US Foods

Frost & Sullivan Recognizes Neuromod Devices with the 2023 New Product Innovation Award for Developing a Robust Solution That Meets Tinnitus Patients' Needs

Retrieved on: 
Wednesday, October 18, 2023
FDA, Frost, Albornoz, Conditional sentence, US Foods, Acquisition, Research, RWE, ROI, Quality of life, Clinical trial, Tinnitus, Overalls, Patient, SAN, Medical device, Dentistry, Pharmaceutical industry

SAN ANTONIO, Oct. 18, 2023 /PRNewswire/ -- Frost & Sullivan recently researched the neuromodulation devices for tinnitus space and, based on its findings, recognizes Neuromod Devices (Neuromod) with the 2023 North American New Product Innovation Award. Neuromod is a medical technology company focused on designing and developing bimodal neuromodulation solutions that address the growing clinical needs of patients with tinnitus.

Key Points: 
  • Neuromod Devices uniquely leverages its sophisticated technology to meet tinnitus patients' dynamic needs and strict global regulatory requirements for medical devices.
  • SAN ANTONIO, Oct. 18, 2023 /PRNewswire/ -- Frost & Sullivan recently researched the neuromodulation devices for tinnitus space and, based on its findings, recognizes Neuromod Devices (Neuromod) with the 2023 North American New Product Innovation Award.
  • Neuromod is a medical technology company focused on designing and developing bimodal neuromodulation solutions that address the growing clinical needs of patients with tinnitus.
  • Neuromod has delivered a groundbreaking medical device and services that support healthcare professionals to achieve exceptional clinical outcomes for their tinnitus patients.

BrainStorm Cell Therapeutics to Meet with US FDA to Discuss Development Plan for NurOwn as a Treatment of ALS

Retrieved on: 
Wednesday, October 18, 2023
FDA, Trial of the century, Food, Biologics license application, Therapy, Prejudice, US Foods, Brainstorm, ALS, Clinical trial, BLA, Pharmaceutical industry

NEW YORK, Oct. 18, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the US Food and Drug Administration (FDA) has invited the Company to request an expedited face-to-face meeting to discuss the path forward for NurOwn® as a treatment for amyotrophic lateral sclerosis (ALS). BrainStorm remains committed to the ALS Community and is actively exploring the next steps in support of NurOwn, including publication of emerging clinical data and development of a protocol for an additional clinical study. 

Key Points: 
  • BrainStorm remains committed to the ALS Community and is actively exploring the next steps in support of NurOwn, including publication of emerging clinical data and development of a protocol for an additional clinical study.
  • "We look forward to working with the FDA to define the path forward.
  • Brainstorm is withdrawing the Biologics License Application (BLA) for NurOwn.
  • The decision to withdraw the BLA was coordinated with FDA and is viewed by FDA as a withdrawal without prejudice.

NeuroPace Announces RNS System Enhancements Designed to Streamline Care

Retrieved on: 
Tuesday, October 17, 2023
Physician, Quality of life, RNS, TRM, Food, Health, Epilepsy, Responsive neurostimulation device, US Foods, Workflow, Quality, Patient, Medical device, Nursing

MOUNTAIN VIEW, Calif., Oct. 17, 2023 (GLOBE NEWSWIRE) -- NeuroPace, Inc. (Nasdaq: NPCE), a commercial-stage medical device company focused on transforming the lives of people living with epilepsy, today announced a series of key enhancements to its RNS System, all designed to streamline care. The nSight Platform, Simple Set Programming, and the Tablet Remote Monitor are all designed to simplify the experience with the RNS System for both clinicians and patients, and to improve patient care.

Key Points: 
  • The nSight Platform, Simple Set Programming, and the Tablet Remote Monitor are all designed to simplify the experience with the RNS System for both clinicians and patients, and to improve patient care.
  • The RNS System is the only commercially available closed-loop system for the treatment of drug-resistant focal epilepsy.
  • By continuously monitoring brain activity, the RNS System can detect abnormal activity and respond to that activity before it results in a clinical seizure.
  • The RNS System then records those events, allowing the clinician to use the data to actively manage patient care.

Villa Dolce Artisan Desserts Opens Brand New Manufacturing and Storage Facility in Arizona

Retrieved on: 
Tuesday, October 17, 2023
Dot, Ice cream, Collection, Creativity, Sysco, US Foods

GLENDALE, Ariz., Oct. 17, 2023 /PRNewswire/ -- Villa Dolce Artisan Desserts, the premier producer of artisanal gelato and sorbetto in the United States, announces the grand opening of its new manufacturing facility in Glendale, AZ. Built on eight acres, the 76,000 square foot facility will feature 18,000 square feet of cold storage with room for future expansion.

Key Points: 
  • Built on eight acres, the 76,000 square foot facility will feature 18,000 square feet of cold storage with room for future expansion.
  • In addition, the cold storage area holds approximately 1,700 palettes or half a million gallons of gelato.
  • As the largest national wholesale gelato brand with over 200 distributors nationwide, offering cold storage helps ensure uncompromised quality to its co-packing customers.
  • These flavors, called Dolce Gold, deliver an unforgettable sensory experience, featuring flavor combinations and reserve ingredients not found anywhere else.

Burning Rock Received Breakthrough Device Designation from China’s NMPA for its Multi-Cancer Early Detection Test

Retrieved on: 
Monday, October 16, 2023
Food, Annals of Oncology, NGS, Risk, National Medical Products Administration, Ageing, Cancer, Rock, US Foods, FDA, LSE, Nucleic acid thermodynamics, NMPA, US FDA, Medical imaging, Water Drops on Burning Rocks

GUANGZHOU, China, Oct. 15, 2023 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”) is pleased to announce that followed an earlier Breakthrough Device Designation granted by the US Food and Drug Administration (FDA) for its OverC™ Multi-Cancer Detection Blood Test (MCDBT) in January 2023, its OverC™ MCDBT has been granted Breakthrough Device Designation by the China National Medical Products Administration(NMPA), which represents the only test globally that has received Breakthrough Device Designation from both US FDA and China NMPA.

Key Points: 
  • GUANGZHOU, China, Oct. 15, 2023 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”) is pleased to announce that followed an earlier Breakthrough Device Designation granted by the US Food and Drug Administration (FDA) for its OverC™ Multi-Cancer Detection Blood Test (MCDBT) in January 2023, its OverC™ MCDBT has been granted Breakthrough Device Designation by the China National Medical Products Administration(NMPA), which represents the only test globally that has received Breakthrough Device Designation from both US FDA and China NMPA.
  • OverC™ MCDBT is intended for early detection of multiple cancer types in adults of either sex, aged 50-75 years old, at average risk for cancer.
  • Mr. Yusheng Han, founder and CEO of Burning Rock, said, “We are very inspired that our multi-cancer early detection product has received recognition from both US and China regulatory authorities.
  • We obtained our first Breakthrough Device Designation from China NMPA in 2016 for NGS-based therapy selection test, and the China NMPA Breakthrough Device Designation granted for OverC™ MCDBT would pave the way for a clearer registration path through confirmative performance validation and utility establishment.

Alvotech Provides Update on Status of U.S. Biologics License Application for AVT04

Retrieved on: 
Thursday, October 12, 2023
Ustekinumab, BLA, Johnson & Johnson, US Foods, FDA, CRL, Patient, Generic drug, Pharmaceutical industry, Teva

No other deficiencies in the application were noted by the FDA.

Key Points: 
  • No other deficiencies in the application were noted by the FDA.
  • Alvotech intends to resubmit the BLA for AVT04 to the FDA shortly, which would likely trigger a six-month review period and a new Biosimilar User Fee Act (BsUFA) goal date.
  • “AVT04 has recently been approved in Japan, and other marketing applications for AVT04 are currently awaiting approval in other major markets.
  • In June 2023 Alvotech and Teva, the exclusive commercialization partner for AVT04 in the U.S., reached a settlement and license agreement with Johnson & Johnson, that grants an entry date for AVT04 in the U.S. no later than February 21, 2025.

GAUGE INTERWOOD LOGISTICS COMMENCES CONSTRUCTION

Retrieved on: 
Tuesday, October 10, 2023
Gauge, Greystar Real Estate Partners, Senior, ESFR, John F. Kennedy Boulevard, FedEx, US Foods, LED, Tenant, George Bush Intercontinental Airport, CBRE, Goodman, Hardy Toll Road, USPS, Life, Sale, Rail freight transport

HOUSTON, Oct. 10, 2023 (GLOBE NEWSWIRE) -- Gauge Real Estate Partners, a precision developer of premier commercial projects, has commenced construction on another Class A, stand-alone industrial building known as Gauge Interwood Logistics.

Key Points: 
  • HOUSTON, Oct. 10, 2023 (GLOBE NEWSWIRE) -- Gauge Real Estate Partners, a precision developer of premier commercial projects, has commenced construction on another Class A, stand-alone industrial building known as Gauge Interwood Logistics.
  • With an ideal position at the intersection of Interwood South Parkway and Heathrow Forest Parkway, Gauge Interwood Logistics sits on 6.94 acres and is the last developable tract within the 440-acre park.
  • “We are thrilled to commence construction on Gauge Interwood Logistics during a turbulent period within the capital markets, and we could not be more pleased with the project’s design and construction progress to date,” said Brian Attaway, Principal at Gauge.
  • “Gauge Interwood Logistics offers a unique lease or sale optionality for a best-in-class asset in the premier North Houston Interwood Business Park.

Verona Pharma to Host Investor Update on Commercialization Preparation for Ensifentrine on October 18, 2023

Retrieved on: 
Friday, October 6, 2023
FCCP, COPD, VRNA, US Foods, FDA, Maintenance, Patient, Pharmaceutical industry, MD

LONDON and RALEIGH, N.C., Oct. 06, 2023 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces it will hold an Investor Update in New York City for investors and analysts on Wednesday, October 18, 2023, from 8:00 - 10:00 AM ET.

Key Points: 
  • LONDON and RALEIGH, N.C., Oct. 06, 2023 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces it will hold an Investor Update in New York City for investors and analysts on Wednesday, October 18, 2023, from 8:00 - 10:00 AM ET.
  • In September 2023, the US Food and Drug Administration (“FDA”) accepted for review Verona Pharma’s New Drug Application (“NDA”) seeking approval for ensifentrine for the maintenance treatment of patients with COPD.
  • In-person attendance for the event will be by invitation only.
  • A live audio webcast of the event will be available on the Events and Presentations link on the Investors page of the Company’s website, www.veronapharma.com .

Life Science Outsourcing, Inc. Welcomes Neil A. Goldman as Chief Financial Officer

Retrieved on: 
Tuesday, October 17, 2023
APTV, Senior, Antibody, NYSE, Aptiv, CPH, Acquisition, EBITDA, LSO, Fortune 500, Delphi, US Foods, Electronics, Kidney, Growth, Ernst & Young, Accredited Business Accountant, Contract manufacturing organization, Ernst, Executive, Miami University, Corporate development, CFO, CPA, Pharmaceutical industry, Management, Unwired

BREA, Calif., Oct. 17, 2023 /PRNewswire/ -- Life Science Outsourcing, Inc. ("LSO"), a premier contract manufacturer and value-added service provider for the medical device and life science sectors, announces the appointment of Neil A. Goldman, CPA, as its new Chief Financial Officer ("CFO"), effective October 16, 2023.

Key Points: 
  • BREA, Calif., Oct. 17, 2023 /PRNewswire/ -- Life Science Outsourcing, Inc. ("LSO"), a premier contract manufacturer and value-added service provider for the medical device and life science sectors, announces the appointment of Neil A. Goldman, CPA, as its new Chief Financial Officer ("CFO"), effective October 16, 2023.
  • Mr. Goldman joins LSO from BioPorto A/S (CPH:BIOPOR), a global developer and manufacturer of kidney diagnostics and a portfolio of antibodies.
  • CEO John Nino commented on the appointment, stating, "We are excited to welcome Neil to our executive team.
  • At Unwired, a hi-tech, tier-1 automotive electronics manufacturer, he held positions including Executive Vice President-Corporate Development and CFO, and Senior Vice President-Chief Operating & Financial Officer.

Dr. Raza Bokhari, Former Executive Chairman and CEO of FSD Pharma, Provides Litigation Update

Retrieved on: 
Monday, October 16, 2023
Bias, Arbitration, Court, Arbitral tribunal, Drug development, US Foods, FDA, Arbitration award, FSD, Section 11 of the Canadian Charter of Rights and Freedoms, Blake, Cassels & Graydon

Files a Motion For Leave Of Court and raises concern over investment strategy of FSD Pharma

Key Points: 
  • Philadelphia, Pennsylvania--(Newsfile Corp. - October 16, 2023) - Dr. Raza Bokhari, the former CEO and Executive Chairman of FSD Pharma intends to challenge the fairness of the Court proceedings recently held in Toronto, Canada.
  • Counsels for Dr. Bokhari have filed a motion for leave to appeal the recent decision of the Commercial List Court.
  • The purpose of the appeal is to set aside the Arbitral Award issued by Arbitrator J. Douglas Cunningham in November 2022, relating to FSD Pharma's termination of Dr. Bokhari's employment.
  • The non-disclosure is contrary to the Arbitrator's disclosure obligations under Section 11 of the Ontario Arbitration Act, 1991, S.O.