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Featured Story | | | Monday, August 7, 2017 MyoKardia just announced that its experimental drug mavacamten improved heart function in patients with an inherited cardiac condition, with eight of 10 showing normal readings after treatment with the drug. |
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Top Stories Monday, August 7, 2017 Gemphire Therapeutics has posted data on its oral inhibitor of cholesterol production. The phase 2b met its primary endpoint but also linked gemcabene to a smaller-than-hoped drop in LDL cholesterol, raising doubts about the commercial viability of the asset. Monday, August 7, 2017 Bluebird Bio plans to bring its gene therapies to market in Europe before the U.S., thanks to a favorable regulatory pathway. The company is already in negotiations with the EMA and the U.K.'s Medicine and Healthcare products Regulatory Agency on possible regulatory filings. Monday, August 7, 2017 Natural killer (NK) cells first earned their title as “killers” nearly 40 years ago when researchers observed the rapid immune response of these lymphocytes as they destroyed host cells infected with a virus or tumor cells. It seemed that NK cells could attach spontaneously without prior activation. Over time, researchers have learned more about the molecular mechanisms that regulate their activation and function. Monday, August 7, 2017 A phase 2 trial of Zynerba Pharmaceuticals’ transdermal cannabinoid candidate has missed all its endpoints. The failure of the study to hit a single goal or show a dose response raises big doubts about the drug's prospects—and wiped more than 55% off Zynerba’s stock price. Monday, August 7, 2017 The FDA has rejected Vernalis’ filing for approval of CCP-08. Vernalis wanted to bring CCP-08 and CCP-07 to market in time for the 2017-18 cough-cold season, but back-to-back FDA rejections have scuttled its plans. Saturday, August 5, 2017 Parkinson’s patients treated with an approved diabetes drug did better on movement tests than did patients who received a placebo, University College London researchers found. If they can prove the drug changes the disease itself, it could transform the way we treat Parkinson’s. Monday, August 7, 2017 Fresenius Medical Care is set to buy NxStage Medical for about $2 billion. The takeover will bolster Fresenius’ presence in the at-home dialysis market, positioning it to continue profiting if patients opt against receiving treatment in its care centers. Monday, August 7, 2017 Here's more of Monday’s biopharma news of note. Resources Sponsored By: Veeva Learn why 99% of respondents report the need to unify their clinical applications, including CTMS, EDC, eTMF, and study start-up. Presented By: MPI Research FierceBiotech interviews Dr. DeWit to discuss a common cause for drug development delays, and strategies to avoid these costly setbacks. Sponsored By: Veeva Learn why 99% of respondents report the need to unify their clinical applications, including CTMS, EDC, eTMF, and study start-up. Sponsored By: RTI Health Solutions In this webinar, we will introduce the rapidly-evolving within-subject clinical trial (WSCT) methods for early phase evidence generation that require fewer people, less time, and usually less funding than traditional early phase methods. Sponsored By: Veeva Join this global webinar to learn a new approach for demonstrating medical affairs' impact with better metrics - beyond reach and frequency, enabling launch success and better engagement with strategic KOL insights, and increasing your organization's share of voice in the healthcare landscape. Drug Development Boot Camp® 2017 November 15-16, 2017 | Boston, MA FierceBiotech 2nd Drug Development Forum September 25-27, 2017 | Boston, MA FierceBiotech Executive Summit- London October 2, 2017 | London 15th Annual Discovery on Target September 25-29, 2017 | Boston, MA |
