NEWS

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

Sun Pharma Reports Topline Data from P-III (INSPIRE-1 & INSPIRE-2) Trials of Ilumya (Tildrakizumab) for Active Psoriatic Arthritis

Shots: Sun Pharma has reported topline data from P-III (INSPIRE-1 & INSPIRE-2) trials assessing Ilumya (100mg) in pts with active psoriatic arthritis (PsA) INSPIRE-1 & INSPIRE-2 trials to evaluate Ilumya (Q12W) vs PBO in ~800 active PsA pts over 52wks., where INSPIRE-1 enrolled pts with prior anti-TNF exposure & INSPIRE-2 enrolled anti-TNF naïve pts Both…

July 21, 2025

Merck Animal Health Reports the US FDA’s Approval of Exzolt for Northern Fowl Mites

Shots: The US FDA has approved Exzolt (fluralaner oral solution) to treat & control northern fowl mites (Ornithinyssus sylviarum) in chickens Exzolt is a parasiticide that targets the nervous system of northern fowl mites, killing those that ingest a blood meal, while remaining safe for laying hens & replacement chickens Exzolt, available in 1L &…

July 21, 2025

Bayer Reports EC’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: The EC has approved Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) ± docetaxel to treat mHSPC pts Approval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT vs PBO + ADT in 669 mHSPC pts Trial showed a 46% reduction in rPFS (1EP), with consistent benefit observed across all subgroups, incl. pts…

July 21, 2025

Autolus Therapeutics’ Aucatzyl Secures the EC’s Approval for R/R B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Shots: The EC has approved Aucatzyl (Obecabtagene Autoleucel) for treating pts (≥26yrs.) with r/r B-ALL in all 30 EEA states The EC approval was based on the FELIX study (n=100+), which showed that pts in cohort IIA (n=94) receiving ≥1 infusion of obe-cel had a 76.6% CR/CRi rate, with a mDoR of 21.2mos. & mEFS…

July 21, 2025

NEWS

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)

Sun Pharma Reports Topline Data from P-III (INSPIRE-1 & INSPIRE-2) Trials of Ilumya (Tildrakizumab) for Active Psoriatic Arthritis

Merck Animal Health Reports the US FDA’s Approval of Exzolt for Northern Fowl Mites

Bayer Reports EC’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Autolus Therapeutics’ Aucatzyl Secures the EC’s Approval for R/R B-Cell Acute Lymphoblastic Leukemia (B-ALL)

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