Shots:Junshi with its subsidiary, TopAlliance, has partnered with LEO to market toripalimab in 32 EU countries incl. EEA, Switzerland & the UK. TopAlliance will remain the authorization holder overseeing development, manufacturing, registration & other activities in the EU
LEO Pharma will handle the drug distribution, promotion & sales plus will pay an upfront…
Hormones have a very important function in our bodies. They assist in controlling everything—from emotions, metabolism, and sleep cycles to even fertility. When the hormones in our body are well-balanced, we usually feel good. However, minor changes can cause significant effects on health.Understanding our hormones' impact on health is of critical importance, so in this…
Shots:InnoCare & KeyMed together have signed an exclusive license agreement with Prolium to develop & commercialize ICP-B02 (CM355)
Prolium gains exclusive rights to develop, manufacture & commercialize ICP-B02 globally (non-oncology) and in ex-Asia regions (oncology) while InnoCare & KeyMed will get a total of ~$520M (upfront & near-term payments), minority equity stake in…
Shots:Health Canada has approved Fruzaqla to treat mCRC patients receiving prior therapy or are ineligible for SoCs based on 2 P-III (FRESCO & FRESCO-2) trials. In addition, the CDA-AMC & INESSS recommended reimbursement of Fruzaqla
FRESCO assessed Fruzaqla + BSC vs PBO + BSC in 3L+ mCRC patients, while FRESCO-2 assessed Fruzaqla +…
Shots:Formycon & Klinge Biopharma have reported the EC’s approval of FYB203, biosimilar of Eylea (aflibercept), under the brand names: Ahzantive & Baiama valid across the EU plus Iceland, Liechtenstein & Norway after receiving the CHMP’s recommendation in Nov 2024
The biosimilar is intended to treat Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other…
Shots: Epilepsy is a chronic, non-communicable brain condition that affects neurons and causes recurring seizuresOur Disease of the Month report covers epidemiology, market size, current management strategies, emerging therapeutic options, and the role of patient advocacy groups. Additionally, we highlight the key industry players advancing treatments for epilepsyFor a detailed analysis and tailored…
Shots:The EC has approved Jemperli + CT (carboplatin & paclitaxel) as a 1L treatment of primary advanced or recurrent endometrial cancer in adults eligible for systemic therapy
Approval was based on part 1 of P-III (RUBY) study assessing Jemperli + CT followed by Jemperli vs CT + PBO followed by PBO and part…
Shots:Fermion & Simcere Pharma have entered into an exclusive license and collaboration agreement to develop FZ002-037 for pain management
As per the agreement, Simcere secures exclusive rights to develop & commercialize FZ002-037 across Greater China (Mainland China, Hong Kong, Macau & Taiwan) in exchange for an undisclosed upfront, milestones and sales-based tiered royalties…
Shots:The P-IIIb (STEP UP) study assessed semaglutide (7.2mg) vs semaglutide (2.4mg) & PBO as an adjunct to lifestyle intervention in obese adults (n=1,407; BMI ≥30kg/m^2) without diabetes for 72wks. STEP program also includes STEP UP T2D study of semaglutide (7.2mg) in obese adults (n=512) with T2D for 72wks.
Study met its 1EP, depicting…
Shots:The US FDA has approved Calquence + bendamustine & rituximab for untreated MCL in patients not for autologous HSCT, also transforming its accelerated approval (Oct 2017) to full approval for previously treated MCL. The combination is under review in Australia, Canada, Switzerland, the EU, Japan & other regions
Approval was based on P-III…
