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PharmaShots Weekly Snapshots (August 22 - 26, 2022)

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PharmaShots Weekly Snapshots (August 22 - 26, 2022)

PharmaShots Weekly Snapshots (August 22 - 26, 2022)

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

Related Post: PharmaShots Weekly Snapshots (August 15 - 19, 2022)

 


Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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