As Acceleron Pharma Inc.’s phase II trial of sotatercept hit its primary endpoint and some key secondary endpoints in significantly reducing pulmonary vascular resistance, the stock (NASDAQ:XLRN) reacted accordingly, gaining 50% on Jan. 28. The stock ended the day at $79.39, up $26.52. Read More
With four gene therapies already approved and more than 900 in development, the FDA has finalized six guidances and issued a draft guidance to clarify the rules of the road for developing and manufacturing the treatments. Read More
Adding further evidence about the global threat of the increase of antimicrobial-resistant (AMR) infections and dearth of new antibiotics to treat those conditions, Thomas Cueni, chair of the AMR Industry Alliance, said the findings from the alliance’s newly released report are “a wake-up call” as they estimate current investments in AMR-relevant R&D are not enough to sustain a viable pipeline that will be needed to combat infectious diseases globally. Read More
HONG KONG and BEIJING – Not just multinational players but domestic Chinese pharmaceutical companies are poised to benefit from China’s promise under a phase one trade deal with the U.S. to better protect intellectual property (IP), even if question marks remain around how the deal will be enforced. The move is in line with China's ambition to strengthen IP rights protection and upgrade the approach to innovation of its pharmaceutical and biotech industries. Read More
Australian researchers led by the Garvan Institute of Medical Research in Sydney have compiled the first reference genome database of healthy older Australians, which potentially can predict disease-linked gene variants more accurately than has been previously possible. Read More
The U.S. Centers for Medicare and Medicaid Services (CMS) has significantly relaxed the national restrictions on coverage of next-generation sequencing for cancer, affirming that early-stage breast and ovarian cancer patients will be covered. However, Medicare administrative contractors can cover tests that have not been reviewed by the FDA, a move that should also significantly boost utilization for makers of next-generation sequencing systems in clinical labs. Read More
The patent subject matter eligibility problem has rattled the world of diagnostics for several years, but the U.S. Senate has been silent about legislation in recent months. Patent attorney Michael Borella, of McDonnell Boehnen Hulbert & Berghoff LLP (MBHB), said he does not expect Congress to provide any legislative fix to the problem any time soon. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications, including: Acceleron, Aeterna Zentaris, Bausch Health, Cassava, Clearside, Ikena, Incyte, Syros Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief, including: Adverum, Achillion, Alexion, Armata, Atrin, Avacta, Biolexis, Clover, Concert, Correvio, Horizon, Incyte, Innovia, Outlook, Oxford Gene, Predictive Technology, Satt Conectus, Seelos, Syndivia, Takeda Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations, including: Alkermes, Arrevus, Blueberry, Boehringer Ingelheim, Eli Lilly, Janssen, Jubilant, Regeneron, Sanofi and Surface Read More
