PharmaShots Weekly Snapshots (November 09-13, 2020)

 PharmaShots Weekly Snapshots (November 09-13, 2020)

Qiagen Launches Portable Digital SARS-CoV-2 Antigen Test in the US

Published: Nov 13,2020 | Tags: Antigen Test, Digital, Launches, Portable, Qiagen, SARS-CoV-2, US

GSK and Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine

Published: Nov 13,2020 | Tags: COVID-19, GSK, Initiate, Medicago, P-II/III, Plant- Derived study, vaccine

BD Acquires the Medical Business Assets of CUBEX

Published: Nov 13, 2020 | Tags: BD, Acquires, Medical Business, Assets, CUBEX

Health2Sync Divulges Benefits of Integrating Fitbit Wearable Devices into Diabetes Care in Taiwan

Published: Nov 13,2020 | Tags: Health2Sync, Divulges, Benefits, Integrating, Fitbit, Wearable Devices, Diabetes, Care, Taiwan

UCB Acquires Handl Therapeutics to Augment its Gene Therapy Portfolio

 Published: Nov 13,2020 | Tags: UCB, Acquires, Handl Therapeutics, Augment, Gene Therapy,  Portfolio

Medtronic Launches InPen Integrated with CGM Data for People with Diabetes on MDI

Published: Nov 13,2020 | Tags: CGM Data, Diabetes, InPen, Integrated, Launches, MDI, Medtronic

Qiagen Collaborate with TScan to Develop T Cell-Based COVID-19 Test

Published: Nov 12,2020 | Tags: COVID-19, Exclusive, License Agreement, Option, Qiagen, Research, Signs, TScan Therapeutics

AstraZenca’s Calquence (acalabrutinib) Fails to Meet its Primary Endpoint in P-II Studies for COVID-19

Published: Nov 12,2020 | Tags: acalabrutinib, AstraZenca, CALAVI, Calquence, COVID-19, P-ll Study, Report, Respiratory Complications, results

Pfizer and BioNTech to Supply EU with up to 200M Doses of BNT162B2 Against COVID-19

Published: Nov 12,2020 | Tags: Agreement, BioNTech, BNT162b2, EU, European Commission, m-RNA Vaccine, Pfizer, Signs, Supply

Pfizer Reports Results of Abrocitinib in Fifth P-lll JADE REGIMEN Across Different Dosing Regimens

Published: Nov 12,2020 | Tags: Abrocitinib, JADE REGIMEN Study, moderate to severe Atopic Dermatitis (AD), P-lll, Pfizer, Positive, Report, results

Moderna Report Results of mRNA-4157 + Keytruda in Interim P-l Study for HNSCC and MSS-CRC

Published: Nov 12,2020 | Tags: HNSCC, Interim, Moderna, mRNA-4157, P-l study, pembrolizumab, Report, results, SITC 2020

J&J Resumes all Clinical Trial of its COVID-19 Vaccine in the EU

Published: Nov 12,2020 | Tags: Clinical Trial, COVID-19, EU, J&J, Resumes, vaccine

CureVac Publishes Results of CVnCoV in Interim P-l Study for COVID-19

Published: Nov 11,2020 | Tags: COVID-19, CureVac, CVnCoV, Interim, P-l study, reports, results

Prestige Signs an Exclusive Agreement with Teva to Commercialize Tuznue (biosimilar, trastuzumab) in Israel

Published: Nov 11,2020 | Tags: Agreement, Biosimilar, Commercialize, Israel, Prestige, Signs, Teva, trastuzumab, Tuznue

NightWare Receives the US FDA’s Approval for the First Medical Device to Stop NightMAres Related to PTSD

Published: Nov 11,2020 | Tags: Designed, Marketing, New Device, Nightmare Disorder, Permit, PTSD, Reduce, Sleep, US FDA

Samsung Bioepis Initiates P-I Study of SB16 Proposed Biosimilar to Prolia (denosumab)

Published: Nov 11,2020 | Tags: (Denosumab), Initiates, P-I study, Prolia, Proposed Biosimilar, Samsung Bioepis, SB16

Abbott Launches IonicRF Generator for Patients with Chronic Pain in the US

Published: Nov 11,2020 | Tags: Abbott, Chronic, Generator, IonicRF, Launch, Pain, patients, US, Use

Henlius Reports First Patients Dosing in P-I Study of HLX14 (denosumab, biosimilar)

Published: Nov 11,2020 | Tags: Henlius, Reports, First, Patient Dosing, P-l Study, HLX14, denosumab, biosimilar

Novavax Receives the US FDA’s Fast Track Designation for NVX-CoV2373 to Treat COVID-19

Published: Nov 10, 2020 | Tags: COVID-19, Fast Track Designation, Novavax, NVX-CoV2373, receives, Treat, US FDA

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR for Asthma

Published: Nov 10,2020 | Tags: Amgen, Asthma, AstraZeneca, NAVIGATOR, P-III, patients, Positive, reports, results, Severe, Tezepelumab, Trial, Uncontrolled

Lilly’s Bamlanivimab (LY-CoV555) Receives the US FDA’s EUA for the Treatment of Recently Diagnosed COVID-19

Published: Nov 10,2020 | Tags: Bamlanivimab, COVID-19, Diagnosed, EUA, Lilly, LY-CoV555, receives, recently, Treatment, Us FDA

Pfizer and BioNTech’s BNT16`2b2 Demonstrates 90% Efficacy in Preventing COVID-19

Published: Nov 10,2020 | Tags: Against, BioNTech, BNT162b2, Clinical, Pfizer, reports, study

AstraZeneca’s Calquence (acalabrutinib) Receives EU’s Approval for Chronic Lymphocytic Leukaemia

Published: Nov 10,2020 | Tags: (acalabrutinib), AstraZeneca’s, Calquence, Chronic Lymphocytic Leukaemia (CLL), EU’s Approval, receives

Bayer Reports Regulatory Submission of Finerenone (BAY 94-8862) to the US and EU for CKD and T2D

Published: Nov 10,2020 | Tags: (BAY 94-8862), Bayer, EMA, Finerenone, Regulatory Applications, Submits, Treat Chronic Kidney Disease (CKD), Type 2 Diabetes (T2D), Us FDA

Alvotech and Cipla Collaborate to Ensure Access to Biosimilars in South Africa

Published: Nov 9,2020 | Tags: Access, Alvotech, Biosimilars, Cipla, Ensure, Exclusive Partnership, Expand, South Africa

Novartis’ Ilaris (canakinumab) Fails to Meet its Primary Endpoints in P-lll Study for COVID-19 Pneumonia and CRS

Published: Nov 9,2020 | Tags: (canakinumab), CAN-COVID Trial, Covid-19, Pneumonia, Cytokine Release Syndrome (CRS), Ilaris, Novartis, P-lll, Report, results

Eisai Reports Results of Lenvima (lenvatinib) + Everolimus in P-II 218 Study for Advanced Renal Cell Carcinoma

Published: Nov 9,2020 | Tags: 2020, 218, Advanced, Renal, Cell, Carcinoma, Eisai, Everolimus, IKCS, lenvatinib, Lenvima, P-II, Presents, results, study

Celltrion Reports Results of CT-P59 in P-I Study for COVID-19

Published: Nov 9, 2020 | Tags: 2020, Celltrion, Clinical, Conference, CT-P59, Fall, Korean Society of Infectious Diseases, P-I, Presents, results, Trial

The US FDA’s Advisory Panel Slams Biogen’s Aducanumab for Alzheimer’s Disease

Published: Nov 9, 2020 | Tags: aducanumab, Advisory, Biogen, Committee, EMERGE, ENGAGE, Meeting, P-III, reports, study, Updates, Us FDA

Merck and Transcenta Collaborate to Implement Continuous Manufacturing for Protein Therapeutics

Published: Nov 9, 2020 | Tags: Collaborate, Continuous Manufacturing, Implement, Merck, Protein Therapeutics, Transcenta

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