PharmaShots Weekly Snapshots (August 16 – 20, 2021)

 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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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