Biotechnology

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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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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Amunix Presents Preclinical Data on Its XPAT T Cell Engager Platform at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics

10/14/2021

– AMX-818, an HER2-targeted T cell engager (TCE), is the lead program in Amunix’s XPAT® (XTENylated Protease-Activated TCE) platform designed to improve the therapeutic index of TCEs for the treatment of patients with solid tumors. – The collective preclinical data indicate that AMX-818 is effective in driving anti-tumor responses, yet has significantly lower toxicity than its unmasked HER2 TCE counterpart. This…

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India’s Bharat Biotech submits data on COVID-19 drug trial in children

10/11/2021

Excerpt from the Press Release: BENGALURU, Oct 6 (Reuters) – Bharat Biotech said on Wednesday it had submitted data from its COVID-19 vaccine trial in children aged 2 to 18 years to India’s drug regulator, becoming the country’s first company to have tested its shot in very young children. The South Asian country is turning…

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Inflammasome Therapeutics’ Kamuvudines Continue to Show Promise for Future Treatment – and Potentially a Cure – for Blindness in Seniors

10/07/2021

New research published today in Science Advances describes precise mechanism of how Alu reverse transcription occurs from RNA to cDNA, and its subsequent triggering of inflammasome activation and consequent cell death in Geographic Atrophy (GA) – the most severe form of dry age-related macular degeneration. Research shows Alu RNA/cDNA reverse transcription confined to rim of…

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Phil Announces Partnership with Impel NeuroPharma in Support of Trudhesa™ (dihydroergotamine mesylate) Nasal Spray for the Acute Treatment of Migraine

10/06/2021

Excerpt from the Press Release: SAN FRANCISCO, Sept. 29, 2021 /PRNewswire/ — Phil, Inc. announces partnership with Impel NeuroPharma, Inc. (NASDAQ: IMPL) in support of Trudhesa™ (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) to provide technology-powered patient support and distribution services through Phil’s proprietary workflow to enhance the patient’s access to therapy. Trudhesa is indicated for the acute treatment of…

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Arch Therapeutics Announces Appointment of Larry Hicks to the Board

10/06/2021

Brings deep industry experience to support commercialization plan Excerpt from the Press Release: FRAMINGHAM, Mass., Sept. 30, 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 announced the appointment of Larry Hicks to its Board of Directors. Mr.…

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Scientists use AI to create drug regime for rare form of brain cancer in children

10/01/2021

Scientists have successfully used artificial intelligence to create a new drug regime for children with a deadly form of brain cancer that has not seen survival rates improve for more than half a century. The breakthrough, revealed in the journal Cancer Discovery, is set to usher in an “exciting” new era where AI can be harnessed to…

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COVID-19 Vaccine Developed by Clover Biopharmaceuticals Using Dynavax’s CpG 1018 Adjuvant Meets Primary and Secondary Efficacy Endpoints in Global Phase 2/3 Trial

10/01/2021

– Global Phase 2/3 SPECTRA Trial enrolled over 30,000 adult and elderly participants across 4 continents; 100% of SARS-CoV-2 strains observed in efficacy analysis were variants– 100% efficacy against severe COVID-19 and hospitalizations, and 84% efficacy against moderate-to-severe COVID-19 caused by any strain of SARS-CoV-2– Favorable safety profile; no significant differences in systemic adverse events…

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Elicio Therapeutics Presents Updated Preclinical Data at the 2021 Vaccines Summit Demonstrating that ELI-005, a Lymph Node Targeted Amphiphile Vaccine, Induces Potent Cellular and Humoral Immunity to SARS-CoV-2

09/30/2021

ELI-005, containing the Amphiphile vaccine adjuvant AMP-CpG, induced >25-fold higher antigen-specific T cells in the peripheral blood and exhibited potent killing of antigen-positive targets in vivo that were maintained for >5 months after vaccination Vaccine responses were highly cross-reactive to SARS-CoV-2 variants of concern Antibody responses favored TH1 isotypes with titers 265-fold higher than natural convalescent patient…

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