National Agency for Food and Drug Administration and Control

ContraFect Reports Fourth Quarter 2022 and Full Year 2022 Financial Results and Provides Business Update

Retrieved on: 
금요일, 3월 31, 2023
PK, S. aureus, National Agency for Food and Drug Administration and Control, Safety, CMC, Pharmacokinetics, Medication, G&A, Acinetobacter, Cons, Staphylococcus aureus, Trial of the century, Staphylococcus, Chemistry, Net, Patient, Klebsiella, Ethics, Campaign, R, Research, IND, Pseudomonas, ChromeOS, Knee, Peptide, ANSM, Pharmaceutical industry, Cryptocurrency

Research and development (R&D) expenses were $4.4 million for the fourth quarter of 2022 compared to $11.0 million in the comparable period in 2021.

Key Points: 
  • Research and development (R&D) expenses were $4.4 million for the fourth quarter of 2022 compared to $11.0 million in the comparable period in 2021.
  • General and administrative (G&A) expenses were $2.3 million for the fourth quarter of 2022 compared to $3.0 million in the comparable period in 2021.
  • G&A expenses were $12.2 million for the year ended December 31, 2022, compared with $11.8 million for the year ended December 31, 2021.
  • As of December 31, 2022, ContraFect had cash, cash equivalents and marketable securities of $13.7 million.

GC Creates Innovation For a Better Quality of Life for the World, Using High-quality Recycled Plastic Resins of Food Grade Level Guaranteed Safe by FDA

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목요일, 3월 30, 2023
Food, Drink, Tree, Quality of life, PET, Carbon, Certification, Ministry, National Agency for Food and Drug Administration and Control, Public health, Ministry of Public Health (Afghanistan), FDA, PTT Global Chemical, GC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Environment, News, PCR, Safety, Bottled water, Recycling

ENVICCO, a high-quality food-grade recycled plastic resin production plant, produces these recycled plastic pellets that meet international standards.

Key Points: 
  • ENVICCO, a high-quality food-grade recycled plastic resin production plant, produces these recycled plastic pellets that meet international standards.
  • This is to provide a better quality of life for all the people in Thailand.
  • ENVICCO can produce up to 45,000 tons of high-quality PCR PET (30,000 tons) and PCR HDPE (15,000 tons) plastic resins annually.
  • GC is also expanding its partnerships with all sectors to participate in the collective journey towards sustainable development.

GC Creates Innovation For a Better Quality of Life for the World, Using High-quality Recycled Plastic Resins of Food Grade Level Guaranteed Safe by FDA

Retrieved on: 
목요일, 3월 30, 2023
Food, Drink, Tree, Quality of life, PET, Carbon, Certification, Ministry, National Agency for Food and Drug Administration and Control, Public health, Ministry of Public Health (Afghanistan), FDA, PTT Global Chemical, GC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Environment, News, PCR, Safety, Bottled water, Recycling

ENVICCO, a high-quality food-grade recycled plastic resin production plant, produces these recycled plastic pellets that meet international standards.

Key Points: 
  • ENVICCO, a high-quality food-grade recycled plastic resin production plant, produces these recycled plastic pellets that meet international standards.
  • This is to provide a better quality of life for all the people in Thailand.
  • ENVICCO can produce up to 45,000 tons of high-quality PCR PET (30,000 tons) and PCR HDPE (15,000 tons) plastic resins annually.
  • GC is also expanding its partnerships with all sectors to participate in the collective journey towards sustainable development.

Biophytis announces the signature of a master service agreement with Intsel Chimos, a pharmaceutical company that will operate Sarconeos (BIO101) in France for the treatment of severe forms of COVID-1

Retrieved on: 
목요일, 3월 2, 2023
Medication, Safety, ANSM, National Agency for Food and Drug Administration and Control, Ageing, Euronext Growth, Haute, CET, Patient, HAS, COVID-19, Respiratory failure, Partnership, Pharmaceutical industry, Health

Biophytis announces the signature of a master service agreement with Intsel Chimos, a pharmaceutical company that will operate Sarconeos (BIO101) in France for the treatment of severe forms of COVID-1

Key Points: 
  • Biophytis announces the signature of a master service agreement with Intsel Chimos, a pharmaceutical company that will operate Sarconeos (BIO101) in France for the treatment of severe forms of COVID-1
    Biophytis announces the signature of a master service agreement with Intsel Chimos, a pharmaceutical company that will operate Sarconeos (BIO101) in France for the treatment of severe forms of COVID-19
    Biophytis and Intsel Chimos signed a master service agreement under which Intsel Chimos will be the operating pharmaceutical company/exploitant, partner and distributor in France for the drug Sarconeos (BIO101) developed by Biophytis in the context of the early access program application.
  • The application request for early access program, currently underway with the Haute Autorité de Santé (the French National Authority for Health, HAS), aims to allow treatment with Sarconeos (BIO101) for hospitalized patients with severe forms of COVID-19 as of the second half of 2023.
  • Stanislas Veillet, CEO of Biophytis, commented: “The signature of a master service agreement with Intsel Chimos, which will distribute Sarconeos (BIO101) in France as our Pharmaceutical Operator in the early access program in COVID-19, is a major event for Biophytis.
  • The positive results of our Phase 2-3 COVA study in severe forms of COVID-19 open new development perspectives for the company.

Biophytis initiates the regulatory process for an early access authorization in France from the French National Authority for Health (HAS) for the treatment with Sarconeos (BIO101) of severe forms of

Retrieved on: 
월요일, 2월 27, 2023
Clinical trial, Safety, HAS, Ageing, CET, Risk, Bangladesh National Authority for Chemical Weapons Convention, Patient, Respiratory failure, COVID-19, National Agency for Food and Drug Administration and Control, ANSM, Medication, Euronext Growth, Pharmaceutical industry

A pre-submission meeting with the HAS is scheduled for March and the application for early access authorisation should be submitted shortly after with the aim of obtaining authorisation in the second quarter of 2023.

Key Points: 
  • A pre-submission meeting with the HAS is scheduled for March and the application for early access authorisation should be submitted shortly after with the aim of obtaining authorisation in the second quarter of 2023.
  • Biophytis continues to prepare conditional marketing authorisation applications in Europe and in the US due to the health emergency.
  • Stanislas Veillet, CEO of Biophytis, said: "We aim to accelerate the availability of Sarconeos (BIO101) to hospitalized patients in France with severe forms of COVID-19 through an early access program that we will present to the HAS in the coming weeks.
  • We plan to file the application formally shortly after with the objective of obtaining approval to start this programme in the second quarter of 2023.

Alterity Therapeutics Receives Regulatory Authorization in France and Austria to Proceed with ATH434 Phase 2 Clinical Trial

Retrieved on: 
목요일, 2월 16, 2023
Biomarker, National Agency for Food and Drug Administration and Control, Neuroimaging, Patient, MSA, ASX, Therapy, Pathology, ATH, Disease, SAN, Multiple system atrophy, Pharmacokinetics, Pharmaceutical industry, Parkinsonism, Safety, Health care, Medicine

“The regulatory approvals in France and Austria will allow us to expand our footprint in Europe and are another important step forward for our ATH434 development program,” said David Stamler, M.D., Chief Executive Officer, Alterity.

Key Points: 
  • “The regulatory approvals in France and Austria will allow us to expand our footprint in Europe and are another important step forward for our ATH434 development program,” said David Stamler, M.D., Chief Executive Officer, Alterity.
  • “With the trial now open in five countries we are focused on providing access to our Phase 2 clinical trial for individuals living with MSA.
  • We expect to open trial sites in France and Austria over the next few months.”
    The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled investigation of ATH434 in patients with early-stage MSA.
  • Additional information on the Phase 2 trial can be found by ClinicalTrials.gov Identifier: NCT05109091 .

Fragrance Creators Association Statement on Inclusion of the 'Modernization of Cosmetics Regulations Act' in the FY2023 Consolidated Appropriations Act

Retrieved on: 
화요일, 12월 20, 2022
Legislation, Feinstein, Food, Senator Murray, Cosmetics, Safety, Congress, Perfume, National Agency for Food and Drug Administration and Control

WASHINGTON, Dec. 20, 2022 (GLOBE NEWSWIRE) -- Statement by Farah K. Ahmed, President & CEO, Fragrance Creators Association (Fragrance Creators), on the inclusion of long-awaited updates to federal cosmetics law in the FY2023 omnibus appropriations bill released earlier this morning:

Key Points: 
  • WASHINGTON, Dec. 20, 2022 (GLOBE NEWSWIRE) -- Statement by Farah K. Ahmed, President & CEO, Fragrance Creators Association (Fragrance Creators), on the inclusion of long-awaited updates to federal cosmetics law in the FY2023 omnibus appropriations bill released earlier this morning:
    "Fragrance Creators applauds the inclusion of the "Modernization of Cosmetics Regulations Act" in the FY2023 omnibus appropriations bill, and we urge Congress to approve it this week.
  • Fragrance Creators Association is the trade association representing the majority of fragrance manufacturing in North America.
  • Fragrance Creators established and administers the Congressional Fragrance Caucus, ensuring ongoing dialogue with members of Congress and staff.
  • Fragrance Creators also produces The Fragrance Conservatory, the comprehensive digital resource for high-quality information about fragrance— www.fragranceconservatory.com .

Transgene Receives Approval to Start a Phase I Trial of TG6050, a Novel IL-12-Armed Oncolytic Virus Given by Intravenous Administration

Retrieved on: 
금요일, 1월 6, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Cancer, ICIS, Euronext Paris, International Cancer Genome Consortium, ANSM, Neoplasm, Patient, Tumor microenvironment, CTA, Disseminated disease, Medication, Lysis, Large-cell lung carcinoma, IL-12, IV, National Agency for Food and Drug Administration and Control, Safety, NSCLC, Pharmaceutical industry, Vaccine

It has been engineered to express human IL-12, a cytokine that triggers a powerful antitumor immune response, and a full length anti-CTLA4 antibody.

Key Points: 
  • It has been engineered to express human IL-12, a cytokine that triggers a powerful antitumor immune response, and a full length anti-CTLA4 antibody.
  • TG6050 has been designed to be administered intravenously, a route of administration that has been demonstrated to be safe and feasible with an Invir.IO™ based OV.
  • Intratumoral injection, where the drug is injected directly into the tumor, is currently the only approved route of administration for an oncolytic virus.
  • Intravenous administration addresses a broader range of patients with solid tumors who are not suitable for intratumoral administration.

The Worldwide Industrial Food and Beverages Filtration System Industry is Projected to Reach $1.9 Billion by 2031 - ResearchAndMarkets.com

Retrieved on: 
화요일, 1월 3, 2023
Food, Beverage, Retail, Food, Public health, Ill, Food safety, Hygiene, Snickers, NSA product types, FSSAI, Safety, FDA, Musketeer, Food Safety and Standards Authority of India, Milky Way, National Agency for Food and Drug Administration and Control, Drink, Bottled water

The global industrial foods and beverages filtration system market size was valued at $1,098.1 million in 2021, and is projected to reach $1,911.5 million by 2031, registering a CAGR of 5.6% from 2022 to 2031.

Key Points: 
  • The global industrial foods and beverages filtration system market size was valued at $1,098.1 million in 2021, and is projected to reach $1,911.5 million by 2031, registering a CAGR of 5.6% from 2022 to 2031.
  • Furthermore, expansion of food & beverages manufacturing facilities around the world creates growth opportunities for industrial foods & beverages filtration system.
  • The industrial foods & beverages filtration system market forecast analysis from 2022 to 2031 is included in the report.
  • The key players with in industrial foods & beverages filtration system market are profiled in this report and their strategies are analysed thoroughly, which help understand the competitive outlook of the industrial foods & beverages filtration system industry.

Glancy Prongay & Murray LLP, a Leading Securities Fraud Law Firm, Continues Investigation of Petróleo Brasileiro S.A - Petrobras (PBR) on Behalf of Investors

Retrieved on: 
목요일, 12월 15, 2022
Class Action Lawsuit, Professional Services, Legal, Publication, National Agency of Petroleum, Natural Gas and Biofuels (Brazil), Person, GPM, Financial Times, Bloomberg Businessweek, The Wall Street Journal, SCAS, DOJ, Natural gas, NYSE, Biofuel, FDA, PBR, National Agency for Food and Drug Administration and Control, Real estate investment trust, Press, News, Associated Press, Information technology, Insurance, Pharmaceutical industry, Reuters, Petrobras, Petroleum

Glancy Prongay & Murray LLP (GPM), a leading national shareholder rights law firm, continues its investigation on behalf of Petrleo Brasileiro S.A. - Petrobras (Petrobras or the Company) (NYSE: PBR ) investors concerning the Companys possible violations of the federal securities laws.

Key Points: 
  • Glancy Prongay & Murray LLP (GPM), a leading national shareholder rights law firm, continues its investigation on behalf of Petrleo Brasileiro S.A. - Petrobras (Petrobras or the Company) (NYSE: PBR ) investors concerning the Companys possible violations of the federal securities laws.
  • On this news, Petrobrass stock price $1.01, or 9.9%, to close at $9.13 per share on December 14, 2022, thereby injuring investors.
  • Whistleblower Notice: Persons with non-public information regarding Petrobras should consider their options to aid the investigation or take advantage of the SEC Whistleblower Program.
  • Glancy Prongay & Murray LLP is a premier law firm representing investors and consumers in securities litigation and other complex class action litigation.