NEWS

Elanco’s Zenrelia Secures the EC’s Approval to Treat Allergy and Atopic Dermatitis in Dogs

Shots: The EC has approved Zenrelia (ilunocitinib) for the treatment of pruritus linked to allergic dermatitis & clinical symptoms of atopic dermatitis in dogs (≥12mos.) As part of the EU approval process, Elanco conducted an H2H non-inferiority study in 338 dogs across 25 sites in 4 countries, which showed that Zenrelia (QD) is at least…

July 25, 2025

Exelixis and Ipsen Report the EC’s Approval of Cabometyx (Cabozantinib) to Treat Advanced Neuroendocrine Tumors (NETs)

Shots: The EC has approved Cabometyx for inoperable, locally advanced or metastatic, well-differentiated pancreatic NET (pNET) & extra-pancreatic NET (epNET) pts, who progressed on ≥1 prior systemic therapy other than somatostatin analogues in all 30 EEA states Approval was based on P-III (CABINET) study assessing Cabometyx (60mg) vs PBO among 298 US pts, which were…

July 25, 2025

Eli Lilly Signs an ~$856M Deal with Gate Bioscience to Develop Molecular Gate Therapeutics

Shots: Eli Lilly has entered into a collaboration & license agreement with Gate Bioscience to identify, develop, & commercialize molecular gate drugs, leveraging Gate’s molecular gate drug discovery engine As per the deal, Gate will receive ~$856M in total, incl. an upfront payment, equity investment, & development, regulatory, & commercial milestones, along with tiered royalties…

July 25, 2025

Matchpoint Therapeutics Collaborates with Novartis to Develop Oral Covalent Inhibitors for Various Inflammatory Diseases

Shots: Matchpoint & Novartis have entered into an exclusive option & license agreement to develop & commercialize oral covalent inhibitors targeting a transcription factor in inflammatory diseases using Matchpoint’s ACE platform As per the deal, Matchpoint will lead all research activities through development candidate selection with funding from Novartis. Matchpoint will receive $60M in upfront & funding…

July 25, 2025

GSK’s Blenrep (Belantamab Mafodotin) Regimens Receive the EC’s Approval to Treat R/R Multiple Myeloma

Shots: The EC has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy. Review ongoing in the US (PDUFA: Oct 23, 2025) & China (priority review for DREAMM-7) Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep + BorDex vs Darzalex + BorDex in 494 pts & Blenrep + PomDex (BPd) vs Velcade…

July 25, 2025

LEO Pharma’s Anzupgo (Delgocitinib) Gains the US FDA’s Approval to Treat Chronic Hand Eczema (CHE)

Shots: The US FDA has approved Anzupgo cream (delgocitinib) for treating mod. to sev. chronic hand eczema (CHE) in adults, who had inadequate response or are unamenable to topical corticosteroids Approval was based on P-III (DELTA 1 & DELTA 2) trials assessing Anzupgo (BID) vs vehicle in 960 adults with mod. to sev. CHE, both of which…

July 24, 2025

Apnimed Reports Topline P-III (LunAIRo) Trial Data of AD109 for Obstructive Sleep Apnea (OSA)

Shots: The P-III (LunAIRo) trial assessed AD109 (aroxybutynin 2.5mg/atomoxetine 75mg; n=329) vs PBO (n=331) for 12mos. in 660 adults with mild to sev. OSA across all weight classes, who are intolerant of or refuse CPAP therapy Trial met its 1EP with a 46.8% vs 6.8% decrease in AHI at 26wks., which remained significant through Wk.…

July 24, 2025

Kling Bio Joins Forces with Sanofi to Identify Neutralizing Antibodies

Shots: Kling Bio has entered into a collaboration & license option agreement with Sanofi to discover antibodies & epitopes leveraging Kling Bio’s Kling-Select platform Collaboration aims to discover & characterize monoclonal antibodies with strong neutralizing activity against human viral pathogen to allow development of novel antiviral therapies Kling-Select is a validated B cell immortalization platform…

July 24, 2025

Servier Reports the CHMP’s Positive Opinion Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma

Shots: The CHMP has recommended to Voranigo for treating patients (age: ≥12yrs.; wt≥ 40kg) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery but do not currently require radiotherapy or CT; anticipated EC decision in all 30 EEA states The CHMP opinion is based on the global P-III (INDIGO) trial (N=331), which included…

July 24, 2025

AstraZeneca Reports P-III (PREVAIL) Trial Data of Gefurulimab for Generalised Myasthenia Gravis (gMG)

Shots: AstraZeneca has reported P-III (PREVAIL) trial assessing gefurulimab vs PBO in 260 gMG adults for 26wks. across North America, EU, & APAC region; eligible pts could then enter an ongoing OLE study Trial met its 1EP & all 2EPs, showing significant improvement in MG-ADL total score from baseline at 26wks. in adults with AChR…

July 24, 2025

NEWS

Elanco’s Zenrelia Secures the EC’s Approval to Treat Allergy and Atopic Dermatitis in Dogs

Exelixis and Ipsen Report the EC’s Approval of Cabometyx (Cabozantinib) to Treat Advanced Neuroendocrine Tumors (NETs)

Eli Lilly Signs an ~$856M Deal with Gate Bioscience to Develop Molecular Gate Therapeutics

Matchpoint Therapeutics Collaborates with Novartis to Develop Oral Covalent Inhibitors for Various Inflammatory Diseases

GSK’s Blenrep (Belantamab Mafodotin) Regimens Receive the EC’s Approval to Treat R/R Multiple Myeloma

LEO Pharma’s Anzupgo (Delgocitinib) Gains the US FDA’s Approval to Treat Chronic Hand Eczema (CHE)

Apnimed Reports Topline P-III (LunAIRo) Trial Data of AD109 for Obstructive Sleep Apnea (OSA)

Kling Bio Joins Forces with Sanofi to Identify Neutralizing Antibodies

Servier Reports the CHMP’s Positive Opinion Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma

AstraZeneca Reports P-III (PREVAIL) Trial Data of Gefurulimab for Generalised Myasthenia Gravis (gMG)

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