Five days after an FDA advisory committee voted overwhelmingly against approving a booster dose of Pfizer Inc.-Biontech SE’s COVID-19 vaccine, Comirnaty, for the general adult population, the CDC’s Advisory Committee on Immunization Practices (ACIP) is weighing in on the booster dose. But whether ACIP’s Sept. 22-23 meeting ends with a vote recommending how the booster should be used will depend on the FDA approving the third dose before the meeting adjourns. Although the FDA’s adcom wasn’t convinced it was time for a booster for people 16 and older, it did recommend the Pfizer booster for those 65 and older and those who are at high risk for severe COVID-19.

Dynavax shares boom amid fall debut of new government actions and trials targeting COVID-19

Autumn's arrival in the Northern Hemisphere swept in significant news of progress for the global fight against COVID-19. A protein-based COVID-19 vaccine candidate from Clover Biopharmaceuticals Ltd. and Dynavax Technologies Corp. appeared wholly effective in preventing severe disease and hospitalization, sending Dynavax shares (NASDAQ:DVAX) climbing as much as 38% by midday. In another study of Gilead Sciences Inc.'s Veklury (remdesivir), the drug significantly reduced hospitalization in high-risk patients with COVID-19. Meanwhile, governments and companies continued to expand efforts to supply new vaccines and therapeutics against the disease even as efforts continued far and wide to evaluate the efficacy of new and emerging candidates in both categories.

Inhaled nanobodies brought to SARS-CoV fight

Trimers of nanobodies, a simpler form of antibody made by some animal species, were effective at preventing and treating COVID-19 in preclinical studies, researchers reported in the Sept. 22, 2021, issue of Nature Communications. The findings, along with others, could form the basis of an inhaled biologics treatment for COVID-19 and ultimately, other respiratory diseases.

Microbial genome development draws $61M for Hexagon

Hexagon Bio Inc. raised $61 million to advance work with small molecules mined from microbial genomes. Using a platform that takes in machine learning, genomics, synthetic biology and automation, the company aims to discover new chemical compounds linked to known protein targets. Hexagon said it has built a database of such genomes that is more than twice the size of all public sources, with thousands of new genomes added monthly. The preclinical pipeline focuses on oncology and infectious diseases. Nextech Invest led the round, with new investors Softbank Vision Fund 2 and Casdin Capital taking part, plus existing investors The Column Group, 8VC and Two Sigma Ventures.

Bluebird files beta-thalassemia gene therapy, but questions mount over $1.8M price tag 

Bluebird Bio Inc. has completed a rolling filing BLA of its beta-thalassemia gene therapy, beti-cel, in the U.S., with analysts predicting that the Cambridge, Mass.-based biotech will have to shoot for a lower price tag after running into trouble with cost regulators in Europe. The company is on track with its predictions about the timing of the filing but assuming the FDA decides to approve, the expectation is that the price will have to be cut from a predicted $1.8 million to around $1 million in order to pick up commercial traction. Analyst Difei Yang, of Mizuho, pointed to the company’s decision in the second quarter to wind down operations in Europe to focus on the U.S. market, after giving up the ghost with the reimbursement systems in countries such as Germany and the U.K.

Incyte wins FDA approval for ruxolitinib cream in AD, with class-related boxed warnings

Following late-stage studies in which Incyte Corp.'s topical ruxolitinib candidate significantly reduced skin inflammation and itch associated with atopic dermatitis (AD), the FDA has approved the medicine, making it the first and only topical JAK inhibitor approved in the U.S. Approval for the medicine, to be marketed as Opzelura, covers its use for the short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised patients 12 and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. The medicine represents a new formulation of ruxolitinib, the active ingredient in Incyte’s JAK1/JAK2 inhibitor, first FDA-approved in oral form as Jakafi in November 2011.

Also in the news

Addex, Advanced Accelerator Applications, Algernon, Arcturus, Azurrx, Betterlife, Blue Water Vaccines, Bluebird, Carisma, Cassava Sciences, Cellectar, CG Oncology, Cinfina, Clinigen Healthcare, Clover, Codagenix, Corvus, Cyclerion, Cyclica, Cytodyn, Dynavax, Eli Lilly, Endeavor Biomedicines, Enlivex, First Wave, Forge, Frequency, Gilead, Humanetics, Huyabio, Immunic, Impact, Incyte, Inovio, Inventiva, Kintara, Leap, Merck, Moberg, Model Medicines, Noxxon, Odyssey Group International, Onconano Medicine, Onconova, Opus Genetics, Oxford Biomedica, Phoxbio, Q Biomed, Radius Health, Rhizen, Rhythm, Roche, Salarius, Secura, Serum Life Sciences, Sirona, Specialised, Tarsier, Taysha Gene Therapies, Theragnostics, Therapeutic Solutions International, Theratechnologies, Tryp