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Experts unpack the implications of CBER Director Vinay Prasad’s claim that COVID vaccines have caused 10+ child deaths; the 2025 Clinical Trials on Alzheimer’s Disease conference continues following two disappointing readouts; and Novo Nordisk’s amycretin yields promising weight loss results.

With new UK clinical trial rules landing in 2026, the EU Biotech Act on the horizon and China and Australia gaining ground, CROs are zeroing in on study timelines, AI/ML and data privacy as the industry’s next pressure points.

Early decisions about manufacturing and supply chains could prove costly as a company reaches the commercial stage.

Venture capital flow to women-founded companies has stabilized in the post-pandemic environment. BioSpace looks back at five companies that have nabbed the most over the past two decades.

While the TrumpRx deals only cover Lilly and Novo for now, the agreements are good for any cardiometabolic biotechs waiting in the wings, according to a new 2026 preview report from PitchBook.

Newly appointed Center for Drug Evaluation and Research director Richard Pazdur has filed retirement papers with the agency—three weeks after accepting the role—amid clashes with Commissioner Marty Makary over certain FDA programs.

With no evidence to support the claim that 10 children died due to COVID-19 vaccines, experts unpack the impact of CBER chief Vinay Prasad’s leaked vaccine memo.

While Imvax’s autologous immunotherapy IGV-001 missed the primary endpoint of progression-free survival in a Phase IIb trial, the company will request a meeting with the FDA to discuss next steps for “synergistic” treatment.

After covering the Alzheimer’s space through every high and low, BioSpace’s Annalee Armstrong welcomes back Roche for the 2026 Alzheimer’s Renaissance.

Trontinemab lowered amyloid levels below the threshold of positivity in 92% of treated patients.

This week’s meeting of the Advisory Committee on Immunization Practices will be led by Kirk Milhoan, a physician and pastor who recently claimed that COVID-19 vaccines contained a contamination that causes cancer.

Agentic AI can help FDA staff manage meetings, conduct pre-market reviews and validate reports, among other tasks, though the agency emphasized that using this technology is optional for its employees.

Patent strengthens Company’s global intellectual property portfolio and reinforces the Company’s commitment to establishing and protecting competitive advantages

• Vial’s INHBE siRNA is a first‑in‑class, liver‑targeted (GalNAc‑conjugated) siRNA therapy that silences INHBE and its gene product, Activin E • Leading key opinion leaders (KOLs) Drs. Jason Fung, Scott Kahan, Lawrence Cheskin, and Lee Kaplan from leading institutions such as Johns Hopkins, GMU, and Dartmouth University respectively shared their insights on challenges with current GLP-1 treatments as well as the potential benefits of INHBE siRNA therapies like Vial’s • INHBE siRNAs are designed to deliver fat-selective weight loss while preserving lean muscle mass • Vial’s INHBE siRNA will be investigated for its potential as both a mono-therapy and in combination with GLP-1s to offer patients flexibility on their weight loss journey

Recognized for Excellence in Drug Discovery Research Services on Global R&D Sourcing Platform in 2025.