Kintor Pharma Receives NMPA’s IND Clearance for KX-826 to Treat Male Androgenetic Alopecia (AGA)

Published: Nov 26, 2021 | Tags: Kintor Pharma, NMPA, IND, KX-826, Male Androgenetic Alopecia

Selecta Biosciences’s Reports the US FDA's Clinical Hold on the P-I/II Clinical Trial of SEL-302 for the Treatment of Methylmalonic Acidemia

Published: Nov 26, 2021 | Tags: Selecta Biosciences, US, FDA, Clinical Hold, P-I/II, Clinical Trial, SEL-302, Methylmalonic Acidemia

Aadi Bioscience’s Fyarro Receives US FDA’s Approval for the Treatment of Malignant Perivascular Epithelioid Cell Tumor

Published: Nov 26, 2021 | Tags: Aadi Bioscience, Fyarro, US, FDA, Approval, Malignant, Perivascular Epithelioid Cell Tumor

Johnson & Johnson’s COVID-19 Vaccine Receives Health Canada Approval for the Prevention of COVID-19 in Individuals Aged ≥18 years

Published: Nov 26, 2021 | Tags: Johnson & Johnson, COVID-19 Vaccine, Health Canada, Approval, COVID-19

Chugai’s Herceptin Receives the MHLW’s Approval for the Treatment of Advanced or Recurrent HER2-Positive Salivary Gland Cancer

Published: Nov 26, 2021 | Tags: Chugai, Herceptin, MHLW, Approval, HER2-Positive, Salivary Gland Cancer

Pfizer and BioNTech’s Comirnaty Receive CHMP’s Positive Opinion for the Treatment of COVID-19 in Children Aged 5 To 12 Years

Published: Nov 26, 2021 | Tags: Pfizer, BioNTech, Comirnaty, CHMP, COVID-19

Arctic Vision Reports First Patient Dosing in P-III Study of ARVN001 for the Treatment of Macular Edema Associated with Uveitis (UME)

Published: Nov 25, 2021 | Tags: Arctic Vision, P-III, Study, ARVN001, Macular Edema, Uveitis, UME

BeiGene’s Brukinsa (zanubrutinib) Receives EC’s Approval for the Treatment of Waldenström’s Macroglobulinemia

Published: Nov 25, 2021 | Tags: BeiGene, Brukinsa, zanubrutinib, EC, Approval, Waldenström’s Macroglobulinemia

Janssen Signs an Option Agreement with Philogen to Discover Small Molecule Therapeutics

Published: Nov 25, 2021 | Tags: Janssen, Philogen, Small Molecule Therapeutics

Pfizer Reports Results of Vupanorsen in P-IIb TRANSLATE-TIMI 70 Study for the Treatment of Dyslipidemia

Published: Nov 25, 2021 | Tags: Pfizer, Vupanorsen, P-IIb, TRANSLATE-TIMI 70 Study, Dyslipidemia

Kura Oncology Reports the US FDA's Clinical Hold on the P-Ib Study of KO-539 for the Treatment of Acute Myeloid Leukemia

Published: Nov 25, 2021 | Tags: Kura Oncology, US, FDA, Clinical Hold, P-Ib, Study, KO-539, Acute Myeloid Leukemia

Gilead and Merck Pause Enrollment in P-II Study of Islatravir + Lenacapavir for the Treatment of HIV

Published: Nov 25, 2021 | Tags: Gilead, Merck, P-II, Study, Islatravir, Lenacapavir, HIV

BMS’ Zeposia (ozanimod) Receives EC‘s Approval for the Treatment of Ulcerative Colitis

Published: Nov 24, 2021 | Tags: BMS, Zeposia, ozanimod, EC, Approval, Ulcerative Colitis

Hutchmed and AstraZeneca Initiate P-III SACHI Trial of Orpathys + Tagrisso for the Treatment of Non-Small Cell Lung Cancer

Published: Nov 24, 2021 | Tags: Hutchmed, AstraZeneca, P-III, SACHI Trial, Orpathys, Tagrisso, Non-Small Cell Lung Cancer

Takeda’s Livtencity (maribavir) Receives the US FDA’s Approval for the Treatment of Post-Transplant Patients with Cytomegalovirus Infection

Published: Nov 24, 2021 | Tags: Takeda, Livtencity, maribavir, US, FDA, Approval, Cytomegalovirus Infection

Scynexis Reports Results of Brexafemme (Ibrexafungerp) in P-III VANISH-306 Study for Vaginal Yeast Infection

Published: Nov 24, 2021 | Tags: Scynexis, Brexafemme, Ibrexafungerp, P-III, VANISH-306 Study, Vaginal Yeast Infection

Apollomics Reports First Patient Dosing in P-III Clinical Trial of Uproleselan for the Treatment of AML

Published: Nov 24, 2021 | Tags: Apollomics, P-III, Clinical Trial, Uproleselan, AML

Galapagos Reports Completion of Patient Enrollment in P-II MANGROVE Trial of GLPG2737 for the Treatment of Polycystic Kidney Disease

Published: Nov 24, 2021 | Tags: Galapagos, P-II, MANGROVE Trial, GLPG2737, Polycystic Kidney Disease

Neurocrine Signs a License Agreement with Sosei Heptares to Develop Novel Muscarinic Receptor Agonists for Schizophrenia and Other Neuropsychiatric Disorders

Published: Nov 23, 2021 | Tags: Neurocrine, Sosei Heptares, Muscarinic Receptor Agonists, Schizophrenia, Neuropsychiatric Disorders

Arrowhead Entered into an Exclusive License Agreement with GSK to Develop and Commercialize ARO-HSD for Nonalcoholic Steatohepatitis

Published: Nov 23, 2021 | Tags: Arrowhead, GSK, ARO-HSD, Nonalcoholic Steatohepatitis

Twist Bioscience to Acquire Abveris for ~$190M

Published: Nov 23, 2021 | Tags: Twist Bioscience, Acquire, Abveris, ~$190M

Pfizer and BioNTech Report Results of COVID-19 Vaccine in P-III Trial for the Treatment of COVID-19

Published: Nov 23, 2021 | Tags: Pfizer, BioNTech, COVID-19 Vaccine, P-III, Trial, for COVID-19

Regeneron Entered into a License Agreement with Nykode to Develop Vaccines Against Cancer and Infectious Diseases

Published: Nov 23, 2021 | Tags: Regeneron, Nykode, Vaccines, Cancer, Infectious Diseases

Mirati Signs a Non-Exclusive Clinical Collaboration Agreement with Verastem to Evaluate Adagrasib + VS-6766 for KRASG12C-Mutant NSCLC

Published: Nov 23, 2021 | Tags: Mirati, Verastem, Adagrasib + VS-6766 for KRASG12C-Mutant NSCLC

BridgeBio Entered into a Collaboration with Helsinn to Co-Develop and Co-Commercialize GPX4 Program for Multiple Cancer

Published: Nov 22, 2021 | Tags: BridgeBio, Helsinn, GPX4 Inhibitor, Multiple Cancer

Innovent Presents Results of Sintilimab in P-III ORIENT-31 Study for the Treatment of EGFR-Mutated Non squamous Non-small Cell Lung Cancer at ESMO 2021

Published: Nov 22, 2021 | Tags: Innovent, Sintilimab, P-III, ORIENT-31 Study, EGFR-Mutated, Non squamous, Non-small Cell Lung Cancer, ESMO 2021

CStone Signs an Exclusive License Agreement with Jiangsu Hengrui to Develop and Commercialize CS1002 in Greater China

Published: Nov 22, 2021 | Tags: CStone, Jiangsu Hengrui, CS1002, Greater China

Zenas Acquires Exclusive WW Rights of Xencor's obexelimab for the Treatment of Autoimmune Diseases

Published: Nov 22, 2021 | Tags: Zenas, Acquires, Xencor, obexelimab, Autoimmune Diseases

Gilead Submits BLA to US FDA for Bulevirtide to Treat Chronic Hepatitis Delta Virus Infection

Published: Nov 22, 2021 | Tags: Gilead, BLA, US, FDA, Bulevirtide, Chronic Hepatitis Delta Virus Infection

UCB Reports Interim Results of Bimekizumab in P-III BE OPTIMAL Study for the Treatment of Active Psoriatic Arthritis

Published: Nov 22, 2021 | Tags: UCB, Bimekizumab, P-III, BE OPTIMAL Study, Active Psoriatic Arthritis

Related post: PharmaShots Weekly Snapshots (November 15-19, 2021)