Aptinyx Reports the Completion of Patient Enrollment of NYX-458 in P-II Study for Cognitive Impairment

Published: Aug 26, 2022 | Tags: Aptinyx, NYX-458, Cognitive Impairment, Parkinson’s disease, dementia, Clinical Trial, P-II Study

Athos Entered into a Proteomics Research Collaboration with Caltech to Advance AI Platform for Inflammatory Bowel Disease

Published: Aug 26, 2022 | Tags: Athos, Caltech, AI Platform, Inflammatory Bowel Disease, Biotech, proteomics analysis, Research Collaboration

PathAI Extends its Multi-Year Collaboration with BMS to Develop Therapies Using AI

Published: Aug 26, 2022 | Tags: PathAI, BMS, AI, oncology, fibrosis, immunology, Pharma

TG Therapeutics Published P-III (ULTIMATE I & II) Trials Results of Ublituximab for RMS in the NEJM

Published: Aug 26, 2022 | Tags: TG Therapeutics, Ublituximab, Relapsing forms of Multiple Sclerosis, Clinical Trial, NEJM, P-III ULTIMATE I & II Trials

Mycovia Reports P-III (ultraVIOLET) Study Results of Vivjoa (oteseconazole) for Recurrent Vulvovaginal Candidiasis

Published: Aug 26, 2022 | Tags: Mycovia, Vivjoa, oteseconazole, Recurrent Vulvovaginal Candidiasis, Clinical Trial, P-III, ultraVIOLET Study

BioMarin’s Roctavian (valoctocogene roxaparvovec) Receives EC’s Conditional Marketing Authorization for Severe Hemophilia A

Published: Aug 26, 2022 | Tags: BioMarin, Roctavian, valoctocogene roxaparvovec, Severe Hemophilia A, Regulatory, EC, Conditional Marketing Authorization

Pfizer Reports P-III (RENOIR) Trial Results of RSVpreF Vaccine for Respiratory Syncytial Virus

Published: Aug 25, 2022 | Tags: Pfizer, RSVpreF Vaccine, Respiratory Syncytial Virus, Clinical Trial, P-III RENOIR Trial

AstraZeneca and MSD’s Lynparza (olaparib) Receive MHLW Approval as Adjuvant Treatment for BRCA-Mutated HER2-Negative High-Risk Early Breast Cancer

Published: Aug 25, 2022 | Tags: AstraZeneca, MSD, Lynparza, Olaparib, BRCA-Mutated, HER2-Negative, High-Risk Early Breast Cancer, Regulatory, MHLW, Approval

Janssen’s Tecvayli (teclistamab) Receives EC’s Conditional Marketing Authorization for Multiple Myeloma

Published: Aug 25, 2022 | Tags: Janssen, Tecvayli, teclistamab, Multiple Myeloma, Regulatory, EC, Conditional Marketing Authorization

GNS Collaborated with Servier to Advance Drug Discovery and Clinical Development for Multiple Myeloma Using AI

Published: Aug 25, 2022 | Tags: GNS, Servier, Multiple Myeloma, AI, Pharma, CoMMpass study, Digital Twin

Apellis Reports P-III (DERBY) and (OAKS) Studies Results of Pegcetacoplan for Geographic Atrophy

Published: Aug 25, 2022 | Tags: Apellis, Pegcetacoplan, Geographic Atrophy, age-related macular degeneration, Clinical Trial, P-III DERBY, OAKS Studies

AbbVie’s Imbruvica (ibrutinib) Receives the US FDA’s Approval for Chronic Graft Versus Host Disease in Pediatric Patients Aged ≥1 Year

Published: Aug 25, 2022 | Tags: AbbVie, Imbruvica, ibrutinib, Chronic Graft Versus Host Disease, Regulatory, US, FDA, Approval

iVeena Entered into a License Agreement with Glaukos to Develop and Commercialize IVMED-80 for keratoconus

Published: Aug 24, 2022 | Tags: Iveena, Glaukos, IVMED-80, keratoconus, pediatric myopia, Pharma

Chugai Receives the MHLW Approval for the Additional Indication of Polivy (polatuzumab vedotin) to Treat Diffuse Large B-cell Lymphoma

Published: Aug 24, 2022 | Tags: Chugai, Polivy, polatuzumab vedotin, Diffuse Large B-cell Lymphoma, Regulatory, MHLW, Approval

Abbott's New Spinal Cord Stimulation Device Receives the US FDA’s Approval for Chronic Pain

Published: Aug 24, 2022 | Tags: Abbott, New Spinal Cord Stimulation Device, Chronic Pain, Regulatory, MedTech, US, FDA, Approval

Oculis Published P-II Study Results of Licaminlimab (OCS-02) for the Treatment of Severe Dry Eye Disease in Clinical Ophthalmology

Published: Aug 24, 2022 | Tags: Oculis, Licaminlimab, OCS-02, OCS-01, OCS-05, Severe Dry Eye Disease, uveitis, Clinical Trial, Clinical Ophthalmology

Sorrento Reports Pivotal Trial Results of Abivertinib for the Treatment of Advanced Non-Small Cell Lung Cancer

Published: Aug 24, 2022 | Tags: Sorrento, Abivertinib, Tagrisso, Advanced Non-Small Cell Lung Cancer, Clinical Trial, NDA

Erasca Entered into a Research Collaboration with MD Anderson for RAS/MAPK-Driven Cancers

Published: Aug 24, 2022 | Tags: Erasca, MD Anderson, RAS/MAPK-Driven Cancers, ERAS-007, ERAS-601, ERAS-4, NSCLC & GI malignancies, Pharma

Merck’s MK-2060 Receives the US FDA’s Fast Track Designation for the Treatment of End-Stage Renal Disease

Published: Aug 23, 2022 | Tags: Merck, MK-2060, End-Stage Renal Disease, Regulatory, US, FDA, Fast Track Designation

Teleflex to Acquire Standard Bariatrics for ~$300M

Published: Aug 23, 2022 | Tags: Teleflex, Standard Bariatrics, ~$300M, M&A, Acquire, MiniLap Percutaneous Surgical System, Weck EFx fascial closure portfolio, Titan SGS stapler

Minerva Neurosciences Reports the NDA Submission of Roluperidone to the US FDA for Schizophrenia

Published: Aug 23, 2022 | Tags: Minerva Neurosciences, Roluperidone, Schizophrenia, Regulatory, US, FDA, NDA

Takeda’s Qdenga (dengue tetravalent vaccine) Receive BPOM’s Approval for the Prevention of Dengue Disease in Indonesia

Published: Aug 23, 2022 | Tags: Takeda, Qdenga, dengue tetravalent vaccine, Dengue Disease, Regulatory, Indonesia, BPOM, Approval

Chugai Entered into a License Agreement with Noile-Immune Biotech for PRIME CAR-T Technology

Published: Aug 23, 2022 | Tags: Chugai, Noile-Immune Biotech, Pharma, PRIME CAR-T Technology

Alcon Entered into a Definitive Merger Agreement to Acquire Aerie for ~$770M

Published: Aug 23, 2022 | Tags: Alcon, Aerie, Rocklatan, Rhopressa, M&A, ~$770M, ophthalmic pharmaceutical eye drop, Acquire

CSL Vifor and Travere Reports the EMA’s Acceptance of Conditional Marketing Authorization Application for Review of Sparsentan to Treat IgA Nephropathy

Published: Aug 22, 2022 | Tags: CSL Vifor, Travere, Sparsentan, IgA Nephropathy, Regulatory, EMA, Acceptance, Conditional Marketing Authorization Application

Insulet’s Omnipod 5 Receives the US FDA’s Clearance for Type 1 Diabetes in Children Aged ≥2 Years

Published: Aug 22, 2022 | Tags: Insulet, Omnipod 5, Type 1 Diabetes, Regulatory, US, FDA, Clearance, Diabetes Care, SmartAdjust technology, Dexcom G6 CGM

SpringWorks Therapeutics Presents P-III (DeFi) Trial Results of Nirogacestat for the Treatment of Progressing Desmoid Tumors at ESMO 2022

Published: Aug 22, 2022 | Tags: SpringWorks Therapeutics, Nirogacestat, Progressing Desmoid Tumors, Clinical Trial, P-III DeFi Trial, ESMO, 2022

Otsuka and Astex Report EMA's Acceptance of MAA for Fixed-Dose Combination of Decitabine and Cedazuridine to Treat Acute Myeloid Leukemia

Published: Aug 22, 2022 | Tags: Otsuka, Astex, Decitabine, Cedazuridine, Acute Myeloid Leukemia, Regulatory, EMA, MAA

Novavax Receives the US FDA Emergency Use Authorization for NVX-CoV2373 in Adolescents Aged 12 Through 17 Years

Published: Aug 22, 2022 | Tags: Novavax, COVID-19 Vaccine, Regulatory, US, FDA, Emergency Use Authorization

Gilead’s Sunlenca (lenacapavir) Receives EC's Marketing Authorization for the Treatment of HIV Infection

Published: Aug 22, 2022 | Tags: Gilead, Sunlenca, lenacapavir, HIV Infection, Regulatory, EC, Marketing Authorization

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