First Humira biosimilar approved in Europe
Amgen has won European approval for its first biosimilar, a version of AbbVie’s blockbuster Humira (adalimumab).
The European Commission has approved Amgevita (biosimilar adalimumab) in all the available indications of its originator product, marking the first European licence for a biosimlar version of Humira【阅读全文】
Merrimack asset sale prompts legal blowback
Merrimack Pharmaceuticals is facing several lawsuits over its decision to divest assets to Ipsen, Boston Business Journal reported Thursday.
In the deal, Merrimack is offloading the pancreatic cancer drug Onivyde plus a generic version of the ovarian cancer drug Doxil.【阅读全文】
FDA decision for Dupixent as Novartis drives its CAR-T
Worldwide sales of Dupixent are expected to hit a huge $4.3bn by 2022, according to sellside consensus from EvaluatePharma, and over half of this is assigned to US sales. The project has an NPV of $15.7bn, or 14% of Sanofi’s market cap; Regeneron collects worldwide royalties.
The MAb is forecast to be Sanofi’s biggest growth driver, looking to plug the gap left by declining Lantus sales, and is also one of the biggest expected launches of the year.【阅读全文】
A new PD-L1 is born, and success for Newron at long last
Yesterday’s US approval of avelumab for Merkel cell carcinoma is unlikely to trouble the competition, but it will be important for having got the Pfizer/Merck KGaA anti-PD-L1 MAb across the regulatory finish line. Indeed, Merkel cell, a rare skin cancer, is perceived as such an economically unviable proposition that, barring a couple of investigator-initiated studies, none of the leading anti-PD-1/PD-L1 projects are in trials specifically for it. An NCI-sponsored study of Keytruda generated positive data in first-line Merkel cell carcinoma at last year’s AACR meeting, but despite this its maker, Merck & Co, has not picked up the gauntlet. 【阅读全文】
Novartis laterals two PhII anti-aging drugs to a PureTech startup, grabbing an equity stake
Pharma giant Novartis is spinning out a pair of Phase IIb-ready drugs now bound for advanced trials on repairing the deteriorating impact of aging on the human immune system.
Boston-based PureTech Health is on the receiving end of the deal, setting up a subsidiary called resTORbio which it will now fund, in tranches, with $15 million. And it can earn a growing stake in the operation, rising to 58% on the allocation of the full $15 million, with an option to increase that to 67% if it adds $10 million more.【阅读全文】
Xenon acne drug misses efficacy endpoints in phase 2
A phase 2 trial of Xenon Pharmaceuticals’ acne candidate XEN801 has missed its primary and key secondary efficacy endpoints. The comprehensive failure prompted Xenon to admit the data don’t support continued development of XEN801 and wiped 44% off its stock price in premarket trading.
Xenon enrolled 165 patients with moderate-to-severe facial acne and randomized them to receive either a gel formulation of XEN801 or placebo. After 12 weeks in which participants applied a gel to their faces each evening, investigators looked for changes against baseline. The study’s primary endpoint was the percent change in lesion count after 12 weeks. Secondary endpoints looked at lesion counts after four and eight weeks, and the change on an investigator assessment scale.【阅读全文】美中药源原创文章，转载注明出处并添加超链接，商业用途需经书面授权。
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