PharmaShots Weekly Snapshot (Nov 16-20, 2020)

Eli Lilly and Incyte Receive FDA’s EUA for Baricitinib + Remdesivir to Treat Hospitalized Patients with COVID-19

Published: Nov 20,2020 | Tags: baricitinib, COVID-19, Eli Lilly, Emergency Use Authorization, FDA’s, Incyte, receives, Remdesivir

Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS

Published: Nov 20,2020 | Tags: Agreement, ARDS, Commercialize, Develop, Manufacture, Mesoblast, Novartis, Remestemcel-L, Signs, Treatment

Alvotech Reports the US FDA and EMA’s Acceptance of AVT02 Proposed Biosimilar to Humira (adalimumab)

Published: Nov 20,2020 | Tags: (adalimumab), Alvotech, AVT-301 Study, AVT-GL-101, AVT02, Chronic Plaque Psoriasis, EMA, Humira, Proposed Biosimilar, Regulatory Applications, Submits, Us FDA

Lilly Signs Agreement with Ypsomed to Advance an Automated Insulin Delivery System for People with Diabetes

Published: Nov 20, 2020 | Tags: Lilly, Signs, Agreement, Ypsomed, Advance, Automated Insulin Delivery System, People, Diabetes

Pfizer And LianBio Collaborate to Expand the Development of Novel Therapeutics in Greater China

Published: Nov 20, 2020 | Tags: Pfizer, LianBio, Collaborate, Expand, Development, Novel Therapeutics, Greater China

AstraZenca’s Imfinzi (durvalumab) Receives the US FDA’s Approval for Less-Frequent Fixed-Dose Use

Published: Nov 20,2020 | Tags: AstraZenca, CASPIAN Study, durvalumab, Imfinzi, P-lll, PACIFIC, US FDA’s

Chiesi’s Bronchitol (mannitol) Inhalation Powder Receives the US FDA’s Approval for Cystic Fibrosis

Published: Nov 19, 2020 | Tags: approval, Bronchitol, Chiesi, Cystic Fibrosis, Inhalation, Mannitol, Powder, Pulmonary, receives, US FDA

Lucira’s All-In-One Test Kit Receives the US FDA’s EUA as the First COVID-19 Test for Self-Testing at Home

Published: Nov 19, 2020 | Tags: Authorization, COVID-19, First, Home, Lucira, Lucira Health, Molecular, Prescription, receives, Test, Us FDA

Bayer to Fund Five New Startup Companies as Part of G4A Digital Health Partnerships Program

Published: Nov 19, 2020 | Tags: Bayer, Collaborate, Developed, G4A Digital Health, Healthcare Solutions, Integrated

ViiV’s PROgress Study Demonstrates Inclusion of PROs into Clinical Practice Can Improve HIV Care

Published: Nov 19, 2020 | Tags: Progress, reports, results, study, ViiV Healthcare

Pear Therapeutics Launches Somryst Insomnia App Via an End-to-End Virtual Care Experience

Published: Nov 19, 2020 | Tags: Chronic Insomnia, Launches, Pear Therapeutics, Somryst

Pfizer and BioNTech’s BNT162b2 Demonstrates 95% Efficacy in Preventing COVID-19

Published: Nov 19, 2020 | Tags: 95%, BioNTech, BNT162b2, COVID-19, Demonstrates, Efficacy, Pfizer, Preventing

Sanofi’s Supemtek (quadrivalent recombinant influenza vaccine) Receives the EC’s Approval to Prevent Influenza

Published: Nov 19, 2020 | Tags: EC’s, Influenza, Marketing Authorization, patients, quadrivalent recombinant influenza vaccine, receives, Sanofi, Supemtek

Samsung Bioepis and Biogen Announces FDA Filing Acceptance of Lucentis’ Biosimilar, SB11 for Retinal Vascular Disorders

Published: Nov 18,2020 | Tags: Acceptance, Biogen, Biosimilar, FDA Filing, Lucentis, ranibizumab, Retinal Vascular Disorders, Samsung Bioepis, SB11

BioMarin Pharmaceutical Signs an Agreement with Deep Genomics on Advancing Programs Identified Using Artificial Intelligence

Published: Nov 18, 2020 | Tags: Advancing, Agreement, Artificial Intelligence, BioMarin Pharmaceutical, Deep Genomics, Identified, Programs, Signs, Using

Pfizer Launches US Pilot Programme for Delivery and Distribution of COVID-19 Vaccine, BNT162b2

Published: Nov 18, 2020 | Tags: 4, COVID-19, Delivery, Deployment, Immunization, Pfizer, Pilot, Program, states, Updates, US,

Sanofi’s Avalglucosidase alfa Receives US FDA’s Priority Review as Enzyme Replacement Therapy for Pompe Disease

Published: Nov 18, 2020 | Tags: Avalglucosidase-alfa, BLA, Enzyme Replacement Therapy, Pompe disease, Priority Review, receives, Sanofi, US, FDA

ViiV Healthcare’s Cabotegravir Receives US FDA’s Breakthrough Therapy Designation for HIV Prevention

Published: Nov 18,2020 | Tags: Breakthrough, Cabotegravir, Designation, HIV, receives, therapy, Us FDA, ViiV Healthcare

Bayer’s Finerenone Demonstrates Positive Outcomes in Patients with Chronic Kidney Disease and Type 2 Diabetes

Published: Nov 18,2020 | Tags: BAY 94-8862, Bayer, Cardiovascular Disease, Chronic Kidney Disease, FIDELIO-DKD Study, Finerenone, Inflammatory, Type 2 Diabetes

QBiotics’ Stelfonta (tigilanol tiglate) Receives the US FDA’s Approval as the First Treatment for Non-Metastatic MCT in Dogs

Published: Nov 17, 2020 | Tags: (tigilanol tiglate injection), Non-Metastatic Mast Cell Tumors, QBiotics Group, receives, Stelfonta, US FDA’s Approval

Johnson & Johnson Initiates Second Global P-III Study of its COVID-19 Vaccine

Published: Nov 17, 2020 | Tags: COVID-19, ENSEMBLE, ENSEMBLE-2 Study, Initiates, Johnson & Johnson, P-lll

Roche Signs a License Agreement with Lead Pharma to Develop Oral Therapies for Immune-Mediated Diseases

Published: Nov 17,2020 | Tags: Develop, Immune Mediated Diseases, Lead Pharma, License Agreement, Research Collaboration, Roche, Signs, Small Oral Molecules

Zymeworks and ALX Oncology Collaborate to Evaluate Zanidatamab + ALX148 for Advanced HER2‑Expressing Breast Cancer

Published: Nov 17,2020 | Tags: Advanced, ALX Oncology, ALX148, Breast Cancer, Collaborate, Evaluate, HER2‑Expressing, Zanidatamab, Zymeworks

Moderna’s mRNA-1273 Demonstrates 94.5% Efficacy in Preventing Symptomatic COVID-19

Published: Nov 17, 2020 | Tags: COVE Study, COVID-19, Interim Analysis, Moderna, mRNA-1273, P-lll, reports, results

Bharat Biotech Initiates P-III Study for Covaxin Against COVID-19

Published: Nov 17,2020 | Tags: Against, Bharat Biotech, Covaxin, COVID-19, Initiates, P-III, study

Microsoft Collaborates with Twist and Illumina to Advance Data Storage in DNA

Published: Nov 16, 2020 | Tags: advance, Collaborates, Data Storage, DNA, Illumina, Microsoft, Twist

J&J and US Government Amends their Agreement for the Next Phase of COVID-19 Vaccine Development

Published: Nov 16, 2020 | Tags: Agreement, Candidate, Covid-19 Vaccine, Development, Expand, J&J, U.S. Department of Health & Human Services

Eisai’s Fycompa (perampanel) Receives EC’s Approval for Expanded Indication in Pediatric Patients with POS and PGTCS

Published: Nov 16, 2020 | Tags: Eisai’s, EU’s Approval, Fycompa, perampanel, PGTCS, POS, receives

Roche’s Xofluza (baloxavir marboxil) Receives CHMP’s Recommendation for Approval to Treat Influenza

Published: Nov 16, 2020 | Tags: baloxavir marboxil, EU’s Approval, Influenza, receives, Roche, Xofluza

Eli Lilly Signs a License Agreement with Seed Therapeutics for Protein Degradation-Based Therapies

Published: Nov 16, 2020 | Tags: Eli Lilly, License Agreement, Protein Degradation-Based Therapies, Seed Therapeutics, Signs

Henlius Report the NMPA’s Acceptance of HLX15 (biosimilar, Daratumumab) to Treat Multiple Myeloma

Published: Nov 16, 2020 | Tags: (biosimilar, Acceptance, daratumumab, Henlius, HLX15, Multiple Myeloma, NMPA, Report, Treat

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