PharmaShots Weekly Snapshot (Feb 01-05, 2021)

Reistone Report Results for SHR0302 in P-II Study to Treat Ulcerative Colitis

Published: Feb 5, 2020 | Tags: Reiston, Report, Result, SHR0302, P-II, Study, Treat, Ulcerative Colitis

Enzene Receives Marketing Authorization for Teriparatide (biosimilar) in India

Published: Feb 5, 2020 | Tags: Enzene, Receives, Marketing Authorization, Teriparatide (biosimilar), India

Johnson & Johnson Reports EUA Submission to US FDA’s for its Single Shot COVID-19 Vaccine Candidate

Published: Feb 5, 2020 | Tags: Johnson & Johnson, Reports, EUA, Submission, US, FDA, Single Shot, COVID-19, Vaccine, Candidate

23andMe Going Public Via Virgin Group SPAC Merger

Published: Feb 5, 2020 | Tags: 23andMe, Going, Public, Virgin Group, SPAC, Merger

Biocon Biologics Signs an Agreement with CHAI to Expand Access to its Oncology Biosimilars in 30 Countries

Published: Feb 5, 2020 | Tags: Biocon Biologics, Signs, Agreement, CHAI, Expand, Access, Oncology, Biosimilars, 30 Countries

AstraZeneca’s Forxiga (dapagliflozin) Receives NMPA’s Approval for Chronic Heart Failure

Published: Feb 5, 2020 | Tags: AstraZeneca, Forxiga (dapagliflozin), Receives, NMPA, Approval, Chronic, Heart Failure

Astellas’ Xospata (gilteritinib) Receives NMPA’s Conditional Approval for R/R AML with a FLT3 Mutation

Published: Feb 4, 2020 | Tags: Astellas, Xospata (gilteritinib), Receives, NMPA, Conditional, Approval, R/R AML, FLT3 Mutation

Daiichi Sankyo Initiates P-II Study of Patritumab Deruxtecan in Patients with EGFR-Mutated NSCLC

Published: Feb 4, 2020 | Tags: Daiichi Sankyo, Initiates, P-II, Study, Patritumab Deruxtecan, Patients, EGFR-Mutated NSCLC

Thermo Fisher Collaborates with JW Therapeutics for CAR-T Therapies in China

Published: Feb 4, 2020 | Tags: Thermo Fisher, Collaborates, JW Therapeutics, CAR-T Therapies, China

Pfizer Signs a License and Research Agreement with Imcyse to Develop Imotopes for Rheumatoid Arthritis

Published: Feb 4, 2020 | Tags: Pfizer, Signs, License, Research Agreement, Imcyse, Develop, Imotopes, Rheumatoid Arthritis

Merck KGaA’s Tepmetko (tepotinib) Receives the US FDA’s Approval for Patients with Metastatic NSCLC with METex14 Skipping Alterations

Published: Feb 4, 2020 | Tags: Merck KGaA, Tepmetko (tepotinib), Receives, US, FDA, Approval, Patients, Metastatic NSCLC, METex14, Skipping, Alterations

Jazz to Acquire GW Pharmaceuticals for $7.2B

Published: Feb 4, 2020 | Tags: Jazz, Acquire, GW Pharmaceuticals, $7.2B

Covaxx Initiates P-II Trial of UB-612 Against COVID-19 in Taiwan

Published: Feb 3, 2020 | Tags: Covaxx, Initiates, P-II, Trial, UB-612, Against, COVID-19, Taiwan

Russia’s Sputnik V Demonstrates 92% Efficacy Against COVID-19

Published: Feb 3, 2020 | Tags: Russia, Sputnik V, Demonstrates, 92%, Efficacy, Against, COVID-19

GSK Collaborate with CureVac to Develop Next Generation mRNA COVID-19 Vaccines

Published: Feb 3, 2020 | Tags: GSK, Collaborate, CureVac, Develop, Next, Generation, mRNA COVID-19, Vaccines

Innovent’s Tyvyt (sintilimab) + Pemetrexed and Platinum CT Receives NMPA’s Approval as 1L Therapy with Non-squamous Non-Small Cell Lung Cancer

Published: Feb 3, 2020 | Tags: Innovent, Tyvyt (sintilimab), Pemetrexed, Platinum CT, Receives, NMPA, Approval, 1L, Therapy, Non-squamous Non-Small Cell Lung Cancer

Genentech Signs an Exclusive License Agreement with X-Chem to Discover Oncology Targets

Published: Feb 3, 2020 | Tags: Genentech, Signs, Exclusive, License, Agreement, X-Chem, Discover Oncology, Targets

BMS’ Deucravacitinib Demonstrate Superiority Over Otezla (apremilast) in P-III POETYK PSO-2 Study for Plaque Psoriasis

Published: Feb 3, 2020 | Tags: BMS, Deucravacitinib, Demonstrate, Superiority, Otezla (apremilast), P-III, POETYK PSO-2, Study, Plaque Psoriasis

Celltrion Receives Health Canada’s Approval for Remsima SC (biosimilar, infliximab) for Rheumatoid Arthritis

Published: Feb 2, 2020 | Tags: Celltrion, Receives, Health, Canada, Approval, Remsima SC (biosimilar, infliximab), Rheumatoid Arthritis

Clover and Dynavax Plan to Initiate P-II/III Trial for Adjuvanted COVID-19 Vaccine Candidate

Published: Feb 2, 2020 | Tags: Clover, Dynavax, Plan, Initiate, P-II/III, Trial, Adjuvanted, COVID-19 Vaccine, Candidate

Medtronic Receives the US FDA’s Approval for DiamondTemp Ablation System to Treat Atrial Fibrillation

Published: Feb 2, 2020 | Tags: Medtronic, Receives, US, FDA, Approval, DiamondTemp, Ablation System, Treat, Atrial Fibrillation

Janssen Reports CHMP’s Acceptance for Accelerated Assessment of Cilta-cel’s MAA to Treat Patients with Heavily Pretreated Multiple Myeloma

Published: Feb 2, 2020 | Tags: Janssen, Reports, CHMP, Acceptance, Accelerated, Assessment, Cilta-cel, MAA, Treat, Patients, Heavily, Pretreated, Multiple Myeloma

Gilead Signs an Option and License Agreement with Gritstone for HIV Vaccine

Published: Feb 2, 2020 | Tags: Gilead, Signs, Option, License Agreement, Gritstone, HIV Vaccine

Horizon Therapeutics to Acquire Viela Bio for ~ $3.05B

Published: Feb 2, 2020 | Tags: Horizon, Therapeutics, Acquire, Viela Bio, ~ $3.05B

Incyte Receive Positive CHMP’s Opinion for Pemigatinib

Published: Feb 1, 2020 | Tags: Incyte, Receive, Positive, CHMP, Opinion, Pemigatinib

Gan & Lee Receives the US FDA’s Fast Track Designation for GLR2007 for the Treatment of Patients with Glioblastoma

Published: Feb 1, 2020 | Tags: Gan & Lee, Receives, US, FDA, Fast Track Designation, GLR2007 Treatment, Patients, Glioblastoma

Johnson & Johnson Report Results from P-III ENSEMBLE Trial for COVID-19 Vaccine

Published: Feb 1, 2020 | Tags: Johnson & Johnson, Report, Results, P-III, ENSEMBLE Trial, COVID-19 Vaccine

Amgen’s Sotorasib Receives NMPA’s Breakthrough Therapy Designation in China for the Treatment of Advanced NSCLC With KRAS G12C Mutation

Published: Feb 1, 2020 | Tags: Amgen, Sotorasib, Receives, NMPA, Breakthrough Therapy Designation, China, Treatment, Advanced, NSCLC, KRAS G12C Mutation

Novo Nordisk Receives the CHMP’s Positive Opinion for Sogroya (somapacitan)

Published: Feb 1, 2020 | Tags: Novo Nordisk, Receives, CHMP, Positive Opinion, Sogroya (somapacitan)

Merck’s Report Results of Keytruda (pembrolizumab) in Combination With Ipilimumab vs Keytruda Monotherapy in P-III KEYNOTE-598 for Metastatic Non-Small Cell Lung Cancer Patients

Published: Feb 1, 2020 | Tags: Merck, Report, Results, Keytruda (pembrolizumab), Combination, Ipilimumab, Keytruda Monotherapy, P-III, KEYNOTE-598, Metastatic, Non-Small Cell Lung Cancer Patients

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