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Home » Newsletters » BioWorld

BioWorld

Sep. 22, 2021

View Archived Issues
COVID-19 three-dose vaccine illustration

ACIP takes turn on COVID-19 booster, but FDA decision needed

Five days after an FDA advisory committee recommended a booster dose of Pfizer Inc.-Biontech SE’s COVID-19 vaccine, Comirnaty, for people 65 and older or those who are at high risk of a serious infection, the CDC’s Advisory Committee on Immunization Practices (ACIP) struggled Sept. 22 with what a U.S. booster program would look like if only one booster is available when three different COVID-19 vaccines are being used in the country. Read More

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

Autumn's arrival in the Northern Hemisphere on Sept. 22 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 26.5% to close at $18.79 on Sept. 22. 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. Read More
Science-James-Naismith-9-22

Inhaled antibodies 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. Read More
DNA on digital background

Sweet six team at Hexagon using $61M honey pot to comb microbial genomes for small-molecule drugs

Hexagon Bio Inc.’s latest, $61 million financing to advance work with small molecules mined from microbial genomes will help the firm build its DNA database, add to the team and advance preclinical work, said CEO Maureen Hillenmeyer. Read More
DNA in drug capsules

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

Bluebird Bio Inc. has completed a rolling BLA filing of 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. Read More

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. Read More

Appointments and advancements for Sept. 22, 2021

New hires and promotions in the biopharma industry, including: Abeona, Algernon, Anheart, Asieris, Dicerna, Frazier Healthcare, Genedit, Jcyte, Ocular, Verastem, Vividion, Xenikos. Read More

Conference data for Sept. 22, 2021: ESMO

New and updated preclinical and clinical data presented by biopharma firms at the European Society for Medical Oncology Congress 2021, including: Aprea, Redx, Syros. Read More

Financings for Sept. 22, 2021

Biopharmas raising money in public or private financings, including: Leap, Opus, Oxford, RD Fund, Serum. Read More

In the clinic for Sept. 22, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Clearside, Demerx, Hightide, Hoth, Hutchmed, J&J, Lyra, Moderna, Poxel, PTC, Rhovac, Small Pharma, Stoke, Vigeo, Zenith. Read More

Other news to note for Sept. 22, 2021

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abcellera, Addex, Azurrx, Blue Water, CG, Charcot-Marie-Tooth Association, Cinfina, Comet, Cyclerion, Eli Lilly, First Wave, Forge, Immunic, J&J, Janssen, Landos, Merck, Mirum, Model, Mosaic, Nektar, Novartis, Oryzon, Oxford University Innovation, Persephone, Pfizer, Pharmacyte, Puretech, Q Biomed, Renovion, Roche, Seneca, Takeda, Therapeutic Solutions, Vectivbio, Vesselon. Read More

Regulatory actions for Sept. 22, 2021

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accutar, Aft, Aim, Ampio, Genmab, Hyloris, Mayne, Seagen, Verrica. Read More

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