CVS Caremark published its Performance Drug List for January 2024, notably removing Amgen’s Amjevita® (adalimumab),...
Approval Alert: Almirall Secures EC Approval for Ebglyss® (lebrikizumab) for Atopic Dermatitis
Almirall announced that its received marketing authorisation from the European Commission (EC) for Ebglyss®...
Biogen, Genentech and Roche Sue Dr Reddy’s and Fresenius Kabi Alleging Infringement of 15 Rituxan®/MabThera® Rituximab Patents in NJ
Biogen, Genentech and Roche instigated proceedings against Dr Reddy’s Laboratories and Fresenius Kabi, alleging...
Approval Alert: EC Approves Sandoz’s & EirGenix’s Herwenda® (trastuzumab)
EirGenix announced that Herwenda®, Eirgenix and Sandoz’s biosimilar to Genentech’s Herceptin® (trastuzumab), received...
PTAB Institutes Samsung Bioepis IPR Against Regeneron’s Eylea® (aflibercept) Patent
The US Patent Trial and Appeal Board (PTAB) has instituted Samsung Bioepis’ inter partes review (IPR) against...
Approval Alert: AZ’s Truqap® (capivasertib) plus Faslodex® FDA Approved to Treat Advanced HR-positive Breast Cancer
AstraZeneca (AZ) announced the FDA approved its Truqap® (capivasertib) in combination with Faslodex (fulvestrant) for...
New Indication Alert: Korean MFDS Approves AbbVie’s Skyrizi® (risankizumab) to Treat Chron’s Disease
Korea Biomed reported that AbbVie’s Skyrizi® (risankizumab) has been approved by the Korean Ministry of Food and Drug...
New Indication Alert: FDA Approves Merck’s Keytruda® (pembrolizumab) Plus Chemotherapy for Gastric / GEJ Adenocarcinoma
Merck announced that the FDA approved its Keytruda® (pembrolizumab) combined with fluoropyrimidine- and...
French Parliament Considers Reform to Enable Biosimilar Substitution by the Pharmacy
The French Parliament is debating 2024 budget reform (Social Security Financing Bill for 2024) which would enable...
Approval Alert: BMS’s Augtyro® (repotrectinib) FDA Approved to Treat ROS1-positive NSCLC
Bristol Myers Squibb (BMS) announced the FDA approved its Augtyro® (repotrectinib) for the treatment of adult patients...
Samsung Bioepis SB27, Keytruda® (pembrolizumab) Biosimilar Enters the Clinic
The Korea Herald reported that Samsung Bioepis has received approval from the Ministry of Food and Drug Safety for a...
First Biosimilar Approval Alert: Health Canada Approves Alvotech’s AVT04 commercialised by JAMP as Jamteki™, the First Stelara® (ustekinumab) Biosimilar in Canada
Alvotech and JAMP Pharma announced that Health Canada has granted marketing authorization for Jamteki™ (AVT04), the...
CHMP Recommends Approval of Roche’s Tecentriq® SC (atezolizumab) Formulation
Roche announced that the EU CHMP recommended the approval of its subcutaneous (SC) formulation of Tecentriq®...
New Indication Alert: AZ’s Imfinzi® (durvalumab) Plus Chemotherapy Approved for BTC by NMPA
AstraZeneca announced that China’s National Medical Products Administration (NMPA) approved its Imfinzi® (durvalumab)...
Approval Alert: Biocon Biologics’ Yesafili® (aflibercept) Approved by MHRA
Biocon Biologics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved its...
Celltrion Confirms Equivalence of CT-P39 to Genentech/Novartis’ Xolair® (omalizumab)
The Korea Herald reported that Celltrion has confirmed in its phase III clinical trial that its omalizumab...