PharmaShots Weekly Snapshots (October 16–20, 2023)

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PharmaShots Weekly Snapshots (October 16–20, 2023)

This week PharmaShots’ news was all about the updates on clinical trials, regulatory, biotech, pharma, and M&A. Check out our full report below:

  • The US FDA has approved BMS’ Opdivo (nivolumab) as adjuvant treatment for completely resected stage IIB or stage IIC melanoma, based on the P-III trial (CheckMate -76K)

Read more: BMS

  • The EMA’s CHMP has adopted a positive opinion recommending approval of GSK’ Jemperli in combination with carboplatin-paclitaxel for adult patients with dMMR/MSI-H primary advanced or recurrent EC, based on interim analysis results from Part 1 of the P-III trial (RUBY/ENGOT-EN6/GOG3031/NSGO) 

Read more: GSK

  • The US FDA has accepted the sNDA & granted Priority Review for AstraZeneca's Tagrisso + CT to treat adult patients with LA or metastatic EGFRm NSCLC

Read more: AstraZeneca

  • The EC has approved Merck’s Keytruda (pembrolizumab) as adjuvant treatment for Non-Small Cell Lung Cancer, based on the P-III trial (KEYNOTE-091) 

Read more: Merck

  • The US FDA has approved Everest Medicines' licensing partner Pfizer’s Etrasimod for adults with moderately to severely active ulcerative colitis, based on the P-III registrational program (ELEVATE UC 52 & 12)

Read more: Pfizer

  • The US FDA has approved UCB’ Zilbrysq (zilucoplan) for adults with generalized myasthenia gravis, based on the P-III study (RAISE) results 

Read more: UCB

  • The NMPA has approved AstraZeneca’s Soliris (eculizumab) for the treatment of adults with Neuromyelitis Optica Spectrum Disorder, based on the P-III trial (PREVENT)

Read more: AstraZeneca

  • The EC has approved Takeda’s Adcetris (brentuximab vedotin) for previously untreated CD30+ Stage III Hodgkin lymphoma, based on the P-III trial (ECHELON-1)  

Read more: Takeda

  • The US FDA has approved UCB’ Bimzelx (bimekizumab) for the treatment of adults with moderate to severe plaque psoriasis, based on the P-III trials (BE READY, BE VIVID and BE SURE)

Read more: UCB

  • The NICE has recommended BeiGene’s Brukinsa (zanubrutinib) for adult patients with chronic lymphocytic leukemia

Read more: BeiGene

The NICE has recommended Roche’s Glofitamab for the treatment of Diffuse Large B-Cell Lymphoma

Read more: Roche 

  • AbbVie highlighted that the head-to-head P-III study (SEQUENCE) of Skyrizi (risankizumab) for Crohn's Disease met both 1EPs of non-inferiority for clinical remission (CDAI) at 24wk.

Read more: AbbVie

  • Eli Lilly announced P-III trial (SURMOUNT-3) results of Tirzepatide for Obesity or Overweight met co-1EPs for the efficacy estimand and treatment-regimen estimand & showed superiority to PBO during the 72wk. treatment period

Read more: Eli Lilly

  • Teva highlighted P-IV (UNITE) study results of Ajovy (fremanezumab) for Migraine and Major Depressive Disorder, presented at the World Congress of Neurology showed a reduction in migraine attacks & depressive symptoms

Read more: Teva

  • BMS highlighted three-year follow-up results from exploratory analyses of the P-III Trial (CheckMate -816) for Opdivo to treat resectable non-small cell lung cancer. In patients with tumor PD-L1 expression ≥1% & <1%, reduction in risk of death (63% & 29%)

Read more: BMS

  • BeiGene reported P-III trial (RATIONALE 315) results of Tislelizumab for resectable non-small cell lung cancer at ESMO Congress 2023, presented at ESMO Congress 2023. The study met its dual 1EPs of MPR by BIPR and EFS by BICR

Read more: BeiGene

  • Numab Therapeutics doses the first patient in the P-I multiple ascending dose study of NM26 for moderate to severe atopic dermatitis

Read more: Numab Therapeutics

  • BMS highlighted P-III trial (CheckMate -67T) results of Nivolumab (nivolumab and hyaluronidase) for advanced or metastatic clear cell renal cell carcinoma

Read more: BMS

  • AEON Biopharma highlighted P-II trial results of ABP-450 (prabotulinumtoxinA) for the preventive treatment of episodic migraine showed that ABP-450 had a treatment effect with mean reductions in MMD of 4.8 & 5.0 days at 150U & 195U doses

Read more: AEON Biopharma

  • Akeso highlighted P-Ia/Ib study (COMPASSION-01) results of Cadonilimab for Solid Tumors in Cell Reports Medicine showed that cadonilimab reached a dose of 25mg/kg, q3w without encountering the MTD, occurrence of sev. irAE

Read more: Akeso

  • SOTIO & Synaffix collaborated to expand ADC pipeline where SOTIO will be responsible for the research, development & commercialization of the ADCs

Read more: SOTIO & Synaffix

  • SpliceBio & Spark Therapeutics collaborated to develop gene therapy. Spark will get an exclusive right globally to develop, manufacture, and commercialize a gene therapy

Read more: SpliceBio & Spark Therapeutics

  • Monte Rosa Therapeutics & Roche collaborated to discover novel molecular glue degraders targeting cancer and neurological diseases

Read more: Monte Rosa Therapeutics & Roche

  • Daiichi Sankyo collaborated with Merck for Three Daiichi Sankyo DXd ADCs i.e., patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan

Read more: Daiichi Sankyo & Merck

  • Ascentage Pharma Entered into Clinical Collaboration with AstraZeneca for Lisaftoclax + Acalabrutinib in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Read more: Ascentage Pharma & AstraZeneca

  • Gilead entered into a 12yr. partnership with Assembly Biosciences to develop novel antiviral therapies. Assembly Bio gets the right to opt-in for profits & cost-sharing in the US if Gilead exercises its option for an Assembly Bio program

Read more: Gilead & Assembly Biosciences

  • Stuart Therapeutics & Glaukos Corporation collaborated to develop the first neuroprotective therapy. Glaukos will assume all costs for the development of ST-113

Read more: Stuart Therapeutics & Glaukos Corporation

  • Elevar Therapeutics & Jiangsu Hengrui Pharma collaborated for Camrelizumab + Rivoceranib to treat unresectable hepatocellular carcinoma

Read more: Elevar Therapeutics & Jiangsu Hengrui Pharma

  • Endeavor BioMedicines & Hummingbird Bioscience collaborated to HMBD-501 for HER3-expressing tumors

Read more: Endeavor BioMedicines & Hummingbird Bioscience

  • Novo Nordisk to acquire Ocedurenone from KBP Biosciences for ~$1.3B to treat uncontrolled hypertension with potential application in cardiovascular & kidney disease

Read more: Novo Nordisk & KBP Biosciences

Related Post: PharmaShots Weekly Snapshots (October 09–13, 2023)

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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