ADVERTISEMENT

Comp

Quick Listen: Scrip’s Five Must-Know Things

This week, a focus on key results from the American Society of Hematology meeting: Jaypirca headed for the front line; Kite’s Anito-cel in multiple myeloma; next-generation CAR-T approaches; Kelownia’s early in vivo CAR-T data; and Novartis’s ianalumab’s potential in ITP.

One Year Later, FDA Reorg Drives Faster Warning Letters, Surge In Facility Classifications

The October 2024 reorganization that moved compliance functions back into the product centers has resulted in speedier issuance of biologics warning letters and an increase in drug manufacturing facility classifications, FDA compliance officials said.

Belgian Regulator Presses Roche Further Over Biosimilar Abuse Allegations

The Belgian Competition Authority has confirmed that it is escalating a complaint against Roche over alleged strategies used to delay biosimilar competition to rituximab and trastuzumab.

Podcast: Kairos Pharma’s Approach To Resensitizing Tumors

In this episode of the In Vivo podcast, Kairos Pharma's chief scientific officer discusses developing therapies to reverse drug resistance in oncology, with ENV-105 showing promising Phase II results in resensitizing hormone-resistant prostate cancer.

Belgian Regulator Presses Roche Further Over Biosimilar Abuse Allegations

The Belgian Competition Authority has confirmed that it is escalating a complaint against Roche over alleged strategies used to delay biosimilar competition to rituximab and trastuzumab.

OTC Firms Must Strike Delicate Balance Between Trust And Personalization

“In the coming years, growth will depend on whether brands can combine trust, personalization, and proof of evidence into one coherent prevention experience,” argue Simon Kucher's Clemens Oberhammer and Christian Rebholz in this exclusive interview.

Biopharma In 2026: From Darwinian Reset To Disciplined Growth

The biopharmaceutical landscape in 2026 will be shaped by rapid technological progress, shifting geographic leadership, a looming patent cliff and a renewed focus on capital efficiency.

David And Goliath: How A Parent-Led Buyers’ Club Challenged Cystic Fibrosis Giant Vertex

After years of fighting and securing treatment for her daughter, cystic fibrosis campaigner Gayle Pledger could not leave other patients behind. This is a story of families coming together and finding a generic drug manufacturer in order to save their children.

Quick Listen: Scrip’s Five Must-Know Things

In this week's episode: Trump’s UK drug pricing win; Novo explains semaglutide Alzheimer's rationale; J&J and Novartis on this year’s biggest M&A deals; a look at the mixed performance of CAR-Ts; and Akeso’s goals beyond ivonescimab.

Pink Sheet Podcast: Understanding the US FDA’s CDER Leadership Shuffle

Pink Sheet reporter and editors discuss the likely impacts of Center for Drug Evaluation and Research Director Richard Pazdur’s retirement from the FDA and Tracy Beth Høeg becoming the center’s acting director.

Drug Combinations May Be The Next Generation Of Alzheimer’s Treatment

Doctors and biopharma executives discussed the opportunities and challenges for researching and administering combination therapy at the Clinical Trials on Alzheimer’s Disease meeting.

UK MHRA’s Medtech Regulatory Update Must Keep Future EU MDR Changes In Mind

The MHRA’s premarket statutory instrument for Great Britain should to be laid before UK parliament in Q2 and be in force by year end, in an ideal world. There are concerns that the new statutory instrument must align with imminent EU MDR changes.