PharmaShots Weekly Snapshots (October 16

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

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

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

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

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