NEWS

The EC Approves Fresenius’ Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva)

Shots: The EC has approved Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab) Approval covers all indications of the reference products incl. osteoporosis in postmenopausal women & men at high risk of fracture, SRE prevention in adults with bone-involved malignancies, giant cell tumors of bone & treatment-related bone loss Additionally, Fresenius & Amgen…

July 23, 2025

HMNC Brain Health and Spruce Biosciences Dose First Patient in P-II (TAMARIND) Trial of Tildacerfont for Major Depressive Disorder

Shots: HMNC & Spruce has dosed the first pts with tildacerfont in P-II (TAMARIND) trial for the treatment of major depressive disorder (MDD) The P-II (TAMARIND) trial will assess tildacerfont vs PBO in 88 MDD adults across the UK for an 8wk. treatment period followed by a 4wk. follow-up period to evaluate change in Hamilton…

July 23, 2025

Slingshot AI launches Ash for Personalized Mental Health Support

Shots: Slingshot AI has launched Ash, a personalized mental health support app, which is now available on both iOS & Android platforms Slingshot AI also secured a Series A extension funding co-led by Radical & Forerunner Ventures, joined by existing investors a16z, Felicis, & Menlo, bringing its total capital raised to $93M Ash is powered…

July 23, 2025

Roche’s Itovebi Regimen Secures the EC’s Approval for PIK3CA-mutated Breast Cancer

Shots: The EC has approved Itovebi + Ibrance & fulvestrant as a 1L therapy for adults with PIK3CA-mutated, ER+/HER2- locally advanced or metastatic breast cancer recurring on or within 12mos. of adj. endocrine therapy, based on the P-III (INAVO120) trial Trial (n=325) assessed the regimen vs PBO + Ibrance & fulvestrant, which showed improved PFS…

July 23, 2025

Concentra Biosciences Enters a Merger Agreement to Acquire iTeos Therapeutics

Shots: Concentra Biosciences has entered into a definitive merger agreement to acquire iTeos Therapeutics As per the deal, iTeos Therapeutics’ shareholders will receive $10.047 per share in cash, along with a non-transferable CVR, which entitles them to 100% of iTeos' net cash exceeding $475M at closing & 80% of net proceeds from the sale of…

July 22, 2025

Merck’s Keytruda Regimen Receives Health Canada’s Approval for FIGO 2014 Stage III-IVA Cervical Cancer

Shots: Health Canada has approved Keytruda + chemoradiotherapy (CRT) for the treatment of adults with FIGO 2014 Stage III-IVA cervical cancer Approval was based on P-III (KEYNOTE-A18/ ENGOT-cx11/GOG-3047) trial assessing Keytruda (200mg, IV, Q3W × 5 cycles) + CRT followed by Keytruda (400mg, IV, Q6W × 15 cycles) vs PBO + CRT in 1060 pts with…

July 22, 2025

Medtronic Reports the European CE Mark of MiniMed 780G System for Automated Insulin Delivery

Shots: Medtronic has received CE mark to extend label of MiniMed 780G system to pts (≥2yrs.), pregnant women & T2D pts; application is under the FDA’s review for T2D, plus US trial for use in pts (2-6yrs.) is underway Approval was backed by extensive clinical data incl. LENNY trial data in T1D pts (2–6 yrs), showing a…

July 22, 2025

Bavarian Nordic Reports the Health Canada’s NDS Acceptance of CHIKV VLP to Prevent Chikungunya

Shots: Health Canada has accepted NDS of CHIKV VLP for active immunization against CHIKV disease in individuals (≥12yrs.); decision is anticipated in H1’26 NDS was based on 2 P-III trials (n>3,500) that met their 1EP, with 97.8% of subjects aged 12–64yrs. & 87.3% aged >65yrs. developing neutralizing antibodies by day 21 post vaccination; seroresponse rates…

July 22, 2025

Sanofi to Acquire Vicebio for ~$1.6B

Shots: Sanofi has entered into an agreement to acquire Vicebio, expanding its respiratory vaccines pipeline & capabilities with Vicebio’s vaccine candidates (VXB-241 & VXB-251) & Molecular Clamp tech As per the deal, Vicebio will receive $1.15B upfront & ~$450M in development & regulatory milestones; closing is expected in Q4’25 Molecular Clamp tech stabilizes viral proteins…

July 22, 2025

Johnson & Johnson Submits NDA to the US FDA for Icotrokinra to Treat Plaque Psoriasis (PsO)

Shots: The US FDA has received NDA of icotrokinra for the treatment of pts (≥12yrs.) with mod. to sev. plaque PsO NDA was backed by P-III (ICONIC-TOTAL, ICONIC LEAD, ICONIC-ADVANCE 1 & 2) trials, where ICONIC-LEAD (vs PBO) met its co-1EPs of IGA 0/1 & PASI 90 at Wk. 16, plus showed higher rates of clear or almost clear…

July 22, 2025

NEWS

The EC Approves Fresenius’ Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva)

HMNC Brain Health and Spruce Biosciences Dose First Patient in P-II (TAMARIND) Trial of Tildacerfont for Major Depressive Disorder

Slingshot AI launches Ash for Personalized Mental Health Support

Roche’s Itovebi Regimen Secures the EC’s Approval for PIK3CA-mutated Breast Cancer

Concentra Biosciences Enters a Merger Agreement to Acquire iTeos Therapeutics

Merck’s Keytruda Regimen Receives Health Canada’s Approval for FIGO 2014 Stage III-IVA Cervical Cancer

Medtronic Reports the European CE Mark of MiniMed 780G System for Automated Insulin Delivery

Bavarian Nordic Reports the Health Canada’s NDS Acceptance of CHIKV VLP to Prevent Chikungunya

Sanofi to Acquire Vicebio for ~$1.6B

Johnson & Johnson Submits NDA to the US FDA for Icotrokinra to Treat Plaque Psoriasis (PsO)

Contact US

FOLLOW US