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Encouraging Progress toward Reproducibility Reported
At AAAS 2017, a pair of panel discussions addressed the reproducibility crisis in science, particularly biomedical science, and suggested that it is manageable, provided stakeholders continue to demonstrate a commitment to quality. One panel, led by Leonard P. Freedman, Ph.D. president of Global Biological standards Institute (GBSI), was comprehensive. It prescribed a range of initiatives:drive quality and ensure greater accountability through strengthened journal and funder policies; create hig -
Scientists Create Active Controllable Electronic DNA Switch
DNA has unique electrical properties that have for years interested pioneering engineers trying to advance the development of tiny, low-cost electronic devices. Now, a research team led by scientists at Arizona State University (ASU) have developed the first controllable DNA switch to regulate the flow of electricity within a single, atomic-sized molecule—much like flipping your light switch at home, only on a scale 1000 times smaller than a human hair."It has been established that charge -
Sarepta Sells Priority Review Voucher to Gilead for $125M
Sarepta Therapeutics said today it will sell its Rare Pediatric Disease Priority Review Voucher to Gilead Sciences for $125 million upfront.Sarepta obtained the voucher when the FDA in September approved the company’s Exondys 51™ (eteplirsen) as a treatment for Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping.Gilead’s identity as the buyer was disclosed by Sarepta in a regulatory filing. Gilead emerged from “multiple pharmaceutical and biotech companies&rdqu -
Trevena's Oliceridine Analgesic Meets Primary Endpoints in Two Phase III Studies
Trevena confirmed that it remains on track to file an NDA with FDA later this year for its intravenous analgesic, oliceridine, on the back of positive topline data from two placebo-controlled Phase III studies. The pivotal APOLLO-1 and APOLLO-2 studies evaluated three doses of oliceridine in the management of moderate-to-severe acute pain following bunionectomy (APOLLO-1), and abdominoplasty, (APOLLO-2).Data reported today confirmed that both trials met their primary responder rate endpoints, an -
Marine Snail Venom May Serve as Opioid-alternative for Pain Relief
Researchers at the University of Utah reportedly have found a compound that blocks pain by targeting a pathway not associated with opioids. Work with rodents indicates that the benefits continue long after the compound have cleared the body, notes the study published online in PNAS.Opioids are highly addictive and, according to the Centers for Disease Control and Prevention, 91 Americans die every day from an opioid overdose. The medical community is in need of alternative therapies that do not -
Roche/Chugai's Alecensa Wins Conditional EC Approval for ALK-Positive NSCLC
Roche and Chugai’s oral ALK inhibitor, Alecensa® (alectinib), was granted conditional approval by the European Commission as monotherapy for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) in adult patients who have previously been treated with crizotinib.Alecensa was originally discovered by Roche’s majority-owned Japanese drugmaker, Chugai. Roche has developed the drug in markets including the U.S. and Europe. Conditional approval -
BioSense, Neovacs Agree €65M Deal for Therapeutic SLE Vaccine in China
BioSense negotiated an option to licence Neovacs’ Phase II-stage IFNalpha Kinoid therapeutic vaccine candidate for treating systemic lupus erythematosus (SLE), in China and selected territories. Under terms of the deal Neovacs could receive up to €65 million (approximately $68.5 million) in up front and milestone payments, not including any future sales royalties. The deal is the second signed by Neovacs for the IFNalpha-Kinoid candidate. During late 2015 the firm inked a strategic pa
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