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Home » Newsletters » BioWorld

BioWorld

Nov. 1, 2024

View Archived Issues
Hand holding ballot over box, US flag backdrop

Change is the constant in wake of US elections

The drug and device industries have a lot hinging on the results of the Nov. 5 U.S. presidential and congressional elections. Tax policies. The reach of the FTC. Legislation aimed at drug prices, competition, pharmacy benefit managers and lab-developed tests. Cabinet and agency appointments that could reshape Medicare drug negotiations, the 340B program, FDA Orange Book device patent listings, regulatory flexibility and Bayh-Dole march-ins. And that’s just the top of the list. Read More
Close up of eye and vision test

Eylea down and slept? Regeneron keeps faith in AMD biosimilar war

The nearer-looming threat of a biosimilar from Amgen Inc. to heavyweight Regeneron Pharmaceuticals Inc.’s age-related macular degeneration (AMD) VEGF therapy, Eylea (aflibercept), along with other issues, pressured shares of the latter (NASDAQ:REGN) since reporting third-quarter earnings Oct 31. But Wall Street pundits are not altogether aligned on how serious the scenario might be. After the earnings update, Regeneron’s stock fell 12%, from $925 to $819.96, and closed Nov. 1 at $843.60, up $5.40. Read More
Digital pills on a circuit board

EFPIA calls for EMA to oversee AI in drug development

Just ahead of the EMA setting out its latest thinking on regulation in the new era of artificial intelligence (AI), the industry has put forward its position on how to ensure AI rules enable, rather than hinder, the drug development and approval process. Read More
Nonprofit stamp

Steady gains in biopharma deals as grants see sharp year-over-year increase

Through September 2024, biopharma firms secured $720.56 million in nonprofit deals, up in value through July and also marking a 21% rise from the $593.23 million in the first three quarters of 2023, though still falling short of 2019-2022 levels. Grants saw an even sharper surge, jumping 131% year-over-year from $1.66 billion to $3.84 billion in the same period, falling short only of 2020 in value. Read More
Prostate-cancer-cells

Essa ends prostate cancer bid, seeks strategic options

Shares of Essa Pharma Inc. tanked Nov. 1 after the company said it is terminating all trials of masofaniten, its N-terminal domain androgen receptor inhibitor and sole clinical-stage program, following a disappointing readout from a phase II study in metastatic castration-resistant prostate cancer. The stock (NASDAQ:EPIX) hit a 52-week low, closing at $1.40, down $3.80, or 73%. 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. 31, 2024

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

Appointments and advancements for Nov. 1, 2024

New hires and promotions in the biopharma industry, including: Kancera, Kashiv, Libra. Read More

Financings for Nov. 1, 2024

Biopharmas raising money in public or private financings, including: Alpha Cognition, Edesa, Evommune, Septerna, Tiziana. Read More

In the clinic for Nov. 1, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anavex, Bioarctic, Cardiff, Curevo, Eisai, Novo Nordisk, Recce, Roche, Ventus. Read More

Other news to note for Nov. 1, 2024

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aerovate, Compass, Forus, Hutchmed, Jade, NRG, Pharmaessentia, Takeda, Teva, Werewolf. Read More

Regulatory actions for Nov. 1, 2024

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations:  Aditxt, Bpgbio. Read More

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