Lilly’s Mounjaro to Pfizer’s Paxlovid, the WuXi group has been part of pharma majors’ sourcing chain. How big is the hole clients are to fill when the proposed BIOSECURE Act comes into effect? Here’s a Scrip infographic using Evaluate Pharma data.

After 10 years of promised investment following its Nobel Prize for iPS cell research, Japan is cautiously narrowing regulations around the conditional approval of cell therapies and cutting some reimbursement prices. Commercial success remains mixed and some products have been withdrawn from the market.

The US Federal Trade Commission’s focus on potential anti-competitive behavior by pharmacy benefit managers picks up steam as Chair Lina Khan approaches the end of her term.

IGBA's secretary general, in an interview with Scrip, bolsters the case for enabling single global development of off-patent medicines and the acceptance of foreign comparators in bioequivalence studies as complex and niche therapeutics increasingly dot pharma’s pipeline. The global off-patent industry association, she maintained, is also “paying attention” to patent quality in various regions.

As India seeks to build on early gains in CAR-T cell therapy, experts call for ecosystem reform and also the need to demonstrate value to payer models of large economies to potentially back international reimbursements.

SK pharmteco CEO Joerg Ahlgrimm talks to Scrip about the "excitement" at BIO, potential CDMO shifts amid the US BIOSECURE Act, and the Korean CDMO's focus on business as usual as it seeks to diversify and grow.

The charges stemmed from allegations of manipulation of Phase II data for the Alzheimer’s disease drug simufilam.

The IL-23 inhibitor was approved by the US FDA for ulcerative colitis, joining AbbVie’s Skyrizi and Lilly’s Omvoh.

But 2024 will see a lull between two strong years.

The group intends to appeal the US FDA’s rejection of its MDMA-based PTSD therapy, midomafetamine, but other psychedelics could advance in the meantime.

After a quiet July, August and September are shaping up to be busy on the approvals front. Already this month, the US FDA has approved Adaptimmune’s Teclera for synovial sarcoma, Phathom’s Voquezna for gastro-esophageal reflux disease and Servier’s Voranigo for gliomas. Here, Scrip takes a look at ten other approvals for novel products in the offing for the third quarter.

Despite initial promise, a novel autologous cell transplant therapy for severe heart failure has faced multiple challenges in gaining full approval in Japan, potentially providing learnings for other developers of regenerative medicines.