The Korea Economic Daily reported that Celltrion announced record quarterly earnings, with an operating profit of...
Revised Indication Alert: FDA Amends Keytruda® (Pembrolizumab) Gastric Cancer Indication
The US Food and Drug Administration (FDA) has revised the existing indication for Keytruda® (pembrolizumab) for the...
Study Demonstrates mAbxience’s MB02 Bioequivalent to Genentech’s Avastin® (bevacizumab)
A pooled analysis study published in Pharmacology Research and Perspectives has concluded that the results support...
Fresenius Kabi’s Launches First EU Tocilizumab Biosimilar
Fresenius Kabi announced it has launched Tyenne®, the first EC-approved biosimilar to Roche’s Actemra®/RoActemra® in...
New Indication Alert: FDA Approves New GI for Merck’s Keytruda®
Merck announced that the US FDA has approved Keytruda® (pembrolizumab) for the treatment of patients with locally...
FDA Accepts Amgen’s BLA for ABP 938, Biosimilar to Regeneron’s Eylea® (Aflibercept)
Amgen announced in its Q3 2023 results that the FDA has accepted its Biologics License Application (BLA) for ABP 938,...
Approval Alert: FDA Approves First Ustekinumab Biosimilar (Amgen)
On 31 October 2023, the FDA approved Amgen’s Wezlana® (ustekinumab-auub), as the first FDA-approved biosimilar to...
New Indication Alert: FDA Approves Novartis’ Cosentyx® (secukinumab) for HS
Novartis announced that the FDA approved Cosentyx® (secukinumab) to treat moderate to severe hidradenitis suppurativa...
Sandoz Study Finds 8 Sandoz Biosimilars are Comparable to Originator Biologics
A Sandoz study published in Drug Safety found that eight Sandoz biosimilars (adalimumab (Hyrimoz®), epoetin alfa...
New Indication Alert: FDA Approves BMS’s Orenica® (abatacept) for JPsA
The FDA has approved Bristol Myers Squibb’s supplemental biologics license application (sBLA) for subcutaneous use of...
Aragen to Establish New US$30M Biologics Manufacturing Facility in India
Aragen announced it is establishing a new US$30M, 160,000m2 biologics manufacturing site in Bangalore, India. The...
EMA Validates BMS’s Type II Variation for Opdivo® (nivolumab)
Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its type II variation...
Dr Reddy’s Biologics Facility Receives Further Form 483 Objections Following US FDA Inspection
Dr Reddy’s informed the Indian National Stock exchange on 28 October 2023 that the FDA issued a Form 483 with ten...
Sanofi to Spin-Off Consumer Business and Focus on Biopharma by End Q4 2023
Sanofi announced that it will separate its Consumer Healthcare Business as soon as the end of Q4 2024, creating a...
July 2023 PBAC Public Summary Documents Available
The Department of Health and Aged Care has published the public summary documents considered at the July 2023 PBAC...
Approval Alert: Coherus/Shanghai Junshi’s Loqtorzi® (toripalimab) Approved to Treat NPC
Coherus BioSciences announced that the FDA has approved its Loqtorzi® (toripalimab) in combination with cisplatin and...