AbbVie’s Rinvoq (upadacitinib) Receives the Health Canada Approval for the Treatment of Moderate to Severe Atopic Dermatitis

Published: Oct 8, 2021 | Tags: AbbVie, Rinvoq, upadacitinib, Health Canada, Approval, Atopic Dermatitis

Takeda Receives the US FDA Advisory Committee’s Recommendation for TAK-620 (maribavir) to Treat CMV Infection in Post-Transplant Recipients

Published: Oct 8, 2021 | Tags: Takeda, US, FDA, Advisory Committee, Maribavir, TAK-620, CMV Infection

Allogene Reports the US FDA’s Clinical Hold on ALPHA2 Study of ALLO-501A to Treat Large B Cell Lymphoma

Published: Oct 8, 2021 | Tags: Allogene, US, FDA, Clinical Hold, ALPHA2 Study, ALLO-501A, Large B Cell Lymphoma

Sanofi Signs a Non-Exclusive Clinical Collaboration Agreement with Mirati to Evaluate Adagrasib + SAR442720 (RMC-4630) in P-I/II Study for KRAS G12C-Mutated Lung Cancer

Published: Oct 8, 2021 | Tags: Sanofi, Mirati, Adagrasib, SAR442720, RMC-4630, P-I/II, Study, KRAS G12C-Mutated Lung Cancer

Schrödinger Signs a Two-Year Research Collaboration with MD Anderson to Advance its WEE1 Program

Published: Oct 8, 2021 | Tags: MD Anderson, Schrödinger, WEE1 Program

AbbVie’s Rinvoq (upadacitinib) Met Primary and Secondary Endpoints in P-III SELECT-AXIS 2 Clinical Trial for Non-Radiographic Axial Spondyloarthritis

Published: Oct 8, 2021 | Tags: AbbVie, Rinvoq, upadacitinib, P-III, SELECT-AXIS 2 Clinical Trial, Non-Radiographic Axial Spondyloarthritis

BMS’ Deucravacitinib Fails to Meet its Primary and Secondary Endpoints in P-II LATTICE-UC Study for the Treatment of Moderate to Severe Ulcerative Colitis

Published: Oct 7, 2021 | Tags: BMS, Deucravacitinib, P-II, LATTICE-UC Study, Ulcerative Colitis

Amgen Signs a R&D Collaboration with Neumora to Advance Novel Precision Therapies for Neuropsychiatric and Neurodegenerative Diseases

Published: Oct 7, 2021 | Tags: Amgen, R&D Collaboration, Neumora, Novel Precision Therapies, Neuropsychiatric, Neurodegenerative Diseases

Denali Presented Results of DNL343 and SAR443820 in P-I Clinical Studies for the Treatment of Amyotrophic Lateral Sclerosis at NEALS 2021

Published: Oct 7, 2021 | Tags: Denali, DNL343, SAR443820, P-I, Clinical Study, Amyotrophic Lateral Sclerosis, NEALS 2021

PharmaTher Initiates P-II KET-LID Study of Ketamine for Levodopa-Induced Dyskinesia in Patients with Parkinson’s Disease

Published: Oct 7, 2021 | Tags: PharmaTher, P-II, KET-LID Study, Ketamine, Levodopa-Induced Dyskinesia, Parkinson’s Disease

Sanofi Reports Interim Results of Fluzone High-Dose Quadrivalent Vaccine + COVID-19 mRNA Booster Dose in First Descriptive Study for COVID-19

Published: Oct 7, 2021 | Tags: Sanofi, Fluzone High-Dose Quadrivalent Vaccine, COVID-19 mRNA Booster Dose, Descriptive Study, COVID-19

Pfizer Signs an Option and License Agreement with Voyager to Develop and Commercialize Gene Therapies for Neurologic and Cardiovascular Diseases

Published: Oct 7, 2021 | Tags: Pfizer, Voyager, Gene Therapies, Neurologic, Cardiovascular Diseases

Boston to Acquire Baylis for ~$1.75B

Published: Oct 6, 2021 | Tags: Boston, Acquire, ~$1.75B, Electrophysiology, Structural Heart Product Portfolios

Kaleido Reports Results of KB295 in Clinical and Preclinical Studies for the Treatment of Mild-to-Moderate Ulcerative Colitis

Published: Oct 6, 2021 | Tags: Kaleido, Clinical, KB295, Preclinical Data, Ulcerative Colitis

Novartis’s Adakveo (crizanlizumab) Receives NICE Recommendation as a New Therapy for Sickle Cell Disease

Published: Oct 6, 2021 | Tags: Novartis, Adakveo, crizanlizumab, NICE, Recommendation, Sickle Cell Disease

Sage and Biogen Present Results of Zuranolone in LANDSCAPE and NEST Clinical Development Programs for the Treatment of MDD and PPD at ECNP 2021

Published: Oct 6, 2021 | Tags: Sage, Biogen, Zuranolone, LANDSCAPE, NEST Clinical Development Programs, MDD, PPD, ECNP 2021

Johnson & Johnson Reports EUA Submission to the US FDA for Supporting the Booster of its Single Shot COVID-19 Vaccine Candidate

Published: Oct 6, 2021 | Tags: Johnson & Johnson, EUA, US, FDA, Single Shot, COVID-19 Vaccine Candidate

Inotiv to Acquire Plato BioPharma for ~$15.0M

Published: Oct 6, 2021 | Tags: Inotiv, Acquire, Plato BioPharma, ~$15.0M

Guardant Health Initiates ORACLE Study of Guardant Reveal Blood Test for the Treatment of Early-Stage Cancers

Published: Oct 5, 2021 | Tags: Guardant Health, ORACLE Study, Guardant Reveal Blood Test, Early-Stage Cancers

Xenon’s XEN1101 Meets its Primary Efficacy Endpoint in P-IIb X-TOLE Clinical Trial for the Treatment of Focal Epilepsy

Published: Oct 5, 2021 | Tags: Xenon, XEN1101, P-IIb, X-TOLE Clinical Trial, Focal Epilepsy

Coherus Report Results of CHS-201 (biosimilar, ranibizumab) in COLUMBUS-AMD Clinical Trial for the Treatment of nAMD

Published: Oct 5, 2021 | Tags: Coherus, CHS-201, biosimilar, ranibizumab, COLUMBUS-AMD Clinical Trial, nAMD

AstraZeneca Seeks the US FDA’s EUA for AZD7442 to Treat COVID-19

Published: Oct 5, 2021 | Tags: AstraZeneca, US, FDA, EUA, ZD7442, COVID-19, US

Polpharma Biologics Reports the US FDA’s Acceptance of BQ201’s (biosimilar, ranibizumab) BLA for Review to Treat Wet Age-Related Macular Degeneration

Published: Oct 5, 2021 | Tags: Polpharma Biologics, US, FDA, Acceptance, BQ201, biosimilar, ranibizumab, BLA, Wet Age-Related Macular Degeneration

Takeda Enters into a License Agreement with Selecta to Develop Gene Therapies for the Treatment of Lysosomal Storage Disorders

Published: Oct 5, 2021 | Tags: Takeda, Selecta, Gene Therapies, Lysosomal Storage Disorders

Xencor Enter into an Exclusive WW License Agreement with Janssen to Develop and Commercialize Plamotamab and Xmab CD28 Bispecific Antibody for B-Cell Malignancies

Published: Oct 4, 2021 | Tags: Xencor, Janssen, Plamotamab, Xmab B-Cell, B-Cell Malignancies

ViiV Healthcare Submits Regulatory Applications to the US FDA for a New Dispersible Tablet Formulation of Abacavir/Dolutegravir/Lamivudine to Treat HIV in Children

Published: Oct 4, 2021 | Tags: ViiV Healthcare, US, FDA, Triumeq, abacavir, dolutegravir, lamivudine, Approval, HIV

Janssen Presented Results of RSV Vaccine in P-IIb CYPRESS Study for Lower Respiratory Tract Disease Due to Respiratory Syncytial Virus at IDWeek 2021

Published: Oct 4, 2021 | Tags: Janssen, RSV Vaccine, P-IIb, CYPRESS Study, Lower Respiratory Tract Disease, Respiratory Syncytial Virus, IDWeek 2021

Formycon and Bioeq Report the US FDA’s Acceptance of BLA for FYB201 (biosimilar, ranibizumab)

Published: Oct 4, 2021 | Tags: Formycon, Bioeq, US, FDA, Acceptance, BLA, FYB201, biosimilar, ranibizumab

Merck KGaA and GSK Terminate their ~$4.2B Collaboration Due to Clinical Failures

Published: Oct 4, 2021 | Tags: Merck KGaA, GSK, ~$4.2B,

Kite’s Tecartus Receives the US FDA’s Approval as the First and Only Car T for Adults with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

Published: Oct 4, 2021 | Tags: Kite, Tecartus, US, FDA, Approval, Car T, Refractory B-cell Acute Lymphoblastic Leukemia

Related Post: PharmaShots Weekly Snapshots (September 27 – October 01, 2021)