European regulators have put off a decision on Biogen Inc and Eisai, Co. Ltd.’s controversial Alzheimer’s drug, aducanumab, for likely another month, after the companies announced further supportive data from a follow-up under review by the FDA. Read More
Technically speaking, the scientific community as a whole cannot say for sure whether and how well Aduhelm (aducanumab, Biogen Inc./Eisai, Co., Ltd.) works. After all, two years after the initial report of the Engage and Emerge data at the 2019 Clinical Trials in Alzheimer’s Disease (CTAD), the full trial data have still not been published in a peer-reviewed publication. Which, of course, is one of the problems with Aduhelm. Read More
Catalyst Biosciences Inc. decided to stop developing marzeptacog alfa (MarzAA), a recombinant human coagulation factor VIIa variant for treating factor VII deficiency, and sell its hemophilia assets to focus on its complement therapeutics and protease medicines platform. Read More
Oncorus Inc. offered initial safety, tolerability and immune activation and clinical response data from its ongoing phase I trial with ONCR-177 at the Society for Immunotherapy of Cancer (SITC) meeting. In the fully enrolled and completed surface lesion, dose-escalation part of the study, single-agent ONCR-177, an oncolytic herpes simplex virus for intratumoral injection, proved well-tolerated with no dose-limiting toxicities. Read More
It’s been a decade since the first checkpoint inhibitors were approved, but the problem of low response rates remains in many forms of cancer. Highlight Therapeutics SL, of Valencia, Spain, hopes to change all that with an approach that primes the body to become more responsive to immunotherapies. Read More
U.S. President Joe Biden on Nov. 12 announced his intent to nominate former FDA Commissioner Robert Califf to return to the regulator’s top job. He would take the place of Janet Woodcock, acting commissioner of the agency since Jan. 20. Read More
A phase III trial testing the oral antiviral favipiravir for the treatment of mild to moderate COVID-19 failed to hit statistical significance on the primary endpoint of time to sustained clinical recovery, sponsor Appili Therapeutics Inc. said. Read More
I-Mab Biopharma Co. Ltd. formed a partnership with Hubei Jumpcan Pharmaceutical Co. Ltd. in a deal worth up to ¥2.016 billion (US$315.2 million) to develop, manufacture and commercialize recombinant human growth hormone (rhGH) eftansomatropin alfa (TJ-101) in mainland China. Read More
PERTH, Australia – Australia’s Medical Research Future Fund is pumping AU$40 million (US$29 million) into a national biotech incubator program called CUREator to fund early stage novel therapeutics and preclinical medical research. Read More
PERTH, Australia – Australian researchers have debunked previous research that suggests autism spectrum disorder behavior may be caused by differences in the composition of the gut microbiota. Read More
Johnson & Johnson (J&J) will spin off its consumer health division as a stand-alone public company, leaving J&J to focus on its pharmaceutical and medical device businesses. Read More
The FDA has taken a hands-off approach to general wellness products that take up residence in smartphones, but that doesn’t mean these products aren’t subject to regulatory drift.
New and updated preclinical and clinical data presented by biopharma firms at the Society for Immunotherapy of Cancer annual meeting, including:: A2, Achilles, Actinium, Actym, Adaptimmune, Adicet, Affimed, Agenus, Anaveon, Apexigen, Aravive, Asher, Aulos, Bicara, Bolt, Candel, Celldex, Cellectis, Celyad, Cero, Checkmate, Codiak, Compugen, Cue, Editas, Elicio, F-star, G1, Grey Wolf. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adaptimmune, Alkermes, Baudax, EIP, Eisai, Gilead, Gmax, Kazia, Merck & Co., Rafael, Synairgen, Urogen. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Dicerna, Équilibre, Gain, Horizon, Humanigen, In8bio, Johnson & Johnson, Lantern, Lilly, Medicinova, Oncoheroes, Oncorus, Opus, Pharmacosmos, Pharmamar, Prokarium, Quoin, Seranovo, Sosei, Yamo, Vaxil. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Elevar, Gamida, Jupiter, Kyowa, Puretech, Rockwell. Read More
