This week PharmaShots’ news was all about the updates on Regulatory, Clinical Trials, Pharma, Animal Health & MedTech.

Check out our full report below: 

Regulatory 

The US FDA Accepts GSK’s BLA of Meningococcal ABCWY Vaccine for Invasive Meningococcal Disease (IMD)

Read More: GSK                                                                                                              

NovelMed’s NM5072 Receives the US FDA’s Orphan Drug Designation to Treat Paroxysmal Nocturnal Hemoglobinuria (PNH)

Read More:  NovelMed                                                                                               

Sentynl Therapeutics’ Nulibry (fosdenopterin) Gains the MHRA’s Approval to Treat Molybdenum Cofactor Deficiency (MoCD) Type A

Read More: Sentynl Therapeutics                                                                                  

Takeda’s Entyvio Receives the US FDA’s Approval for Subcutaneous Administration to Treat Moderately to Severely Active Crohn’s Disease (CD)

Read More: Takeda 

Nxera Pharma Collaborates with Handok to Commercialize Pivlaz in South Korea

Read More: Nxera Pharma & Handok

Medincell Collaborates with AbbVie for the Development of Therapies Across Various Indications

Read More: Medincell & AbbVie                          

IGM Biosciences Revises its Collaboration with Sanofi

Read More: IGM Biosciences & Sanofi

GV20 Therapeutics Collaborates with Merck to Evaluate GV20-0251 + KEYTRUDA in Patients with Advanced Solid Tumors

Read More: GV20 Therapeutics & Merck

Alvotech and Teva Pharmaceuticals Collaborates to Expand Access for Adalimumab-ryvk (Interchangeable Biosimilar, Humaira) in US

Read More: Alvotech & Teva

Essential Pharma Acquires Reminyl (galantamine hydrobromide) Oral Capsules from Janssen

Read More: Essential Pharma & Reminyl

TELA Bio Launches OviTex IHR to Repair Inguinal Hernia Across the US

Read More: TELA Bio

Shinobi Therapeutics Teams Up with Panasonic to Develop Affordable and Efficient iPS Cell Therapy Manufacturing Technology

Read More: Shinobi Therapeutics & Panasonic

AbbVie Reports Data from the P-III Trial of Atogepant as a Preventive Treatment of Migraine

Read More: AbbVie

Roche Reports Data from the P-III Clinical Evaluation of Columvi to Treat R/R Diffuse Large B-cell Lymphoma 

Read More: Roche 

MaaT Pharma to Highlight Data from the Early Access Program of MaaT013 to Treat Acute Graft-Versus-Host Disease (aGvHD) at EBMT 2024

Read More: MaaT Pharma 

Novartis Reports Data from the P-III Study of Fabhalta (iptacopan) for the Treatment of IgA Nephropathy (IgAN)

Read More: Novartis

ORIC Pharmaceuticals Doses First Patients Across Expansion Arms in the P-Ib Study of ORIC-114 for the Treatment of Mutated NSCLC

Read More: ORIC Pharmaceuticals

Corcept Concludes Patient Recruitment in the P-II Study of Dazucorilant for Amyotrophic Lateral Sclerosis (ALS)

Read More: Corcept

AstraZeneca Reports Results from the P-III (TOPAZ-1) Study of Imfinzi for Treating Advanced Biliary Tract Cancer

Read More: AstraZeneca

Sanofi to Highlight New Data from the P-II Study of Frexalimab for the Treatment of Multiple Sclerosis at AAN 2024

Read More: Sanofi 

GSK to Feature Results from the P-III (ZOSTER-049) Study of Shingrix for Protection Against Shingles at ESCMID Global 2024

Read More: GSK 

Roche to Highlight the P-III (OCARINA II) Trial Results of Ocrevus for Treating Progressive and Relapsing Multiple Sclerosis at AAN 2024

Read More: Roche

GSK to Highlight Results from the P-III (EAGLE-1) Study of Gepotidacin for Treating Uncomplicated Urogenital Gonorrhoea (GC) at ESCMID 2024

Read More: GSK 

Lilly Reports the P-III (SURMOUNT-OSA) Study Data of Tirzepatide in Patients with Obstructive Sleep Apnea (OSA) and Obesity

Read More: Eli Lilly 

Artiva Biotherapeutics Doses First Patient with AlloNK in the P-I Study for Treating Lupus Nephritis

Read More: Artiva

Cerevel Therapeutics Reports Results from P-III Adjunctive Study Evaluating Tavapadon for the Treatment of Advanced Parkinson’s Disease

Read More: Cerevel

Oncternal Therapeutics Reports First Patient Dosing in Fourth Cohort of P-I/II Study of ONCT-534 for the Treatment of R/R mCRPC

Read more: Oncternal Therapeutics

Ventus Therapeutics Reports Results from the P-I Study of VENT-02 in Healthy Volunteers

Read more: Ventus Therapeutics 

Teva and Alvotech’s Selarsdi (Biosimilar, Stelara) Receives the US FDA’s Approval

Read More: Teva Pharmaceuticals

Seismic Therapeutic Highlights Preclinical Data of S-1117 for the Treatment of Autoimmune Disorders at AAN 2024

Read More: Seismic Therapeutic

Related Post:- PharmaShots Weekly Snapshots (April 08 – April 12, 2024)