PharmaShots Weekly Snapshots (August 16 – 20, 2021)

Janssen Presents Results of Rybrevant (amivantamab-vmjw) in P-I CHRYSALIS Study for Advanced NSCLC with METex14 Mutations at WCLC

Published: Aug 20, 2021 | Tags: Astellas, FibroGen, Evrenzo, Roxadustat, EC, Approval, Symptomatic Anemia, Chronic Kidney Disease

Astellas and FibroGen’s Evrenzo (roxadustat) Receive EC’s Approval for Symptomatic Anemia Associated with Chronic Kidney Disease

Published: Aug 20, 2021 | Tags: Astellas, FibroGen, Evrenzo, Roxadustat, EC, Approval, Symptomatic Anemia, Chronic Kidney Disease

Gilead Reports EMA’s Validation of MAA for Lenacapavir to Treat HIV-1 in People with Limited Therapy Options

Published: Aug 20, 2021 | Tags: Gilead, EMA, Validation, MAA, Lenacapavir, HIV-1

BMS’ Abecma (Idecabtagene Vicleucel) Receives EC’s Conditional Approval for Relapsed and Refractory Multiple Myeloma

Published: Aug 20, 2021 | Tags: BMS, Abecma, Idecabtagene Vicleucel, EC, Conditional Approval, Multiple Myeloma

Merck Enters in Third Clinical Trial Collaboration with Adagene to Advance ADG106 + Keytruda (pembrolizumab) for Solid Tumors and Hematological Malignancies

Published: Aug 19, 2021 | Tags: Adagene, Merck, ADG106, Keytruda, pembrolizumab, Advanced, Metastatic, Solid Tumour, Hematological Malignancies

Orion Signs a License and Research Agreement with Alligator to Develop Bispecific Antibody for the Treatment of Cancer

Published: Aug 19, 2021 | Tags: Orion, Research Agreement, Alligator, Develop, Bispecific Antibody, Cancer Therapeutics

Merck Signs a Supply Agreement with Werewolf for WTX-124 INDUKINE Program to Treat Solid Tumors

Published: Aug 19, 2021 | Tags: Merck, Werewolf, WTX-124, INDUKINE Program, Solid Tumors

Coherus and Junshi Report Interim Results of Toripalimab + CT in P-III CHOICE-01 Trial as 1L Treatment for Non-Small Cell Lung Cancer

Published: Aug 19, 2021 | Tags: Coherus, Junshi, Toripalimab, CT, P-III, CHOICE-01 Trial, Non-Small Cell Lung Cancer

Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) Receive the US FDA’s Approval for the Treatment of Heart Failure with Reduced Ejection Fraction

Published: Aug 19, 2021 | Tags: Boehringer Ingelheim, Eli Lilly, Jardiance, empagliflozin, US, FDA, Approval, Heart Failure with Reduced Ejection Fraction

AbbVie Publishes 12-week Results of Atogepant in P-III ADVANCE Trial for the Preventive of Migraine in NEJM

Published: Aug 19, 2021 | Tags: AbbVie, Atogepant, P-III, ADVANCE Trial, Migraine, NEJM

BMS Exercises its Option to Develop Exscientia’s AI-Designed Drug Candidate

Published: Aug 18, 2021 | Tags: BMS, Exscientia, AI-Designed, Immune-modulating, Drug Candidate

Novartis Reports Results of Beovu (brolucizumab) in P-III KITE & KINGFISHER Trials for the Treatment of Diabetic Macular Edema

Published: Aug 18, 2021 | Tags: Novartis, Beovu, P-III, KITE, KINGFISHER Trials, Diabetic Macular Edema

BeiGene and EUSA Receive the NMPA’s Approval of Qarziba (dinutuximab beta) for High-Risk Neuroblastoma

Published: Aug 18, 2021 | Tags: BeiGene, EUSA, NMPA, Approval, Qarziba, dinutuximab beta, High-Risk Neuroblastoma

Verily Acquires SignalPath to Expand its Clinical Research Capabilities

Published: Aug 18, 2021 | Tags: Verily, Acquire, SignalPath, Expand, Clinical Research Capabilities

Agios Reports the US FDA’s Acceptance of NDA and Priority Review for Mitapivat to Treat Pyruvate Kinase Deficiency

Published: Aug 18, 2021 | Tags: Agios, US, FDA, Acceptance, NDA, Priority Review, Mitapivat, Pyruvate Kinase Deficiency

GSK’s Jemperli (dostarlimab-gxly) Receives the US FDA’s Accelerated Approval for the Treatment of dMMR Recurrent or Advanced Solid Tumors

Published: Aug 18, 2021 | Tags: GSK, Jemperli, Dostarlimab-gxly, US, FDA, Accelerated Approval, dMMR, Recurrent, Advanced, Solid Tumors

BMS Reports EMA’s Validation of MAA for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + CT to Treat Esophageal Squamous Cell Carcinoma

Published: Aug 17, 2021 | Tags: BMS, EMA, Validation, MAA, Opdivo, nivolumab, Yervoy, ipilimumab, Opdivo, CT, Esophageal Squamous Cell Carcinoma

Novartis’ Cosentyx (secukinumab) Receives the NMPA’s Approval for the Treatment of Pediatric Psoriasis in China

Published: Aug 17, 2021 | Tags: Novartis, Cosentyx, secukinumab, NMPA, Approval, Pediatric Psoriasis, China

Abbott’s Amplatzer Amulet Device Receives the US FDA’s Approval for the Treatment of Atrial Fibrillation

Published: Aug 17, 2021 | Tags: Abbott, Amplatzer Amulet Device, US, FDA, Approval, Atrial Fibrillation

Exelixis Expands its Collaboration with Invenra to Develop Novel Biologics in Oncology

Published: Aug 17, 2021 | Tags: Exelixis, Invenra, Expand Collaboration, Develop, Novel Biologics, Oncology

Incyte Signs a License Agreement with InnoCare to Develop and Commercialize Tafasitamab in Greater China

Published: Aug 17, 2021 | Tags: Incyte, InnoCare, Develop, Commercialize, Tafasitamab, Greater China

Eli Lilly’s Lyumjev (insulin lispro-aabc injection) Receives the US FDA’s Expanded Label Approval for the Treatment of Type 1 and Type 2 Diabetes

Published: Aug 17, 2021 | Tags: Eli Lilly, Lyumjev, insulin lispro-aabc injection, US, FDA, Expanded Label Approval, Type 1 and Type 2 Diabetes

The US FDA Lifts the Clinical Hold of Rocket’s RP-A501 Clinical Trial to Treat Danon Disease

Published: Aug 16, 2021 | Tags: US, FDA, Clinical Hold, Rocket, RP-A501, Clinical Trial, Danon Disease

Merck Reports the Initiation of Rolling Submission to Health Canada for Molnupiravir to Treat COVID-19

Published: Aug 16, 2021 | Tags: Merck, Rolling Submission, Health Canada, Molnupiravir, COVID-19

Pfizer’s Ticovac Receives the US FDA’s Approval for the Prevention of Tick-Borne Encephalitis

Published: Aug 16, 2021 | Tags: Pfizer, Ticovac, US, FDA, Approval, Tick-Borne Encephalitis

Lilly Reports Results of Lebrikizumab in P-III ADvocate 1 and 2 Studies for the Treatment of Moderate to Severe Atopic Dermatitis

Published: Aug 16, 2021 | Tags: Lilly, Lebrikizumab, P-III, ADvocate 1 & 2 Studies, Atopic Dermatitis

The US FDA Rejects Sesen Bio’s Vicineum (oportuzumab monatox-qqrs) for the Treatment of BCG-Unresponsive NMIBC

Published: Aug 16, 2021 | Tags: US, FDA, Reject, Sesen Bio, Vicineum, oportuzumab monatox-qqrs, BCG, Unresponsive, NMIBC

Merck’s Welireg (belzutifan) Receives the US FDA’s Approval for the Treatment of Von Hippel-Lindau Disease Associated Tumors

Published: Aug 16, 2021 | Tags: Merck, Welireg, belzutifan, US, FDA, Approval, Von Hippel-Lindau Disease, Tumors