Shares in Akero Therapeutics Inc. more than doubled in value after the company announced results from a phase IIb nonalcoholic steatohepatitis trial that it believes show lead candidate efruxifermin could challenge other candidates in development for the fatty liver disease targeted by so many biotechs and big pharmas. Read More
Rayzebio Inc. raised $160 million in a series D round and unveiled its lead targeted radiopharmaceutical drug candidate, RYZ-101, which has entered clinical development in patients with gastroenteropancreatic neuroendocrine tumors expressing the somatostatin receptor type 2. Read More
Rubius Therapeutics Inc. is taking a giant step back so that it can attempt taking a few steps forward. The company said it’s restructuring to focus on taking its Rubius Erythrocyte Design (RED) cell therapeutics platform from what it considers a good thing and turn it into a better one. Rubius engineers red blood cells to become cancer fighters but a lack of progress and the lure of similar but new technology could lead to bigger and better results. Read More
Pricing new drugs for the U.S. market, especially those treating rare diseases, is getting a lot more complex now that the Medicare inflation rebate is in play. The rebate provision in the newly enacted Inflation Reduction Act incentivizes companies to set higher launch prices for drugs that will be used by Medicare beneficiaries since their future price increases will be limited to the rate of inflation. Although some of the other drug pricing measures included in the new law won’t kick in for a few years, the Medicare inflation rebate is to become effective next year. Read More
An investigational drug developed in Cuba for the potential treatment of Alzheimer´s and Parkinson's diseases has moved forward to phase III trials there, where scientists are optimistic about results of previous studies. The candidate, named Neuroepo and branded Neuralcim, was developed by the Center of Molecular Immunology (also known by its Spanish acronym CIM), a state-owned lab in the Caribbean nation. Read More
Melbourne-based Occurx Pty Ltd. announced a AU$16 million (US$11 million) series B round that will progress lead candidate OCX-063 to phase II trials in chronic kidney disease. The capital raise was jointly led by Brandon Biocatalyst and Uniseed and includes a AU$1.5 million grant from Australian biomedical incubator Cureator. Read More
The toxicity associated with oncology therapies is the stuff of legend with clinicians and patients, and thus the U.S. FDA and manufacturers have been working to fine tune these dosing regimens. However, the FDA's Oncology Center of Excellence (OCE) includes a programmatic effort to optimize dosing regimens, which led to an editorial by FDA officials that calls on industry to consider whether the maximum tolerated dose paradigm is really the optimal approach to oncology drug development. Read More
While COVID-19 remains a top research priority globally for government and nonprofit entities in partnership with biopharma companies, deal activity also is heavily focused on other infectious diseases, such as smallpox and influenza. Read More
More than four years after Right to Try legislation was enacted in the U.S., the FDA is issuing a final rule, Annual Summary Reporting Requirements Under the Right to Try Act, specifying the deadline and content for the annual reports the law requires participating drug sponsors or manufacturers to submit. Read More
New hires and promotions in the biopharma industry, including: Aptose, Endpoint Health, Essa, Gensight, Hemostemix, Immpact, Immutep, Kiora, Promontory, Ukko, Vyriad. Read More
New and updated preclinical and clinical data presented by biopharma firms at the European Society for Medical Oncology Congress 2022, including: Adagene, Amgen, Ammax, Anaveon, Apexigen, Astellas, Astrazeneca, Ayala, Cardiff, Cel-Sci, Clovis, Daiichi, Deciphera, Eisai, Enlivex, Fore, Gritstone, GT, Ideaya, I-Mab, Imcheck, Immunogen, Merck & Co., Mereo, Neoimmunetech, Plus, Point, Regeneron, Shasqi, SQZ, Transgene, Wugen. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Agenus, Biomed, BMS, Cabaletta, Concert, Dynavax, Entera, Horizon, Keros, Lyra, Novartis, Pharnext, Regulus, Revolo. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Eligo, Epivario, Kiniksa, Kovina, Marker, Roche, Sisaf. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Biolinerx, BMS, Chiesi, Mersana, Vaxxinity. Read More
