PharmaShots Weekly Snapshots (September 20 – 24, 2021)

Everest’s SPR206 Receives the NMPA’s IND Approval for the Treatment of MDR Gram-Negative Bacterial Infections

Published: Sept 24, 2021 | Tags: Everest, SPR206, NMPA, IND, Approval, MDR Gram-Negative Bacterial Infections

GE Healthcare to Acquire BK Medical for ~ $1.45B

Published: Sept 24, 2021 | Tags: GE Healthcare, Acquire, BK Medical, ~ $1.45B

Roche Presents Results of Evrysdi (risdiplam) in RAINBOWFISH Study for the Treatment of Neuromuscular Disorder at WMS 2021

Published: Sept 24, 2021 | Tags: Roche, Evrysdi, risdiplam, RAINBOWFISH, Study, Neuromuscular Disorder, WMS 2021

Pfizer and BioNTech’s COVID-19 Vaccine Booster Receive the US FDA’s EUA for the Treatment of COVID-19

Published: Sept 24, 2021 | Tags: Pfizer, BioNTech, COVID-19 Vaccine Booster, US, FDA, EUA, COVID-19

Innovent Reports the First Patient Dosing in P-II CIBI112A201 Trial of IBI112 for the Treatment of Plaque Psoriasis

Published: Sept 24, 2021 | Tags: Innovent, P-II, CIBI112A201 Trial, IBI112 Plaque Psoriasis

AstraZeneca Collaborates with VaxEquity to Develop and Commercialize Self-Amplifying RNA Therapeutics

Published: Sept 24, 2021 | Tags: AstraZeneca, VaxEquity, Self-Amplifying RNA Therapeutics

Immunic Sign a License Agreement with University Medical Center Goettingen for IMU-838 & N4-Hydroxycytidine to Treat Viral Infections

Published: Sept 23, 2021 | Tags: Immunic, University Medical Center Goettingen, IMU-838, N4-Hydroxycytidine, Viral Infections

Gilead Reports Results of Veklury (remdesivir) in P-III Trial for the Treatment of COVID-19

Published: Sept 23, 2021 | Tags: Gilead, Veklury, remdesivir, P-III, Trial, COVID-19

Incyte’s Jakafi (ruxolitinib) Receives the US FDA’s Approval for the Treatment of Chronic Graft-Versus-Host Disease

Published: Sept 23, 2021 | Tags: Incyte, Jakafi, ruxolitinib, US, FDA, Approval, Chronic Graft-Versus-Host Disease

Abbott’s Epic Plus Tissue Valves Receives the US FDA’s Approval for the Treatment of Mitral or Aortic Valve Replacement

Published: Sept 23, 2021 | Tags: Abbott, Epic Plus Tissue Valves, US, FDA, Approval, Mitral, Aortic Valve Replacement

Innovent Reports NMPA’s Acceptance of sNDA for Sintilimab as 1L Treatment for Esophageal Squamous Cell Carcinoma

Published: Sept 23, 2021 | Tags: Innovent, NMPA, sNDA, Sintilimab, Esophageal Squamous Cell Carcinoma

AbCellera Enters into a License Agreement with Everest to Discover Antibody Therapies

Published: Sept 23, 2021 | Tags: AbCellera, Everest, Antibody Therapies

Vigeo Reports Completion of VT1021 in P-I/II Study for the Treatment of Recurrent Glioblastoma and Pancreatic Cancer

Published: Sept 22, 2021 | Tags: Vigeo, VT1021, P-I/II, Study, Recurrent Glioblastoma, Pancreatic Cancer

Takeda Enters into an Exclusive License Agreement with Mirum to Develop and Commercialize Maralixibat for Rare Pediatric Liver Diseases in Japan

Published: Sept 22, 2021 | Tags: Takeda, Mirum, Maralixibat, Rare Pediatric Liver Diseases, Japan

Exelixis Presents Results of Cabometyx (cabozantinib) in P-III COSMIC-311 Trial for the Treatment of Radioactive Iodine-Refractory DTC at ESMO 2021

Published: Sept 22, 2021 | Tags: Exelixis, Cabometyx, cabozantinib, P-III, COSMIC-311 Trial, Radioactive Iodine-Refractory DTC, ESMO 2021

Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv) Receive the US FDA’s Accelerated Approval for the Treatment of Recurrent or Metastatic Cervical Cancer

Published: Sept 22, 2021 | Tags: Seagen, Genmab, Tivdak, tisotumab vedotin-tftv, US, FDA, Accelerated Approval, Cervical Cancer

Boehringer Ingelheim Acquires Abexxa to Expands its Immuno-oncology Research

Published: Sept 22, 2021 | Tags: Boehringer Ingelheim, Acquire, Abexxa, Cancer Immunocology Therapies

Incyte’s Opzelura (ruxolitinib) Receives the US FDA’s Approval for the Treatment of Atopic Dermatitis

Published: Sept 22, 2021 | Tags: Incyte, Opzelura, ruxolitinib, US, FDA, Approval, Atopic Dermatitis

Boston Scientific to Acquire Devoro for ~$336M

Published: Sept 21, 2021 | Tags: Boston, Acquire, Devoro, ~$336M

Amgen Collaborates with Verastem to Evaluate VS-6766 + Lumakras (Sotorasib) in P-I/II Trial for KRAS G12C-Mutant Non-Small Cell Lung Cancer

Published: Sept 21, 2021 | Tags: Amgen, Verastem, VS-6766, Lumakras, Sotorasib, KRAS G12C-Mutant, Non-Small Cell Lung Cancer

Novartis to Acquire Arctos to Boost its Optogenetics Portfolio to Treat Eye Diseases

Published: Sept 21, 2021 | Tags: Novartis, Acquire, Arctos, Optogenetics Portfolio, Gene Therapies, Eye Diseases

Bayer Signs a License and Research Agreement with Gubra to Develop Novel Peptide Therapeutics for Cardiorenal Diseases

Published: Sept 21, 2021 | Tags: Bayer, Gubra, Novel Peptide Therapeutics, Cardiorenal Diseases

Abbott’s Portico with Flexnav Tavr System Receives the US FDA’s Approval for the Treatment of Aortic Valve Disease

Published: Sept 21, 2021 | Tags: Abbott, Portico, Flexnav Tavr System, US, FDA, Approval, Aortic Valve Disease

Samsung Bioepis and Biogen’s Byooviz (biosimilar, ranibizumab) Receives the US FDA’s Approval for the Treatment of Retinal Vascular Disorders

Published: Sept 21, 2021 | Tags: Samsung Bioepis, Biogen, Byooviz, biosimilar, ranibizumab, US, FDA, Approval, Retinal Vascular Disorders

AstraZeneca Presents the Updated Results of Imfinzi (durvalumab) in P-III CASPIAN Trial for the Treatment of Extensive-Stage Small Cell Lung Cancer at ESMO 2021

Published: Sept 20, 2021 | Tags: AstraZeneca, Imfinzi, durvalumab. P-III, CASPIAN Trial, Extensive-Stage Small Cell Lung Cancer, ESMO 2021

Exelixis’ Cabometyx (cabozantinib) Receives the US FDA’s Approval for the Treatment of Locally Advanced or Metastatic Differentiated Thyroid Cancer

Published: Sept 20, 2021 | Tags: Exelixis, Cabometyx, cabozantinib, US, FDA, Approval, Differentiated Thyroid Cancer

Merck Reports Results of Keytruda (pembrolizumab) in P-III KEYNOTE-826 Trial as 1L Treatment for Cervical Cancer

Published: Sept 20, 2021 | Tags: Merck, Keytruda, pembrolizumab, P-III, KEYNOTE-826 Trial, Cervical Cancer

Regeneron and Sanofi Present Results of Libtayo (cemiplimab) in P-III EMPOWER-Lung 3 Study as 1L Treatment of Advanced NSCLC at ESMO 2021

Published: Sept 20, 2021 | Tags: Regeneron, Sanofi, Libtayo, cemiplimab, P-III, EMPOWER-Lung 3 Study, Advanced NSCLC, ESMO 2021

Mirati Presents Results of Adagrasib (MRTX849) in P-I/II KRYSTAL–1 Study for the Treatment of KRAS G12C-Mutated Colorectal Cancer at ESMO 2021

Published: Sept 20, 2021 | Tags: Mirati, Adagrasib, MRTX849, P-I/II, KRYSTAL–1 Study, KRAS G12C-Mutated Colorectal Cancer, ESMO 2021

Everest Enter into an Exclusive License Agreement with Sinovent and SinoMab to Develop and Commercialize XNW1011 for Renal Diseases

Published: Sept 20, 2021 | Tags: Everest, Sinovent, SinoMab, XNW1011, SN1011, Renal Diseases

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