Breakthrough

BioNTech and DualityBio Receive FDA Breakthrough Therapy Designation for Antibody-Drug Conjugate Candidate BNT323/DB-1303 in Endometrial Cancer

Retrieved on: 
Thursday, December 21, 2023
Food, HER2, Breakthrough therapy, ASCO, Collection, FDA, ESGO, Mortality, Gene amplification, BNTX, Incidence, Endometrial cancer, BioNTech, Breakthrough, Fast track (FDA), Patient, Uterine cancer, Data, ADC, Pharmaceutical industry

The designation is based on encouraging topline data from a Phase 1/2 study ( NCT05150691 ) with BNT323/DB-1303 in patients with HER2-expressing advanced endometrial cancer.

Key Points: 
  • The designation is based on encouraging topline data from a Phase 1/2 study ( NCT05150691 ) with BNT323/DB-1303 in patients with HER2-expressing advanced endometrial cancer.
  • Endometrial or uterine cancer is the second most common gynecologic cancer globally, with over 400,000 cases occurring each year1,2 and both incidence and mortality are increasing3,4.
  • “The Breakthrough Therapy designation for BNT323/DB-1303 shows the potential of our ADC candidate to address current treatment challenges for patients with advanced HER2-expressing endometrial cancer who progressed under several lines of systemic therapy.
  • The BNT323/DB-1303 program received FDA Fast Track designation for the treatment of endometrial cancer in January 2023.

Radiogel™ Precision Radionuclide Therapy™ Receives FDA Breakthrough Device Designation

Retrieved on: 
Wednesday, December 20, 2023
Food, Classification, Lymph, Risk management, FDA, Papillary thyroid cancer, IDE, Breakthrough, Mayo Clinic, OTCQB, Patient, Radiation, Pharmaceutical industry

Richland WA, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc is pleased to announce that the Food and Drug Administration has granted RadioGel Precision Radionuclide Therapy the designation as a Breakthrough Device pursuant to the FDA’s Breakthrough Devices Program.

Key Points: 
  • Richland WA, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc is pleased to announce that the Food and Drug Administration has granted RadioGel Precision Radionuclide Therapy the designation as a Breakthrough Device pursuant to the FDA’s Breakthrough Devices Program.
  • Dr. Mike Korenko stated “We are pleased with the FDA’s decision to grant Breakthrough Device Designation following our recent data submissions.
  • The analysis in our Risk Management Report concluded that RadioGel™ is intrinsically safe and our animal therapy data verified its effectiveness.
  • The FDA’s Breakthrough Devices program facilitates accelerated development and expedites the review of breakthrough technologies to help patients potentially gain timely access to technologies that can provide more effective treatment options.

New Study Reveals Important Insights on the Carbon Footprint of Beef Production

Retrieved on: 
Wednesday, December 13, 2023
Carbon footprint, Livestock, Research, Manure, UC, PLOS, Doctor of Philosophy, Breakthrough Institute, Breakthrough, Carbon, Climate, Economics, Soil

Many companies claim to sell carbon-neutral beef or reduce their carbon footprint by offering grass-fed alternatives.

Key Points: 
  • Many companies claim to sell carbon-neutral beef or reduce their carbon footprint by offering grass-fed alternatives.
  • Specifically, the study found that grass-fed beef operations had 20% higher emissions from production than grain-finished systems and a 42% higher carbon footprint overall when considering carbon sequestration and land use.
  • A 10% increase in beef production per acre was associated with a 4.8% decrease in emissions from production and a 9.0% decrease in carbon footprint, encompassing production emissions, soil carbon sequestration, and carbon opportunity cost.
  • According to co-author Linus Blomqvist “studies looking at the carbon footprint of beef have long been incomplete, often just including the production side and sometimes also accounting for carbon sequestration on grazing land.

Burning Rock Reports Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 30, 2023
Lung cancer, Depreciation, Minimal, NGS, Food, Boehringer Ingelheim, MRD, Research, FDA, Hospital, CDX, Cancer cell, Breakthrough, NMPA, ID, Marketing, Investment, Webcast, Patient, NSCLC, Cryptocurrency

GUANGZHOU, China, Nov. 30, 2023 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, today reported financial results for the three months ended September 30, 2023.

Key Points: 
  • GUANGZHOU, China, Nov. 30, 2023 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, today reported financial results for the three months ended September 30, 2023.
  • Personalized Minimal Residual Disease (MRD) product, brPROPHETTM supports advancement in early-stage non-small cell lung cancer treatment, with results published in the Cancer Cell in September 2023.
  • Total value of new contracts for the provision of pharma services entered into during the third quarter of 2023 amounted to RMB90 million, representing an 8% year-over-year increase.
  • Burning Rock will host a conference call to discuss the third quarter 2023 financial results at 7:00 a.m. U.S. Eastern Time (8:00 p.m. Hong Kong time) on November 30, 2023.

Sol-Gel Technologies Screens First Patient for SGT-610 Phase 3 Study

Retrieved on: 
Thursday, November 30, 2023
Dermatology, Probability, FDA, Nevoid basal-cell carcinoma syndrome, Disease, Sol–gel process, Breakthrough, BCC, Patient, Carcinoma, Executive director, NESS, KOL, Pharmaceutical industry

Patidegib was acquired by Sol-Gel from PellePharm and is currently the only therapy in development to prevent the development of new BCC lesions in Gorlin syndrome patients.

Key Points: 
  • Patidegib was acquired by Sol-Gel from PellePharm and is currently the only therapy in development to prevent the development of new BCC lesions in Gorlin syndrome patients.
  • "We are pleased to initiate patient screening in this Phase 3 trial that has been long awaited by the Gorlin syndrome patient community,” said Alon Seri-Levy, Ph.D., Chief Executive Officer of Sol-Gel.
  • Sol-Gel will conduct the Phase 3 study to investigate SGT-610 in approximately 140 subjects at approximately 40 experienced clinical centers in North America, United Kingdom and Europe.
  • The event will highlight the patient’s experience through the eyes of a Gorlin syndrome patient as well as discuss the therapeutic potential of SGT-610 to prevent new BCCs in Gorlin syndrome patients and Sol-Gel’s Phase 3 trial.

EQS-News: RadioGel Precision Radionuclide Therapy Receives FDA Breakthrough Device Designation

Retrieved on: 
Thursday, December 21, 2023
FDA, Risk management, Radiation, Lymph, Patient, OTCQB, Breakthrough, Food, Mayo Clinic, Papillary thyroid cancer, IDE, Classification, Pharmaceutical industry

RICHLAND, WA - (NewMediaWire) - December 20, 2023 -- Vivos Inc. (OTCQB: RDGL), is pleased to announce that the Food and Drug Administration has granted RadioGel Precision Radionuclide Therapy the designation as a Breakthrough Device pursuant to the FDA’s Breakthrough Devices Program.

Key Points: 
  • RICHLAND, WA - ( NewMediaWire ) - December 20, 2023 -- Vivos Inc. (OTCQB: RDGL), is pleased to announce that the Food and Drug Administration has granted RadioGel Precision Radionuclide Therapy the designation as a Breakthrough Device pursuant to the FDA’s Breakthrough Devices Program.
  • Dr. Mike Korenko stated, “We are pleased with the FDA’s decision to grant Breakthrough Device Designation following our recent data submissions.
  • The analysis in our Risk Management Report concluded that RadioGel™ is intrinsically safe and our animal therapy data verified its effectiveness.
  • The FDA’s Breakthrough Devices program facilitates accelerated development and expedites the review of breakthrough technologies to help patients potentially gain timely access to technologies that can provide more effective treatment options.

Palvella Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Microcystic Lymphatic Malformations

Retrieved on: 
Thursday, November 16, 2023
Disease, Natural history, Food, European Medicines Agency, Therapy, Cellulitis, Patient, Breakthrough therapy, Infection, FDA, Breakthrough, DSM-IV codes, Skin, Bleeding, Cyst, Orphan, Life, Patent, Pharmaceutical industry, Microcystic lymphatic malformation

WAYNE, Pa., Nov. 16, 2023 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc., a clinical-stage biopharmaceutical company developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no FDA-approved therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to QTORIN rapamycin™ for the treatment of Microcystic Lymphatic Malformations (Microcystic LMs). QTORIN rapamycin is a novel, 3.9% rapamycin anhydrous gel currently under development by Palvella for the treatment of Microcystic LMs and other serious, functionally debilitating skin diseases driven by the overactivation of the mammalian target of rapamycin (mTOR) pathway.

Key Points: 
  • QTORIN rapamycin is a novel, 3.9% rapamycin anhydrous gel currently under development by Palvella for the treatment of Microcystic LMs and other serious, functionally debilitating skin diseases driven by the overactivation of the mammalian target of rapamycin (mTOR) pathway.
  • Microcystic LMs is a rare, chronically debilitating genetic disease caused by dysregulation of the PI3K/mTOR pathway.
  • In addition to Breakthrough Therapy Designation, the FDA previously granted Fast Track Designation and Orphan Drug Designation to QTORIN rapamycin for the treatment of Microcystic LMs.
  • The European Medicines Agency has also granted Orphan Drug Designation to QTORIN rapamycin for the treatment of Microcystic LMs.

AVITA Medical Reports Third Quarter Financial Results with 51% Revenue Growth over the Same Period the Prior Year

Retrieved on: 
Thursday, November 9, 2023
Assistant, PMA, AVH, Avita Medical, Telephone, Announcement (computing), Commercial, Regenerative medicine, FDA, Breakthrough, ASX, Marketing, G&A, Human services, Development, Growth, Skin, Medical device, Video game, Cryptocurrency

“We continue to execute our growth strategy, paving the way to profitability,” said Jim Corbett, Chief Executive Officer of AVITA.

Key Points: 
  • “We continue to execute our growth strategy, paving the way to profitability,” said Jim Corbett, Chief Executive Officer of AVITA.
  • “We are diligently working through supplemental in-house testing to support the FDA’s review of our PMA supplement for RECELL GO.
  • Total revenue, which includes BARDA revenue, increased by 50% to $13.6 million compared to $9.1 million in the same period in 2022.
  • Total operating expenses for the quarter were $21.0 million, compared to $14.2 million in the same period in 2022.

Wells Fargo and Enterprise Announce Winners of $20 Million Housing Innovation Challenge

Retrieved on: 
Tuesday, November 14, 2023
Construction & Property, Finance, Urban Planning, Banking, Professional Services, Philanthropy, Other Philanthropy, Foundation, Residential Building & Real Estate, Carbon, Construction, Engineering, Organization, Housing, Workforce, Mississippi Delta, Learning, CO2, Student, Multimedia, House, Future Fund, Thought, Breakthrough, Enterprise Community Partners, Partner, HBCU, UP, Box, LIHTC, Partnership, Education, Management, Real estate, Enterprise

The Wells Fargo Foundation and Enterprise Community Partners (Enterprise) today announced the winners of the 2023 Housing Affordability Breakthrough Challenge , a $20 million nationwide competition to find and seed innovative housing solutions.

Key Points: 
  • The Wells Fargo Foundation and Enterprise Community Partners (Enterprise) today announced the winners of the 2023 Housing Affordability Breakthrough Challenge , a $20 million nationwide competition to find and seed innovative housing solutions.
  • View the full release here: https://www.businesswire.com/news/home/20231114901101/en/
    Build UP in Birmingham, Alabama named winner of 2023 Housing Affordability Breakthrough Challenge.
  • “Through the Housing Affordability Breakthrough Challenge, we are intentionally lifting up solutions to serve communities that have experienced disinvestment and marginalization for far too long.
  • The cohort will gain access to a network of leaders from across the housing sector, including experts from Enterprise and past winners of the competition.

Gravitas Medical Inc. Announces SECOND FDA Breakthrough Device Designation for its Entarik System; Pediatric Patients to Benefit from Enteral Nutrition Innovation!

Retrieved on: 
Wednesday, December 13, 2023
Adolescence, Infant, SAN, Food, Stomach, Incidence, Patient, Medicine, FDA, Breakthrough, Child, Diagnosis, Gastrointestinal tract, Gravitas, Pharmaceutical industry, Nursing

SAN FRANCISCO, Dec. 13, 2023 /PRNewswire-PRWeb/ -- Gravitas Medical Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted a second Breakthrough Device Designation to Entarik, the innovative Enteral Feeding System. This award allows Gravitas Medical to accelerate development and approval processes to expedite pediatric patient access to Entarik's revolutionary technology.

Key Points: 
  • SAN FRANCISCO, Dec. 13, 2023 /PRNewswire-PRWeb/ -- Gravitas Medical Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted a second Breakthrough Device Designation to Entarik, the innovative Enteral Feeding System.
  • This award allows Gravitas Medical to accelerate development and approval processes to expedite pediatric patient access to Entarik's revolutionary technology.
  • "This second designation recognizes the lifesaving potential of Entarik for pediatric and adolescent patients in addition to neonates."
  • "This second Breakthrough Designation recognizes the importance of the Gravitas Medical team's work and Entarik's potential to save lives of pediatric patients," concluded Hansen.