Commercial

China gets more complicated as multinational drug makers venture deep into it. Even with a local savvy business partner, Merck is learning to navigate through fast-shifting market dynamics amid policy changes, consumer perceptions of foreign brands, and competition from local firms as it takes stock of its market access, pricing and life cycle management strategies.

The US major is investing over $360m in new money into the UK but the country has being losing its lustre as an appealing place to invest since Brexit and needs to offer more to multinationals.

Dealmakers from CAR-T biotech Poseida Therapeutics and Astellas recently sat down with In Vivo to discuss how they reached a $600m deal that combines their technologies and how they plan on moving forward.

Impressed by the data to date on bexicaserin for epileptic encephalopathies syndromes, the Danish drugmaker hopes the drug, through the acquisition of Longboard, will become a cornerstone of its new neuro-rare disease franchise.

This week, J&J announced that it was buying heart failure device firm V-Wave; Procept got the FDA’s OK on a clinical trial of its Aquablation treatment for prostate cancer; and CMS began to consider Medicare reimbursement of Abbott’s TriClip tricuspid repair device.

The US FDA approved the drug for hemophilia A and B, and while it may struggle to compete in hemophilia A against Roche’s Hemlibra, it has a big convenience advantage in hemophilia B.

Public Company Edition: Upstream grossed $255m and CAMP4 raised $75m in October’s first initial public offerings. In follow-on offerings, Crinetics and Scholar Rock brought in $500m and $300m, respectively. Also, Turnstone cut 60% of its workforce and Gritstone filed for bankruptcy.

Data from Evaluate show that biopharma venture capital investment fell from $7.95bn in Q2 to $6.59bn in Q3, but both outpaced every quarter in 2023 as the financial market recovery continues.

Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.

The Swiss company is aiming to regain its innovator status and expand its offering across all breast cancer settings. Approval of Itovebi is just the start.