News

Regulatory clearances and approvals continue as agencies work to disseminate literature, raise awareness, redouble research efforts, and improve the efficacy of clinical trials.

BioPharm International® chatted with Preeya Beczek, managing director and co-founder of Beczek.COM, about industry trends from 2024 and which of those might impact the industry in 2025, including the big trend of AI.

The report from Boston Consulting Group and Innovative Pharmaceutical Services Organization said the market in India is currently expanding at a 15% compound annual growth rate.

More than 6000 rare diseases—those which affect fewer than one in 2000 people each—are acknowledged in the medical community, with 72% of them being genetic.

Previous domestic capital expansion commitments since 2020 had been made in Research Triangle Park and Concord, both in North Carolina; Kenosha County, Wisconsin; Lebanon, Indiana; and Lilly’s home city of Indianapolis.

Single-use solutions are the company’s focus this year, including tubing and custom-molded parts.

Avtozma references Roche’s tocilizumab offering and has also shown promise as a treatment for CAR-T cell-induced cytokine release syndrome as well as COVID-19.

The European Commission has approved Biocon Biologics’ YESINTEK, a biosimilar referencing Janssen Biotech’s Stelara (ustekinumab).

BioPharm International® sat down with Kate Coleman from Arriello to run through the major trends from 2024, including the importance of technological advances, and how these may progress in 2025.

Vector Bioscience Cambridge is developing highly porous nanomaterials that can help reduce toxicities due to the small amount of vehicle material.

The new AI co-scientist is a multi-agent AI system that acts as a virtual scientific collaborator to aid scientific research.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss the implications of FDA’s new draft guidance on complying with 21 CFR 211.110.

Vimkunya was granted approval under priority review based on positive results from two Phase III trials.

Ospomyv, or Obodence in the EU, and Xbryk were approved for all indications referencing Prolia and Xgeva, respectively.

This expanded label allows IZERVAY (avacincaptad pegol intravitreal solution) to be used without a limitation on duration of dosing for treating geographic atrophy.

The vaccine combines the antigenic components of two previously well-established meningococcal vaccines made by GSK.

In this interview, BioPharm International® discusses the trend of AI in pharma and how it may play out in 2025 and beyond with Ben Sidders from Biorelate.

The transaction includes abelacimab, which is a late-stage medicine that is in development for prevention of stroke and systemic embolism in patients with atrial fibrillation.

The approval of an ADCETRIS combination regimen is based on positive data from a Phase III trial where the combination regimen demonstrated a clinically meaningful reduction in the risk of death.

William Oh, MD, led a panel discussion during which the practicalities of incorporating AI tools into the daily workflow of busy clinicians were discussed.

The company plans to assess alternate payloads for its gene therapy program, which will shift its timeline.

BioPharm International® sat down with Adam Sherlock, CEO of Qinecsa, to discuss the changing political landscapes in the US and Europe and how that may affect the bio/pharma industry.

BioPharm International® spoke with Adam Sherlock, CEO of Qinecsa, about the industry trends of 2024, the future technology agenda, and M&A prospects in 2025.

Feb. 11, 2025 marks the 10th anniversary of the International Day of Women and Girls in Science.

On the back of FDA’s designation, March Biosciences is preparing to advance MB-105, a CD5-targeted CAR-T cell therapy, to a Phase II clinical trial in early 2025.

Eswar Iyer, MS, PhD, CEO and co-founder at Aikium Inc., describes a tool to overpower the data paucity problem in proteins.

The approval makes Susvimo the first and only continuous delivery treatment for diabetic macular edema.

Under this early stage R&D collaboration, the companies aim to engineer recombinant biologics for blocking Fc receptors, which play a key role in autoimmune diseases.