Month: October 2021

Arch Therapeutics Provides Corporate Update

10/21/2021

90-Day Report Card for Commercialization Effort Excerpt from the Press Release: FRAMINGHAM, Mass., Oct. 13, 2021 (GLOBE NEWSWIRE) — Arch Therapeutics, Inc. (OTCQB: ARTH) (“Arch” or the “Company”), a marketer and developer of novel self-assembling wound care and biosurgical devices, today provided a corporate update at the LD Micro Main Event XIV investor conference in…

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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…

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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…

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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…

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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…

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NeuroBo Pharmaceuticals Announces Positive Recommendation from Independent Data Safety Monitoring Committee of Phase 2/3 Clinical Trial of ANA001 in Hospitalized Patients with Moderate to Severe COVID-19

10/19/2021

Committee Advises Continuation of Trial Without Modification Excerpt from the Press Release: BOSTON, Oct. 13, 2021 /PRNewswire/ — NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal disease-modifying therapies for viral, neuropathic and neurodegenerative diseases, today announced that an independent Data Monitoring Committee (DMC) reviewed safety data from 36 patients treated in the Phase…

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Twist Bioscience and the Broad Institute Create Custom Whole Exome Target Enrichment Panel for Clinical Research

10/19/2021

– Twist Bioscience to Offer Clinically Validated, Expert-Designed Exome Panel that Enriches Loci Relevant to Cancer, Rare and Inherited Diseases – Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, today announced an…

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Viridian Therapeutics Submits Investigational New Drug Application for VRDN-001, an IGF-1R antibody for the treatment of Thyroid Eye Disease, to the U.S. Food and Drug Administration

10/18/2021

– VRDN-001 program remains on track for key proof of concept clinical data in Thyroid Eye Disease patients in the second quarter of 2022 – Excerpt from the Press Release: WALTHAM, Mass., Oct. 14, 2021 (GLOBE NEWSWIRE) — Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical company advancing new treatments for patients suffering from serious diseases…

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Inhalable anti-COVID-19 antibody from TFF and Augmenta tamps down viral load in hamsters

10/18/2021

Excerpt from the Press Release: When startup TFF Pharmaceuticals raised $14 million in a series A in 2018, its intention was to deploy its dry-powder drug-delivery technology toward making novel inhalable therapies for asthma, chronic obstructive pulmonary disease and other serious lung diseases. Then COVID-19 hit, and the company saw an opportunity to apply the…

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Sacituzumab Govitecan Receives Positive CHMP Opinion as 2L Treatment for Adult Patients With Metastatic Triple-Negative Breast Cancer

10/18/2021

— Recommendation is Based on the Phase 3 ASCENT Study Showing that Sacituzumab Govitecan Significantly Improved Overall Survival in 2L vs. Physician’s Choice of Chemotherapy in Metastatic Triple-Negative Breast Cancer — — Sacituzumab Govitecan Could Offer a New Treatment Option for an Aggressive Type of Metastatic Breast Cancer if Approved — Excerpt from the Press…

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