PharmaShots Weekly Snapshots (July 05 – 09, 2021)

Lysogene Receives the US FDA’s Fast Track Designation for LYS-GM101 Gene Therapy to Treat GM1 Gangliosidosis

Published: July 9, 2021 | Tags: Lysogene, US, FDA, Fast Track Designation, LYS-GM101 Gene Therapy, GM1 Gangliosidosis

Jazz’s Vyxeos (daunorubicin and cytarabine liposome) for Injection Receives Health Canada Approval for the Treatment of High-risk Acute Myeloid Leukemia

Published: July 9, 2021 | Tags: Jazz, Vyxeos, daunorubicin, cytarabine liposome, Health Canada Approval, High-risk Acute Myeloid Leukemia

Janssen Collaborates with Vor to Develop Engineered Hematopoietic Stem Cell Transplants with Bi-Specific Antibody Therapy to Treat AML

Published: July 9, 2021 | Tags: Janssen, Vor, Engineered Hematopoietic Stem Cell Transplants, Bi-Specific Antibody Therapy, AML

Lilly Signs a Three-Year Collaboration with Verge Genomics to Discover and Develop Novel Therapies for ALS

Published: July 9, 2021 | Tags: Lilly, Verge Genomics, Novel Therapies, ALS

BeiGene’s Kyprolis (carfilzomib) Receives NMPA’s Conditional Approval for the Treatment of Relapsed or Refractory Multiple Myeloma

Published: July 9, 2021 | Tags: BeiGene, Kyprolis, carfilzomib, NMPA, Conditional Approval, Multiple Myeloma

AstraZeneca Signs an Exclusive License Agreement with F-star Therapeutics for Novel STING Inhibitors

Published: July 9, 2021 | Tags: AstraZeneca, Exclusive License Agreement, F-star Therapeutics, Novel STING Inhibitors

AstraZeneca and Amgen Report the US FDA’s Acceptance of BLA and Priority Review of Tezepelumab for the Treatment of Asthma

Published: July 8, 2021 | Tags: AstraZeneca, Amgen, US, FDA, BLA, Tezepelumab, Priority Review, Asthma

BeiGene Reports NMPA’s Acceptance of sBLA for Tislelizumab to Treat Esophageal Squamous Cell Carcinoma in China

Published: July 8, 2021 | Tags: BeiGene, NMPA, sBLA, Tislelizumab, Esophageal Squamous Cell Carcinoma, China

BeiGene Signs a Supply Agreement with PureTech for LYT-200 and Tislelizumab in Patients with Difficult-to-Treat Solid Tumors

Published: July 8, 2021 | Tags: BeiGene, Supply Agreement, PureTech, LYT-200, Tislelizumab, Difficult-to-Treat Solid Tumors

Roche Enters into a Clinical Collaboration with Treos Bio for PolyPEPI1018 + atezolizumab in P-I/II Trial to Treat Late Stage Microsatellite Stable Metastatic Colorectal Cancer

Published: July 8, 2021 | Tags: Roche, Treos Bio, PolyPEPI1018, atezolizumab, P-I/II, Trial, Late Stage, Microsatellite Stable Metastatic Colorectal Cancer

Chugai Files an Application with MHLW for an Additional Indication of Tecentriq as an Adjuvant Treatment for NSCLC in Japan

Published: July 8, 2021 | Tags: Chugai, MHLW, Tecentriq, NSCLC, Japan

Teva Enters Into a Commercialization Agreement with Bioeq for FYB201 (biosimilar, ranibizumab)

Published: July 8, 2021 | Tags: Teva, Commercialization Agreement, Bioeq, FYB201, biosimilar, ranibizumab

Mallinckrodt Reports Results of StrataGraft in P-III STRATA2016 Study for Thermal Burns

Published: July 7, 2021 | Tags: Mallinckrodt, StrataGraft, P-III, STRATA2016 Study, Deep Partial-thickness Thermal Burns

Y-mAbs Reports BLA Submission to the NMPA for Danyelza (naxitamab-gqgk) to Treat Relapsed/Refractory High-Risk Neuroblastoma

Published: July 7, 2021 | Tags: Y-mAbs, BLA, NMPA, Danyelza, naxitamab-gqgk, High-Risk Neuroblastoma, China

Merck Collaborates with OncoSec to Evaluate TAVO (tavokinogene telseplasmid) + Keytruda (pembrolizumab) in P-III KEYNOTE-C87 Trial for Late-Stage Metastatic Melanoma

Published: July 7, 2021 | Tags: Merck, Supply Agreement, OncoSec, TAVO, tavokinogene telseplasmid, Keytruda, pembrolizumab, P-III, KEYNOTE-C87 Trial, Late-Stage Metastatic Melanoma

Sorrento’s Resiniferatoxin Receives the US FDA’s Clearance to Initiate P-II Trial for the Treatment of Knee Pain in Patients with Osteoarthritis

Published: July 7, 2021 | Tags: Sorrento, Resiniferatoxin, US, FDA, Clearance, P-II, Trial, Knee Pain, Osteoarthritis

Alvotech Initiates AVT04-GL-301 Study of AVT04 Proposed Biosimilar to Stelara (ustekinumab) for the Treatment of Plaque Psoriasis

Published: July 7, 2021 | Tags: Alvotech, AVT04, biosimilar, Ustekinumab, AVT04-GL-301 Study, Plaque Psoriasis

Sanofi Signs ~$1B Agreement with Eureka & MSK for their Multiple Myeloma Candidate

Published: July 7, 2021 | Tags: Sanofi, License Agreement, Eureka Therapeutics, MSK, GPRC5D, Multiple Myeloma

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Expanded Indication in Patients with Locally Advanced Cutaneous Squamous Cell Carcinoma

Published: July 6, 2021 | Tags: Merck, Keytruda, pembrolizumab, US, FDA, Approval, Locally Advanced, Cutaneous Squamous Cell Carcinoma

Roche Enter into a Collaboration with Mimetas to Develop Human Disease Models for Drug Development

Published: July 6, 2021 | Tags: Roche, Mimetas, Human Disease Models, Drug Development

Hutchmed Initiates P-I Trial of HMPL 295 for the Treatment of Advanced Solid Tumors in China

Published: July 6, 2021 | Tags: Hutchmed, P-I, Trial, HMPL 295, Advanced Solid Tumors, China

Abbisko Signs an Exclusive License Agreement with Sperogenix to Develop ABSK021 for ALS and Other Rare Neurological Diseases in Greater China

Published: July 6, 2021 | Tags: Abbisko, Sperogenix, ABSK021, ALS, Rare Neurological Diseases, Greater China, ABSK021

Immunic’s IMU-838 Receives the US FDA’s IND Approval to Initiate P-III ENSURE & P-II CALLIPER Studies for RRMS & PMS

Published: July 6, 2021 | Tags: Immunic, IMU-838, US, FDA, IND, Clearance, P-III, ENSURE, P-II, CALLIPER Studies, RRMS, PMS

Spero Therapeutics Enters into a License Agreement with Pfizer for SPR206 to Treat MDR Gram Negative Infections

Published: July 6, 2021 | Tags: Spero Therapeutics, License Agreement, Pfizer, SPR206, MDR Gram Negative Infections

Lupin’s Solosec (secnidazole) Receives the US FDA’s Approval for the Treatment of Trichomoniasis

Published: July 5, 2021 | Tags: Lupin, Solosec, secnidazole, US, FDA, Approval, Trichomoniasis

Merck Amends Collaboration with NGM to Advance Novel Therapies for Retinal and CVM Diseases

Published: July 5, 2021 | Tags: NGM, Merck, Novel Medicines, Retinal, CVM Diseases

Ocugen and Bharat Biotech Present Results of Covaxin in P-III Study Against COVID-19

Published: July 5, 2021 | Tags: Ocugen, Bharat Biotech, Covaxin, P-III Study, COVID-19

Roche to Present New data of Hemlibra (emicizumab) in P-IIIb STASEY Study for Hemophilia A at ISTH 2021

Published: July 5, 2021 | Tags: Roche to Present New data of Hemlibra (emicizumab) in P-IIIb STASEY Study for Hemophilia A at ISTH 2021

Gan Lee Presents P-I Results of Proposed Biosimilar Insulins Aspart, Lispro and Glargine at ADA 2021

Published: July 5, 2021 | Tags: Gan Lee, P-I, Proposed Biosimilar Insulins Aspart, Lispro, Glargine, ADA 2021

GSK and Alector Sign $2.2B Collaboration to Develop Therapies for Neurodegenerative Diseases

Published: July 5, 2021 | Tags: GSK, Alector, $2.2B, Therapies, Neurodegenerative Diseases

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