Breakthrough

Breakthrough Institute Appoints Varun Sivaram to Board of Directors

Retrieved on: 
Monday, July 10, 2023
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BERKELEY, Calif., July 10, 2023 (GLOBE NEWSWIRE) -- The Breakthrough Institute , a global research center that identifies and promotes technological solutions to environmental and human development challenges, is pleased to announce the appointment of Varun Sivaram to its Board of Directors.

Key Points: 
  • BERKELEY, Calif., July 10, 2023 (GLOBE NEWSWIRE) -- The Breakthrough Institute , a global research center that identifies and promotes technological solutions to environmental and human development challenges, is pleased to announce the appointment of Varun Sivaram to its Board of Directors.
  • Mr. Sivaram has been a board member or advisor for the United Nations, the World Economic Forum, Stanford's Woods Institute and Precourt Institute, the Aspen Institute, ITIF, the Energy for Growth Hub, and the cities of Los Angeles and New York City.
  • “We have been fellow travelers with Varun for years, and we’re really excited to now have him on our board,” said Breakthrough’s Executive Director Ted Nordhaus.
  • Previously, Varun has offered counsel on Breakthrough Institute research projects, spoken on panels at Breakthrough events, and been published in the Breakthrough Journal.

AVITA Medical Submits FDA PMA Supplement for RECELL GO

Retrieved on: 
Thursday, June 29, 2023
Avita Medical, AVH, ASX, AC, Regenerative medicine, PMA, FDA, Health, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Breakthrough, Food, Medical device, Pharmaceutical industry

The supplement follows the original PMA of its RECELL Autologous Cell Harvesting Device and subsequent PMA supplements.

Key Points: 
  • The supplement follows the original PMA of its RECELL Autologous Cell Harvesting Device and subsequent PMA supplements.
  • With its innovative capabilities, RECELL GO revolutionizes the current, manually operated RECELL device by eliminating the need for manual management of skin samples.
  • “This step is pivotal to advancing our platform and strategic growth plans,” said Jim Corbett, Chief Executive Officer of AVITA Medical.
  • Authorized for release by the Chief Executive Officer of AVITA Medical, Inc.

FDA Grants De Novo Marketing Authorization for KidneyIntelX.dkd to Assess Risk of Progressive Kidney Function Decline in Adults with Diabetes and Early-Stage Kidney Disease

Retrieved on: 
Thursday, June 29, 2023
Insurance, LSE, LDT, De novo, Icahn School of Medicine at Mount Sinai, Marketing, Intelligence, Mount Sinai, Biomarker, SALT, Medicare, Patient, Risk, Laboratory developed test, Artificial intelligence, Diabetic nephropathy, Chronic kidney disease, FDA, Health insurance coverage in the United States, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Breakthrough, Food, Kidney disease, Pharmaceutical industry, Medical device

LONDON and SALT LAKE CITY, June 29, 2023 (GLOBE NEWSWIRE) -- Renalytix plc (LSE: RENX) (NASDAQ:RNLX) announces that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for its KidneyIntelX.dkd ™ prognostic test. This affirms KidneyIntelX as a first-in-class, artificial intelligence enabled prognostic testing platform to guide care management for adults with type 2 diabetes and early-stage chronic (diabetic) kidney disease. Renalytix believes FDA authorization will lead to increasing test adoption, informing clinical guidelines, expanding insurance coverage, and pursuing additional international regulatory approvals.

Key Points: 
  • This affirms KidneyIntelX as a first-in-class, artificial intelligence enabled prognostic testing platform to guide care management for adults with type 2 diabetes and early-stage chronic (diabetic) kidney disease.
  • Renalytix believes FDA authorization will lead to increasing test adoption, informing clinical guidelines, expanding insurance coverage, and pursuing additional international regulatory approvals.
  • This result provides comprehensive information on patient risk for progressive decline in kidney function within five years, independently of the current standard of care measures.
  • KidneyIntelX.dkd is the name used to differentiate tests to be provided under the De Novo marketing authorization by the FDA from those provided under the KidneyIntelX name as a Laboratory Developed Test.

FDA Accepts Pfizer’s Application for Hemophilia B Gene Therapy Fidanacogene Elaparvovec

Retrieved on: 
Tuesday, June 27, 2023
Biotechnology, Pharmaceutical, Health, Inc., Duchenne muscular dystrophy, European Medicines Agency, PFE, ABR, Haemophilia, Pfizer, FIX, Duchenne, AAV, EMA, Patient, Breakthrough, PDUFA, MAA, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, BLA, NYSE, Food, Pharmaceutical industry

Fidanacogene elaparvovec is a novel, investigational gene therapy that contains a bio-engineered adeno-associated virus (AAV) capsid (protein shell) and a high-activity variant of human coagulation Factor IX (FIX) gene.

Key Points: 
  • Fidanacogene elaparvovec is a novel, investigational gene therapy that contains a bio-engineered adeno-associated virus (AAV) capsid (protein shell) and a high-activity variant of human coagulation Factor IX (FIX) gene.
  • “Gene therapy marks a new era of scientific advancement, and if approved, we believe fidanacogene elaparvovec has the potential to transform the lives of people living with hemophilia B who are eligible for treatment.
  • Fidanacogene elaparvovec has been granted Breakthrough, Regenerative Medicines Advanced Therapy (RMAT) and orphan drug designations from the FDA.
  • Pfizer currently has three Phase 3 programs investigating gene therapy in populations where there is a high unmet need: hemophilia B, hemophilia A, and Duchenne muscular dystrophy.

94% of transportation professionals say reducing emissions is a top priority in the next 12 months, new Breakthrough research finds

Retrieved on: 
Monday, June 26, 2023
Technology, Automotive, Other Transport, Trucking, Recycling, Alternative Energy, Air, Energy, Transport, Logistics, Supply Chain Management, Software, Sustainability, Retail, Environment, EV, Electric Vehicles, Data Management, EVS, Organization, United States House Transportation Subcommittee on Highways and Transit, Carbon, Airline, Cargo, Breakthrough

Breakthrough , a leading transportation management technology provider, today unveils the findings of its 2023 State of Transportation study .

Key Points: 
  • Breakthrough , a leading transportation management technology provider, today unveils the findings of its 2023 State of Transportation study .
  • The study surveyed 500 transportation leaders, including carriers and shippers, at enterprises across the United States about their goals, priorities, and predictions for the next 12 months.
  • One of the most significant findings from the report reveals that nearly 94% of transportation professionals say consumer demand for more sustainable products makes reducing emissions a top priority for the next year.
  • In fact, 70% of transportation leaders say forging mutually beneficial partnerships is an important focus area in the next 12 months.

Anumana Receives U.S. FDA Breakthrough Device Designation for its Cardiac Amyloidosis Algorithm

Retrieved on: 
Wednesday, June 21, 2023
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This breakthrough device designation was granted to provide patients and healthcare providers timely access to the algorithm, subject to approval.

Key Points: 
  • This breakthrough device designation was granted to provide patients and healthcare providers timely access to the algorithm, subject to approval.
  • Anumana previously announced a multi-year research agreement with Pfizer to develop ECG-AI solutions to aid in early identification of cardiac amyloidosis.
  • Anumana has received four Breakthrough Device Designations from the U.S. FDA for algorithms aimed at early identification of low ejection fraction, pulmonary hypertension, hyperkalemia, and now, cardiac amyloidosis.
  • “Receiving the FDA Breakthrough Device Designation for our Cardiac Amyloidosis ECG-AI Algorithm recognizes the significant potential of this tool to detect disease early.”

Precigen Receives Breakthrough Therapy Designation for PRGN-2012 AdenoVerse™ Immunotherapy for the Treatment of Recurrent Respiratory Papillomatosis

Retrieved on: 
Tuesday, June 20, 2023
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GERMANTOWN, Md. , June 20, 2023 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the first-in-class investigational PRGN-2012 AdenoVerse immunotherapy for the treatment of recurrent respiratory papillomatosis (RRP).

Key Points: 
  • – First FDA Breakthrough Therapy Designation granted for AdenoVerse immunotherapy platform; designation prioritizes PRGN-2012 as a potential treatment for RRP –
    GERMANTOWN, Md.
  • "This Breakthrough Therapy Designation is the first for Precigen's AdenoVerse platform and recognizes the immense potential of PRGN-2012 to change the lives of patients with RRP," said Helen Sabzevari, PhD, President and CEO of Precigen.
  • The potential of PRGN-2012 to reduce surgical interventions and improve outcomes for these patients makes us incredibly proud to receive the FDA's Breakthrough Therapy Designation.
  • Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated therapies toward clinical proof-of-concept and commercialization.

U.S. Oil and U.S. Gain Combine to Form U.S. Energy™

Retrieved on: 
Monday, June 12, 2023
Koel, Reunion, Sustainable energy, United States Oil Fund, Marketing, Hydrogen, Ethanol, Gasoline, Risk management, Lubricant, Carbon, Forestry, Natural gas, Transport, U.S. Venture Partners, Renewable energy, Breakthrough

U.S. Energy is a vertically integrated energy solutions provider proficient in refined products, alternative fuels, and environmental credits.

Key Points: 
  • U.S. Energy is a vertically integrated energy solutions provider proficient in refined products, alternative fuels, and environmental credits.
  • Tenured in trading, logistics, storage, compliance, and marketing, U.S. Energy is uniquely positioned to serve its customers’ current and future energy needs.
  • U.S. Oil was most recently led by Eric Kessenich who joined the company in 2010 and was promoted to president in 2017.
  • In May 2017, Koel was named president of U.S. Gain: a Sustainable Energy Solutions™ company he founded within U.S. Oil in 2011.

AVITA Medical Announces FDA Approval of RECELL for Treatment of Full-Thickness Skin Defects

Retrieved on: 
Thursday, June 8, 2023
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“This is a landmark approval representing an inflection point for AVITA Medical,” said Jim Corbett, AVITA Medical Chief Executive Officer.

Key Points: 
  • “This is a landmark approval representing an inflection point for AVITA Medical,” said Jim Corbett, AVITA Medical Chief Executive Officer.
  • “We had a high level of confidence in the FDA’s approval timeline of RECELL for the treatment of skin defects,” continued Mr. Corbett.
  • Currently, skin grafting is the standard of care for full-thickness skin defects, including post-trauma and post-surgical skin reconstruction.
  • The PMA supplement approval follows the original PMA approval of the RECELL System for the treatment of severe burns in September 2018.

Pixium Vision announces receipt of € 1.8 million from the French Government as Research Tax Credit

Retrieved on: 
Thursday, June 8, 2023
Diamond, Retina, Research report, Geographic atrophy, Research, Edise, ESGO, Patient, Prima, Mnemos EP, FDA, Annual report, Safety, Breakthrough, Pharmaceutical industry, EU

This cash injection will help extend the company’s cash runway until the end of September 2023, providing more flexibility to pursue its longer-term funding needs to support its strategic ambitions.

Key Points: 
  • This cash injection will help extend the company’s cash runway until the end of September 2023, providing more flexibility to pursue its longer-term funding needs to support its strategic ambitions.
  • Furthermore, Pixium Vision announces participation at the Octane Ophthalmology Tech Forum.
  • Lloyd Diamond, Chief Executive Officer of Pixium Vision, will give an in-person presentation - Registration for the conference is open here .
  • In May 2023 Edision published an updated investment research report after the announcement of the annual report of Pixium Vision for 2022, the receipt of the Breakthrough Device Designation in the US and the subsequent conversion of ESGO, valuing Pixium Vision at €140 million.