16 NOV 2023 | US | Approval Alert: AZ’s Truqap® (capivasertib) plus Faslodex® FDA Approved to Treat Advanced HR-positive Breast Cancer
AstraZeneca (AZ) announced the FDA approved...
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By Naomi Pearce | Nov 20, 2023
16 NOV 2023 | US | Approval Alert: AZ’s Truqap® (capivasertib) plus Faslodex® FDA Approved to Treat Advanced HR-positive Breast Cancer
AstraZeneca (AZ) announced the FDA approved...
By Bioblast Editor | Nov 20, 2023
AbbVie commenced proceedings in the US District Court of Delaware against Sandoz, Hetero Labs, Aurobindo Pharma, Intas Pharmaceuticals, Accord Healthcare and Sun Pharma, alleging infringement of 34 Rinvoq® (upadacitinib) patents, including compound, process and method of tr...
By Bioblast Editor | Nov 20, 2023
Sam Chun Dang Pharmaceutical announced in a corporate filing that it has signed an exclusive 10-year distribution agreement with an unnamed distributor regarding SCD411, biosimilar to Regeneron’s Eylea® (aflibercept), to be supplied to Austria, Germany, Italy, Spain and Swi...
By Bioblast Editor | Nov 20, 2023
CVS Caremark published its Performance Drug List for January 2024, notably removing Amgen’s Amjevita® (adalimumab), the first Humira® biosimilar launched in the US, and replacing it with Sandoz’s Hyrimoz® (adalimumab-adaz) as the preferred adalimumab product.
CVS wil...
By Bioblast Editor | Nov 17, 2023
Almirall announced that its received marketing authorisation from the European Commission (EC) for Ebglyss® (lebrikizumab) for the treatment of adult and adolescent patients (12 years and older with a body weight of at least 40 kg) with moderate-to-severe atopic dermatitis ...
By Bioblast Editor | Nov 17, 2023
Biogen, Genentech and Roche instigated proceedings against Dr Reddy’s Laboratories and Fresenius Kabi, alleging infringement of 15 patents relating to Genentech/Biogen’s Rituxan®/MabThera® (rituximab) products in the US District Court of New Jersey. The alleged infringemen...
By Bioblast Editor | Nov 17, 2023
EirGenix announced that Herwenda®, Eirgenix and Sandoz’s biosimilar to Genentech’s Herceptin® (trastuzumab), received approval from the European Commission for the same indications as Herceptin®: HER2-positive breast cancer and metastatic gastric cancers. On 30 April 2019,...
By Bioblast Editor | Nov 17, 2023
The US Patent Trial and Appeal Board (PTAB) has instituted Samsung Bioepis’ inter partes review (IPR) against Regeneron’s Eylea® (aflibercept) patent no. 11,253,572 in IPR proceeding IPR2023-00884. The ‘572 patent relates to methods of use of aflibercept in treating angiog...
By Bioblast Editor | Nov 16, 2023
AstraZeneca (AZ) announced the FDA approved its Truqap® (capivasertib) in combination with Faslodex (fulvestrant) for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker a...
By Bioblast Editor | Nov 16, 2023
Korea Biomed reported that AbbVie’s Skyrizi® (risankizumab) has been approved by the Korean Ministry of Food and Drug Safety (MFDS) for a new indication: to treat adult patients with moderate to severe active Crohn’s disease who have not responded adequately to or can...
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