On 29 February 2024, Biocon Biologics Ltd, announced a settlement with J&J and Janssen, under which it can launch...
Amgen High Concentration PFS Xgeva® (denosumab) Approved by UK MHRA in 30 Days under New International Recognition Procedure
On 29 February 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorisation...
Celltrion files Korean Application for CT-P47, Tocilizumab Biosimilar
On 28 February 2024, Celltrion announced that it filed an application with MFDS for CT-P47, biosimilar to Genentech’s...
Celltrion’s Zymfentra® (SC infliximab) launched in US
On 28 February 2024, Celltrion announced that its first batch of Zymfentra® (SC infliximab) arrived in Atlanta, with...
Akeso Announces Phase 2 Clinical Study Results for Cadonilimab
On 27 February 2024, Akeso announced results of a Phase II clinical trial for cadonilimab combined with standard...
FDA Grants Priority Review of AbbVie’s sBLA for EPKINLY® (epcoritamab SC)
On 27 February 2024, AbbVie announced that the U.S. Food and Drug Administration (FDA) granted priority review of its...
BeiGene’s BLA for TEVIMBRA® (tislelizumab) Accepted by FDA for Treatment of First-Line Gastric or Gastroesophageal Junction Cancers
On 27 February 2024, BeiGene, announced that the U.S. Food and Drug Administration (FDA) accepted BeiGene's Biologics...
CHMP Recommends AZ’s Voydeya® (danicopan) with Ravulizumab or Eculizumab
On 26 February 2024, AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the...
CHMP Issues Positive Opinion for BeiGene’s TEVIMBRA® (tislelizumab) for NSCLC
On 26 February 2024, BeiGene announced that the Committee for Medicinal Products for Human Use (CHMP) of the European...
Takeda Pharmaceuticals Releases Long term results of IV SC Vedolizumab Switching Study
On 26 February 2024, the results of an 18 month study sponsored by Takeda Pharmaceuticals were published in Crohn's...
Approval Alert: First Aflibercept Biosimilar Approved in Korea, as Samsung Bioepis’ Afilivu® Gets the Green Light
On 26 February 2024, Daily Pharm Korea reported that Samsung Bioepis received approval from the Korean Ministry of...
Alvotech Shares Rise Premarket After SIMLANDI® (Biosimilar to AbbVie’s Humira® (adalimumab)) Approval by FDA
On 26 February 2024, Alvotech announced the sale of 10,127,132 ordinary shares at a purchase price of USD 16.41 per...
Samsung Bioepis Presented Study Results for ustekinumab SB17, Biosimilar to Janssen’s Stelara®, at ECCO
On 23 February 2024, Samsung Bioepis presented two new study results for ustekinumab SB17 (biosimilar to Janssen’s...
Approval Alert: Alvotech announces US approval of First High Concentration Buffer Free Interchangeable Adalimumab Biosim
Alvotech and Teva Pharmaceuticals announced that FDA approved SIMLANDI® (adalimumab-ryvk/ AVT02) as an interchangeable...
Eli Lilly’s Donanemab Nears FDA Approval Decision
On 23 February 2024, the Australian quoted Eli Lilly’s CEO David Ricks as stating that its Alzheimer’s drug donanemab...
Regeneron Announces FDA priority review of Dupixent® (Dupilumab) for the treatment of COPD with type 2 inflammation
On 23 February 2024, Regeneron and Sanofi announced that the FDA has accepted to priority review their Dupixent®'s...