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Eye drug setback hits Shire shares amid Baxalta pursuit

Shares in Shire Plc fell 2 percent on Monday after the U.S. Food and Drug Administration (FDA) decided not to approve its most important pipeline medicine for dry eye disease and asked for more information.   The news is a blow for Shire, which is to trying to buy Baxalta Inc to forge the leading […]

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FDA Approves Praxbind (idarucizumab), Specific Reversal Agent for Pradaxa (dabigatran etexilate mesylate)

RIDGEFIELD, Conn., Oct. 16, 2015 /PRNewswire/ — Boehringer Ingelheim Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) granted approval of Praxbind® (idarucizumab). PRAXBIND is indicated for patients treated with Pradaxa® (dabigatran etexilate mesylate), when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. […]

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PTC says DMD drug data supports U.S. approval despite trial failure

PTC Therapeutics Inc’s experimental muscle disorder drug failed to meet the main goal in a keenly watched late-stage study, but the company said data from all trials on the drug supported a U.S. marketing application. The company’s stock fell about 16 percent in extended trading on Thursday, before reversing course to notch marginally gains. PTC […]

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Valeant subpoenaed by US prosecutors over drug pricing

Valeant Pharmaceuticals International Inc (VRX.TO) (VRX.N), under fire for price increases of its two heart drugs, said it was subpoenaed by U.S. prosecutors on its pricing, drug distribution and patient assistance programs. Valeant’s U.S.-listed shares were down 9 percent at $156.53 in premarket trading on Thursday. The company, which came under attack from Democratic lawmakers […]

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FDA declines to expand approval of Pfizer arthritis drug

U.S. health regulators declined to approve Pfizer Inc’s oral rheumatoid arthritis drug Xeljanz to treat moderate to severe cases of the scaly skin condition plaque psoriasis, the drugmaker said on Wednesday. Pfizer said it received a so-called complete response letter from the Food and Drug Administration. Such letters typically outline concerns and conditions that must […]

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Lilly pill trumps Humira in arthritis study

Eli Lilly and Co’s experimental pill for rheumatoid arthritis proved superior to Abbvie Inc’s leading injectable Humira treatment in a large study, which analysts said could prod them to raise sales forecasts for the medicine. Lilly said on Wednesday it was the first study to show that a once-daily oral treatment was superior to $13 […]

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Japan’s Astellas looking for more deals to refuel drug pipeline

Japan’s Astellas is seeking more deals to refill its drug pipeline as the pharmaceutical company created through a merger 10 years ago explores opportunities in both established and new therapy areas.   “We’re never satisfied with what we have, so we are looking at strategies to augment the portfolio. Nothing is off the table for […]

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U.S. prescription opioid misuse and deaths increase

(Reuters Health) – The proportion of people reporting use of prescription opioids for reasons other than medical necessity fell between 2003 and 2013, but use disorders and overdose deaths increased, according to a new study. “The results underscore the importance of addressing the prescription opioid crisis,” said lead author Dr. Beth Han of the Substance Abuse […]

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Protalix Sells Back ELELYSO Rights to Pfizer for $46 Million

Karmiel, Israel-based Protalix Biotherapeutics, Inc. (PLX) announced today that it was selling its share of a collaboration deal back to Pfizer Inc. (PFE)   Under the original deal, Pfizer took 60 percent and Protalix took 40 percent of revenues and expenses for the development and commercialization of ELELYSO, except in Israel and Brazil. Under the […]

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Merck cholesterol drug’s odds dim after Lilly failure

The odds that Merck & Co’s high-stakes cholesterol drug will succeed have dropped dramatically after Eli Lilly and Co said its similar medicine failed to reduce heart attacks and strokes, top U.S. heart doctors said. Lilly on Monday said it was halting a 12,000-patient study of its drug, evacetrapib, an oral medication. In earlier studies, […]

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