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Home » Newsletters » BioWorld

BioWorld

May 21, 2021

View Archived Issues
Europe-pills-syringe-flag

Bluebird Bio cerebral adrenoleukodystrophy gene therapy on the brink of European approval as CHMP nods through eight applications

DUBLIN – Skysona (elivaldogene autotemcel, Lenti-D), Bluebird Bio Inc.’s gene therapy for cerebral adrenoleukodystrophy, received a nod from the EMA’s Committee for Human Medicinal Products (CHMP) during its May meeting this week, paving the way for a formal European authorization in the coming weeks. It will constitute the first approval for the product. An FDA approval is some way behind – the company will not complete its BLA filing with the FDA until around midyear. Read More

A CHMP thumbs up for the Vir-GSK early COVID-19 treatment

The EMA issued a positive scientific opinion on Glaxosmithkline plc (GSK) and Vir Biotechnology Inc.’s sotrovimab for early COVID-19 treatment. The Committee for Human Medicinal Products (CHMP)’s opinion concerns the monoclonal antibody’s use for adolescents ages 12 and older weighing at least 40 kg (88 pounds), plus adults. All must risk progressing to severe COVID-19 and not require oxygen supplementation. Read More
Lung cancer illustration

Both ORRs in the water: Cullinan ASCO data near, J&J’s bispecific Rybrevant approved in NSCLC subset

The FDA’s approval for Johnson & Johnson (J&J) of Rybrevant (amivantamab-vmjw) not only brings the first treatment for adults with non-small-cell lung cancer (NSCLC) whose tumors bear EGFR exon 20 insertion mutations, but also sets a high overall response rate bar for other developers in the space. Read More

Annovis shares jump on midstage Alzheimer's study readout

Shares of Annovis Bio Inc. (NYSE:ANVS) leapt 127.3% to $60 May 21 on news that, following 25 days of treatment with its lead candidate, ANVS-401 (posiphen), 14 early Alzheimer's disease patients enrolled in its ongoing phase IIa study showed cognitive improvement of 22% vs. those who received placebo. Pending successful completion of the study, the company is targeting advancement to late-stage studies later this year. Read More
Botanical drug illustration

Yiviva takes botanical cancer drug deeper into the clinic

VANCOUVER, British Columbia – Yiviva Inc., a pharmaceutical company focused on developing botanical drugs, has moved its lead candidate further into an international phase IIb trial for liver cancer and closer to an application through the FDA’s little-used botanicals pathway and a similar pathway in China. The company’s lead candidate, YIV-906, is intended for use in immunotherapy, chemotherapy and radiation therapy. Read More

Appointments and advancements for May 21, 2021

New hires and promotions in the biopharma industry, including: C4, Codiak, Cullinan. Cytodyn, Ichnos, Inflarx, Prothena. Read More

Financings for May 21, 2021

Biopharmas raising money in public or private financings, including: Allarity, Evofem, Giiant, Janux, Larimar, VBI. Read More

In the clinic for May 21, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Annovis, Aurinia, Beigene, Immunitybio, J&J, Meiji Seika, Medivir, Onconova, Phosplatin, Poxel, Regulus. Read More

Other news to note for May 21, 2021

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biogen, Bostongene, Ginkgo, Kiromic, Nektar, Promis, Recce, Selexis, Therapeutic Solutions. Read More

Regulatory actions for May 21, 2021

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Albireo, Alexion, Almirall, Astrazeneca, Athenex, Bayer, Bluebird, BMS, Eli Lilly, Genmab, Glaxosmithkline, Janssen, Larimar, Moderna, Myovant Sciences, Rhythm, Takeda, Vir. Read More

Money raised by biopharma: 2021 vs. 2020 vs. 2019

Total raised in public, private and other financings of biopharma companies, comparing 2021 vs. 2020 vs. 2019. Read More

Biopharma money raised: Jan. 1-May 20, 2021

Year-to-date money raised in public, private and other financings of biopharma companies. Read More
stock prices up

Biggest gainers and losers for the week of May 17-21, 2021

The top 10 biopharma stock gainers and losers for the week. Read More

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