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Home » Newsletters » BioWorld

BioWorld

Sep. 23, 2021

View Archived Issues
COVID-19 vaccine vials

ACIP struggles with COVID-19 booster recommendations

Constrained by the U.S. FDA’s authorized conditions of use for a booster dose of Pfizer Inc. and Biontech SE’s COVID-19 vaccine, the CDC’s Advisory Committee on Immunization Practices (ACIP) struggled with making recommendations Sept. 23 for the use of the booster, with several members questioning the need for a third dose in some of the populations the FDA identified. Read More

Black box warnings and risky CNS efforts weigh heavily on biopharma stocks

For the first time since February, the BioWorld Biopharmaceutical Index (BBI) took a sharp plummet with shares falling in the last few weeks for 18 of the 22 stock components. Read More
Close-up of elderly eye

Immunocore’s phase III in melanoma shows survival benefit

When an independent data monitoring committee told Immunocore Ltd. plc’s David Berman in November that tebentafusp had met a phase III study’s pre-defined boundaries for statistical significance in overall survival (OS) after its first pre-planned interim analysis, the head of R&D was shocked. Read More

saRNA newcomer Vaxequity lands Astrazeneca as partner

LONDON – Self-amplifying RNA (saRNA) specialist Vaxequity Ltd. has sealed a commercialization deal with Astrazeneca plc after delivering safety data in a phase I/II trial of the technology in a COVID-19 vaccine. Read More
Emma-Walmsley-CEO-Glaxosmithkline-hero-pic-6-23

Activist investor Bluebell is latest to call for ‘sleeping’ GSK’s CEO to quit

A second activist investor has questioned the leadership of Glaxosmithkline plc’s CEO Emma Walmsley, after Bluebell Capital Partners Ltd. took a reported £10 million (US$13.7 million) stake in the embattled U.K. pharma. Read More

Cstone presents positive phase III data of sugemalimab for NSCLC

Cstone Pharmaceuticals Co. Ltd. released positive data from the phase III trial, Gemstone-302, of sugemalimab plus chemotherapy for the first-line treatment of patients with stage IV squamous and non-squamous non-small cell lung cancer. Read More

Appointments and advancements for Sept. 23, 2021

New hires and promotions in the biopharma industry, including: Biorchestra, Draupnir, Hyloris, Surrozen, Tubulis. Read More

Financings for Sept. 23, 2021

Biopharmas raising money in public or private financings, including: Garuda, Genedit, Synlogic. Read More

In the clinic for Sept. 23, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Betterlife, Cassava Sciences, Cellectar, Clover, Codagenix, Corvus, Endeavor Biomedicines, Enlivex, Frequency, Gilead Sciences, Humanetics, Huyabio International, Kintara, Noxxon, Odyssey Group International, Onconova, Phoxbio, Rhizen, Rhythm, Tarsier, Theratechnologies. Read More

Other news to note for Sept. 23, 2021

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abcellera Biologics, Advanced Accelerator Applications International, Apitope International, Aptinyx, Awakn Life Sciences, Bioinnovation Institute, Biovaxys Technology, Clene, Clinigen, Cyclica, Elicio, Embark, Eurocine Vaccines, Impact, Inhibikase, Inotify, Novartis, Onconano Medicine, Orbit Health, Pephexia, Quell, Rezolute, Salarius, Second Genome, Secura, Sirona, Stealth, Theragnostics, Tonix, Transcode, Worg. Read More

Regulatory actions for Sept. 23, 2021

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advaccine, Algernon, Arcturus, Bluebird, Carisma, Cytodyn, Incyte, Inovio, Inventiva, Moberg, Pharmamar, Radius Health, Rhythm, Taysha Gene Therapies, Tryp. Read More

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