Tags : Multiple

Merck’s Brenzys (etanercept, biosimilar) Receives Health Canada Approval for Multiple

Shots: Health Canada has approved Brenzys for new indications that include adults & pediatric patients (4-17yrs.) with PsO who are candidates for systemic therapy/ phototherapy, adult patients with PsA, and patients aged 4-17yrs. with JIA The clinical efficacy and safety studies conducted in patients with RA demonstrate clinical comparability between Brenzys and the reference product. […]Read More

Bayer and One Drop Collaborate to Develop Digital Therapies Across

Shots: The two partners will jointly enhance the existing platform utilizing One Drop’s know-how and capabilities of the One Drop platform and will co-develop digital health therapies across multiple therapeutic areas                One Drop will receive $98M financing, development fees and commercial milestones while in exchange Bayer will receive royalties on sales. In the future, Bayer […]Read More

BMS Signs an Exclusive Worldwide Agreement with Repare Therapeutics to

Shots: BMS to receive $65M up front, including $15M equity investment and is eligible to receive $3B as license fees, discovery, development, regulatory and commercial milestones, in addition to royalty payments on commercialization of each product commercialized by BMS The companies will Repare’s SNIPRx platform to jointly identify multiple synthetic lethal precision oncology targets for […]Read More

Biocon Receives EMA’s GMP Certification for Multiple Biosimilars Manufacturing Facilities

Shots: Biocon has received the EMA’s Certificate of GMP compliance for multiple biologics drug substance (DS) and drug product (DP) manufacturing facilities at Biocon Park, Bengaluru. The facilities are used for the manufacture biosimilars: bevacizumab, trastuzumab, pegfilgrastim and secondary packaging of Insulin Glargine for EU and were inspected in Mar’2020 The approval expands Biocon’s capabilities […]Read More

Thermo Fisher Scientific Collaborates with Janssen to Co-Develop CDx for

Shots: The alliance will validate multiple biomarkers to be used in Thermo Fisher’s Oncomine Dx Target Test, which will be used to identify variant-positive patients for enrollment into clinical studies focusing NSCLC and may follow other cancer indications The ability of the Oncomine Dx Target test to rapidly detect variants from small quantities of DNA/ […]Read More

GSK Signs an Agreement with Immatics to Develop Adoptive Cell

Shots: Immatics to receive ~$50M up front for two initial programs & ~$550M as milestones/ product along with royalties. Immatics is eligible to receive option, milestones and royalties on each additional program GSK to get access to two Immatic’s TCR-T programs and will get an option to select additional targets to include in the collaboration. […]Read More

GSK Reports EMA’s Acceptance of MAA for Belantamab Mafodotin to

Shots: The MAA is based on DREAMM-2 P-II study (DRiving Excellence in Approaches to Multiple Myeloma) study which involves assessing of Belantamab Mafodotin in heavily pre-treated patients with MM who were refractory to an immunomodulatory drug and a proteasome inhibitor and were refractory and/or intolerant to an anti-CD38Ab The study resulted in 31% ORR with […]Read More

Mundipharma Collaborates with Samsung Bioepis to Commercialize Multiple Biosimilar Candidates

Shots: Mundipharma to get exclusive commercialization rights for Samsung Bioepis’ first-wave biosimilar candidates in Taiwan and Hong Kong while Samsung Bioepis will remain MAH, responsible for the development, regulatory and manufacturing activities of therapies The biosimilar candidates include SB5 (adalimumab), SB4 (etanercept), SB3 (trastuzumab), and SB8 (bevacizumab) targeting immunology & oncology The collaboration combines Samsung […]Read More