This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, M&A, & Biotech. Check out our full report below:

Paratek Pharmaceuticals Reports Topline Results from P-IIb Study of Nuzyra (Omadacycline) for Nontuberculous Mycobacterial Abscessus Pulmonary Disease

Read More: Paratek Pharmaceuticals

Relief Therapeutics Reports Final Data from the Study of RLF-TD011 for Treating Epidermolysis Bullosa

Read More: Relief Therapeutics

AbbVie Reports the P-II (EMPOWER) Studies Data of Emraclidine for Treating Schizophrenia

Read More: AbbVie

Merck KGaA Reports Results from the P-III (MANEUVER) Study of Pimicotinib for Treating Tenosynovial Giant Cell Tumor (TGCT)

Read More: Merck KGaA

AstraZeneca Provides Update on P-III (KOMET) Study of Koselugo for Treating Neurofibromatosis Type 1

Read More: AstraZeneca

Syros Pharmaceuticals Reports the P-III (SELECT-MDS-1) Study Data of Tamibarotene for Treating Myelodysplastic Syndrome

Read More: Syros Pharmaceuticals

Structure Therapeutics Reports the First Patient Dosing in P-IIb (ACCESS) Trial of GSBR-1290 for Obesity

Read More: Structure Therapeutics

GSK Provides Update on P-III (DREAMM-7) Trial of Blenrep for Treating R/R Multiple Myeloma

Read More: GSK

Johnson & Johnson to Feature Analysis from P-II (DAHLIAS) Study of Nipocalimab for Treating Sjögren’s Disease at ACR Convergence 2024

Read More: Johnson & Johnson

Autolus Therapeutics’ Aucatzyl (Obecabtagene Autoleucel) Receives the UA FDA’s Approval to Treat R/R B-Cell Acute Lymphoblastic Leukemia

Read More: Autolus Therapeutics

Atamyo Therapeutics Reports the US FDA’s IND Clearance of ATA-200 for Treating Limb-Girdle Muscular Dystrophy Type 2C/R5 (LGMD2C/R5)

Read More: Atamyo Therapeutics

argenx and Zai Lab Report the NMPA’s Approval of Vyvgart Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy 

Read More: argenx and Zai Lab

GSK’s Ojjaara (Momelotinib) Receives the Health Canada’s Approval to Treat Myelofibrosis in Adults with Moderate to Severe Anemia

Read More: GSK

Caliway Biopharmaceuticals’ CBL-514 Receives the EMA’s Orphan Drug Designation for the Treatment of Dercum’s Disease

Read More: Caliway Biopharmaceuticals

Genascence Corporation’s GNSC-001 Receives the US FDA’s Fast Track Designation for Treating Osteoarthritis (OA) of the Knee

Read More: Genascence Corporation

Actuate Therapeutics’ Elraglusib Receives the US FDA’s Rare Pediatric Disease Designation for Treating Ewing Sarcoma

Read More: Actuate Therapeutics

PTC Therapeutics Reports the US FDA’s Accelerated Approval of its Gene Therapy for AADC Deficiency

Read More: PTC Therapeutics

Eisai and Biogen Reports the CHMP’s Positive Opinion of Lecanemab to Treat Early Alzheimer’s Disease

Read More: Eisai and Biogen

Regeneron and Sanofi Report the US FDA’s sBLA Acceptance of Dupixent (Dupilumab) to Treat Chronic Spontaneous Urticaria (CSU)

Read More: Regeneron and Sanofi

AlveoGene’s AVG-0020 Secures the US FDA’s Rare Pediatric Disease Designation (RPDD) for Lethal Neonatal Surfactant Protein B (SP-B) Deficiency

Read More: AlveoGene

BMS’ Repotrectinib Gains the CHMP’s Positive Opinion to Treat Advanced ROS1+ NSCLC and NTRK+ Solid Tumors

Read More: BMS

Alteogen and Daiichi Sankyo Partner to Develop and Commercialize SC Formulation of Enhertu

Read More: Alteogen and Daiichi Sankyo

IDEAYA Biosciences Nominates IDE034 as a Development Candidate Under Partnership with Biocytogen

Read More: IDEAYA Biosciences and Biocytogen

Apollo Therapeutics Joins Forces with Sunshine Lake Pharma to Develop APL-18881 for Multiple Indications

Read More: Apollo Therapeutics and Sunshine Lake Pharma

Schrödinger Enters into a Multi-Target Collaboration and Expanded Software Licensing Agreement with Novartis

Read More: Schrödinger and Novartis

Nippon Shinyaku Collaborates with Atsena Therapeutics to Commercialize ATSN-101 Across the US and Japan

Read More: Nippon Shinyaku and Atsena Therapeutics

Merck Join Forces with LaNova Medicines to Advance LM-299 for Advanced Solid Tumors

Read More: Merck and LaNova Medicines

Kalaris Therapeutics Reverse Merges with AlloVir to Advance Therapies Focussing on Retinal Diseases

Read More: Kalaris Therapeutics and AlloVir

BioNTech to Acquire Biotheus, Enhancing its R&D Capabilities in Oncology and Expanding Reach Across China

Read More: BioNTech and Biotheus

Flare Therapeutics Inks Pact with Roche to Develop Small Molecules Targeting Undrugged Transcription Factors in Oncology

Read More: Flare Therapeutics and Roche

Related Post: PharmaShots Weekly Snapshots (November 04 – November 08, 2024)