PharmaShots Weekly Snapshots (July 26 – 30, 2021)

Roche Publishes the Results of Evrysdi (risdiplam) in FIREFISH Study to Treat of Type 1 SMA at NEJM

Published: July 30, 2021 | Tags: Roche, Evrysdi, risdiplam, FIREFISH Study, Type 1 SMA, NEJM

BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III SEQUOIA Trial for the Treatment of Chronic Lymphocytic Leukemia

Published: July 30, 2021 | Tags: BeiGene, Brukinsa, zanubrutinib, P-III, SEQUOIA Trial, Chronic Lymphocytic Leukemia

Alnylam Signs a License Agreement with PeptiDream to Develop and Commercialize Peptide-siRNA Conjugates for Delivery of RNAi Therapeutics to a Broader Range of Extrahepatic Tissues

Published: July 30, 2021 | Tags: Alnylam, PeptiDream, Peptide-siRNA Conjugates, RNAi Therapeutics, Extrahepatic Tissues

Junshi Reports NMPA’s Acceptance of sNDA for Toripalimab + CT as 1L Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Published: July 30, 2021 | Tags: Junshi, NMPA, Acceptance, sNDA, Toripalimab, CT, Advanced, Metastatic, Esophageal Squamous Cell Carcinoma

GSK’s Nucala (mepolizumab) Receives the US FDA’s Approval for the Treatment of Chronic Rhinosinusitis with Nasal Polyps

Published: July 30, 2021 | Tags: GSK, Nucala, mepolizumab, US, FDA, Chronic Rhinosinusitis, Nasal Polyps

Lilly Collaborates with Kumquat to Develop Novel Small Molecules that Enhance Tumor-Specific Immune Responses

Published: July 30, 2021 | Tags: Lilly, Kumquat, Novel Small Molecules, Tumor-Specific Immune Responses

Takeda’s TAK-994 Receives Breakthrough Therapy Designation for the Treatment of Narcolepsy Type 1

Published: July 29, 2021 | Tags: Takeda, TAK-994, Breakthrough Therapy Designation, Narcolepsy Type

Janssen Amends its Agreement with Protagonist to Develop and Commercialize IL-23 Antagonists

Published: July 29, 2021 | Tags: Protagonist, Amendment Agreement, Janssen, IL-23 Antagonists

Viatris and Biocon’s Semglee (biosimilar, insulin glargine) Receive the US FDA’s Approval as the First Interchangeable Biosimilar for Diabetes

Published: July 29, 2021 | Tags: Viatris, Biocon, Semglee, biosimilar, Insulin Glargine, US, FDA, Approval, Diabetes

Regeneron and Sanofi Report Results of Dupixent (dupilumab) in P-III LIBERTY CUPID Clinical Program for Chronic Spontaneous Urticaria

Published: July 29, 2021 | Tags: Regeneron, Sanofi, Dupixent, dupilumab, P-III, LIBERTY CUPID Clinical Program, Chronic Spontaneous Urticaria

Roche Reports the US FDA’s Acceptance of BLA for Faricimab to Treat Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration

Published: July 29, 2021 | Tags: Roche, US, FDA, Acceptance, BLA, Faricimab, Diabetic Macular Edema, Neovascular Age-Related Macular Degeneration

BD Acquires Tepha to Boost its Surgical Mesh Portfolio

Published: July 29, 2021 | Tags: BD, Tepha, Surgical Mesh Portfolio

Arena and Aristea Collaborate to Develop RIST4721 for Treatment of Complicated Immune-Mediated Inflammatory Diseases

Published: July 28, 2021 | Tags: Arena, Aristea, RIST4721, Immune-Mediated Inflammatory Diseases

BridgeBio Enters into Clinical Collaboration with BMS to Evaluate BBP-398 + Opdivo for Advanced Solid Tumors with KRAS Mutations

Published: July 28, 2021 | Tags: BridgeBio, BMS, BBP-398, Opdivo, Advanced Solid Tumors, KRAS Mutations

Sanofi’s Avalglucosidase alfa Receives CHMP’s Positive Opinion for Patients with Pompe Disease

Published: July 28, 2021 | Tags: Sanofi, Avalglucosidase alfa, CHMP, Pompe Disease

AbbVie and Calico Expand its Existing Collaboration to Focus on Aging and Age-Related Diseases

Published: July 28, 2021 | Tags: AbbVie, Calico, Age-Related Diseases

PeptiDream and Takeda Expand its Research and License Agreement to Develop Peptide Drug Conjugates Targeting CNS Diseases

Published: July 28, 2021 | Tags: PeptiDream, Takeda, Peptide Drug Conjugates, CNS Diseases

Amgen to Acquire Teneobio for ~$2.5B

Published: July 28, 2021 | Tags: Amgen, Acquire, Teneobio, ~$2.5B

AstraZeneca and Regeneron Collaborate to Research, Develop and Commercialize Therapies for Obesity

Published: July 27, 2021 | Tags: AstraZeneca, Regeneron, Develop, Commercialize, Therapies, Obesity

BioNTech Plans to Initiate the Clinical Study of Malaria and Tuberculosis Vaccines in 2022

Published: July 27, 2021 | Tags: BioNTech, Malaria, Tuberculosis Vaccines, 2022

Adagio Collaborates with Biocon to Provide COVID-19 Ab Treatment to Patients in India and Other Emerging Markets

Published: July 27, 2021 | Tags: Adagio, Biocon, COVID-19 Ab

GSK’s Shingrix Receives the US FDA’s Approval to Prevent Shingles in Immunocompromised Adults

Published: July 27, 2021 | Tags: GSK, Shingrix, US, FDA, Approval, Shingles, Immunocompromised

Prothena Presents Preclinical Data of its Alzheimer’s Candidates at AAIC 2021

Published: July 27, 2021 | Tags: Prothena, Preclinical Data, Alzheimer Candidates, AAIC 2021

BeiGene’s Brukinsa (Zanubrutinib) Receives Health Canada’s Approval for Mantle Cell Lymphoma

Published: July 27, 2021 | Tags: BeiGene, Brukinsa, Zanubrutinib, Health Canada, Approval, Mantle Cell Lymphoma

PerkinElmer to Acquire BioLegend for $5.25B

Published: July 26, 2021 | Tags: PerkinElmer, Acquire, BioLegend, $5.25B

Denali Reports Results of DNL310 in P-I/II Study in Patients with the Lysosomal Storage Disease Hunter Syndrome (MPS II)

Published: July 26, 2021 | Tags: Denali, DNL310, P-I/II, Study, Lysosomal Storage Disease Hunter Syndrome, MPS II

The US FDA Declines to Approve Incyte’s Retifanlimab to Treat Patients with Squamous Cell Carcinoma of the Anal Canal

Published: July 26, 2021 | Tags: US, FDA, Incyte, Retifanlimab, Squamous Cell Carcinoma, Anal Canal

AbbVie Presents Results of AGN-190584 in P-III GEMINI 1 Study for Presbyopia at 2021 ASCRS

Published: July 26, 2021 | Tags: AbbVie, AGN-190584, P-III, GEMINI 1 Study, Presbyopia, 2021 ASCRS

Alexion’s Ultomiris (ravulizumab) Receives CHMP’s Positive Opinion Recommending its Approval for Children and Adolescents with PNH

Published: July 26, 2021 | Tags: Alexion, Ultomiris, ravulizumab, CHMP, PNH

AstraZeneca’s Vaxzevria Demonstrates Effectiveness After One Dose Against Beta/Gamma and Delta Variants of SARS-CoV-2 Virus

Published: July 26, 2021 | Tags: AstraZeneca, Vaxzevria, Delta Variants, SARS-CoV-2 Virus