Announcements

ONO PHARMA USA Announces Initiation of Phase 1 Study of ONO-4685, an Anti-PD-1/CD3 Bispecific Antibody, in Patients with Relapsed or Refractory T-cell Lymphoma in the U.S

10/25/2021

Excerpt from the Press Release: CAMBRIDGE, Mass., Oct. 19, 2021 /PRNewswire/ — ONO PHARMA USA, INC. (President and CEO, Kunihiko Ito) announced the initiation of a Phase 1 study of ONO-4685, an anti-PD-1/CD3 bispecific antibody, in patients with relapsed or refractory T-cell Lymphoma in the U.S. This study is a multicenter, open label, dose escalation Phase 1 study to…

Read More

VistaGen Therapeutics Expands Clinical Development of PH94B with Initiation of Phase 2A Trial in Adjustment Disorder

10/22/2021

Study Launches Phase 2A Clinical Program Designed to Explore PH94B’s Potential in Multiple Additional Anxiety Disorders Phase 2A Study in Adjustment Disorder to Run in Parallel with Ongoing Phase 3 Studies in Acute Treatment of Social Anxiety Disorder Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Oct. 14, 2021 (GLOBE NEWSWIRE) — VistaGen Therapeutics, Inc.…

Read More

Immune-Onc Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating IO-108, a Novel Antagonist Antibody Targeting LILRB2 (ILT4), in Patients With Advanced Solid Tumors

10/22/2021

– Multicenter Phase 1 study to evaluate IO-108 as monotherapy and in combination with an anti-PD-1 – – IO-108 is Company’s second program to advance to clinic – Excerpt from the Press Release: PALO ALTO, Calif.–(BUSINESS WIRE)–Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, today announced that…

Read More

“Pre-IPO” Biotech Startup Kills Advanced Stage Breast Cancers; Accepts Global Crowdfunding Investors

10/22/2021

Excerpt from the Press Release: SAN FRANCISCO, Oct. 14, 2021 /PRNewswire/ — In recognition of Breast Cancer Awareness Month, DeoBioSciences, Inc. (“DBS”), a minority/female founded, preclinical stage, biotech company, is highlighting its impressive research results against several types of treatment-resistant breast cancer. DeoBioSciences’ drug candidate, DBX-31, can selectively target and kill a wide range of tough, treatment-resistant, advanced…

Read More

TFF Pharmaceuticals and Augmenta Bioworks Publish Positive In Vivo Data Showing Dry Powder Formulation of COVID-19 Antibody, AUG-3387, Neutralizes SARS-CoV-2 Infection and Reduces Viral Load

10/21/2021

Results published in bioRxiv Show That Delivery of Dry Powder AUG-3387 Following Viral Inoculation Led to Dose-Dependent Reduction in Lung Viral Load in Hamsters Dry Powder Formulations Show Equivalent Binding as Original Antibody with No Loss of Biologic Activity Study Indicates AUG-3387 Binds to Both Lambda and Mu Variants of SARS-CoV-2 Excerpt from the Press Release: AUSTIN,…

Read More

Benchmark Genome Study Demonstrates Accuracy of Artificial Intelligence in Rapidly Diagnosing Rare Diseases in Critically Ill Patients

10/21/2021

Pivotal study led by Fabric Genomics and Rady Children’s Institute for Genomic Medicine demonstrates that artificial intelligence can enable the accurate and rapid clinical diagnosis of rare diseases in critically ill newborns based on whole-genome or whole-exome analyses Excerpt from the Press Release: OAKLAND, Calif. & SAN DIEGO, Calif.–(BUSINESS WIRE)–Fabric Genomics and Rady Children’s Institute…

Read More

Agilent Receives FDA Companion Diagnostic Approval for Ki-67 IHC MIB-1 pharmDx in High-Risk Early Breast Cancer

10/20/2021

Excerpt from the Press Release: Agilent Technologies Inc. (NYSE: A) today announced its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is now FDA approved as an aid in identifying patients with early breast cancer (EBC) at high risk of disease recurrence, for whom adjuvant treatment with Verzenio® (abemaciclib) in combination with endocrine therapy is being considered. This…

Read More

First Patient Enrolled in U.S. STAR-T Pivotal Trial Evaluating the DrugSorb-ATR™ Antithrombotic Removal System to Remove Ticagrelor During Cardiothoracic Surgery

10/20/2021

Excerpt from the Press Release: MONMOUTH JUNCTION, N.J., Oct. 14, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced today that the first patient has been enrolled in the Safe and Timely Antithrombotic Removal-Ticagrelor (STAR–T) double-blind, randomized, controlled clinical trial designed to support…

Read More

Moderna Announces FDA Advisory Committee Unanimously Votes in Support of Emergency Use for a Booster Dose of Moderna’s COVID-19 Vaccine in the U.S.

10/20/2021

Positive unanimous vote for mRNA-1273 booster at the 50 µg dose level for individuals aged 65 and older as well as individuals aged 18 through 64 at high risk of contracting COVID-19 at least 6 months after completion of the primary series Company estimates that booster at the 50 µg dose level could result in…

Read More

Rhythm Pharmaceuticals Presents New Data on Experience of People Living with Rare Genetic Diseases of Obesity and Provides Updates on Uncovering Rare Obesity® Genetic Testing Program

10/19/2021

— New data in patients with POMC or LEPR deficiency obesity show setmelanotide led to clinically meaningful improvements in health related quality of life measures and hunger — — Updated results from Uncovering Rare Obesity® testing program suggest up to 64.5 percent of individuals with early-onset, severe obesity may carry variants linked to rare genetic diseases of…

Read More