Generally recognized as safe

Superbrewed Food is the World’s First Company to Receive U.S. FDA No-Questions for Bacteria Biomass Protein and to Progress in Global Jurisdictions

Retrieved on: 
Wednesday, March 6, 2024
Professional Services, Patent Law, Retail, Health, FDA, Venture Capital, Food, Beverage, IMAGE, EFSA, Multimedia, Zinc, Generally recognized as safe, Temperature, European, Partnership, Vitamin, Animal, GRAS, Letter, Probiotic, Sport, QPS, Human, Drink, Patent, Bel Group, Nutritional science, Credit, Environment, Iron, Dietary supplement

View the full release here: https://www.businesswire.com/news/home/20240306922266/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240306922266/en/
    Superbrewed Food Postbiotic Cultured Protein and Beverage made with Postbiotic Cultured Protein.
  • GRAS is a designation created by the FDA under the Federal Food, Drug and Cosmetic Act.
  • Superbrewed has filed applications for market authorization of Postbiotic Cultured Protein as a “novel food” in the European Union, Great Britain and Canada.
  • Postbiotic Cultured Protein is over 85% protein, with a high content of essential and branched-chain amino acids.

PainReform Announces Plans to Commence Second Part of Phase 3 Clinical Trial to Evaluate PRF-110 in Patients Undergoing Bunionectomy Surgery Following Positive FDA Review of Drug Master File

Retrieved on: 
Monday, September 11, 2023
Drug Master File, Suture, GRAS, Drug development, Therapy, API, Trial of the century, Șaeș, Hernia, TEL, Patient, DMF, Ropivacaine, Generally recognized as safe, FDA, Safety, Pharmaceutical industry, Q4

TEL AVIV, Israel, Sept. 11, 2023 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced plans to commence the second part of the Company’s phase 3 trial to evaluate PRF-110 in patients undergoing bunionectomy surgery.

Key Points: 
  • (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced plans to commence the second part of the Company’s phase 3 trial to evaluate PRF-110 in patients undergoing bunionectomy surgery.
  • Starting the second part of the bunionectomy Phase III study follows the clearance by FDA of the DMF (Drug Master File) held by the Company’s API manufacturer.
  • This second part of the trial is expected to proceed in the next quarter of 2023.
  • As announced earlier this year, the company completed the first part of its Phase 3 clinical trial of PRF-110, in which 15 patients undergoing bunionectomy surgery were enrolled at two clinical sites in Texas.

PainReform Announces Positive Pharmacokinetic (PK) Data in First Part of Phase 3 Clinical Trial of PRF-110 in Patients Undergoing Bunionectomy Surgery

Retrieved on: 
Thursday, May 18, 2023
PK, GRAS, Therapy, Cmax, Trial of the century, Hernia, Plasma, TEL, Patient, Ropivacaine, Generally recognized as safe, FDA, Safety, Pharmaceutical industry

During Part I of this study, blood samples were collected at specified time points post-surgery, through 72 hours, to determine maximum plasma ropivacaine concentrations (Cmax).

Key Points: 
  • During Part I of this study, blood samples were collected at specified time points post-surgery, through 72 hours, to determine maximum plasma ropivacaine concentrations (Cmax).
  • Cmax value among all of the 15 patients, was approximately 10% of the safety window set by FDA.
  • Ilan Hadar, Chief Executive Officer of PainReform, stated, "We are encouraged by the PK results which demonstrated that PRF-110 showed a favorable pharmacokinetic profile, a critical step towards regulatory approval.
  • As previously reported, PRF-110 provided pain reduction for up to 72 hours post-operatively in the Company’s prior Phase 2 proof-of-concept clinical study in herniorrhaphy (hernia repair).

FEMA GRAS status for Sweegen’s sweet protein brazzein technology

Retrieved on: 
Thursday, May 4, 2023
Taste, Brazzein, Generally recognized as safe, Collection, Food, GRAS, Drink, FEMA GRAS, Soviet South building, Perception, Fruit, II, Flavor and Extract Manufacturers Association, Protein, Flavor, FEMA, SVP, Tongue, Safety, Bottled water

Rancho Santa Margarita, Calif., May 04, 2023 (GLOBE NEWSWIRE) -- Global sweetness and flavor innovator, Sweegen has announced that its highly sought-after sweet protein Ultratia™ brazzein technology received the Generally Recognized As Safe (GRAS) status from the Flavor and Extract Manufacturers Association (FEMA).

Key Points: 
  • Rancho Santa Margarita, Calif., May 04, 2023 (GLOBE NEWSWIRE) -- Global sweetness and flavor innovator, Sweegen has announced that its highly sought-after sweet protein Ultratia™ brazzein technology received the Generally Recognized As Safe (GRAS) status from the Flavor and Extract Manufacturers Association (FEMA).
  • "Our customers and the industry have eagerly anticipated our brazzein FEMA GRAS status, and now we are excited to offer it as the star sweet protein in our Sweetensify Flavors Collection ,” said Luca Giannone, SVP of Sales.
  • Sweegen is the first to attain FEMA GRAS status and to produce brazzein commercially globally .
  • “Now, the timing of the FEMA GRAS status perfectly coincides with the launch of Sweegen’s Sweetensify Flavors, which offers the best sensory experience in better-for-everyone products.”
    Sweegen recently attained FEMA GRAS status for thaumatin II, a sweet protein complementary to brazzein.

PainReform Announces Positive Safety Data in First Part of Phase 3 Clinical Trial of PRF-110 in Patients Undergoing Bunionectomy Surgery

Retrieved on: 
Monday, May 1, 2023
Lower segment Caesarean section, GRAS, Drug development, Therapy, Aes, Trial of the century, Șaeș, Hernia, TEL, Patient, Physician, Ropivacaine, Generally recognized as safe, FDA, Pain, Safety, Pharmaceutical industry

PRF-110 was administrated intra-operatively to validate the lead formulation's safety further and confirm optimal product instillation in the surgical wound.

Key Points: 
  • PRF-110 was administrated intra-operatively to validate the lead formulation's safety further and confirm optimal product instillation in the surgical wound.
  • The initial results demonstrated a solid safety profile of PRF-110.
  • The Phase 3 trial is a randomized, double-blind, placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of intra-operative administration of PRF-110 following unilateral bunionectomy.
  • “We look forward to presenting the pharmacokinetic (PK) data on the first 15 patients next month and then proceeding to the second stage of the Phase 3 trial.

PainReform Completes First Part of Phase 3 Clinical Trial in Patients Undergoing Bunionectomy Surgery

Retrieved on: 
Tuesday, March 28, 2023
PK, NRS, GRAS, Surgeon, Drug development, Therapy, Safety, Physical examination, Trial of the century, Hernia, TEL, Incidence, Pain, Morphine, Vital signs, Patient, AUC, Ropivacaine, Generally recognized as safe, FDA, Wound healing, Pharmaceutical industry

The Phase 3 trial is a randomized, double-blind, placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of intra-operative administration of PRF-110 following unilateral bunionectomy.

Key Points: 
  • The Phase 3 trial is a randomized, double-blind, placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of intra-operative administration of PRF-110 following unilateral bunionectomy.
  • The first part of the Phase 3 trial was conducted at two clinical sites in Texas (First Surgical Hospital in Bellaire Texas and Endeavor Clinical Trials in San Antonio Texas).
  • Following the successful conclusion of this part of the trial the second, larger, part of the trial will start recruiting patients.
  • Ilan Hadar, Chief Executive Officer of Pain Reform, stated, “Completion of enrollment and administration of PRF-110 in the first part of our Phase 3 clinical trial marks a major clinical milestone for PRF-110.

PainReform Announces Commencement of Phase 3 Clinical Trial to Evaluate PRF-110 in Patients Undergoing Bunionectomy Surgery

Retrieved on: 
Tuesday, March 14, 2023
AUC, PK, Surgeon, Suture, Drug development, National Center for Health Research, Generally recognized as safe, TEL, Ropivacaine, Anesthetic, Trial of the century, Vital signs, Drug overdose, Probability, National Center for Health Statistics, Patient, Pain, Medical statistics, III, Physician, FDA, GRAS, Physical examination, Incidence, Wound healing, Safety, CDC, Hernia, Clinical trial, Centers for Disease Control and Prevention timeline, Morphine, NRS, Therapy, Pharmaceutical industry

The Phase 3 trial is a randomized, double-blind, placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of intra-operative administration of PRF-110 following unilateral bunionectomy.

Key Points: 
  • The Phase 3 trial is a randomized, double-blind, placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of intra-operative administration of PRF-110 following unilateral bunionectomy.
  • PRF-110 will be administered intra-operatively to measure peak blood concentration in order to further validate safety of the lead formulation.
  • Following the confirmation of peak blood levels, the study will proceed to the second, larger, part of the Phase 3 clinical trial.
  • Upon completion of the bunionectomy trial, we also plan to initiate the Phase 3 hernia repair clinical trial.

Farlong Nutraceutical Concludes 30-Day Clinical Study to Determine Safety and Effectiveness of Farlong InnerPure® Colon Detox

Retrieved on: 
Thursday, December 8, 2022
Food, Exercise, Pimple, Science, Skin, Metabolism, Orient, Good agricultural practice, Generally recognized as safe, Digestion, Capsule, Cardiovascular disease, Nutrient, GRAS, Defecation, Bentham Science Publishers, Weight loss, Acne, Constipation, Safety, Thought, Health, Safe, Blood pressure, CGMP, GAP, Risk, Dietary supplement

WALNUT, Calif., Dec. 8, 2022 /PRNewswire-PRWeb/ -- Farlong Nutraceutical, a vertically integrated, plant-based ingredient and supplement company, conducted a 30-day double blind, placebo-controlled safety and efficacy study with 125 healthy human subjects using InnerPure® Colon Detox to determine the effects on healthy bowel movement, weight management and acne.

Key Points: 
  • Conducted by M. Montgomery PhD and E. Masters M.D., the study followed 100 subjects taking various dosages of InnerPure supplements, and 25 subjects on placebo.
  • The 25 subjects on placebo took one capsule twice daily for the duration of the study.
  • InnerPure Colon Detox is an all-natural blend of eight different herbal extracts that have been processed to release toxins from the body.
  • Farlong is currently conducting a 90-day double blind, randomized, controlled, parallel study to determine the safety and effectiveness of Farlong Lifeflower Breviscapine on improving long and short-term memory, concentration, and clarity of thinking in healthy individuals.

Cyanotech Reports Financial Results for the Second Quarter and First Six Months of Fiscal 2023

Retrieved on: 
Wednesday, November 9, 2022
Retail, Health, Other Health, Fitness & Nutrition, Specialty, Vitamins, Supplements, Operating cost, Nasdaq, Forward-looking statement, Marketing, Health, Microalgae, U.S. Securities and Exchange Commission, Weather, Food, EST, Food and Drug Administration, File, Eye, Private Securities Litigation Reform Act, Interest, Generally recognized as safe, Forgiveness, Company, Disease, Corporation, Skin, Paycheck Protection Program, Table, Security (finance), Cyanotech, Income, Management, Dietary supplement, Spirulina

Cyanotech Corporation (Nasdaq Capital Market: CYAN), a world leader in microalgae-based, high-value nutrition and health dietary supplement products, announced financial results for the second quarter and first six months of fiscal year 2023, ended September 30, 2022.

Key Points: 
  • Cyanotech Corporation (Nasdaq Capital Market: CYAN), a world leader in microalgae-based, high-value nutrition and health dietary supplement products, announced financial results for the second quarter and first six months of fiscal year 2023, ended September 30, 2022.
  • Cyanotech reported net sales of $5,179,000 for the second quarter of fiscal 2023 compared to $9,419,000 for the second quarter of fiscal 2022, a decrease of 45.0%.
  • Operating loss for the second quarter of fiscal 2023 was $837,000 compared to operating income of $1,082,000 in the same period of the prior year.
  • Cyanotech reported net sales of $11,895,000 for the first six months of fiscal 2023 compared to $18,383,000 for the same period in fiscal 2022, a decrease of 35.3%.

WILLOW BIOSCIENCES PROVIDES CBG UPDATE

Retrieved on: 
Wednesday, August 31, 2022
COVID-19, AB, AMRI, Food, Willow Springs Distilling Company, Research, Hand, View, Government, Protein, DSP, Generally recognized as safe, Technology transfer, Interim, Risk, WLLW, TSX, Patent, Willow Garage, Multimedia, MSA, CDMO, Company, Certification, Contract, News, Failure, Fermentation, GRAS, Intellectual property, Cannabinoid, Industry, Health, Forward-looking statement, CBG, Fine chemical, Willow

CALGARY, AB and MOUNTAIN VIEW, Calif, Aug. 31, 2022 /PRNewswire/ - Willow Biosciences Inc. ("Willow" or the "Company") (TSX:WLLW) (OTCQB: CANSF), a leading biotechnology company focused on revolutionizing industrial manufacturing of pure, consistent and sustainable functional ingredients, is pleased to provide an update on cannabigerol ("CBG"), the Company's first commercialized functional ingredient in its portfolio.

Key Points: 
  • CALGARY, AB and MOUNTAIN VIEW, Calif, Aug. 31, 2022 /PRNewswire/ - Willow Biosciences Inc. ("Willow" or the "Company") (TSX:WLLW) (OTCQB: CANSF), a leading biotechnology company focused on revolutionizing industrial manufacturing of pure, consistent and sustainable functional ingredients, is pleased to provide an update on cannabigerol ("CBG"), the Company's first commercialized functional ingredient in its portfolio.
  • As the market for biosynthetically produced CBG continues to develop, Willow will be in a strong position to deliver commercial scale volumes.
  • When the regulatory environment permits, Willow is also well-positioned to develop additional cannabinoids beyond CBG.
  • Willow previously announced that it had successfully completed the initial toxicological assessment for Generally Recognized as Safe ("GRAS") for its FutureGrown CBG product.