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Sanofi announced that it will cut the list price of its Lantus® insulin by 78% and establish a US$35 cap on OOP costs for patients with commercial insurance, with effect from 1 January 2024.  This is in addition to Winthrop’s (a Sanofi company) launch of its unbranded Lantu...

Janssen Biotech, Inc. has filed a redacted, public version of its opening brief in support of its motion for a preliminary injunction in proceedings relating to Amgen’s Stelara® (ustekinemab) biosimilar.  Janssen is seeking to enjoin Amgen, Inc. from manufacturing and using...

The US District Court for Eastern Pennsylvania has made final orders to approve a US$25M settlement in the anti-trust class action lawsuit against Johnson & Johnson (J&J) and Janssen Biotech Inc relating to the supply of Remicade® (infliximab) between 5 April 2016 a...

The US Department of Health and Human Services and the White House have announced that AbbVie will be required to pay rebates to the Centers for Medicare & Medicaid Services for raising the price of Humira® (adalimumab) faster than inflation. This new mechanism was brou...

The Veterans’ Health Administration (VHA) announced coverage of Esai’s LEQEMBI™ (lecanemab) for veterans with early stages of Alzheimer’s disease (AD), two months after the FDA approved LEQEMBI™ under the Accelerated Approval Pathway.  This Pathway requires Eisai to continu...

Lupin Ltd announced that the FDA completed an inspection of its Bioresearch Centre in Pune, India, which was closed without any observation.  The Lupin share price increased by 1.4% on the day of the announcement.

A mAbxience study published in Pharmacology and Research Perspective has found in a randomised, double-blind phase I clinical trial that its MB02 (bevacizumab) is bioequivalent to Genentech’s Avastin®.  MB02 has previously been shown to be bioequivalent to the originator pr...

Luye Pharma Group announced that it has completed patient enrolment in Ph III trials of BA9101 (also known as OT-702), biosimilar to Regeneron’s aflibercept/Eylea®.  BA9101 was developed by Luye Pharma’s subsidiary Boan Biotech with clinical studies being conducted in conju...

PTAB denied institution of the IPR filed by Apotex against Regeneron’s 11,253,572 patent relating to a method of treating an angiogenic eye disorder by administering a VEGF antagonist, including Eylea® (aflibercept).  Apotex filed the IPR in September 2022, challenging clai...