PharmaShots Weekly Snapshots ( October 30– November 03, 2023)

The US FDA Approved Merck’s Keytruda with Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer 

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Coherus and Junshi Bioscience’s Loqtorzi (toripalimab-tpzi) Received the US FDA’s Approval to Treat Nasopharyngeal Carcinoma (NPC) 

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The US FDA Grants Santhera’s Agamree (vamorolone) Approval for the Treatment of Duchenne Muscular Dystrophy (DMD) 

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Idorsia Pharmaceuticals Reports the NDA Submission of Daridorexant to the PMDA for the Treatment of Insomnia 

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BMS Receives EMA’s Validation of Opdivo (nivolumab) + Cisplatin-Based CT for 1L Treatment of Unresectable or Metastatic Urothelial Carcinoma 

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Novartis Received The US FDA’s Approval for Cosentyx to Treat Hidradenitis Suppurativa 

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The US FDA Approved Amgen’s Wezlana (Biosimilar, ustekinumab) for the Treatment of Multiple Inflammatory Diseases 

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Abbott’s Alinity M High Risk (HR) HPV assay for the Detection of HPV Infections has been approved by the US FDA 

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The US FDA has accepted to review the resubmitted NDA of Supernus’ SPN-830 for the Treatment of Off Episodes in Parkinson’s Disease 

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GSK Reports Positive Results of P-III Study (RUBY) for Jemperli + CT in Primary Advanced or Recurrent Endometrial Cancer Patients 

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Novartis’ Reports Results of Atrsentan in P-III Study for the Treatment of IgA Nephropathy 

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Otsuka Pharmaceutical Reports Results for Centanafadine in Two P-III Trials for the Treatment of ADHD 

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Teva Pharmaceutical Reports P-III Results of Uzedy (risperidone) Extended-Release Injectable Suspension for Schizophrenia 

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T3D Therapeutics has announced promising outcomes from the P-II study (PIONEER) of T3D-959 in the treatment of Alzheimer’s Disease 

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Innate Pharma Presents P-II Study (TELLOMAK) Results of Lacutamab for the Treatment of Sézary Syndrome 

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Roche Reports Positive Efficacy Results from the P-III Study (EMBARK) of Elevidys for Duchenne Muscular Dystrophy (DMD) 

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Merck Reports Secondary Endpoint Results of Keytruda in P-III Trial for the Treatment of Renal Cell Carcinoma (RCC) 

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Adaptimmune Reports Positive Data from the P-II Trial Assessing Lete-cel for the Treatment of Synovial Sarcoma And Myxoid/Round Cell Liposarcoma (MRCLS) 

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UCB Publishes the Results for Nayzilam in P-III Trial for the Treatment of Epilepsy in ‘Epilepsy & Behavior’ 

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Henlius Brings Hansizhuang (serplulimab injection) to Europe and India Through an Exclusive Licensing Agreement with Accord Healthcare 

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Sosei Heptares Receives a Milestone Payment of $3.75M as a Part of its Multi-Target Agreement with Genentech 

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Merck KGaA and Hengrui Pharma Entered into a Licensing Agreement for the Development of HRS-1167 and SHR-A1904 to Treat Cancer 

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Zydus and Guardant Health will Co-Promote the Guardant360 portfolio which includes Guardant360 and Guardant360 TissueNext tests for advanced solid cancers in India and Nepal 

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AstraZeneca Signs a Collaboration Agreement with Cellectis to Develop Novel Cell and Gene Therapies for Oncology and Immunology Indications 

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Abcellera and Prelude Therapeutics Entered into a Partnership to Develop ADCs Therapies for the Treatment of Cancer 

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Aldeyra Therapeutics Signs an Agreement with AbbVie for Reproxalap to Treat Dry Eye Disease 

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GSK Enters into an Agreement with Janssen and Arrowhead for JNJ-3989 to Treat Chronic Hepatitis B 

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Abbott Reports Trial Data for Esprit BTK Drug-Eluting Resorbable Scaffold to Treat Chronic Limb-Threatening Ischemia (CLTI) 

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Shorla Oncology Acquires Jylamvo form Therakind as a Therapy Targeting Oncology and Autoimmune Indications 

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The collaboration marks the expansion between R1 RCM and Microsoft to develop and integrate Generative AI and Revenue Cycle Management Platform 

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