Read our latest updates & insights

The FDA has approved AbbVie’s RINVOQ® (upadacitinib) for adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers.  RINVOQ® is the first oral treatment approved to this in...

Amneal announced it has launched FLYNETRA™ (pegfilgrastim) in the US, biosimilar to Amgen’s Neulasta®.  FLYNETRA™ is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive a...

Boan Biotech announced that it has completed patient enrolment in its phase III clinical trial for BA5101, its proposed biosimilar to Eli Lilly’s Trulicity® (dulaglutide) used in patients with insufficiently controlled type 2 diabetes mellitus.  Boan’s clinical trial will c...

The US Supreme Court denied Teva’s petition for certiorari to review the August 2021 decision of the US Court of Appeals for the Federal Circuit in relation to skinny label carve-outs and Teva’s US$235M loss in its patent dispute with GSK.   The issue that Teva sought to pu...

Korea Biomed reported that Celltrion submitted a phase III investigational new drug (IND) plan to the FDA for its CT-P53, biosimilar to Genentech’s Ocrevus® (ocrelizumab), used to treat multiple sclerosis.  The phase III global clinical trial will be a comparative study on ...

Biogen and Eisai Co., Ltd announced that Health Canada has accepted a new drug submission (NDS) for LEQEMBI® (lecanemab) to treat early Alzheimer’s disease (AD) and mild AD dementia with confirmed amyloid pathology in the brain.  LEQEMBI® is an investigational anti-amyloid ...

Byondis announced that the FDA has issued a complete response letter (CRL) for its Biological License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985).  Byondis sought approval for its anti-HER2 antibody-drug conjugate in HER2-positive unresectable locally adva...

Viatris investor Jason Taylor has brought proceedings on behalf of a class of Viatris shareholders against the company and its executive officers and directors, seeking remedies under the Securities Exchange Act of 1934 including damages, interest, costs, and equitable, inj...

A Senju study has shown that its ranibizumab biosimilar (biosim to Roche/Genentech’s Lucentis®) is more cost-effective in treat-and-extend (TAE) regimens compared to aflibercept based on higher quality-adjusted life-years (QALYs) and lower cost in treating neovascular age-r...