Novo Nordisk Reports the US FDA’s NDA Acceptance of Oral Wegovy for Weight Management

Shots:The US FDA has accepted NDA of oral Wegovy for chronic weight management & major adverse CV events risk reduction in adults with obesity or overweight & comorbidities (PDUFA: Q4’25)Submission was based on the P-III (OASIS 4) trial assessing oral Wegovy (25mg; OD) vs PBO over 64wks. (incl. 12wk. dose escalation & 7wk.…

ByRidhi RastogiMay 5, 20250Comments

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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 cancerApproval 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…

ByRidhi Rastogi35 minutes ago0Comments

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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 underwayApproval was backed by extensive clinical data incl. LENNY trial data in T1D pts (2–6 yrs), showing a…

ByRidhi Rastogi2 hours ago0Comments

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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 H1’26NDS 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…

ByRidhi Rastogi4 hours ago0Comments

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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 techAs per the deal, Vicebio will receive $1.15B upfront & ~$450M in development & regulatory milestones; closing is expected in Q4’25Molecular Clamp tech stabilizes viral proteins…

ByRidhi Rastogi5 hours ago0Comments

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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 PsONDA 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…

ByRidhi Rastogi6 hours ago0Comments

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LIFE SCIENCES | DAILY NEWS | JUL 21, 2025 | PHARMASHOTS

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Next-Gen T Cell Engagers for Solid Tumors: Shaun Murphy in a Riveting Dialogue Exchange with PharmaShots

Shots: Unlike hematologic malignancies, where the elimination of most or all tumor cells results in immunosuppression, making headways in solid tumors requires a new holistic approach when using T Cell Engagers Abpro’s ABP-102/CT-P72, co-developed by Celltrion leverages a tetravalent format; bivalent for both HER2 and CD3 PharmaShots welcomes Shaun Murphy, Vice President, Nonclinical Research and…

BySaurabh Chaubey23 hours ago0Comments

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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 evaluateIlumya (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 ptsBoth trials…

ByRidhi Rastogi24 hours ago0Comments

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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 chickensExzolt, available in 1L &…

ByRidhi Rastogi1 day ago0Comments

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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 ptsApproval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT vs PBO + ADT in 669 mHSPC ptsTrial showed a 46% reduction in rPFS (1EP), with consistent benefit observed across all subgroups, incl. pts…

ByRidhi Rastogi1 day ago0Comments

Novo Nordisk Reports the US FDA’s NDA Acceptance of Oral Wegovy for Weight Management

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)

LIFE SCIENCES | DAILY NEWS | JUL 21, 2025 | PHARMASHOTS

Next-Gen T Cell Engagers for Solid Tumors: Shaun Murphy in a Riveting Dialogue Exchange with PharmaShots

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)

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