by Jakub Jarolím, Business Intelligence Department
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SOTIO Biotech
14/5/2024
April 2024 Biotechnology: Review of news from the most innovative therapeutic areas and the business development transactions
Market
NBI dropped by 6 % during April as the bets on interest rate cuts are fading away
The biotech sector is once again at the whims of expectations for US interest rates, but this time in a negative way as NBI dropped by 6 %. NBI saw a similar dependence on interest rates for last two months of 2023 when it climbed on expectations that FED would start cutting rates this year.
Interleukin-15 and Interleukin-2
FDA approved Anktiva for treatment of non-muscle invasive bladder cancer
ImmunityBio announced that FDA has approved Anktiva (N-803) plus BCG for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. Antkiva, a first-in-class IL-15 agonist immunotherapy for NMIBC, received Breakthrough Therapy Designation and approval from the FDA based on the safety and efficacy outcome of complete responses and duration of complete response.
Antibody-Drug Conjugates
FDA granted full approval for Elahere for certain ovarian cancer patients
AbbVie announced that FDA has granted full approval for Elahere (mirvetuximab soravtansine-gynx) for the treatment of FRα-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies.
Cell Therapies
Carvykti was approved in the US and Europe for treatment of multiple myeloma
Legend Biotech announced that FDA and European Commision have approved Carvykti (cilta-cel) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor, and an immunomodulatory agent, and are refractory to lenalidomide.
Other Innovative Treatment Areas
Astellas’ zolbetuximab approved in Japan for treatment of gastric cancer
Astellas announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) approved Vyloy (zolbetuximab), an anti-CLDN18.2 monoclonal antibody for patients with CLDN18.2 positive, unresectable, advanced or recurrent gastric cancer. Vyloy is the first and only CLDN18.2-targeted therapy approved by any regulatory agency in the world.
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