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

• AstraZeneca and Daiichi Sankyo highlighted initial results from the P-Ib (TROPION-Lung04) trial of datopotamab deruxtecan + Imfinzi as 1L advanced NSCLC showed an encouraging response with no new safety signals

Read more: AstraZeneca and Daiichi Sankyo

• BMS reported P-II study results of BMS-986278 for Progressive Pulmonary Fibrosis, presented at ERS 2023 showed 69% & 42% reduction in rate of decline in percent predicted forced vital capacity at 30 & 60mg doses

Read more: BMS

• Daiichi Sankyo reported P-II (HERTHENA-Lung01) trial results of Patritumab Deruxtecan for EGFR-mutated metastatic NSCLC, presented at WCLC 2023 showed clinically meaningful & durable responses

Read more: Daiichi Sankyo

• AstraZeneca highlighted P-III trial (FLAURA2) results of Tagrisso for EGFR-mutated advanced lung cancer showed an improvement in PFS & a 38% reduction in risk of disease progression or death

Read more: AstraZeneca

• Janssen highlighted P-Ib/II study (CHRYSALIS-2) results of Rybrevant (amivantamab-vmjw) + Lazertinib for EGFR-mutated advanced NSCLC showed durable progression-free survival, presented at IASLC 2023 WCLC

Read more: Janssen

• Hoth Therapeutics reports positive results of HT-KIT from preclinical study in Gastrointestinal Stromal Tumors and Acute Myeloid Leukemia

Read more: Hoth Therapeutics

• AN2 Therapeutics begins P-III part of a P-I/II study for Epetraborole to treat Treatment-Refractory MAC Lung Disease

Read more: AN2 Therapeutics

• AbbVie highlighted P-III (SEQUENCE) head-to-head study results of Skyrizi for Crohn's Disease, showed that risankizumab met both 1EPs of non-inferiority for clinical remission & superiority of endoscopic remission

Read more: AbbVie

• Neurocrine Biosciences highlighted P-III study (CAHtalyst) results of Crinecerfont for Congenital Adrenal Hyperplasia in adults which met its 1EPs at 24wk. & showed a significant percent reduction in daily glucocorticoid (GC) dose

Read more: Neurocrine Biosciences

Novartis highlighted P-III trial (NATALEE) results of Kisqali (ribociclib) for early breast cancer showed that patients maintained physical & social functioning for ~3yrs, presented at ESMO Virtual Plenary

Read more: Novartis

• The NICE has recommended Eli Lilly’s Tirzepatide for the treatment of adults with Type 2 Diabetes and Tirzepatide substantially declined blood sugar levels & body weight

Read more: Eli Lilly

• The US FDA has approved BioLineRx’s Aphexda (motixafortide) + Filgrastim for Multiple Myeloma, based on the 2-part P-III study (GENSIS) results 

Read more: BioLineRx

• The US FDA has accepted the NDA for Verona Pharma’s Ensifentrine to treat Chronic Obstructive Pulmonary Disease, based on the P-III trials (ENHANCE-1 & 2)

Read more: Verona Pharma

• The US FDA has granted the Fast Track Designation to Affimed’s AFM13 + AlloNK for Relapsed or Refractory Hodgkin Lymphoma

Read more: Affimed

• The NICE has recommended Pfizer’s Vydura (rimegepant) for acute treatment of migraine

Read more: Pfizer

• The EMA’s CHMP has adopted a positive opinion recommending the approval of Ascendis Pharma’s TransCon PTH (palopegteriparatide) for Chronic Hypoparathyroidism, based on the P-III (PaTHway) & P-II (PaTH Forward) trials

Read more: Ascendis Pharma

• The NMPA has approved an IND Application of InnoCare’s ICP-189 + Furmonertinib to Initiate P-I study of ICP-189 + Furmonertinib for NSCLC Patients

Read more: InnoCare

• The EMA has adopted the positive opinion recommending approval of argenx’s Efgartigimod for Generalized Myasthenia Gravis, based on the P-III study (ADAPT-SC)

Read more: argenx

• Sandoz & Samsung Bioepis collaborated to commercialize SB17, a proposed biosimilar to Stelara in the US, Canada, EEA, Switzerland, and UK

Read more: Sandoz & Samsung Bioepis

• BioFactura highlighted P-I study results of BFI-751 (biosimilar, ustekinumab) that met the standard bioequivalence criteria

Read more: BioFactura

• Bausch + Lomb launches Miebo (perfluorohexyloctane ophthalmic solution) for Dry Eye Disease

Read more: Bausch + Lomb

• First Wave BioPharma Licenses Capeserod from Sanofi for Gastrointestinal Disorders

Read more: First Wave BioPharma and Sanofi

• AbbVie and Harpoon Therapeutics terminates its development and option agreement for HPN217

Read more: AbbVie and Harpoon Therapeutics

• Pharmazz and Sun Pharma collaborated to commercialize Sovateltide under the brand name of Tyvalzi in India 

Read more: Pharmazz and Sun Pharma

• LIB Therapeutics & Hasten Biopharmaceutical collaborated to develop and commercialize Lerodalcibep in Greater China (Chinese Mainland, Hong Kong, Macau & Taiwan)

Read more: LIB Therapeutics & Hasten Biopharmaceutical

• Menarini & Astellas collaborated to commercialize Smyraf in Taiwan and selected South-East Asian markets. Menarini also gets an option to extend the rights to select South-East Asian markets

Read more: Menarini & Astellas

• Moderna collaborated with Immatics to develop innovative oncology therapies where Moderna will be responsible for the clinical development & commercialization of cancer vaccines and TCER therapeutics

Read more: Moderna and Immatics

• Cure Genetics & Frametact collaborated to develop gene therapy for Familial Neurological Diseases

Read more: Cure Genetics & Frametact

• Health Canada has authorized Moderna’s updated COVID-19 vaccines SPIKEVAX targeting the Omicron XBB.1.5 subvariant in individuals aged ≥6mos.

Read more: Moderna

•  Zomedica commercialize its Truforma Diagnostic platform for diagnosis and management of Cushing’s Disease in Horses

Read more:  Zomedica

Read more: PharmaShots Weekly Snapshots (September 04–08, 2023)