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 Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) for adults with chronic kidney disease, based on the P-III trial (EMPA-KIDNEY)

Read more: Boehringer Ingelheim and Eli Lilly

• The NMPA has accepted the NDA of Henlius’ Hansizhuang (serplulimab) for Esophageal Squamous Cell Carcinoma, based on the P-III trial (ASTRUM-007)

Read more: Henlius

• The NMPA has granted the marketing authorization of Sanofi’ Altuviiio for Hemophilia A, based on the positive results incl. the (XTEND-1) trial in adults & adolescents and the (XTEND-Kids) trial in children under 12yrs.

Read more: Sanofi

• The MHLW has approved Genmab’ Epkinly (epcoritamab) for adults patients with Large B-Cell Lymphoma, based on the P-I/II (EPCORE NHL-1 & 3) trials

Read more: Genmab

• The EC has granted conditional marketing authorization for Tepkinly to treat adult patients with r/r DLBCL, based on the results from the P-I/II trial (EPCORE NHL-1)

Read more: AbbVie and Genmab

• The US FDA has accepted the sBLA for Priority Review of Regeneron and Sanofi’ Dupixent to treat Eosinophilic Esophagitis in children aged 1-11Years, based on the P-III (EoE KIDS) trial (Parts A and B)

Read more: Regeneron and Sanofi

• The MHLW has approved UCB’ Rystiggo (rozanolixizumab) and Zilbrysq (zilucoplan) for adult patients with generalized myasthenia gravis in Japan, based on the P-III (MycarinG) & (RAISE) studies

Read more: UCB

• The US FDA has cleared an IND application to initiate a P-II clinical trial of AltruBio’ ALTB-268 for the treatment of ulcerative colitis

Read more: AltruBio

• The US FDA has approved Viatris and Ocuphire’ Ryzumvl (Phentolamine Ophthalmic Solution) for pharmacologically-induced mydriasis, based on the MIRA clinical program

Read more: Viatris and Ocuphire

• Karuna Therapeutics submits the NDA of KarXT to the US FDA for the treatment of Schizophrenia, based on the (EMERGENT) program i.e., (EMERGENT-1/2/3) trials

Read more: Karuna Therapeutics

• The US FDA has approved Amicus Therapeutics’ Pombiliti (cipaglucosidase alfa-atga) + Opfolda for Pompe Disease, based on the P-III study (PROPEL)

Read more: Amicus Therapeutics

• HUTCHMED submits the NDA of Fruquintinib for previously treated metastatic colorectal cancer in Japan, based on the results from the P-III trial (FRESCO-2) as well as results from the P-III (FRESCO) trial

Read more: HUTCHMED

• Novartis highlighted P-III trial (NETTER-2) results of Lutathera as 1L advanced Gastroenteropancreatic Neuroendocrine Tumors demonstrated a significant improvement in PFS over high-dose long-acting octreotide alone

Read more: Novartis

• Lantern Pharma dosed the first patient of LP-184 in the P-I study for advanced solid tumors

Read more: Lantern Pharma

• Ionis highlighted P-III study (Balance) results of Olezarsen for Familial Chylomicronemia Syndrome met its primary efficacy EPs with a reduction in triglyceride levels with olezarsen

Read more: Ionis

• Basilea highlighted P-III study (ERADICATE) results of Ceftobiprole for Staphylococcus Aureus Bacteremia published in the NEJM showed that ceftobiprole was non-inferior to daptomycin with overall treatment success

Read more: Basilea

• Janssen highlighted P-III study (MARIPOSA) results of Rybrevant (amivantamab-vmjw) + Lazertinib for EGFR-mutated NSCLC showed a significant & clinical improvement in PFS

Read more: Janssen

• Ionis Reports P-III Study (NEURO-TTRansform) Results of Eplontersen for Hereditary Transthyretin-Mediated Amyloid Polyneuropathy. In the 66wk. primary analysis, eplontersen showed an improvement across all co-1EPs & 2EPs

Read more: Ionis

Ascletis highlighted positive interim results from the P-IIb expansion cohort of ASC22 (envafolimab) for Chronic Hepatitis B functional cure

Read more: Ascletis

• Pierre Fabre Laboratories & Vernalis to identify pre-clinical candidates against multiple oncology targets

Read more: Pierre Fabre Laboratories & Vernalis

• Ono & Adimab signs an agreement to discover novel antibody drugs for cancer where Ono will get an exclusive rights option to globally develop, manufacture, and commercialize the candidates

Read more: Ono & Adimab

• Ionis & Roche collaborated for two novel RNA-targeted programs for Alzheimer's and Huntington's Disease

Read more: Ionis & Roche

• Ginkgo Bioworks & Pfizer collaborated for RNA-based drug candidates

Read more: Ginkgo Bioworks & Pfizer

• AcuraStem & Takeda collaborated to advance PIKFYVE therapies for amyotrophic lateral sclerosis

Read more: AcuraStem & Takeda

• Valo Health Signs an Agreement with Novo Nordisk to Discover and Develop Novel Treatments for Cardiometabolic Diseases using Valo’s Opal Computational Platform

Read more: Valo Health and Novo Nordisk

• Evommune Collaborated with Maruho to Develop and Commercialize EVO756, a potent, highly selective small molecule antagonist of MRGPRX2 in Japan

Read more: Evommune and Maruho

• Cosmo & Glenmark collaborated for Winlevi in Europe and South Africa. Glenmark will get an exclusive right from Cassiopea, a subsidiary of Cosmo to commercialize Winlevi in 15 EU countries

Read more: Cosmo & Glenmark

• BioCity & AstraZeneca collaborated to evaluate BC3402 + Imfinzi (durvalumab) for Advanced Hepatocellular Carcinoma in China

Read more: BioCity & AstraZeneca

• Alfasigma to buy Intercept Pharmaceuticals for $794M expanding the global footprint in the US market and expanding its portfolio in liver diseases and digestive system disorders

Read more: Alfasigma and Intercept Pharmaceuticals

• The EC has granted marketing authorization for Sandoz’s first and only biosimilar Tyruko to treat relapsing forms of MS

Read more: Sandoz

Related Post: PharmaShots Weekly Snapshots (September 18–22, 2023)