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Today's Rundown Little Abeona gets big setback with FDA clinical hold on pivotal phase 3 Placebo-drug mix-up adds subplot to Helixmith phase 3 failure Bayer, Boston academics form joint lab to research lung disease Takeda’s CMV med outshines Roche’s Valcyte in phase 2 Quiet biotech Amphivena nabs $62M funding round New CRISPR approach could improve gene and cell therapies FDA device head Shuren talks about getting to 2-week 510(k) reviews Novartis is first to recall generic Zantac after confirming suspected carcinogen Featured Story | | | Tuesday, September 24, 2019 Just under a year ago, Abeona Therapeutics rejected its CEO; now, it’s the biotech’s turn to be spurned, as the FDA has slapped the company with a clinical hold. |
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Top Stories Tuesday, September 24, 2019 A phase 3 trial of Helixmith’s DNA plasmid gene therapy in painful diabetic peripheral neuropathy missed its primary endpoint. Helixmith noted people in the placebo cohort received the experimental therapy as a potential explanation for the failure. Tuesday, September 24, 2019 Bayer, Brigham and Women's Hospital (BWH) and Massachusetts General Hospital have teamed up to work on treatments for chronic lung diseases. They will work out of a joint lab in Boston that will receive more than $30 million over the next five years. Tuesday, September 24, 2019 Takeda’s cytomegalovirus drug, maribavir, beat Roche’s Valcyte at clearing the virus from patients’ blood in a phase 2 study. The study compared the drugs in patients with CMV infection after receiving an organ transplant or a stem cell transplant, a group that's particularly vulnerable to the virus. Tuesday, September 24, 2019 Little-known and super quiet biotech Amphivena has grabbed a strong and healthy $62 million series C round funding haul. Monday, September 23, 2019 Biomedical engineers at Duke are developing a new CRISPR system designed to alter the epigenome, which they believe could address some of the shortcomings of CRISPR-Cas9 and be used to perform many different genome engineering tasks simultaneously. Tuesday, September 24, 2019 Speaking at the annual MedTech Conference hosted by industry trade association AdvaMed, CDRH Director Jeffrey Shuren outlined a few of the initiatives the FDA has planned to help accelerate its 510(k) review timelines. Tuesday, September 24, 2019 Novartis quickly pivoted from suspending distribution of its generic Zantac drugs to recalling them from the U.S. after determining they contain a suspected carcinogen. It is likely to be the first of a wave of recalls. | | Congratulations to the Fierce 15 You have proven that great innovations are created with breakthrough science, insightful leaders and unwavering resolve. Thank you. And we look forward to helping you advance to your next milestone. |
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