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Home » Newsletters » BioWorld

BioWorld

Oct. 18, 2024

View Archived Issues
Baby with bandage on thigh

Merck’s clesrovimab tortoise to Beyfortus in RSV race?

Wall Street promptly began trying to weigh the compound’s marketplace odds after Merck & Co. Inc. detailed positive data from the phase IIb/III trial known as MK-1654-004 with clesrovimab, an investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season. The results, plus interim findings from the ongoing phase III experiment dubbed MK-1654-007 were offered during IDWeek 2024 in Los Angeles. Read More
3D rendering of CAR T therapy in cell

By the numbers: US leads charge of cell and gene therapies

U.S. biotechs and regulators ushered in the era of gene therapy in 2023, experts at Bio Japan said, but medical reform is needed to pave the way for the “year of cell therapy” in 2024 and implement wider access to ultra-expensive cell and gene therapies. Read More
3d illustration of ovarian cancer

Verastem preps an NDA as the stock struggles

With fresh phase II ovarian cancer data in hand, Verastem Oncology Inc. plans to file an NDA by the end of the month for its avutometinib and defactinib combination treatment. The NDA will be for adults who have recurrent KRAS mutant recurrent low-grade serous ovarian cancer, a direction that may have caused the stock to wilt. Read More
FDA approved metal stamp

32 NMEs gain US FDA clearance through Q3, approvals up over 2023

The U.S. FDA approved 23 drugs in September, up from 22 in August and 17 in July, bringing the 2024 monthly average to nearly 20. This surpasses last year's 16 per month, 12.5 in 2022, and 17 per month in both 2021 and 2020. Read More
Illustration of female reproductive system under magnifying glass

Study paves way for therapy, easier diagnosis in endometriosis

According to World Health Organization data, endometriosis affects about 10% of reproductive-age females globally. That already makes endometriosis a wildly underresearched and underfunded disease in relation to its prevalence. Plus, Rama Kommagani thinks even 10% is an underestimation. “Diagnosis is very underreported, particularly in low- and middle-income countries,” Kommagani, who is an associate professor of pathology at Baylor College of Medicine, told BioWorld. Read More

Former Bellus Health exec consents to insider trading judgment

The U.S. SEC filed insider trading charges against Ruimin Xie, the former director of analytical development at Bellus Health Inc., for allegedly receiving ill-gotten gains of $59,408.42 by acting on word of a potential acquisition by GSK plc. Read More

BioWorld Insider podcast: A quantum leap into the future of drug development

In the newest BioWorld Insider podcast, Victoria Lipinska, the America's lead for Quantum Innovation Centers at IBM Quantum, talks about the future of drug development using quantum computing. “The new technology is a completely different branch of computing as opposed to what we know right now, and it's meant to complement what we know, not to really replace it,” she said. Read More

Money raised by biopharma

Total raised in public, private and other financings of biopharma companies, comparing 2019-2024. Read More

Biopharma money raised: Jan. 1-Oct. 17, 2024

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

Appointments and advancements for Oct. 18, 2024

New hires and promotions in the biopharma industry, including: Photys, Vianautis. Read More

Financings for Oct. 18, 2024

Biopharmas raising money in public or private financings, including: Capricor, Curanex, Terray, Xortx. Read More

In the clinic for Oct. 18, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Athos, Glaukos, Marinus, Noema, Verastem. Read More

Other news to note for Oct. 18, 2024

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avacta, Cerus, Concentra, Eterna, Factor, Kezar, Lexicon, Orano Med, Poseida, Radiomedix, Roche, Sage, Sanofi, Viatris. Read More

Regulatory actions for Oct. 18, 2024

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Acadia, Avadel, Biogen, CSL Vifor, Eisai, Intercept, Limmatech, Travere, Valneva. Read More

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