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Home » Newsletters » BioWorld

BioWorld

Nov. 12, 2021

View Archived Issues
Aduhelm product image

European regulators put off decision on Biogen’s controversial Alzheimer’s drug

European regulators have put off a decision on Biogen Inc and Eisai, Co. Ltd.’s controversial Alzheimer’s drug, aducanumab, for likely another month, after the companies announced further supportive data from a follow-up under review by the FDA. Read More

As EMA’s CHMP delays recommendation, US skepticism abides about Aduhelm approval

Technically speaking, the scientific community as a whole cannot say for sure whether and how well Aduhelm (aducanumab, Biogen Inc./Eisai, Co., Ltd.) works. After all, two years after the initial report of the Engage and Emerge data at the 2019 Clinical Trials in Alzheimer’s Disease (CTAD), the full trial data have still not been published in a peer-reviewed publication. Which, of course, is one of the problems with Aduhelm. Read More
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Catalyst Biosciences will adjust its focus, halt work on MarzAA in hemophilia

Catalyst Biosciences Inc. decided to stop developing marzeptacog alfa (MarzAA), a recombinant human coagulation factor VIIa variant for treating factor VII deficiency, and sell its hemophilia assets to focus on its complement therapeutics and protease medicines platform. Read More

Oncorus line: SITC hosts good phase I show, curtain falls on stock

Oncorus Inc. offered initial safety, tolerability and immune activation and clinical response data from its ongoing phase I trial with ONCR-177 at the Society for Immunotherapy of Cancer (SITC) meeting. In the fully enrolled and completed surface lesion, dose-escalation part of the study, single-agent ONCR-177, an oncolytic herpes simplex virus for intratumoral injection, proved well-tolerated with no dose-limiting toxicities. Read More
Skin exam

SITC 2021: Highlight Therapeutics’ BO-112 boosts checkpoint response rate in phase II

It’s been a decade since the first checkpoint inhibitors were approved, but the problem of low response rates remains in many forms of cancer. Highlight Therapeutics SL, of Valencia, Spain, hopes to change all that with an approach that primes the body to become more responsive to immunotherapies. Read More
Regulatory-US-FDA-HQ.png

Biden says he’ll nominate Califf for FDA commissioner

U.S. President Joe Biden on Nov. 12 announced his intent to nominate former FDA Commissioner Robert Califf to return to the regulator’s top job. He would take the place of Janet Woodcock, acting commissioner of the agency since Jan. 20. Read More

Favipiravir falls short in Appili's phase III COVID-19 trial

A phase III trial testing the oral antiviral favipiravir for the treatment of mild to moderate COVID-19 failed to hit statistical significance on the primary endpoint of time to sustained clinical recovery, sponsor Appili Therapeutics Inc. said. Read More

I-Mab and Jumpcan work together on recombinant human growth hormone in $315M deal

I-Mab Biopharma Co. Ltd. formed a partnership with Hubei Jumpcan Pharmaceutical Co. Ltd. in a deal worth up to ¥2.016 billion (US$315.2 million) to develop, manufacture and commercialize recombinant human growth hormone (rhGH) eftansomatropin alfa (TJ-101) in mainland China. Read More
Flag of Australia, sky background

Australia launches first biotech incubator with AU$40M to give research commercial boost

PERTH, Australia – Australia’s Medical Research Future Fund is pumping AU$40 million (US$29 million) into a national biotech incubator program called CUREator to fund early stage novel therapeutics and preclinical medical research. Read More
Autism and microbiome illustration

Gut microbiome changes are effect, not cause, of autism spectrum disorders: study

PERTH, Australia – Australian researchers have debunked previous research that suggests autism spectrum disorder behavior may be caused by differences in the composition of the gut microbiota. Read More
Arrows opposite directions

J&J splits off consumer health division

Johnson & Johnson (J&J) will spin off its consumer health division as a stand-alone public company, leaving J&J to focus on its pharmaceutical and medical device businesses. Read More

Clinical trials are a regulatory danger zone for unregulated wellness apps

The FDA has taken a hands-off approach to general wellness products that take up residence in smartphones, but that doesn’t mean these products aren’t subject to regulatory drift.

Read More

Appointments and advancements for Nov. 12, 2021

New hires and promotions in the biopharma industry, including: Isoplexis, Kronos. Read More

Conference data for Nov. 12, 2021: SITC

New and updated preclinical and clinical data presented by biopharma firms at the Society for Immunotherapy of Cancer annual meeting, including:: A2, Achilles, Actinium, Actym, Adaptimmune, Adicet, Affimed, Agenus, Anaveon, Apexigen, Aravive, Asher, Aulos, Bicara, Bolt, Candel, Celldex, Cellectis, Celyad, Cero, Checkmate, Codiak, Compugen, Cue, Editas, Elicio, F-star, G1, Grey Wolf. Read More

Financings for Nov. 12, 2021

Biopharmas raising money in public or private financings, including: Acrivon, Ankyra, Avenue, Journey Medical, Mingsight, Nervgen. Read More

In the clinic for Nov. 12, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adaptimmune, Alkermes, Baudax, EIP, Eisai, Gilead, Gmax, Kazia, Merck & Co., Rafael, Synairgen, Urogen. Read More

Other news to note for Nov. 12, 2021

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Dicerna, Équilibre, Gain, Horizon, Humanigen, In8bio, Johnson & Johnson, Lantern, Lilly, Medicinova, Oncoheroes, Oncorus, Opus, Pharmacosmos, Pharmamar, Prokarium, Quoin, Seranovo, Sosei, Yamo, Vaxil. Read More

Regulatory actions for Nov. 12, 2021

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Elevar, Gamida, Jupiter, Kyowa, Puretech, Rockwell. 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-Nov. 11, 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 Nov. 8-12, 2021

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

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