PharmaShots Weekly Snapshot (Nov 23 – 27, 2020)

Merck Collaborates with Siemens for the Digitalization of Production

Published: Nov 26, 2020 | Tags: Agreement, Collaborative, Digitalization, Merck, Siemens, Sign

CoSara Receives CDSCO’s Approval for its Saragene COVID-19 2-Gene Multiplex Test

Published: Nov 26, 2020 | Tags: approval, CDSCO, Co-Diagnostics JV CoSara, COVID-19 2-gene multiplex RT-PCR, India, Manufacture, receives, Saragene, Sell, Test

PostEra Collaborates with NeuroLucent to Identify Therapies for Alzheimer’s Disease

Published: Nov 25, 2020 | Tags: Agreement, Alzheimer Disease, Collaborative, Develop, NeuroLucent, Novel, PostEra, Sign, Treatment

BASE10 Collaborates with DNA Link to Support Authorization of COVID-19 IgG Antibody Test at the Point of Care

Published: Nov 26, 2020 | Tags: BASE10, Collaborates, DNA, Link, Support, Authorization, COVID-19, IgG Antibody, Test, Point, Care

Egle Identifies First Novel Regulatory T-cell Targets Under its Collaboration with Takeda

Published: Nov 26, 2020 | Tags: Agreement, Alliance, Egle, First, Identifies, Novel, Regulatory, Research, T-cell, Takeda, Targets, therapeutics

Merck KGaA Reports EMA’s Validation of MAA for Tepotinib to Treat Advanced NSCLC with METex14 Skipping Alterations

Published: Nov 26, 2020 | Tags: Advanced NSCLCs, EMA’s Validation, MAA, Merck, reports, Tepotinib, Treat

Y-mAbs’ Danyelza (naxitamab-gqgk) Receives the US FDA’s Approval for Neuroblastoma

Published: Nov 25, 2020 | Tags: (naxitamab-gqgk), approval, Danyelza, Neuroblastoma, receives, US FDA’s, Y-mAbs Therapeutics

CorticoMetrics’s THINQ Receives the US FDA’s 510(k) Clearance for MRI Brain Volumetric Reporting

Published: Nov 24, 2020 | Tags: 510(k), Brain, Clearance, CorticoMetrics, MRI, receives, Reporting, THINQ, Us FDA, Volumetric

BioNTech and Fosun Pharma Initiate P-ll Study of BNT162b2 Against COVID-19 in China

Published: Nov 25, 2020 | Tags: BioNTech, BNT162b2, China, Clinical Trial, Covid-19 Vaccine, Fosun Pharma, Lead mRNA, P-ll, Resumes

Urovant’s Vibegron Fails to Meet its Primary Endpoint in P-IIa Study for IBS Pain

Published: Nov 24, 2020 | Tags: Irritable Bowel Syndrome, P-IIa, reports, results, Sciences, study, Treatment, Urovant, Vibegron

Bio-Thera Reports MAA Submission to EMA for BAT1706 a Proposed Biosimilar to Avastin

Published: Nov 25, 2020 | Tags: Avastin, BAT1706 Proposed Biosimilar, Bio-Thera Solutions, Cancer, EMA, Marketing Authorization Application, Submits

Janssen’s Tremfya (guselkumab) Receives EC’s Approval as a First in Class Treatment for Active Psoriatic Arthritis

Published: Nov 25, 2020 | Tags: Active Psoriatic Arthritis (PsA), EC’s Approval, First in Class, guselkumab, Janssen’s, receives, Treatment, Tremfya

Bausch Health Initiates Second P-III Study for NOV03 (perfluorohexyloctane) to Treat DED Associated With MGD

Published: Nov 24, 2020 | Tags: Associated, Bausch Health, Disease, Dry Eye, Initiates, Investigational, MGD, NOV03, P-III, Second, study, Treatment

Evotec Collaborates with Rappta Therapeutics to Focus on Oncology Target

Published: Nov 24, 2020 | Tags: Agreement, Development, Discovery, Evotec, Focused, Oncology, Rappta, Signs, Target, therapeutics

Russia’s Sputnik V Demonstrates 91.4% Efficacy Against COVID-19

Published: Nov 24, 2020 | Tags: COVID-19, Gamaleya Center, P-lll Study, RDIF, reports, results, Second Interim Analysis, Sputnik V

Alvotech and Alvotech & CCHT Sign an Exclusive Commercialization Agreement with Yangtze River for Eight Biosimilars in China

Published: Nov 24, 2020 | Tags: Alvotech, CCHT, China, Eight Biosimilar Medicines, Exclusive Commercialization Agreement, Sign, Yangtze River

Alnylam’s Oxlumo (lumasiran) Receives the US FDA’s Approval for Treatment of Primary Hyperoxaluria Type 1 in Pediatric and Adult Patients

Published: Nov 24, 2020 | Tags: Adult, Alnylam, approval, Hyperoxaluria, Lumasiran, OXLUMO, patients, Pediatric, Primary, receives, Treatment, Type 1, Us FDA

BMS’ Opdivo (nivolumab) Receives EC’s Approval as 2L Treatment for Unresectable Advanced and Metastatic Esophageal Squamous Cell Carcinoma

Published: Nov 24, 2020 | Tags: 2L Treatment, Bristol Myers Squibb, EC’s Approval, Metastatic Esophageal Squamous Cell Carcinoma (ESCC), Nivolumab, Opdivo, receives, Unresectable Advanced

Selvita to Acquire Fidelta from Galapagos for ~$37M

Published: Nov 23, 2020 | Tags: $37.08M, Acquire, Fidelta, Galapagos, Selvita

Targovax Reports Results of ONCOS-102 in P-l/ll Study as 1L and 2L Treatment for Malignant Pleural Mesothelioma

Published: Nov 24, 2020 | Tags: (SoC), 1L and 2L Treatment, Malignant Pleural Mesothelioma (MPM), ONCOS-102, P-l/ll Study, reports, results, SITC Annual Meeting, Standard of Care, Targovax

Roche’s Xofluza (baloxavir marboxil) Receives the US FDA’s Approval for Post-Exposure Prevention of Influenza

 Published: Nov 24, 2020 | Tags: approval, baloxavir marboxil, Contact, Following, Infected,  Influenza, Person, Prevention, receives, Roche, Us FDA, Xofluza

Baxter’s Homechoice Claria APD System Receives the US FDA’s 510 (k) Clearance for Kidney Failure

Published: Nov 23, 2020 | Tags: Baxter’s, Claria Automated Peritoneal Dialysis (APD) System, Clearance, Homechoice, Kidney Failure, receives, US, US FDA’s 510 (k)

Schrödinger Signs a $2.7B Agreement with BMS to Develop and Commercialize Therapies in Multiple Disease Areas

Published: Nov 23, 2020 | Tags: Agreement, Areas, BMS, Commercialize, Develop, Discover, Disease, Multiple, Schrödinger, Signs, therapeutics

Merck to Acquire OncoImmune for $425M

Published: Nov 23, 2020 | Tags: Acquire, CD24Fc program, Merck, OncoImmune

AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19

Published: Nov 23, 2020 | Tags: AstraZeneca, AZD1222, COV002, COV003, COVID-19, P-II/III, P-III, Positive, Preventing, reports, results, Trial, vaccine

Eli Lilly Signs an Exclusive Agreement with Precision BioSciences on Genome Editing Research

Published: Nov 20, 2020 | Tags: Develop of Potential, Genetic Disorders, License Agreement, Lilly, Precision, Research, Research Collaboration, Signs, Vivo Therapies

Eiger’s Zokinvy (lonafarnib) Receives the US FDA’s Approval for Treatment of Progeria and Processing-Deficient PL

Published: Nov 20, 2020 | Tags: approval, Deficient, Eiger, lonafarnib, PL, Processing, Progeria, receives, Treatment, Us FDA, Zokinvy

Innovent Reports Results of Tyvyt + Byvasda (biosimilar, bevacizumab) in P-lll ORIENT-32 Study as 1L Treatment for HCC

Published: Nov 22, 2020 | Tags: 1L treatment, Advanced Hepatocellular Carcinoma (HCC), Byvasda, ESMO ASIA Virtual Congress 2020, Innovent, ORIENT-32 Study, P-lll, reports, results, Tyvyt

Lilly’s Bamlanivimab (LY-CoV555) Receives Health Canada’s Interim Authorization as a Treatment for COVID-19

Published: Nov 20, 2020 | Tags: Authorization, Bamlanivimab, canada, COVID-19, health, Interim, Lilly, LY-CoV555, receives, Treatment

Regeneron’s Casirivimab and Imdevimab Receive the US FDA’s EUA as the First Combination Therapy for COVID-19

Published: Nov 21, 2020 | Tags: Casirivimab, COVID-19, EUA, Imdevimab, patients, receives, Regeneron, US FDA’s

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