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Home » Newsletters » BioWorld

BioWorld

Feb. 26, 2021

View Archived Issues
Vaccination

As COVID-19 vaccines feel variant strain, FDA panel backs J&J single shot

As expected, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) looked favorably upon the latest COVID-19 entry: Ad26.COV2.S, a one-shot product that emerged from the same Johnson & Johnson (J&J) platform, AdVac, that let the firm devise an Ebola vaccine cleared in Europe last year. Read More

Two COVID-19 vaccines approved in China in less than 24 hours

China’s National Medical Products Administration granted conditional approval two Chinese-developed COVID-19 vaccines in less than 24 hours on Feb. 25. One of the vaccines approved was developed by Tianjin-based Cansino Biologics Inc., and the other by China National Pharmaceutical Group (Sinopharm) through its Wuhan Institute of Biological Products subsidiary. Read More
women-gyno-uterus-ovary

GSK a late arrival at the PD-1 inhibitor party as EMA backs dostarlimab approval

DUBLIN – Glaxosmithkline plc and Anaptysbio Inc. were able to get over some of the disappointment arising from a delayed FDA decision on their PD-1 inhibitor, dostarlimab, earlier this month, as the EMA came through Feb. 26 with a positive recommendation for the drug in endometrial cancers that are deficient in DNA mismatch repair or that are categorized as having high microsatellite instability. Read More

Tricida's veverimer troubles continue with appeal denied

A failure of Tricida Inc.'s most recent efforts to overcome FDA objections to an NDA for the company's sole candidate, veverimer, for treating metabolic acidosis, sent company shares (NASDAQ:TCDA) 30.6% lower to $5.11 on Feb. 26. The complex story appears focused now on the agency's desire for additional and more reliable data to support a potential approval. Tricida President and CEO Gerrit Klaerner on Thursday suggested the ongoing renal outcomes study, Valor-CKD, might provide it. Read More
MA-strategy.png

Roivant acquires Silicon Therapeutics for $450M in equity

Roivant Sciences Ltd. is buying Silicon Therapeutics LLC for $450 million in Roivant equity plus regulatory and commercial milestone payments. The combination of Silicon’s computational physics platform for in silico design or optimizing small-molecule drugs with Roivant’s newly unveiled protein degradation platform will be powered by Roivant’s machine learning models. Read More
obesity-weight.png

Gene variants can increase fat, decrease cardiometabolic risk

In the public mind, fat and unhealthy are more or less synonymous. But reality is more complicated, as reality often is. Read More

Ascletis joins Madrigal and Viking in global race for THR-β agonist for NASH

Liver disease specialist Ascletis Pharma Inc. said its nonalcoholic steatohepatitis (NASH)-focused subsidiary, Gannex Pharma Co. Ltd., will start global development of its oral THR-β agonist, ASC-41, after it obtained an IND approval from the FDA based on positive phase I data generated in China. Read More

Biopharma M&As off to a slow start for 2021; deals level with last year

Without any mega-mergers completed in the first two months of 2021, M&A values have significantly plummeted from those recorded in each of the last two years, although both deals and M&As in January and February are tracking similarly to prior years in terms of volume. Read More

Appointments and advancements for Feb. 26, 2021

New hires and promotions in the biopharma industry, including: Karolinska, Nabriva, Paragon, Sumitomo Dainippon, Ziopharm. Read More

Earnings for Feb. 26, 2021

Quarterly snapshots from biopharma companies with marketed products, including: Biomarin, PTC, Radius. Read More

Financings for Feb. 26, 2021

Biopharmas raising money in public or private financings, including: Artiva, Edesa, Ibere, Liscure. Read More

In the clinic for Feb. 26, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amgen, Arbutus, Assembly, Astrazeneca, Innovation, Partner, Pharvaris, Revive, XNK. Read More

Other news to note for Feb. 26, 2021

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Beigene, Canbridge, Inventiva, FCC Horiuchi, Lilly, Mallinckrodt, Motif, Pierre Fabre, Puma, Shepherd, Silence. Read More

Regulatory actions for Feb. 26, 2021

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocryst, Biontech, BMS, Exelixis, GC, GW, Harbour, Incyte, Opko Health, Pfizer, PTC, Regeneron, Roche, Sarepta, Tricida. 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-Feb. 25, 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 Feb. 22-26, 2021

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

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