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UTR Therapeutics
News

UTR Therapeutics Seeks the US FDA’s IND Clearance of UTRxM1-18 to Target c-MYC-Driven Cancers

Shots: The US FDA has received the IND application for UTRxM1-18, a novel therapy targeting c-MYC-driven cancers, to initiate P-I trial in 2026 pending approval, focusing on c-MYC driven tumors incl. triple-negative breast, pancreatic, colorectal, & ovarian cancer UTRxM1-18 has demonstrated strong, dose-dependent efficacy against human-derived tumors from multiple cancer subtypes, with no dose-limiting toxicities…
May 9, 20250Comments

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Minghui Pharmaceutical & Qilu Pharmaceutical
News

Minghui Pharmaceutical and Qilu Pharmaceutical Enter an Exclusive Licensing and Collaboration Agreement for MHB088C

Shots: Minghui has granted Qilu exclusive rights to develop, manufacture & market MHB088C in Greater China (incl. Mainland China, Hong Kong, Macau, & Taiwan) As per the deal, Minghui will receive ~$185.9M (CN¥ 1.345B) incl. $38.7M as upfront & near-term milestone payments & ~$147.2M in development, regulatory & sales milestones, plus double-digit net sales-based royalties;…
May 9, 20250Comments

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ALK
News

ALK Reports Health Canada’s Approval of Itulatek to Treat Children and Adolescents with Allergic Rhinitis

Shots: Health Canada has approved Itulatek (tree pollen sublingual tablet) to treat mod. to sev. seasonal allergic rhinitis &/or conjunctivitis, induced by pollen from birch, alder, hazel, &/or oak in pts (5-17yrs.); applications under the Swissmedic & MHRA’s review, with decision expected this year Approval was based on P-III (TT-06) trial assessing Itulatek vs PBO…
May 9, 20250Comments

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Cognition Therapeutics
News

Cognition Therapeutics Reports Topline P-II (MAGNIFY) Trial Data of Zervimesine for Geographic Atrophy (GA)

Shots: Cognition has reported topline P-II (MAGNIFY/COG2201) trial data assessing zervimesine (200mg, QD, PO) vs PBO in adults with GA secondary to dry AMD; trial concluded after enrolling ~100 of 246 planned subjects In the trial, nearly 2/3 pts completed 12mos. & 1/3 completed 18mos. of dosing, showing a 28.6% slower GA progression & ~12%,…
May 9, 20250Comments

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ALPCO
News

ALPCO Launches its Calprotectin Immunoturbidimetric Assay for Irritable Bowel Disease Diagnosis in the EU

Shots: ALPCO has launched its Calprotectin Immunoturbidimetric Assay for the diagnosis of IBD, incl. Crohn's disease & ulcerative colitis in the EU ALPCO has also enrolled 1st pts in its pivotal trial for FDA clearance of its automated chemiluminescent calprotectin assay on the KleeYa system, following completion of the FDA pre-submission in Mar 2025, with…
May 9, 20250Comments

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Verastem Oncology
News

FDA Grants Verastem Oncology’s Avmapki + Fakzynja Accelerated Approval for KRAS-Mutated Low-Grade Serous Ovarian Cancer (LGSOC)

Shots: This accelerated approval for the combination of Avmapki (avutometinib) + Fakzynja (defactinib) was granted in advance to the planned PDUFA of Jun 30, 2025, which will be available in the US within a week as a co-pack  Approval was based on P-II (RAMP 201) trial assessing Avmapki (3.2mg, twice weekly) + Fakzynja (200 mg,…
May 9, 20250Comments

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GSK
News

GSK Reports the P-III (GLISTEN) Study Results of Linerixibat for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Shots: GSK has reported P-III (GLISTEN) trial data assessing linerixibat (n=119) vs PBO (n=119) to treat PBC pts (N=238) with cholestatic pruritus; pts could switch to linerixibat in Part B of the trial Trial met its 1EP, showing significantly reduced itch per WI-NRS scale in PBC pts, as assessed by monthly itch score, over 24wks.…
May 8, 20250Comments

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MAGAZINE

PharmaShots Magazine-May-2025 Edition

Automation remained a quintessential force throughout 2024 in shaping the biopharma industry. 2025 on the other hand is experiencing advanced applications of automated tools and enablers in different aspects of drugs life cycles. PharmaShots through this magazine navigates automated packaging by decrypting the complexities of automation.  The magazine unfolds the role of automation in biopharma…
May 8, 20250Comments

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