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NEWS

Alcon
Alcon Reports the US FDA’s Approval of Tryptyr to Treat Dry Eye Disease
Shots: The US FDA has approved Tryptyr (0.003% acoltremon ophthalmic solution; AR-15512) to treat signs & symptoms of dry eye disease (DED); US launch expected in Q3’25 Approval was backed by 2 P-III (COMET-2 & COMET-3) trials assessing Tryptyr vs vehicle in >930 pts with DED, where Tryptyr showed ≥10mm natural tear production increase by…
May 29, 2025
Bayar
The US FDA Grants Priority Review to Bayer’s Sevabertinib for HER2-mutant NSCLC
Shots: The US FDA has granted priority review to sevabertinib (BAY 2927088; reversible TKI) for the treatment of previously treated pts with advanced NSCLC harboring HER2 mutations Designation was based on the P-I/II (SOHO-01) trial assessing (20mg, BID, PO) in HER2-mutant NSCLC, with data previously reported from 2 cohorts: pts progressing on ≥1 systemic therapy who…
May 29, 2025
Snap Bio & Monarch Therapeutics
SNAP Biosciences Licenses Monarch Therapeutics’ Technology to Advance Snap-Car NK Cell Therapy for Cancer Targets
Shots: SNAP Biosciences & Monarch Therapeutics have entered into a licensing agreement for Monarch’s small molecule adaptor tech to develop & commercialize SNAP's Snap-Car NK cell therapy platform in oncology   Financial terms remain undisclosed but incl. an upfront licensing payment, future development milestones, with net sales-based royalties Monarch’s tech enables SNAP-CAR cells to be…
May 29, 2025
Alvotech & Advanz Pharma
Alvotech Expands its Partnership with Advanz Pharma to Commercialize Three Additional Biosimilars in the EU
Shots: Alvotech has entered into an agreement with Advanz Pharma to expand their commercial partnership to include 3 more biosimilar candidates As per the deal, Advanz will register & commercialize biosimilars of Ilaris (canakinumab), Kesimpta (ofatumumab), & an undisclosed biologic in the EU, while Alvotech will handle development & commercial supply; partners will share revenues,…
May 29, 2025
biogen & City Therapeutics
Biogen Joins Forces with City Therapeutics to Develop Novel RNAi Therapies
Shots: Biogen has collaborated with City Therapeutics to develop novel RNAi therapies, leveraging the former’s drug delivery tech & City’s RNAi engineering tech As per the deal, City will receive $46M incl. $16M upfront + $30M investment in exchange for its convertible note, also eligible to receive ~$1B as development & commercial milestones, with high…
May 28, 2025
Samsung Bioepis and Organon
Samsung Bioepis and Organon’s Hadlima (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation for All Presentations
Shots: FDA has granted interchangeability designation to Hadlima, a biosimilar version of Humira (adalimumab) for prefilled syringe (40mg/0.4mL) & autoinjectors (40mg/0.4mL & 40mg/0.8mL) expanding on the prior designation for prefilled syringe (40mg/0.8mL) & single-dose vial Designation was based on trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev. plaque PsO…
May 28, 2025
AnX Robotica
AnX Robotica’s MotiliCap and MotiliScan Receive the US FDA’s 510(k) Clearance for GI Motility Monitoring
Shots: The US FDA has granted 510(k) clearance to MotiliCap & MotiliScan for GI motility monitoring MotiliCap is a radiation & sedation-free motility capsule that evaluates gastrointestinal transit across stomach, small bowel, & colon, with detailed GI data exported directly to MotiliScan for analysis MotiliScan is a companion software that offers intuitive visualization, data analysis,…
May 28, 2025
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