Shots:
GSK & Spero Therapeutics have reported early conclusion of P-III (PIVOT-PO) trial for efficacy of tebipenem HBr to treat cUTIs, incl. pyelonephritis following IDMC recommendation based on positive interim analysis; US FDA’s filing is expected in H2’25
The P-III (PIVOT-PO) trial assessed tebipenem pivoxil HBr (600mg, PO, every 6hrs.) vs imipenem-cilastin (500mg, IV, every…
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…
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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…
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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…
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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,…
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:
Characterized by the thickening or hardening of arteries due to plaque buildup, atherosclerosis leads to complications like heart attack or stroke
PharmaShots' Disease of the Month report aims to familiarize the general population with conditions impacting communities worldwide. The report outlines disease characteristics, types, symptoms, diagnosis, treatments, epidemiology, market size, clinical trial analysis, patient…
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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…