On 21 February 2024, Regeneron announced that the FDA has accepted for priority review its BLA for Linvoseltamab for...
Regeneron Receives Adverse IPR Judgment After Disclaiming Rights to US Aflibercept Formulation Patent
On 21 February 2024, the US Patent Trial and Appeal Board (PTAB) entered an adverse judgment against Regeneron in...
FDA Accepts BMS’s sNDA for KRAZATI® (adagrasib) in Combination with Cetuximab
On 20 February 2024, BMS announced that FDA has accepted, for priority review, its supplemental new drug application...
FDA Approves J&J’s sBLA for Use of its TECVAYLI® (teclistamab) in the Treatment of Relapsed or Refractory Multiple Myeloma
On 20 February 2024, FDA approved J&J ‘s supplemental biologics license application to use TECVAYLI® (teclistamab)...
New Approval Alert: First Denosumab Biosimilar Approved in Canada, as Sandoz Celebrates the Approval of Jubbonti®
On 20 February 2024, Sandoz announced that Health Canada approved Jubbonti® (denosumab) biosimilar to Amgen’s Prolia®,...
New Approval Alert: Health Canada Approves Celltrion’s Remsima™ SC (infliximab) for IBD
Health Canada announced that Celltrion’s Remsima™ SC (SC infliximab) has been approved for maintenance therapy in...
FDA Accepts AstraZeneca and Daiichi Sankyo’s BLA for Datopotamab Deruxtecan
On 19 February 2024, AstraZeneca and Daiichi Sankyo announced that FDA has accepted its biologics license application...
March a Bumper Month for Biopharma at the Pharmaceutical Benefits Assessment Committee (PBAC) in Australia
According to the Pharmaceutical Benefits Assessment Committee (PBAC) agenda for March 2024, published on 5 January...
Celltrion Wins Peru Tenders for Adalimumab, Trastuzumab & Rituximab Biosimilars
On 19 February 2024, the Korea Biomedical Review published that Celltrion secured a series of tenders to supply...
New Indication Alert: FDA Approves Genentech’s Xolair® (omalizumab) for Treatment of Food Allergies
Genentech announced that FDA has approved Xolair® for the reduction of allergic reactions, including anaphylaxis, in...
New Indication Alert: Japan’s MHLW grants approval for Dupixent® (dupilumab) to Treat Chronic Spontaneous Urticaria
Regeneron and Sanofi announced that they have received approval in Japan for Dupixent® (dupilumab) for the treatment...
Alvotech Announces Settlement and Launch Dates for Ustekinumab Biosimilar in Europe, Japan and Canada
Alvotech announced that it has settled with Johnson & Johnson in the European Economic Area (EEA), Japan and...
FDA Grants Priority Review for BMS’s Augtyro® (repotrectinib)
BMS announced that the FDA has accepted a priority review for its Augtyro® (repotrectinib) for the treatment of...
FDA and EMA Accept Galderma’s Regulatory Filings for Nemolizumab in Patients with Prurigo Nodularis and Atopic Dermatitis
On 14 February 2024, Galderma announced that the FDA accepted its Biologics License Applications, and the EMA accepted...
Celltrion Submits Application for Tocilizumab Biosimilar
On 13 February 2024, Korea IT Times reported that Celltrion has submitted a Marketing Authorization Application to the...
Qilu’s Aflibercept Biosimilar Equivalent to Regeneron’s Eylea® for nAMD
A study sponsored by Qilu Pharmaceutical, published in Ophthalmology and Therapy reports that, in a Chinese,...