PharmaShots Weekly Snapshots (July 05 – 09, 2021)

 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

Related Post: PharmaShots Weekly Snapshots (June 28 – July 02, 2021)

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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