PharmaShots Weekly Snapshot (Oct 5-9, 2020)

Takeda Signs ~$1B Pact with Arrowhead for ARO-AAT Targeting Alpha-1 Antitrypsin-Associated Liver Disease

Published: Oct 9, 2020 | Tags: Alpha-1 Antitrypsin-Associated Liver Disease, Arrowhead, Collaborates, Commercialize. ARO-AAT, Develop, Takeda, with

Lilly and Incyte’s Olumiant (baricitinib) Reports Additional Data Demonstrating Reduction in COVID-19 Recovery Time

Published: Oct 9, 2020 | Tags: COVID-19, Demonstrate, Incyte, Lilly, Olumiant, Recovery Time, Reduction

Genentech Collaborates with Imbio to Develop Imaging Diagnostics for Lung Diseases

Published: Oct 9, 2020 | Tags: Agreement, Develop, Diagnostics, Diseases, Genentech, Imaging, Imbio, Lung, Signs

Regeneron Seeks the US FDA’s EUA for REGN-COV2 Antibody Combination to Treat COVID-19

Published: Oct 9, 2020 | Tags: Approve, COVID-19, Emergency, Regeneron, REGN-COV2, Seeks, Use, USFDA

Amgen Report Mixed Results of Omecamtiv Mecarbil in P-lll GALACTIC-HF Study for Heart Failure

Published: Oct 9, 2020 | Tags: Amgen, GALACTIC-HF Study, Heart Failure, Omecamtiv Mecarbil, P-lll, Report, results

J&J to Supply EU with up to 400M Doses of its COVID-19 Vaccine

Published: Oct 9, 2020 | Tags: 200M Doses, Advance Purchase Agreement, EU, J&J, Janssen COVID-19 Vaccine, Candidate

BioMarin Receives the US FDA’s Approval Allowing Maximum Dose of 60mg with Palynziq (pegvaliase-pqpz) for PKU

Published: Oct 8, 2020 | Tags: BioMarin, Palynziq, pegvaliase-pqpz, Phenylketonuria (PKU), US FDA Approval

BMS’ Zeposia (ozanimod) Receives Health Canada Approval for Relapsing Remitting Multiple Sclerosis

Published: Oct 8, 2020 | Tags: (ozanimod), BMS, Health Canada Approval, Relapsing Remitting Multiple Sclerosis, Zeposia

Eli Lilly Seeks the US FDA’s EUA for its COVID-19 Antibody Treatment

Published: Oct 8, 2020 | Tags: Antibody Treatment, COVID-19, Eli Lilly, EUA, FDA, Seeks, US

Eli Lilly Collaborates with Dexcom for Diabetes Management

Published: Oct 8, 2020 | Tags: DexCom, Diabetes, Help, Improve, Lilly, Management, New, Program, Teams

Polarean Reports the NDA Submission of Hyperpolarised 129Xenon Gas Drug-Device Diagnostic to the US FDA for Lung Imaging

Published: Oct 8, 2020 | Tags: (129Xe) gas, hyperpolarised, Lung Imaging, NDA submission, Polarean, reports, Us FDA

BMS Report Results of Opdivo (nivolumab) + CT in P-III CheckMate-816 Trial for Resectable Non-Small Cell Lung Cancer

Published: Oct 8, 2020 | Tags: BMS, CheckMate-816, CT, Nivolumab, Opdivo, P-III, Report, Resectable Non-Small Cell Lung Cancer, results, Trial

PhaseBio Reports First Patients Dosing in its P-III REVERSE-IT Study of Bentracimab in Canada

Published: Oct 7, 2020 | Tags: Antiplatelet Effects, Bentracimab, Dosing, Generics, PhaseBio, REVERSE-IT Study, ticagrelor

GSK Signs an Agreement with Vir Biotechnology to Develop Solutions for Coronaviruses

Published: Oct 7, 2020 | Tags: Agreement, Collaboration, Coronavirus, GSK, Immune System Stimulation, Pathogen Neutralization, vaccine, Vir Biotechnology

BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2 Vaccine Candidate, BNT162b2

Published: Oct 7, 2020 | Tags: BioNTech, BNT162b2, Candidate, EMA, Pfizer, reports, Rolling Submission, SARS-CoV-2, vaccine

Merck Signs an Out-Licensing Agreement with Novartis for M6495 (Anti-ADAMTS5 Nanobody) for Osteoarthritis

Published: Oct 7, 2020 | Tags: Ablynx, Anti-ADAMTS5 Nanobody, Merck, Novartis, Osteoarthritis, Out-Licensing Agreement

Samsung Bioepis and Biogen Announce EMA Filling Acceptance of SB11 (biosimilar, Lucentis)

Published: Oct 7, 2020 | Tags: Biogen, Biosimilar, EMA Filling, Lucentis, Ophthalmology, Samsung Bioepis, SB11

Exact Sciences and Pfizer Announce Extension and Amendment of their Cologuard Promotion Agreement

Published: Oct 7, 2020 | Tags: Agreement, Amend, Cologuard, Exact Sciences, Extend, Pfizer, Promotion, Signs

Santhera Halts P-III SIDEROS Study Evaluating Puldysa in Patients with DMD

Published: Oct 6, 2020 | Tags: Discontinue, Duchenne Muscular Dystrophy (DMD), Idebenone, Puldysa, Santhera

GSK and AstraZeneca Plan to Deploy NVIDIA’s Supercomputer for Drug Development

Published: Oct 6, 2020 | Tags: AstraZeneca, Deploy, Drug Development, GSK, NVIDIA, Plan, Supercomputer

Amgen Report Results of Sotorasib in P-II CodeBreaK 100 Study for Advanced Non-Small Cell Lung Cancer

Published: Oct 6, 2020 | Tags: Amgen, CodeBreaK 100 clinical study, Investigational KRAS G12C Inhibitor, NSCLC, Sotorasib

Novartis Reports Results of Beovu (brolucizumab) in Two New Post-Hoc Analyses of P-III HAWK and HARRIER Studies for Wet AMD

Published: Oct 6, 2020 | Tags: Beovu, Brolucizumab, EURETINA 2020 virtual congress, HAWK and HARRIER clinical trials, Novartis, P-III, wet AMD patients

Qiagen to Launch Viral RNA Epidemiology Test for COVID-19 and Other RNA Viruses

Published: Oct 6, 2020 | Tags: Accelerates, COVID-19, Kit, Launch, Novel, PCR Analysis, Qiagen, Simplifies, Testing Portfolio

Pfizer Signs an Agreement with SpringWorks to Evaluate Nirogacestat + PF‐06863135 for R/R Multiple Myeloma

Published: Oct 6, 2020 | Tags: Agreement, Collaboration, Evaluate, Nirogacestat + PF‐06863135, patients, Pfizer, Relapsed or Refractory Multiple Myeloma, Signs, SpringWorks Therapeutics

GSK’s Zejula (niraparib) Receives Health Canada Approval for 1L Treatment of Women with Advanced Ovarian Cancer

Published: Oct 6, 2020 | Tags: 1L, Advanced Ovarian Cancer, approval, GSK, Health Canada, niraparib, receives, Treatment, Women, Zejula

Novartis Reports Results of Zolgensma in P-III STR1VE-EU Study for SMA Type 1

Published: Oct 5, 2020 | Tags: Novartis, P-III STR1VE-EU Study, reports, results, Spinal Muscular Atrophy Type 1, Zolgensma

Amgen Report Five Year Data of Aimovig (erenumab-aooe) in Open-Label Treatment Period of P-II Study for Episodic Migraine

Published: Oct 5,2020 | Tags: Aimovig, Amgen, Dual Study, erenumab-aooe, P-ll, Report, Result

AstraZeneca’s Farxiga Receives the US FDA’s Breakthrough Therapy Designation for Chronic Kidney Disease

Published: Oct 5, 2020 | Tags: AstraZenca, Breakthrough Therapy Designation, Chronic Kidney Disease, Farxiga, US FDA’s

AstraZeneca Resumes Clinical Study of its COVID-19 Vaccine in Japan

Published: Oct 5, 2020 | Tags: AstraZeneca, Clinical Study, Covid-19 Vaccine, Resumes

BMS to Acquire MyoKardia for ~$13.1B

Published: Oct 5, 2020 | Tags: ~$13.1B, Acquire, BMS, MyoKardia

STADA Expands its Specialty Footprint with the Acquisition of Lobsor Pharmaceuticals

Published: Oct 5, 2020 | Tags: Acquires, Advanced, Footprint, Innovative Therapy, Lobsor Pharmaceuticals, Parkinson’s Disease, Specialty Pharmaceuticals, STADA, Strengthen, Treating

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