G Medical: patent issuance from USPTO for vital signs sensors

 G Medical Innovations Holdings Ltd. (Nasdaq: GMVD) (the “Company” or “G Medical Innovations”) today announced that it has received a patent issue notification from the United States Patent and Trademark Office (“USPTO”) for its monitoring products marketed in the United States. The patent, expected to be issued on February 7, 2023, Method and System for Vital Signs Monitoring with Earpiece, covers the vital signs monitoring system that the Company is developing using multiple sensing mechanisms to be used on different body locations. This vital sign monitoring system will potentially provide physicians more versatility in patients’ monitoring and would simplify in and out-patients’ monitoring.

Together with the two patents received in December 2022, G Medical Innovations continues to strengthen its position in the market with its unique technologies and services. The Company believes that obtaining these patents places the Company at the forefront of the industry and provides the Company a significant advantage over its competitors, specifically with regards to accurate monitoring of patients. This will potentially allow the Company to increase the market size for its products and its monitoring services.

https://finance.yahoo.com/news/g-medical-innovations-announces-receiving-111500706.html

Edwards cut to Neutral from Overweight by Piper

 Target to $80 from $95

https://finviz.com/quote.ashx?t=EW&ty=c&ta=1&p=d

Xeris: Orphan-drug Exclusivity for Recorlev

 Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced that the Food and Drug Administration (FDA) granted its subsidiary Xeris Pharmaceuticals, Inc., orphan-drug exclusivity (ODE) for Recorlev® (levoketoconazole) for the treatment of adult patients with endogenous Cushing’s syndrome for whom surgery is not an option or has not been curative.

As the first approval of levoketoconazole (Recorlev) for Cushing’s syndrome, Xeris is entitled to seven years of orphan-drug market exclusivity from its FDA approval date of December 30, 2021. The FDA's Orphan Drug Designation program is designed to advance the development of drugs that treat a condition affecting 200,000 or fewer U.S. patients annually. This regulatory exclusivity is in addition to the patent exclusivity under Xeris’ U.S. patents covering Recorlev and its therapeutic use, which extends to at least March 2040.

https://finance.yahoo.com/news/xeris-biopharma-announces-fda-grants-120000141.html

Moderna: Breakthrough Therapy Designation for mRNA RSV Vax

 Designation based on positive topline data from the ConquerRSV Phase 3 pivotal efficacy trial, which demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease, defined by 2 or more symptoms in older adults

https://finance.yahoo.com/news/moderna-granted-fda-breakthrough-therapy-121500939.html

Aethlon: Contract with NAMSA to Advance Hemopurifier Clinical Programs in Cancer

 Aethlon Medical, Inc. (Nasdaq: AEMD), a company developing medical technology to treat cancer and life-threatening infectious diseases, today announced that it has entered into an agreement with NAMSA, a world leading MedTech Contract Research Organization (CRO) offering global end-to-end development services to oversee the company's clinical trials investigating the Hemopurifier, Aethlon's immunotherapeutic device , for oncology indications.

Pursuant to the agreement, NAMSA will manage Aethlon's study of the Hemopurifier for patients in the United States and Australia with various types of cancer tumors. It is anticipated the initial clinical trials will begin in Australia.

https://finance.yahoo.com/news/aethlon-medical-announces-contract-namsa-130100837.html

Vera Atacicept Dose Group Achieved Delta of 48% Versus Placebo

 Vera continuing plans to rapidly advance atacicept into a pivotal Phase 3 trial in 1H 2023; full data to be presented at upcoming medical congresses

Company plans to prioritize and focus current resources on the advancement of atacicept in IgA Nephropathy into a pivotal Phase 3 trial, extending cash runway to Q4 2024

Conference call and webcast to take place on January 30th at 8:00am ET

Vera will host a conference call and webcast with slide presentation at 8:00 a.m. ET on January 30, 2023. The live webcast will be available here, and on the Events & Presentations page of the Vera website, with the recording and presentation available immediately following the event.

https://finance.yahoo.com/news/vera-therapeutics-releases-36-week-110000414.html

CureVac Positive Data in Older Adults from COVID-19 and Flu mRNA Vaccine Development

 

• Continued technology platform validation with extended preliminary data from older adults in ongoing Phase 1 studies in COVID-19 and flu

• COVID-19: monovalent modified mRNA construct CV0501 successfully boosted antibody titers against BA.1 and ancestral variants in adults age ≥65

• Flu: monovalent modified mRNA construct Flu-SV-mRNA elicited antibodies approximately 2.3 times those of licensed vaccine comparator in adults aged 60-80

• Reaffirming plan to advance modified mRNA COVID-19 and flu candidates to the next stages of clinical development in collaboration with GSK in 2023

https://finance.yahoo.com/news/curevac-announces-positive-data-older-133000416.html