With the FDA’s granting of emergency use authorization (EUA) to Johnson & Johnson (J&J), there is now a third vaccine – and the first requiring only a single shot – against COVID-19 for adult Americans. Though it packs less of an efficacy punch, the EUA allows J&J’s Ad26.COV2.S to join mRNA vaccines from Moderna Inc. and Pfizer Inc./Biontech SE as protection against the virus. Read More
Debiopharm International SA is more interested in developing drugs than marketing them. Bertrand Ducrey, CEO of Debiopharm, said he envisions the drugs the company is stewarding through development as a "living pipeline" that needs to be refreshed as drugs get to late-stage development. So Debiopharm is shipping global rights to xevinapant (Debio-1143) and its follow-on inhibitor of apoptosis proteins antagonist, Debio-4028, to Merck KGaA, of Darmstadt, Germany. Read More
The cost of newly FDA approved Pepaxto (melphalan flufenamide) from Oncopeptides AB is designed to put the therapy in the middle of the range compared to other multiple myeloma therapies, CEO Marty Duvall told BioWorld. “There are products well entrenched in that space,” he added. Read More
Molybdenum cofactor deficiency (MoCD) type A, an ultra-rare metabolic disorder causing intractable seizures, brain injury and death, now has a world-first treatment in Nulibry (fosdenopterin), a new I.V. therapy developed by Bridgebio Pharma Inc. subsidiary Origin Biosciences Inc. The agency's priority review, supported by its orphan, breakthrough and rare pediatric disease programs, also yielded a priority review voucher (PRV) for Origin. Read More
Tenaya Therapeutics Inc. raised $106 million in a series C round to continue its build-out as a fully integrated gene therapy and regenerative medicine specialist focused on cardiovascular disease. Read More
LONDON – Oxular Ltd. has raised $37 million in a series B, enabling the company to take OXU-001, its long-acting treatment for diabetic macular edema (DME) into phase II development later this year. Read More
In divvying up U.S. spending on orphan vs. nonorphan indications for drugs approved for both, a new study could fuel future debates and inform policy on orphan drug incentives. The study, led by a team of University of Michigan and Boston University researchers, found that 21% of the total dollars spent in 2018 in the U.S. on the 15 top-selling partial orphan drugs went to the treatment of rare diseases, while more than 70% went to the treatment of common diseases. Read More
PERTH, Australia – Sydney-based Kazia Therapeutics Ltd. has out-licensed its ovarian cancer drug, Cantrixil (TRX-E-002-1), to Sweden’s Oasmia Pharmaceutical AB in a deal worth up to $46 million.
Oasmia will pay $4 million up front, and development milestones worth up to $42 million and double-digit sales royalties. Read More
A team led by researchers at Johns Hopkins University School of Medicine has developed bispecific antibodies that were able to target tumors driven by mutations in the tumor suppressor TP53 and the oncogene RAS, as well as subsets of T cells in T-cell malignancies. Read More
In a move that caught analysts and investors by surprise, the FDA rejected Athenex Inc.’s NDA for Oraxol, its oral version of paclitaxel, for use in metastatic breast cancer, citing safety risks and questioning the reliability of the clinical data supporting the application. Read More
New hires and promotions in the biopharma industry, including: 9 Meters, Algernon, Bioxcel, Catalym, Cerecor, Checkpoint, ERS Genomics, Genentech, Hansa, Immunicum, Innocare, Karolinska, Orphazyme, Xwpharma. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Accure, Algernon, Annexon, Aslan, Bioinvent, Innovent, Morphic, Ocular, Samsung Bioepis, Santhera, Satsuma, Takis, Transgene, VBL. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Anokion, Boehringer Ingelheim, Chinook, Claritas, Clene, Enlivex, Evotec, Gubra, Homology, Hoth, Kalytera, Novartis, Uppthera. Read More
