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Home » Newsletters » BioWorld

BioWorld

Jan. 30, 2023

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Women jogging

As weight loss medicine advances, its relevance recedes

Metabolic health is at an odd juncture. With the advent of glucagon-like peptide (GLP-1) agonists, pharmacologically induced weight loss has matured into a viable therapeutic option at long last. GLP-1R agonists, which are also called incretin mimetics and GLP-1 analogs, are likely to continue their success across multiple areas of medical care. Already, the class has transformed diabetes care, making a splash in weight management, and it may yet do the same for other indications. Read More

The BioWorld Insider Podcast: Rethinking obesity – Fitness may be more directly linked to health than weight

After many years of research and development, drug-induced weight loss has matured into a viable therapeutic option. But do the drugs directly help people become healthier or is it the weight loss? There are longstanding concerns that the health effects of weight might be overrated. And new studies show fitness improves health outside of weight. So, can a person still be considered healthy despite being over a “normal” weight? How will future medical science consider what is called the obesity epidemic? In this edition of the BioWorld Insider podcast, BioWorld Science Managing Editor Anette Breindl, discusses her new analysis of multiple studies related to weight loss, metabolic health and fitness which in many ways goes against the mainstream health care state of mind about obesity. Read More
Orserdu bottle and pill

First oral SERD cleared for breast cancer: FDA approves Menarini’s Orserdu

Winning the race to market with the first oral selective estrogen receptor degrader (SERD) for breast cancer is Menarini Group’s elacestrant, which gained U.S. FDA approval for use as second- and third-line therapy in patients with ER-positive/HER2-negative advanced or metastatic disease with the ESR1 mutation. It marks the first therapy approved specifically targeting ESR1, found in up to 40% of patients with ER-positive/HER2-negative disease. Read More

China approves two oral drugs to treat COVID-19

China’s NMPA granted conditional approvals to two COVID-19 drugs under a special examination and approval procedure aimed at addressing urgent needs. The approvals are both for oral small-molecule drugs for adult patients with mild to moderate COVID-19 infections. One of the approved drugs is Simcere Pharmaceutical Group Ltd.’s Xiannuoxin (simnotrelvir/ritonavir). The other is Shanghai Junshi Biosciences Co. Ltd.’s VV-116 (deuremidevir hydrobromide). Read More
M&A cityscape

US FTC asked to oppose biopharma M&As that replace R&D

Taking aim at big pharma’s current penchant for acquisition over in-house innovation, Sen. Elizabeth Warren (D-Mass.) is asking the Federal Trade Commission (FTC) to consider the impact a biopharma merger, whether it’s proposed or a done deal, may have on future innovation. Read More

Equilibre’s anti-inflammatory sees phase II success in epilepsy

Equilibre Biopharmaceuticals Corp. has positive top-line data from the phase II study of its lead asset, EQU-001, an anti-inflammatory adjunctive therapy for treating focal seizures for adults with epilepsy. Read More

Per-protocol IgAN data with atacicept in phase IIb Origin come through for Vera

Vera Therapeutics Inc.’s latest results from the phase IIb Origin trial with atacicept in patients with IgA nephropathy (IgAN) provided cause for optimism with regard to the phase III experiment targeted for the first half of this year – which should yield 36-week data in the first half of 2025 – and the company is budgeting to make the later-stage effort happen. Read More

FDA grants breakthrough therapy designation to Abbisko’s CSF-1R inhibitor, pimicotinib

The U.S. FDA granted breakthrough therapy designation to Abbisko Therapeutics Co. Ltd.’s colony-stimulating factor 1 receptor (CSF-1R) inhibitor, pimicotinib, for patients with tenosynovial giant cell tumors who are not able to have surgery. Read More

Supplier exec to pay back insider trading gains

A Jan. 27 settlement the U.S. SEC reached with a former vice president at a biotech company serves as a reminder that insider trading rules applies to suppliers as well as the companies involved in an M&A. Read More

ICYMI: Week in review, Jan. 23-27, 2023

A quick look back at top stories.

Read More

Biggest gainers and losers for the week of Jan. 23-27, 2023

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

Appointments and advancements for Jan. 30, 2023

New hires and promotions in the biopharma industry, including: Aprea, Chiesi, Bluesphere, Regel, Ring, TC, Vaccitech, Vesigen. Read More

Financings for Jan. 30, 2023

Biopharmas raising money in public or private financings, including: Alto, Avenue, Inhibikase, Pliant, Precigen, Ribon, Structure, Summit. Read More

In the clinic for Jan. 30, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Index, Janssen, Marengo, Skye. Read More

Other news to note for Jan. 30, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arcellx, Gilead, Kite, Pfizer, Ribon, Scpharmaceuticals. Read More

Regulatory actions for Jan. 30, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Argenx, Astrazeneca, Bioaegis, Bloomsbury, Bristol Myers Squibb, Eisai, Eli Lilly, Exegi, Ipsen, Merck, Orion, Regeneron, Sana, Sanofi, Viatris. Read More

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