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

EnteroBiotix Concludes Recruitment for P-II Trial of EBX-102-02 in IBS

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Eli Lilly Reports the Data from P-II Trial of Muvalaplin in Adults with High Risk for Cardiovascular Events

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GSK Reports the P-III (GLISTEN) Study Results of Linerixibat to Treat Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Read More: GSK

Merck Reports the Data from P-III Study Assessing Subcutaneous Keytruda with Berahyaluronidase Alfa to Treat Metastatic NSCLC

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Novo Nordisk Highlights the Part 1 Results from P-III (ESSENCE) Study of Semaglutide to Treat MASH at AASLD 2024 - The Liver Meeting

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Endeavor BioMedicines Reports the First Patient Dosing Under P-IIb (WHISTLE-PF) Study of Taladegib (ENV-101) to Treat Idiopathic Pulmonary Fibrosis

Read More: Endeavor BioMedicines

Puma Biotechnology Commences the P-II (ALISCA-Breast1) Study of Alisertib in HR-Positive, HER2-Negative Metastatic Breast Cancer

Read More: Puma Biotechnology

Merck Reports the CHMP’s Positive Opinion of Keytruda Plus CT as a 1L Treatment of Unresectable Non-Epithelioid Malignant Pleural Mesothelioma (MPM)

Read More: Merck

BMS’ Opdivo + Yervoy Receives the CHMP’s Positive Opinion as a 1L Treatment of Metastatic Colorectal Cancer

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AbbVie’s Elahere (Mirvetuximab Soravtansine) Receives the EC’s Approval to Treat Platinum-Resistant Ovarian Cancer

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AstraZeneca Reports the CHMP’s Positive Opinion of Tagrisso (Osimertinib) for Treating Unresectable EGFR-Mutated Lung Cancer

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Pfizer Reports the EC’s Approval of Hympavzi (Marstacimab) to Treat Hemophilia A/B without Inhibitors in Adults and Adolescents

Read More: Pfizer

Sangamo Therapeutics Receives the US FDA’s IND Approval for ST-503 to Treat Idiopathic Small Fiber Neuropathy

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Jazz Pharmaceuticals’ Ziihera (Zanidatamab-hrii) Secures the US FDA’s Accelerated Approval to Treat HER2-Positive (IHC 3+) Biliary Tract Cancer (BTC)

Read More: Jazz Pharmaceuticals

UCB’s Bimzelx (Bimekizumab-bkzx) Secures the US FDA’s Approval for Treating Moderate to Severe Hidradenitis Suppurativa (HS)

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Nurix Therapeutics’ NX-5948 Secures the EMA’s PRIME Designation for Treating R/R Chronic Lymphocytic Leukemia

Read More: Nurix Therapeutics

InxMed’s Ifebemtinib Secures the NMPA’s Breakthrough Therapy Designation as a 1L Treatment of KRAS G12C Mutated NSCLC

Read More: InxMed

GSK’s Arexvy Vaccine Receives the MHLW’s Approval for its Expanded Age Indication to Prevent RSV Disease

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Bayer Reports the US FDA’s sNDA Acceptance of Nubeqa (Darolutamide) to Treat Metastatic Hormone-Sensitive Prostate Cancer

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Ratio Therapeutics Partners with Novartis to Advance SSTR2-Targeting Radiotherapeutic Candidate for Cancer

Read More: Ratio Therapeutics and Novartis

Bayer Join Forces with Cytokinetics to Develop and Commercialize Aficamten in Japan

Read More: Bayer and Cytokinetics

Pharmanovia Collaborates with Lindis Biotech to Commercialize Catumaxomab for Treating Malignant Ascites

Read More: Pharmanovia and Lindis Biotech

Alloy Therapeutics Inks a Pact with Takeda to Develop Cell Therapy Platform

Read More: Alloy Therapeutics and Takeda

BrightHeart Receives the US FDA Approval for its AI Software Transforming Prenatal Fetal Heart Ultrasound Evaluations

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Fresenius Kabi Reports the Reguatory Submission to the US FDA for the Aurora Xi Plasmapheresis System Software Version 2.0 with New Nomogram

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Abbott Reports Late-Breaking Data of Amplatzer Amulet Device for Treating Patients with Atrial Fibrillation at Risk of Stroke

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Novartis Reports the Acquisition of Kate Therapeutics for ~$1.1B

Read More: Novartis and Kate Therapeutics

Samsung Bioepis and Biogen Report the EC’s Approval of Opuviz (Biosimilar, Eylea)

Read More: Samsung Bioepis and Biogen

Xbrane Biopharma and Intas Pharmaceuticals Join Forces to Develop Biosimilar of Opdivo (Nivolumab)

Read More: Xbrane Biopharma and Intas Pharmaceuticals

Xenetic Biosciences Reports Preclinical Data of Potential Co-Administration of DNase I with CAR T Cells for Melanoma Lung Metastasis

Read More: Xenetic Biosciences

Related Post: PharmaShots Weekly Snapshots (November 11 – November 15, 2024)