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,…
NEWS
Shots:
Rezolute has completed pts enrollment in P-III (sunRIZE/RZ358-301) trial of ersodetug as an add-on treatment of hypoglycemia in congenital hyperinsulinism pts, with 62 pts enrolled, exceeding the target of 56; the US FDA’s BLA filing is expected in 2026
Trial assessed ersodetug (5 or 10mg/kg, Q2W during initial loading then Q4W for 6mos.) + SoC vs…
Shots:
Part 1 of P-III (MANEUVER) trial assessed pimicotinib (n=63) vs PBO (n=31) for 24wks. in 94 TGCT pts who required systemic therapy & had no prior anti-CSF-1/CSF-1R treatment; trial also incl. an open-label Part 2 (data expected in mid-2025) & an OLE phase (Part 3)
Trial met its 1EP of improved ORR (54.0% vs…
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…
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…
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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,…
Shots:
GRIN has granted Angelini Pharma exclusive rights to commercialize radiprodil worldwide, while GRIN will retain its rights in the US, Canada, & Mexico as well as lead global development
As per the deal, GRIN will get $50M upfront & ~$520M in development, regulatory & sales milestones, with net sales-based tiered royalties & payments from…
Shots:
Eli Lilly has entered into a definitive agreement to acquire SiteOne Therapeutics incl. its asset, STC-004, expanding its pain pipeline
As per the deal, SiteOne shareholders will receive an upfront payment as well as regulatory & commercial milestones for a total consideration of ~$1B in cash
STC-004 is a non-opioid Nav1.8 inhibitor, which will advance into…
Shots:
The CHMP has recommended Imfinzi as a perioperative treatment of MIBC; regulatory review is ongoing in Japan & other regions
Opinion was based on the P-III (NIAGARA) trial (n=1063) MIBC pts randomized to either neoadj. Imfinzi + CT before cystectomy followed by adj. Imfinzi or neoadj. CT with no further treatment after surgery …
Shots:
The NMPA has approved telitacicept for the treatment of AChR antibody-positive gMG in combination with standard therapies
In P-III trial for gMG, telitacicept demonstrated favorable efficacy vs PBO, with 98.1% vs 12% pts achieving ≥3-point MG-ADL reduction (-5.74 vs -0.91) as well as 87% vs 16% pts having ≥5-point QMG reduction (-8.66 vs -2.27) at…

