PharmaShots Weekly Snapshots (October 25 – 29, 2021)

ADC Reports EMA’s Validation of MAA for Zynlonta to Treat R/R Diffuse Large B-Cell Lymphoma

Published: Oct 29, 2021 | Tags: ADC, EMA, MAA, Zynlonta, R/R Diffuse Large B-Cell Lymphoma

Impact Receives US FDA’s IND Clearance for IMP9064 to Treat Solid Tumor

Published: Oct 29, 2021 | Tags: Impact, US, FDA, IND, IMP9064, Solid Tumor

Novartis Reports the US FDA and EMA’s Acceptance of sBLA for Kymriah (tisagenlecleucel) and Granted Priority Review to Treat R/R Follicular Lymphoma

Published: Oct 29, 2021 | Tags: Novartis, US, FDA, EMA, sBLA, Kymriah, Tisagenlecleucel, Priority Review, R/R Follicular Lymphoma

AbbVie Reports Results of ABBV-951 (foslevodopa/foscarbidopa) in P-III M15-736 Study for the Treatment of Advanced Parkinson’s Disease

Published: Oct 29, 2021 | Tags: AbbVie, ABBV-951, foslevodopa, foscarbidopa, P-III, M15-736 Study, Advanced Parkinson’s Disease

Kite’s Tecartus (brexucabtagene autoleucel) Receives Health Canada’s Approval for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Published: Oct 29, 2021 | Tags: Kite, Tecartus, brexucabtagene autoleucel, Health Canada, Approval, Mantle Cell Lymphoma

Incyte Reports EMA’s Validation of MAA for Ruxolitinib Cream to Treat Vitiligo

Published: Oct 29, 2021 | Tags: Incyte, EMA, MAA, Ruxolitinib Cream, Vitiligo

Immunic Reports Completion of Patient Enrollment in P-II CALDOSE-1 Trial of IMU-838 for the Treatment of Ulcerative Colitis

Published: Oct 28, 2021 | Tags: Immunic, P-II, CALDOSE-1 Trial, IMU-838, Ulcerative Colitis

Hutchmed Initiates P-III ESLIM-01 Trial of HMPL-523 for the Treatment of Immune Thrombocytopenia in China

Published: Oct 28, 2021 | Tags: Hutchmed, P-III, ESLIM-01 Trial, HMPL-523, Immune Thrombocytopenia, China

Innovent Entered into a Collaboration Agreement with NeoCura to Evaluate Sintilimab + NEO_PLIN2101 for Cancer in China

Published: Oct 28, 2021 | Tags: Innovent, NeoCura, Sintilimab, NEO_PLIN2101, Cancer, China

Alnylam Reports Results of Vutrisiran in P-III HELIOS-A Study for the Treatment of hATTR Amyloidosis with Polyneuropathy

Published: Oct 28, 2021 | Tags: Alnylam, Vutrisiran, P-III, HELIOS-A Study, hATTR Amyloidosis, Polyneuropathy

Curacle Signs a License and Collaboration Agreement with Théa for Development and Commercialization of CU06-RE to treat Diabetic Macular Edema and Wet-AMD

Published: Oct 28, 2021 | Tags: Curacle, Théa, CU06-RE, Diabetic Macular Edema, Wet-AMD

Takeda to Acquire GammaDelta to Advance the Development of Allogeneic γδT Cell Therapies for the Treatment of Solid Tumors

Published: Oct 28, 2021 | Tags: Takeda, GammaDelta, Allogeneic γδT Cell Therapies, Solid Tumors

Merck Presents Results of Islatravir + Doravirine in P-IIb Clinical Trial for the Treatment of HIV-1 at EACS 2021

Published: Oct 27, 2021 | Tags: Merck, Islatravir, Doravirine, P-IIb, Clinical Trial, HIV-1, EACS 2021

Teva Signs an Exclusive WW License Agreement with Modag to Develop Anle138b and Sery433 for Neurodegenerative Disease

Published: Oct 27, 2021 | Tags: Teva, Modag, Anle138b, Sery433, Neurodegenerative Disease

Vifor and Angion’s ANG-3777 Fail to Meet its Primary and Secondary Endpoint for Patients with High-Risk Kidney Transplant

Published: Oct 27, 2021 | Tags: Vifor, Angion, ANG-3777, High-Risk Kidney Transplant,Delayed Graft Function

Pfizer and BioNTech’s COVID-19 Vaccine Receive the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19

Published: Oct 27, 2021 | Tags: Pfizer, BioNTech, COVID-19 Vaccine, US, FDA, Advisory Committee, EUA, COVID-19

Selecta Collaborates with Ginkgo to Develop Therapeutic Enzymes for the Treatment of Orphan and Rare Diseases

Published: Oct 27, 2021 | Tags: Selecta, Ginkgo Bioworks, Orphan, Rare Diseases, Therapeutic Enzymes

Vertex Collaborates with Mammoth Biosciences to Develop In Vivo Gene-Editing Therapies for Genetic Diseases

Published: Oct 27, 2021 | Tags: Vertex, Mammoth Biosciences, In Vivo Gene-Editing Therapies, Genetic Diseases

Moderna Reports Results of COVID-19 Vaccine in P-II/III KidCOVE Study for the Treatment of COVID-19

Published: Oct 26, 2021 | Tags: Moderna, COVID-19 Vaccine, mRNA-1273, P-II/III, KidCOVE Study, COVID-19

Glenmark launches Remogliflozin + Vildagliptin + Metformin as Fixed Dose Combination for the Treatment of Type 2 Diabetes in India

Published: Oct 26, 2021 | Tags: Glenmark, Remogliflozin, Vildagliptin, Metformin, Type 2 Diabetes, India

Guardant Health Presents Results of LUNAR-2 Blood Test for the Treatment of Early-Stage Colorectal Cancer at ACG 2021

Published: Oct 26, 2021 | Tags: Guardant Health, LUNAR-2 Blood Test, Early-Stage Colorectal Cancer, ACG 2021

MSD Entered into a Clinical Trial Collaboration with Evaxion to Evaluate EVX-01 + Keytruda (pembrolizumab) for Metastatic Melanoma

Published: Oct 26, 2021 | Tags: MSD, Evaxion, EVX-01, Keytruda, pembrolizumab, Metastatic Melanoma

AstraZeneca Reports Results of Imfinzi in P-III TOPAZ-1 Trial as 1L Treatment for Advanced Biliary Tract Cancer

Published: Oct 26, 2021 | Tags: AstraZeneca, Imfinzi, P-III, TOPAZ-1 Trial, Advanced Biliary Tract Cancer

Daiichi Sankyo and AstraZeneca Entered into a Second Clinical Trial Collaboration with Merck for Datopotamab Deruxtecan (Dato-DXd) + Keytruda (pembrolizumab)

Published: Oct 26, 2021 | Tags: Daiichi Sankyo, AstraZeneca, Merck, Datopotamab Deruxtecan, Dato-DXd, Keytruda, pembrolizumab, Metastatic NSCLC

Merck Reports Results of Doravirine/Islatravir as Fixed Dose Combination in P-III Trials for the Treatment of HIV-1 Infection

Published: Oct 25, 2021 | Tags: Merck, Doravirine, Islatravir, Fixed Dose Combination, P-III, Trials, HIV-1 Infection

Merck and Ridgeback Report the Initiation of EMA Rolling Review of Molnupiravir for the Treatment of COVID-19

Published: Oct 25, 2021 | Tags: Merck, Ridgeback, EMA, Molnupiravir, COVID-19

Novartis Reports Results of Canakinumab in P-III CANOPY-1 Study for the Treatment of Lung Cancer

Published: Oct 25, 2021 | Tags: Novartis, Canakinumab, P-III, CANOPY-1 Study, Lung Cancer

Regeneron and Sanofi Report Results of Dupixent (dupilumab) in P-III Trial for the Treatment of Eosinophilic Esophagitis

Published: Oct 25, 2021 | Tags: Regeneron, Sanofi, Dupixent, dupilumab, P-III, Trial, Eosinophilic Esophagitis

Agenus Reports the Withdrawal of BLA for Balstilimab to Treat Cervical Cancer

Published: Oct 25, 2021 | Tags: Agenus, Withdrawal, BLA, Balstilimab, Cervical Cancer

Genentech’s Susvimo Receives the US FDA’s Approval for the Treatment of Wet Age-Related Macular Degeneration

Published: Oct 25, 2021 | Tags: Genentech, Susvimo, US, FDA, Approval, Wet Age-Related Macular Degeneration

Related Post: PharmaShots Weekly Snapshots (October 18 – 22, 2021)