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)