Drug Delivery
Sun Pharmaceutical is bringing Merck spinoff Organon into the fold, paying $11.75 billion in hopes of becoming a top global biosimilar player.
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Following Insmed’s decision to hold off on launching a newly approved lung disease drug in Europe, experts anticipate more companies will do the same as they seek to avoid price erosion in the U.S. Will Chinese biotechs fill the void?
If the U.S. can help Japan reform its drug pricing controls, both countries stand to benefit.
Industry groups have identified upfront costs as a barrier to streamlining U.S. drugmaking. The nonprofit API Innovation Center has a proposed answer for how to tilt finances in favor of investments in continuous manufacturing.
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As the field grows rapidly, companies are luring people from other nuclear industries and tapping the expanding educational talent pipeline, but are constrained by a steep learning curve and the value of real-world experience.
The administration’s direct-to-consumer pharmaceutical sales platform will offer products from Eli Lilly, Pfizer, Novo Nordisk, Amgen and more at a discount, though the impact of such pricing remains to be seen.
Regulatory challenges have been even more top of mind than usual given recent upheaval at the FDA. BioSpace spoke to three industry experts about key issues, which include applying new artificial intelligence guidance. The experts also shared advice for working with regulators.
Pfizer announces the first data from its Metsera-acquired pipeline just ahead of its earnings call, where analysts pressed execs for more details; Merck and Roche also released Q4 and full year earnings, with Eli Lilly, Novo Nordisk and others reporting Wednesday; REGENXBIO hits a regulatory snag ahead of its upcoming PDUFA; more.
After suffering in the wake of expired tax incentives for pharmas, the island is trying to take advantage of geopolitics to grow its drug manufacturing sector.
The facility, which is part of Lilly’s $50 billion reshoring drive, will make obesity drugs such as tirzepatide and retatrutide when it starts operations in 2031.
The program will allow for frequent communication with the FDA, giving manufacturers timely input and guidance regarding the design of their facilities.
Opening up about drug pricing decisions is not optional for biopharma anymore. For the sake of credibility, companies should embrace it.
In a Cabinet meeting, Health Secretary Robert F. Kennedy Jr. said the website could go live “probably in the next 10 days,” but an exact launch date remains unclear.
After years of contraction, investors see biotech reentering a growth cycle driven by scientific progress, asset quality and renewed conviction in oncology, obesity and neuroscience innovation.