| This week's sponsor is RAPS. | |  | |
Featured Story | | | Monday, July 10, 2017 The FDA and its new Trump-picked commissioner Scott Gottlieb took to social media to talk up the agency’s plans to speed up the drug regulation process. |
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Top Stories Monday, July 10, 2017 Ahead of the first-ever FDA AdComm for a CAR-T medication, the agency says experts should focus on the safety side of the new med, more than efficacy. Monday, July 10, 2017 Shire has obtained a preliminary injunction to stop Roche spreading “inaccurate and misleading” statements about clinical trial data. The legal tussle centers on Roche’s attempt to pin the blame for blood clotting in patients in its phase 3 emicizumab program on Shire’s bypassing agent Feiba. Monday, July 10, 2017 Inotek Pharmaceuticals has posted its second set of subpar data of 2017. The latest readout shows the addition of Inotek’s trabodenoson to glaucoma patients’ regimens failed to perform better than latanoprost alone, wiping 45% off the company’s share price and prompting it to seek strategic alternatives. Monday, July 10, 2017 An FDA greenlight for sickle cell disease therapy Endari has catapulted its developer, Emmaus Medical, into the spotlight, but commercializing the new drug could be challenging. Monday, July 10, 2017 Researchers at the Washington University School of Medicine in St. Louis have been searching for ways to create barriers that shield fetuses from Zika infection. Now, they've discovered that they can manipulate autophagy—the process by which a placental barrier is created—using a common and inexpensive malaria drug. Monday, July 10, 2017 Owlstone Medical and Cancer Research UK have begun a clinical trial designed to identify biomarkers of cancer in breath samples. The goal is to find volatile organic compounds that indicate the presence of cancer, enabling physicians to make quick, noninvasive diagnoses. | | | Concert Pharmaceuticals has seen the FDA lift the clinical hold on its CTP-543 phase 2a trial for alopecia areata, as the company plans to resume enrollment later this month and expects to complete the trial in the second half of 2018. Release Ignyta has been granted an orphan drug tag from the FDA for entrectinib in NTRK fusion-positive solid tumors. Statement PDS Biotechnology is the latest in a long line of biotechs to team up with Merck in a combo trial of its drug and Keytruda. Release | |
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