South African Health Products Regulatory Authority

PaxMedica, Inc. Announces Second Quarter 2023 Financial Results and Business Update

Retrieved on: 
Wednesday, August 9, 2023
Suramin, IV, Spectrum, African, NDA, Disorder, SAHPRA, US, Patient, ASD, South African Health Products Regulatory Authority, Emodin, Security (finance), TBR, Hand, US FDA, Common, Pharmaceutical industry

TARRYTOWN, NY, Aug. 09, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – PaxMedica, Inc. (Nasdaq: PXMD), a clinical stage biopharmaceutical company focusing on the development of novel anti-purinergic drug therapies (“APT”) for the treatment of disorders with intractable neurologic symptoms, today provided a business update and reported financial results for the second quarter 2023, ended June 30, 2023.

Key Points: 
  • TARRYTOWN, NY, Aug. 09, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – PaxMedica, Inc. (Nasdaq: PXMD), a clinical stage biopharmaceutical company focusing on the development of novel anti-purinergic drug therapies (“APT”) for the treatment of disorders with intractable neurologic symptoms, today provided a business update and reported financial results for the second quarter 2023, ended June 30, 2023.
  • Importantly, this positive topline data from our retrospective HAT-301 study, demonstrated both statistically significant and clinically meaningful results.
  • Subsequent to quarter end, the Company received proceeds of approximately $0.8 million from the issuance of approximately 1.0 million shares of the Company’s common stock.
  • For PaxMedica’s complete financial results for the three-month period ended June 30, 2023, see the Company’s Quarterly Form 10-Q that will be filed with the Securities and Exchange Commission on August 9, 2023.

PaxMedica Submits Clinical Trial Request in Autism Spectrum Disorder

Retrieved on: 
Wednesday, June 14, 2023
Suramin, Autism spectrum, API, Clinical trial, SAHPRA, ASD, South African Health Products Regulatory Authority, APT, IND, Safety, Pharmaceutical industry

TARRYTOWN, NY, June 14, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – PaxMedica, Inc. (Nasdaq: PXMD), a clinical stage biopharmaceutical company focusing on the development of novel anti-purinergic drug therapies (APT) for the treatment of Autism Spectrum Disorder (ASD) and other serious conditions with intractable neurologic symptoms, today announced that it has submitted a request to the South African Health Products Regulatory Authority (SAHPRA), seeking approval to conduct a double-blind, placebo-controlled study, PAX-ASD-101.  This trial will seek to enroll a total of 30 subjects with confirmed ASD, ages 4 to 18, at multiple sites in South Africa.  This is the first new clinical trial on the safety, tolerability, and efficacy of suramin since the Company announced the results of its prior Phase II trial in 2021. Enrollment is expected to begin in Q4 2023, following SAHPRA’s potential approval later this summer.

Key Points: 
  • This trial will seek to enroll a total of 30 subjects with confirmed ASD, ages 4 to 18, at multiple sites in South Africa.
  • This is the first new clinical trial on the safety, tolerability, and efficacy of suramin since the Company announced the results of its prior Phase II trial in 2021.
  • PaxMedica is also preparing additional submissions for planned PAX-101 trials with other regulatory authorities outside of South Africa in 2023.
  • “In 2021, PaxMedica reported that it had completed a Phase II clinical trial on the use of suramin in boys with ASD.

The Prime Minister announces changes in the senior ranks of the Public Service

Retrieved on: 
Friday, February 10, 2023
Justice, Environment, Employment, Treasury Board of Canada, National security, Refugee, Agriculture and Agri-Food Canada, Public Service of Canada, Employment and Social Development Canada, Public Health Agency, Assistant, Privy Council Office (Canada), Communication, Privy council, Retirement, Emergency, Social change, Climate change, Canadian Food Inspection Agency, Health Canada, Communications Security Establishment, Senior, Public, Treasury Board of Canada Secretariat, Public service, Social Development Canada, Associate, Cabinet, Cabinet Secretary for Covid Recovery, COVID, Privy Council Office, South African Health Products Regulatory Authority, Health Products and Food Branch, Public Health Agency of Canada, Management, Nursing, Health, Agriculture

OTTAWA, ON, Feb. 10, 2023 /CNW/ - The Prime Minister, Justin Trudeau, today announced the following changes in the senior ranks of the Public Service:

Key Points: 
  • OTTAWA, ON, Feb. 10, 2023 /CNW/ - The Prime Minister, Justin Trudeau, today announced the following changes in the senior ranks of the Public Service:
    Shalene Curtis-Micallef, currently Associate Deputy Minister of Justice, becomes Deputy Minister of Justice, effective February 13, 2023.
  • Chris Forbes, currently Deputy Minister of Agriculture and Agri-Food, becomes Deputy Minister of Environment and Climate Change, effective February 20, 2023.
  • Arun Thangaraj, currently Associate Deputy Minister of Immigration, Refugees and Citizenship, becomes Deputy Minister of Transport, effective February 20, 2023.
  • Stefanie Beck, currently Associate Deputy Minister of National Defence, becomes Deputy Minister of Agriculture and Agri-Food, effective February 20, 2023.

Dyadic Announces Initiation of Dosing of First-In-Human Phase 1 Trial to Demonstrate Clinical Safety and Antibody Response in Humans for DYAI-100 COVID-19 Recombinant Protein RBD Booster Vaccine Candidate

Retrieved on: 
Tuesday, January 24, 2023
SAHPRA, Human, South African Health Products Regulatory Authority, COVID-19, RBD, Vaccine, Safety, Patient, Clinical trial, C1, Dyadic

The Phase 1 randomized, double blind, placebo-controlled trial is designed as a first-in-human trial to assess the clinical safety and antibody response of DYAI-100, a C1-SARS-CoV-2 recombinant protein RBD vaccine, produced using the C1 platform, administered as a booster vaccine at two single dose levels in healthy volunteers.

Key Points: 
  • The Phase 1 randomized, double blind, placebo-controlled trial is designed as a first-in-human trial to assess the clinical safety and antibody response of DYAI-100, a C1-SARS-CoV-2 recombinant protein RBD vaccine, produced using the C1 platform, administered as a booster vaccine at two single dose levels in healthy volunteers.
  • The trial will include healthy patients ages 18-55 in a randomization scheme of 4:1 with 15 subjects per cohort.
  • “With the initiation of the Phase 1 clinical trial, this is the first time a vaccine or treatment manufactured from our C1 protein production platform is being tested in humans.
  • Importantly, this study is expected to demonstrate clinical safety and antibody response in humans to help further combat the COVID-19 pandemic.

Dyadic Receives Regulatory Approval to Initiate Phase 1 Clinical Trial to Demonstrate Clinical Safety and Efficacy in Humans for DYAI-100 COVID-19 Recombinant Protein RBD Booster Vaccine Candidate

Retrieved on: 
Thursday, October 27, 2022
China Biologic Products, Food, SEC, Company, Securities Exchange Act of 1934, Clinical trial, Antibody, CTA, NASDAQ, Safety, CEO, Vaccine, RBD, Patient, Gene expression, Protein, Risk, South African Health Products Regulatory Authority, COVID-19, SAHPRA, GLOBE, Health, Securities Act of 1933, Drug Quality and Security Act, Pharmaceutical industry, Dyadic

The Phase 1 randomized, double blind, placebo-controlled trial is designed to demonstrate clinical safety and preliminary efficacy of the DYAI-100, COVID-19 recombinant protein RBD booster vaccine candidate.

Key Points: 
  • The Phase 1 randomized, double blind, placebo-controlled trial is designed to demonstrate clinical safety and preliminary efficacy of the DYAI-100, COVID-19 recombinant protein RBD booster vaccine candidate.
  • Preparations are now underway to initiate the Phase 1 clinical trial to evaluate the safety and immunogenicity of the vaccine, with current plans to begin enrolling patients later this year in South Africa.
  • Dyadic and our South African partner, Rubic, are pleased to have achieved this regulatory milestone for the DYAI-100 COVID-19 booster vaccine candidate, commented Mark Emalfarb, President and Chief Executive Officer of Dyadic.
  • Dyadic assumes no obligation to update publicly any such forward-looking statements, whether because of new information, future events or otherwise.

Pearl’s Second Opinion® Gains Regulatory Clearance in South Africa

Retrieved on: 
Wednesday, August 31, 2022
Software, Biometrics, Radiology, Health, Artificial Intelligence, Health Technology, Technology, Dental, CEO, Impacted wisdom teeth, Radioactive decay, Calculus, SAHPRA, Solution, Crown, Dental care, Multimedia, South African Health Products Regulatory Authority, Health, FDA, X-ray, Bone loss, Efficiency, Craft Ventures, Dentist, Second, Patient, Medical device, Dentistry, Pearl

Pearl , the global leader in dental AI solutions, today announced that Second Opinion , its chairside clinical artificial intelligence (AI) software, has received clearance from the South African Health Products Regulatory Authority (SAHPRA).

Key Points: 
  • Pearl , the global leader in dental AI solutions, today announced that Second Opinion , its chairside clinical artificial intelligence (AI) software, has received clearance from the South African Health Products Regulatory Authority (SAHPRA).
  • Second Opinion is the first and only FDA-cleared chairside AI software to help dentists detect numerous conditions in x-rays of dental patients 12 and older.
  • South Africa joins the growing list of medical device authorizations for Second Opinion, which already includes clearances in the United States, European Union, Canada, Australia, New Zealand, United Arab Emirates, Saudi Arabia, and Brazil.
  • Second Opinion satisfies both of those desires, so its SAHPRA clearance is something that patients and practices in South Africa can smile about.

Dyadic Reports Second Quarter 2022 Financial Results and Highlights Recent Company Developments

Retrieved on: 
Wednesday, August 10, 2022
COVID-19 vaccine, GLOBE, SEC, Clinical trial, Investment, Livestock, Research, Aluminium hydroxide, CTA, Mono, Pandemic, HA, Phibro, SAHPRA, Securities Act of 1933, Securities Exchange Act of 1934, Health, National Food Security Act, 2013, Investor relations, Industry, Enzyme, NA, Form 10-K, C1, Safety, Janssen, Vaccine, Webcast, Neuraminidase, RBD, Alpha, South African Health Products Regulatory Authority, COVID-19, Food, D, Variants of SARS-CoV-2, Program, Severe acute respiratory syndrome coronavirus 2, China Biologic Products, Antibody, Mab, Gene expression, CGMP, Review, Company, Infection, Therapy, NASDAQ, General officer, Third party, Protein, Human, Antigen, Adoption, Fine chemical, Pharmaceutical industry, Cryptocurrency, Animal Health, Dyadic, Omicron

Mr. Emalfarb continued, The Company now has commercial agreements in each of its three core verticals: Human Health, Animal Health, and Alternative Proteins.

Key Points: 
  • Mr. Emalfarb continued, The Company now has commercial agreements in each of its three core verticals: Human Health, Animal Health, and Alternative Proteins.
  • On July 22, 2022, the Company submitted its Clinical Trial Application (CTA) to the South African Health Products Regulatory Authority (SAHPRA) for expedited review.
  • Phibro/Abic Animal Health On February 10, 2022, Dyadic entered into an exclusive license agreement for a Phibro/Abic targeted disease.
  • Dyadic assumes no obligation to update publicly any such forward-looking statements, whether because of new information, future events or otherwise.

Proactive news headlines including Chalice Mining, Magmatic Resources, Hawsons Iron and Alkane Resources

Retrieved on: 
Friday, July 8, 2022
Lithium, MAG, OTC, OTCQB, Patient, MXC, Peep, HIO, GLOBE, ASX, COVID-19, Commerce, South African Health Products Regulatory Authority, Proactivity, PGE, LSE, Lachlan Fold Belt, LRS, Partnership, Bodangora Wind Farm, Research, BFS, Mining, Rare-earth element

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Key Points: 
  • Click here
    Magmatic Resources Ltd (ASX:MAG) has recorded strong and shallow gold at the Dicks Reward historic mine in the Bodangora prospect in New South Wales.
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    Alkane Resources Limited (ASX:ALK)'s tangible assets now cover 136% of the company's share price, according to estimates by Edison Investment Research, up from 56% previously.
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    Proactive is a unique tech-enabled platform providing companies globally with a comprehensive investor engagement solution across their business lifecycle.
  • For more information on how Proactive can help you make a difference, email us at [email protected]

SINOVAC COVID-19 Vaccine Is Conditionally Registered In South Africa

Retrieved on: 
Saturday, June 25, 2022
Biotechnology, Pharmaceutical, Health, COVID-19, Influenza A virus subtype H1N1, Research, SAHPRA, Chinese government award for outstanding self finance students abroad, Polio, COVID-19, South African Health Products Regulatory Authority, Company, Hepatitis A, Hepatitis, Ageing, Infection, H5N1, Streptococcus, Sinovac Biotech, Risk management, Foot-and-mouth disease virus, NASDAQ, Vaccine, HFMD, Chickenpox, Safety, Mumps, EV71, WHO, Pharmaceutical industry

All the evidence suggested that the SINOVAC COVID-19 vaccine was safe and effective.

Key Points: 
  • All the evidence suggested that the SINOVAC COVID-19 vaccine was safe and effective.
  • SINOVAC COVID-19 vaccine has been available in more than 60 countries, with a total supply of almost 2.9 billion doses.
  • Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the research, development, manufacturing, and commercialization of vaccines that protect against human infectious diseases.
  • SINOVAC has been continually dedicating itself to new vaccine research and development, with more combination vaccine products in the pipeline, and constantly exploring opportunities in the international market.

Frankfurt Listed Labat Africa, strengthens it cannabis business value chain

Retrieved on: 
Tuesday, April 5, 2022
Business development, CSIR, Biopolymer, Private sector, Frankfurt Stock Exchange, Labat, Genetics, THC, Council for Scientific and Industrial Research, Cannabidiol, Research, MOU, Council, Pain management, Industrial Research Limited, Government, Textile, SweetWater Brewing Company, Biomass, Industry, Biodata, Time, GLOBE, South African Health Products Regulatory Authority, Acceleration, Cannabis, Science, Patient, Drug, Renewable energy, CBD

Brian van Rooyen, Labats Group Chief Executive, said the agreement will solidify co-operation between the CSIR and Labat across the value chain of cannabis and hemp production for industries ranging from pharmaceuticals to textiles.

Key Points: 
  • Brian van Rooyen, Labats Group Chief Executive, said the agreement will solidify co-operation between the CSIR and Labat across the value chain of cannabis and hemp production for industries ranging from pharmaceuticals to textiles.
  • The CSIR wants to commercialise medicinal cannabis and gain traction on the industrial side of hemp production and processing.
  • Van Rooyen added that by industrialising cannabis and hemp production, Labat will be able to meet global demands.
  • We want to be involved in almost every part of the cannabis value chain, from genetics to retail and dispensary, says Herschel Maasdorp, Labats Group Executive for Business Development.