PharmaShots Weekly Snapshots (November 15 – 19, 2021)

Jazz’ Sunosi (solriamfetol) Receives NICE Recommendation for the Treatment of Excessive Daytime Sleepiness Caused by Narcolepsy

Published: Nov 19, 2021 | Tags: Jazz, Sunosi, solriamfetol, NICE, Recommendation, Excessive Daytime Sleepiness, Narcolepsy

Antengene’s Selinexor (ATG-010) Receives NMPA’s IND Approval for P-I/II SWATCH Study to Treat Non-Hodgkin Lymphoma

Published: Nov 19, 2021 | Tags: Antengene, Selinexor, ATG-010, NMPA, IND, Approval, P-I/II, SWATCH Study, Selinexor, ATG-010, Non-Hodgkin Lymphoma

Daiichi Sankyo Reports Results of Quizartinib in P-III QuANTUM-First Trial for the Treatment of FLT3-ITD Positive AML

Published: Nov 19, 2021 | Tags: Daiichi Sankyo, Quizartinib, P-III, QuANTUM-First Trial, FLT3-ITD Positive AML

Gilead Exercises its Options with Arcus for its Three Clinical-Stage Programs to Treat Cancers

Published: Nov 19, 2021 | Tags: Gilead, Exercises, Options, Arcus, domvanalimab, AB308, etrumadenant, quemliclustat, Cancers

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval as a Adjuvant Therapy for Renal Cell Carcinoma

Published: Nov 19, 2021 | Tags: Merck, Keytruda, pembrolizumab, US, FDA, Approval, Renal Cell Carcinoma

Novo Nordisk to Acquire Dicerna for ~$3.3B

Published: Nov 19, 2021 | Tags: Novo Nordisk, Acquire, Dicerna, ~$3.3B

GSK’s Nucala (mepolizumab) Receives the EC’s Approval for the Treatment of Eosinophil-Driven Diseases

Published: Nov 18, 2021 | Tags: GSK, Nucala, mepolizumab, EC, Approval, Eosinophil-Driven Diseases

AstraZeneca Reports Results of AZD7442 in P-III PROVENT and TACKLE Trial for the Treatment of COVID-19

Published: Nov 18, 2021 | Tags: AstraZeneca, AZD7442, P-III, PROVENT, TACKLE Trial, COVID-19

OncoOne Entered into an Agreement with GenScript ProBio for the Manufacturing of Monoclonal Antibody Therapies Targeting oxMIF

Published: Nov 18, 2021 | Tags: OncoOne, GenScript ProBio, Monoclonal Antibody, oxMIF

AstraZeneca’s Lokelma Receives Fast Track Designation for the Treatment of Chronic Haemodialysis with Hyperkalaemia

Published: Nov 18, 2021 | Tags: AstraZeneca, Lokelma, Fast Track Designation, Chronic Haemodialysis, Hyperkalaemia

Merck KGaA Collaborated with Burning Rock for Liquid-biopsy Based CDx Development

Published: Nov 18, 2021 | Tags: Merck KGaA, Burning Rock, Liquid-biopsy, CDx Development

Takeda Exercises its Option with Denali to Co-Develop and Co-Commercialize DNL593 (PTV:PGRN) for Frontotemporal Dementia-Granulin

Published: Nov 18, 2021 | Tags: Takeda, Denali, DNL593, PTV:PGRN, Frontotemporal Dementia-Granulin

Merck and Ridgeback Present Results of Molnupiravir in P-III MOVe-OUT Trial for the Treatment of COVID-19 at ASTMH 2021

Published: Nov 17, 2021 | Tags: Merck, Ridgeback, Molnupiravir, P-III, MOVe-OUT Trial, COVID-19, ASTMH 2021

AbbVie’s Skyrizi (risankizumab) Receives EC’s Approval for the Treatment of Active Psoriatic Arthritis

Published: Nov 17, 2021 | Tags: AbbVie, Skyrizi, Risankizumab, EC, Approval, Active Psoriatic Arthritis

Biogen’s Vumerity (diroximel fumarate) Receives the EC’s Approval for the Treatment of Relapsing-Remitting Multiple Sclerosis

Published: Nov 17, 2021 | Tags: Biogen, Vumerity, diroximel fumarate, EC, Approval, Multiple Sclerosis

Merck Reports Results of Arpraziquante in P-III Clinical Trial for the Treatment of Schistosomiasis

Published: Nov 17, 2021 | Tags: Merck, Arpraziquante, P-III, Clinical Trial, Schistosomiasis

Viatris and Biocon Launch Semglee (insulin glargine-yfgn) and Insulin Glargine (insulin glargine-yfgn) for the Treatment of Diabetes in the US

Published: Nov 17, 2021 | Tags: Viatris, Biocon, Semglee, Insulin Glargine, insulin glargine-yfgn, Diabetes

Sotio Signs a Multiple Agreement with LegoChem Biosciences to Develop Novel Therapeutics for the Treatment of Solid Tumors

Published: Nov 17, 2021 | Tags: Sotio, LegoChem Biosciences, Novel Therapeutics, Solid Tumors

Mirum Reports Six Years Results of LIvmarli (maralixibat) for the Treatment of Alagille Syndrome

Published: Nov 16, 2021 | Tags: Mirum, LIvmarli, maralixibat, Alagille Syndrome

Celltrion’s Regdanvimab Receives the EC’s Approval for the Treatment of COVID-19

Published: Nov 16, 2021 | Tags: Celltrion, Regdanvimab, EC, Approval, COVID-19

AstraZeneca and Moderna Present Results of AZD8601 in P-IIa EPICCURE Trial for the Treatment of Heart Failure at AHA 2021

Published: Nov 16, 2021 | Tags: AstraZeneca, Moderna, AZD8601, P-IIa, EPICCURE Trial, Heart Failure, AHA 2021

Entos Entered into an Agreement with BioMarin for Gene Therapies to Treat Genetic Diseases

Published: Nov 16, 2021 | Tags: Entos, BioMarin, Gene Therapies, Genetic Diseases

Janssen and BMS Present Results of Milvexian in P-II AXIOMATIC-TKR Study for the Treatment of TKR Surgery at AHA 2021, Published in NEJM

Published: Nov 16, 2021 | Tags: Janssen, BMS, Milvexian, P-II, AXIOMATIC-TKR Study, TKR Surgery, AHA 2021, NEJM

Coherus and Junshi’s Toripalimab Receive the US FDA’s Orphan Drug Designation for the Treatment of Esophageal Cancer

Published: Nov 16, 2021 | Tags: Coherus, Junshi, Toripalimab, US, FDA, Orphan Drug Designation, Esophageal Cancer

AcelRx to Acquire Lowell for ~$32.5M

Published: Nov 15, 2021 | Tags: AcelRx, Acquire, Lowell, ~$32.5M

Vertex’s Kaftrio (ivacaftor/tezacaftor/elexacaftor) + Ivacaftor Receives CHMP’s Positive Opinion for the Treatment of Cystic Fibrosis in Children Aged 6 to 11

Published: Nov 15, 2021 | Tags: Vertex, Kaftrio, ivacaftor, tezacaftor, elexacaftor, Ivacaftor, CHMP, Cystic Fibrosis

Innovent Presented Results of IBI302 in P-Ib Clinical Trial for the Treatment of Neovascular Age-Related Macular Degeneration at AAO 2021

Published: Nov 15, 2021 | Tags: Innovent, IBI302, P-Ib, Clinical Trial, Neovascular Age-Related Macular Degeneration, AAO 2021

Regenxbio Presented Interim Results of RGX-314 in P-II AAVIATE and ALTITUDE Trials for Wet AMD and Diabetic Retinopathy at AAO 2021

Published: Nov 15, 2021 | Tags: Regenxbio, RGX-314, P-II, AAVIATE, ALTITUDE Trials, Wet AMD, Diabetic Retinopathy, AAO 2021

GSK and Vir’s Sotrovimab Meet its Primary Endpoints in P-III COMET-TAIL Trial for the Treatment of COVID-19

Published: Nov 15, 2021 | Tags: GSK, Vir, Sotrovimab, P-III, COMET-TAIL Trial, COVID-19

Amgen’s Lumykras (sotorasib) Receives CHMP’s Positive Opinion for the Treatment of KRAS G12C-Mutated Advanced Non-Small Cell Lung Cancer

Published: Nov 15, 2021 | Tags: Amgen, Lumykras, sotorasib, CHMP, KRAS G12C-Mutated, Non-Small Cell Lung Cancer

Related Post: PharmaShots Weekly Snapshots (November 08 – 12, 2021)