Research & Development

Karyopharm Aims For Xpovio Myelofibrosis Approval Despite Endpoint Miss

The Phase III study’s principal investigator said that if Xpovio doesn’t win approval, NCCN Guidelines could enable off-label use, as has occurred with BMS’s Reblozyl.

Debiopharm Plots Synthetic Lethality Course

Scrip spoke with Debiopharm’s Luke Piggott about the Swiss biotech’s interest in synthetic lethality and strategy around development and partnering.

ACC/AHA Guidelines Recommend Lp(a) Testing, A Boost For Drug Developers

Newly published guidelines for treating dyslipidemia recommend testing for Lipoprotein(a), a cardiovascular disease risk factor with no treatments, but with multiple candidates in the clinic.

Samsung Bioepis Partners With G2GBIO For Long-Acting Semaglutide

Samsung Bioepis’ explorations for an alternate semaglutide formulation will be powered by G2GBIO’s microsphere technology.

Novella Innovative Hires CEO In ‘Pivotal Year’ For Plant-Cell-Based Health, Wellness Ingredients

Antonio Martinez Descalzo has more than 20 years' experience in life sciences, health and nutraceutical industries, including with food and beverage giant ADM. Israeli firm has completed pilot production and is moving into full manufacturing.

The Autonomous Lab: Part 2

In this two-part series, In Vivo examines who is building the autonomous lab, what architectural and business model choices they are making, and what the implications are for drug discovery organizations, external R&D partnerships and the workforce that will be asked to operate these systems.

French Health Care Professionals Warn Of Medicine Access Problems

A new survey of French healthcare professionals reveals concerns that France is increasingly being excluded from major international clinical studies.

FDA’s First PSG Batch Of 2026 Includes 98 Guidances

The US FDA released one of the highest numbers of product-specific guidances for generic development in a single batch.

Almirall On The Lookout For More China Collaborations

The Spanish company has set up shop in Shanghai to be closer to current and future dermatology partners.

Biogen Unveils Phase III Salanersen Program To Bring Longer-Acting SMA Option

As Spinraza’s sales have slumped, Biogen is developing the once-yearly salanersen, showing efficacy in patients with suboptimal responses to Novartis’s Zolgensma.

France Joins EU Race For Faster Clinical Trial Approvals, Prioritizes Early-Phase Research

France is preparing to roll out a fast‑track pathway that offers the possibility of 14-day approvals for applications of certain early‑phase national trials, adding fresh momentum to the race for clinical research leadership among countries in the EU.

Korea Developing AI Drug Reviews, Unveils National Biopharma AI Strategy

South Korea starts development of AI-supported system to dramatically shorten drug approval reviews and announces new national strategy for AI in biopharma targeting 10x expansion in the country’s new drug pipeline.