinical Trial Disclosure Regulations

Join TrialScope’s Chief Strategy Officer, Thomas Wicks and Senior Product Specialist, Matt DeFranco, for a timely discussion of how life sciences teams can prepare for these changing requirements.

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Sun Pharma to seek FDA re-inspection of Halol plant by end-June; Agrees to Call off JV with Merck & Co.

India’s largest drugmaker, Sun Pharmaceutical Industries, plans to ask U.S. regulators by the middle of this year to re-inspect a plant in Gujarat after they criticised manufacturing standards there, Sun’s founder said. Dilip Shanghvi said the company would ask the U.S. Food and Drug Administration (FDA) for the new inspection of the Halol plant in […]

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WHO sees Zika link proven in weeks as U.S., India lead vaccine race

Suspected links between the Zika virus and two neurological disorders, microcephaly in babies and Guillain-Barre syndrome, should be confirmed within weeks, the World Health Organization (WHO) said on Friday. A sharp increase in birth defects in Brazil has triggered a global health emergency over the mosquito-borne virus and spurred a race to develop a vaccine […]

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