Sinopharm's COVID-19 Vaccine Demonstrates 79% Efficacy in P-III Study

Published: Dec 30, 2020 | Tags: COVID-19, Interim Analysis, New Coronavirus Inactivated Vaccine, P-lll Study, reports, results, Sinopharm

Vertex Reports Health Canada's Acceptance of Trikafta's NDA for Priority Review to Treat Cystic Fibrosis

Published: Dec 28, 2020 | Tags: CysticFibrosis, Drug, New, reports, Submission, Treatment, Trikafta, Vertex

The US FDA Grants EUA for Quanterix's Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test

Published: Dec 29, 2020 | Tags: Emergency Use Authorization, Grants, Quanterix’s Simoa, Semi-Quantitative SARS-CoV-2 IgG Antibody Test, Us FDA

Sorrento Reports Submission of MAA to COFEPRIS for COVI-STIX Rapid Detection Test

Published: Dec 30, 2020 | Tags: COFEPRIS, Marketing Authorization Application, reports, Sorrento, Submission

Health Canada Accelerates the Review for AstraZeneca's COVID-19 Vaccine

Published: Dec 30, 2020 | Tags: AstraZeneca, Authorization, COVID-19, Health Canada, reports, Statement, UK, vaccine

Incyte Collaborates with Cellenkos for CK0804 to Treat Myelofibrosis

Published: Dec 30, 2020 | Tags: Cellenkos, CK0804, Development, Global, Incyte, License Agreement, Myelofibrosis, Signs

Zydus Cadila Seeks Approval to Commence P-III Clinical Study of ZyCoV-D

Published: Dec 24, 2020 | Tags: Clinical, Data, Nod, P-I/II, P-III, Seeks, Start, Submits, Trial, Trials, ZyCoV-D, Zydus Cadila

Regeneron's Antibody Cocktail Demonstrate Promising Results in Hospitalized Patients on Low-Flow Oxygen

Published: Dec 29, 2020 | Tags: antibody, Cocktail, COVID-19, Data, Encouraging, flow, Hospitalized, Initial, Low, Oxygen, patients, Regeneron, reports, Trial

AstraZeneca's AZD1222 Receives MHRA's Emergency Supply Authorization in the UK

Published: Dec 30, 2020 | Tags: AstraZeneca, Authorization, AZD1222, Emergency, MHRA, receives, Supply, UK

Skyhawk Collaborates with Vertex to Discover and Develop Novel Small Molecules Modulating RNA Splicing for Serious Diseases

Published: Dec 22, 2020 | Tags: Develop, Discover, License Agreement, Novel Small Molecules for Serious Diseases, Sign, Skyhawk, Strategic Research, Vertex

Novo Nordisk Reports Submission of Label Extension Application to the EMA for Semaglutide (once weekly, 2.0 mg) for T2D

Published: Dec 29, 2020 | Tags: EMA, Label Extension, Novo Nordisk, reports, Semaglutide, Submission, T2D

Chi-Med Initiates Rolling Submission of NDA to the US FDA of Surufatinib to Treat Advanced Neuroendocrine Tumors

Published: Dec 28, 2020 | Tags: Advanced, Chi-Med, Initiates, NDA, Neuroendocrine, Rolling, Submission, Surufatinib, Treat, Tumors, Us FDA

Alligator Bioscience Submits CTA for the P-II OPTIMIZE-1 Study of Mitazalimab

Published: Dec 28, 2020 | Tags: Alligator Bioscience, CTA, Mitazalimab, OPTIMIZE-1, P-II, study, Submits

Pfizer Report the US FDA's Acceptance and Priority Review of sNDA for Lorbrena (lorlatinib) to treat (ALK)-Positive (NSCLC)

Published: Dec 28, 2020 | Tags: Acceptance, Lorbrena (lorlatinib), Pfizer, Priority Review, Report, sNDA, treat (ALK)-Positive (NSCLC), US FDA's

Biocon has Launched Tacrolimus Capsules in the US

Published: Dec 28, 2020 | Tags: Biocon, Launches, Tacrolimus Capsules, US

Myovant Signs Agreement with Pfizer to Develop and Commercialize Relugolix in Oncology and Women's Health

Published: Dec 28, 2020 | Tags: Agreement, Commercialize, Develop, health, Myovant, Oncology, Pfizer, Relugolix, Signs, Women

Janssen Report MAA Submission of Amivantamab to EMA for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Published: Dec 28, 2020 | Tags: Amivantamab, EGFR Exon 20 Insertion Mutations, EMA, Janssen, MAA, Metastatic Non-Small Cell Lung Cancer, Report, Submission

Zai Lab Signs an Exclusive License Agreement with Cullinan Oncology for the Development and Commercialization of CLN-081 in Greater China

Published: Dec 28, 2020 | Tags: CLN-081, Commercialization, Cullinan Oncology, Development, Exclusive License Agreement, Greater China, Signs, Zai Lab

Algernon's Last Patient Out in NP-120 (Ifenprodil) P-IIb/III Study for COVID-19

Published: Dec 24, 2020 | Tags: Algernon, COVID-19, Ifenprodil, Last Patient Out, Multinational, P-IIb, P-IIb/III, reports

Casi and Juventas Cell Therapy's CNCT19 (CD19 CAR-T) Receives China NMPA's BT Designation for Relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Published: Dec 24, 2020 | Tags: (CD19 CAR-T), Breakthrough Therapy Designation, BT Designation, Casi, CNCT19, NMPA, receives, Relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Amyrt's AP103 Receives the US FDA's Orphan Drug designation for Dystrophic Epidermolysis Bullosa (DEB)

Published: Dec 23, 2020 | Tags: Amyrt's, AP103, Dystrophic Epidermolysis Bullosa (DEB), receives, Treatment, US FDA's

Aurobindo Pharma Sign Agreement with COVAXX to Develop and Commercialize COVID-19 Vaccine UB-612 for India and UNICEF

Published: Dec 24, 2020 | Tags: Agreement, Aurobindo, Commercialize, COVAXX, COVID-19, Develop, India, Pharma, Sign, UB-612, UNICEF, vaccine

Innovent's Byvasda (Bevacizumab Biosimilar) Receive NMPA's Approval for Adult Recurrent Glioblastoma

Published: Dec 28, 2020 | Tags: Adult Recurrent Glioblastoma, approval, BYVASDA (Bevacizumab Biosimilar) Treatment, Innovent, NMPA

Innovent's Sulinno (Adalimumab biosimilar) Receives China's NMPA Approval for Pediatric Plaque Psoriasis and Non-infectious Uveitis

Published: Dec 23, 2020 | Tags: Adalimumab Biosimilar, Innovent, NMPA's Approval, Non-infectious Uveitis, panuveitis in adults, Pediatric Plaque Psoriasis, posterior uveitis, Receive, Sulinno

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