PharmaShots Weekly Snapshot (April 27 -May 01, 2020)

WuXi Biologics and Aravive Collaborate to Develop Novel High-Affinity Bispecific Antibodies for Cancer and Fibrosis

Published: Apr 30, 2020 | Tags: WuXi Biologics, Aravive, Collaborate, Develop, Novel, High-Affinity Bispecific Antibodies, Cancer,  Fibrosis

 Novartis’ Enerzair Breezhaler (QVM149, IND/GLY/MF) Receives CHMP’s Recommendation for Approval as a Treatment for Uncontrolled Asthma

Published: May 01, 2020 | Tags: Novartis, Enerzair, Breezhaler, QVM149, IND/GLY/MF, Receives, CHMP, Recommendation, Approval, Treatment, Uncontrolled Asthma

 Moderna Signs a Ten-Year Worldwide Agreement with Lonza to Manufacture mRNA-1273 Against COVID-19

Published: May 01, 2020 | Tags: Moderna, Signs, Ten-Year, Worldwide, Agreement, Lonza, Manufacture, mRNA-1273, Against, COVID-19

Pfizer Signs a Development and Commercialization Agreement with Valneva for Lyme Disease Vaccine

Published: Apr 30, 2020 | Tags: Pfizer, Signs, Development, Commercialization, Agreement, Valneva, Lyme Disease, Vaccine Candidate

 MSD Signs a Two-Year Research Agreement with Almac to Discover DUB Therapeutic Targets for Neurodegenerative Diseases

Published: Apr 29, 2020 | Tags: MSD, Signs, Two-Year, Research Agreement, Almac, Discover, DUB Therapeutic Targets,  Neurodegenerative Diseases

Bergenbio’s Bemcentinib Selected to be Fast-Tracked Under UK’s ACCORD Program Targeting COVID-19

Published: Apr 23, 2020 | Tags: Bergenbio, Bemcentinib, Fast-Tracked, UK, ACCORD Program, Targeting, COVID-19

 GSK’s Zejula (niraparib) Receives the US FDA’s Approval as 1L Monotherapy Maintenance Treatment for Women with Advanced Ovarian Cancer Regardless of Biomarker Status

Published: Apr 29, 2020 | Tags: GSK, Zejula, niraparib, Receives, US, FDA, Approval, 1L, Monotherapy, Maintenance Treatment, Women, Advanced Ovarian Cancer, Biomarker Status

AstraZeneca Signs a Worldwide Development and Distribution Agreement with Oxford University for Vaccine Against COVID-19

Published: Apr 30, 2020 | Tags: AstraZeneca, Signs, Worldwide, Development, Distribution, Agreement, Oxford University, Vaccine, Against, COVID-19

Gilead Reports Results of Remdesivir in P-III SIMPLE Studies for Patients with Severe COVID-19

Published: Apr 29, 2020 | Tags: Gilead, Reports, Results, Remdesivir, P-III, SIMPLE Studies, Patients, Severe COVID-19

Johnson & Johnson Signs a Manufacturing Agreement with the Catalent to Bolster the Capacity of COVID-19 Vaccine in the US

Published: Apr 29, 2020 | Tags: Johnson & Johnson, Manufacturing Agreement, Catalent, Bolster, Capacity, COVID-19 Vaccine, US

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Additional Recommended Dose of 400 mg Every Six Weeks for All Approved Indications

Published: Apr 29, 2020 | Tags: Merck, Keytruda, pembrolizumab, Receives, US, FDA, Approval, Additional, Recommended Dose, 400 mg, Every Six Weeks, All Approved Indications

Novartis Plans to Commence P-III Clinical Study Evaluating Canakinumab for Patients with COVID-19 Pneumonia

Published: Apr 28, 2020 | Tags: Novartis, Plans, Commence, P-III, Clinical Study, Evaluating, Canakinumab, Patients, COVID-19 Pneumonia

Astellas Signs a Three-Year Research Alliance with Harvard University Across Multiple Therapeutic Areas

Published: Apr 29, 2020 | Tags: Astellas, Signs, Three Years, Research Alliance, Harvard University, Multiple Therapeutics Areas

BioNTech and Pfizer Complete Dosing of BNT162 in First Cohort of P-I/II Study in Germany

Published:  Apr 22, 2020 | Tags: BioNTech, Pfizer, Completes, Dosing, First Cohort, P-I/II, Study, Evaluating, BNT162, Germany

Novartis’ Cosentyx (secukinumab) Receives EC’s Approval for Axial Spondyloarthritis Spectrum Marking its Fourth Indication in EU

Published: Apr 22, 2020 | Tags: Novartis, Cosentyx ,secukinumab, Receives, EC, Approval, Axial Spondyloarthritis Spectrum, Marking, Fourth Indication, EU

Sarepta Signs a Research Agreement with the US Department of Defense to Identify Antisense Oligonucleotides Against COVID-19

Published: Apr 28, 2020 | Tags: Sarepta, Signs, Research Agreement, US Department of Defense, Identify, Antisense Oligonucleotides, Against, COVID-19

Biocon and Mylan Launch Fulphila (biosimilar, pegfilgrastim) in Canada

Published: Apr 28, 2020 | Tags: Biocon, Mylan, Launch, Fulphila, biosimilar, pegfilgrastim, Canada

Moderna to Initiate P-II Study of mRNA-1273 Against Novel COVID-19

Published: Apr 27, 2020 | Tags: Moderna, Initiate, P-II, Study, mRNA-1273, Against, COVID-19

Abbott’s Freestyle Libre System Receives Health Canada Authorization Under Interim Order for Hospitalized Patients During COVID-19

Published: Apr 21, 2020 | Tags: Abbott, Freestyle Libre System, Receives, Health Canada Authorization, Under Interim Order, Hospitalized Patients, COVID-19

Takeda’s Mobocertinib (TAK-788) Receives the US FDA’s Breakthrough Therapy Designation for NSCLC Patients with EGFR Exon 20 Insertion Mutations

Published:  Apr 27, 2020 | Tags:  Takeda, Mobocertinib, TAK-788, Receives, US, FDA, Breakthrough Therapy Designation, NSCLC, Patients, EGFR Exon 20 Insertion Mutations

CEPI Collaborates with Clover to Support the Development of Vaccine Against COVID-19 in Australia

Published: Apr 27, 2020 | Tags: CEPI, Collaborates, Clover, Support, Development of Vaccine, COVID-19, Australia

Roche and PTC Therapeutics Report Results of Risdiplam in FIREFISH Part 2 Study for Infants with Type 1 Spinal Muscular Atrophy

Published: Apr 28, 2020 | Tags: Roche, PTC Therapeutics, Report, Results, Risdiplam, FIREFISH Part 2, Study, Infants, Type 1 Spinal Muscular Atrophy

Merck Collaborates with ISB to Evaluate the Mechanism of COVID-19 and to Identify Potential Prognostic Biomarkers

Published: Apr 27, 2020 | Tags: Merck, Collaborates, ISB, Evaluate, Mechanism of COVID-19, Identify, Potential, Prognostic Biomarkers

Capital Health Launches Antibody Testing Initiative for COVID-19

Published: Apr 27, 2020 | Tags: Capital Health, Launches, Antibody Testing Initiative, COVID-19

Regeneron and Sanofi Provide Update of P-II/III Adaptive-Designed Trial of Kevzara in Hospitalized Patients with COVID-19 in the US

Published: Apr 27, 2020 | Tags: Otsuka, Signs, Development, Commercialization, Agreement, Esperion, Nexletol, bempedoic acid, Nexlizet, bempedoic acid and ezetimibe, Japan

Chugai Reports Results of P-III SAkuraStar Study of Satralizumab for Neuromyelitis Optica Spectrum Disorder

Published: Apr 24, 2020 | Tags: Chugai, Reports, Results, SAkuraStar, Satralizumab, NOSD

Janssen Reports Submission of Two sBLA to the US FDA for SIMPONI ARIA (golimumab) to Treat Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis

Published: Apr 24, 2020 | Tags: Janssen, sBLA, US FDA, SIMPONI ARIA, Polyarticular Juvenile Idiopathic Arthritis, Juvenile Psoriatic Arthritis

Santhera Signs a Clinical Trial Agreement with Cold Spring Harbor Laboratory to Evaluate Lonodelestat (POL6014) Against Acute Respiratory Distress Syndrome Associated with COVID-19

Published: Apr 27, 2020 | Tags: Santhera, Signs, Clinical Trial Agreement, Cold Spring Harbor Laboratory,  Evaluate, Lonodelestat, (POL6014), Against, Acute Respiratory Distress Syndrome Associated, COVID-19