Health Canada

PharmAla releases Profitable Q1 Interim Financial Statement and Business Update

Retrieved on: 
Wednesday, January 31, 2024

VANCOUVER, British Columbia, Jan. 31, 2024 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to present its Q1 Interim Financial Statement for the period ending November 30, 2023.

Key Points: 
  • VANCOUVER, British Columbia, Jan. 31, 2024 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to present its Q1 Interim Financial Statement for the period ending November 30, 2023.
  • PharmAla showed a quarterly profit for the first time in its history, validating its low-overhead manufacturing business model.
  • PharmAla believes that this is the first quarterly profit for any publicly-traded psychedelics company.
  • PharmAla will be hosting an investor webinar on Friday the 2nd to further elaborate on its financial report as well as discuss their recent achievement of obtaining a Controlled Drugs & Substances Dealer’s License (CDSL) from Health Canada.

Align Technology Announces Fourth Quarter and Fiscal 2023 Financial Results

Retrieved on: 
Wednesday, January 31, 2024

As of December 31, 2023, we had $300.0 million available under a revolving line of credit.

Key Points: 
  • As of December 31, 2023, we had $300.0 million available under a revolving line of credit.
  • Commenting on Align's 2023 results, Align Technology CFO and EVP Global Finance, John Morici said, "I am pleased with our fourth quarter and fiscal 2023 results, and I am especially proud of our continued focused execution of our product roadmap and innovation pipeline.
  • Data on file at Align Technology, Inc. as of October 30, 2023.
  • ET, 2:30 p.m. MT, to review our fourth quarter and full year 2023 results, discuss future operating trends, and our business outlook.

The Government of Canada introduces legislation to delay Medical Assistance in Dying expansion by 3 years

Retrieved on: 
Thursday, February 1, 2024

OTTAWA, ON, Feb. 1, 2024 /CNW/ - Medical assistance in dying (MAID) is a very personal choice and a deeply sensitive topic.

Key Points: 
  • OTTAWA, ON, Feb. 1, 2024 /CNW/ - Medical assistance in dying (MAID) is a very personal choice and a deeply sensitive topic.
  • In Canada, MAID may be an option for some people who are suffering intolerably due to an eligible medical condition.
  • The Government of Canada recognizes that mental illness can cause the same level of suffering as that of physical illnesses.
  • On October 24, 2023, Health Canada released the Fourth Annual Report on Medical Assistance in Dying in Canada 2022 containing data providing insights into MAID assessment and delivery in Canada.

More than 400,000 Canadian seniors have been approved for dental care under the Canadian Dental Care Plan

Retrieved on: 
Wednesday, January 31, 2024

"The Canadian Dental Care Plan is already seeing significant uptake, with more than 400,000 seniors successfully applying for the plan in just the first month, all without any wait time on the phone.

Key Points: 
  • "The Canadian Dental Care Plan is already seeing significant uptake, with more than 400,000 seniors successfully applying for the plan in just the first month, all without any wait time on the phone.
  • The Canadian Dental Care Plan has already got hundreds of thousands of uninsured seniors approved for dental care, and more are joining every day.
  • By expanding applications to the Canadian Dental Care Plan, we help ensure seniors have access to the essential dental care services they deserve.
  • "Once fully deployed, the Canadian Dental Care Plan will extend to eligible Canadians of all ages whose adjusted family net income is less than $90,000.

New Digestive Line from Specialty Enzymes & Probiotics Receives Natural Product Numbers (NPNs) & Claims from Health Canada

Retrieved on: 
Wednesday, January 31, 2024

CHINO, Calif., Jan. 31, 2024 /PRNewswire/ -- Specialty Enzymes & Probiotics, a leading manufacturer specializing in high-quality enzymes and probiotics, is proud to announce it has received product licenses with claims from Health Canada for its digestive enzyme blends: SEBDigest, SEBDigest Plus and SEBDigest Super.

Key Points: 
  • CHINO, Calif., Jan. 31, 2024 /PRNewswire/ -- Specialty Enzymes & Probiotics, a leading manufacturer specializing in high-quality enzymes and probiotics, is proud to announce it has received product licenses with claims from Health Canada for its digestive enzyme blends: SEBDigest, SEBDigest Plus and SEBDigest Super.
  • Powerful and expertly formulated, SEBDigest, SEBDigest Plus and SEBDigest Super, are designed to promote optimal digestion and nutrient absorption.
  • In 2023, Specialty Enzymes & Probiotics was awarded Health Canada licenses for their three spore-forming Bacilli probiotics, SEBiotic®, SEBtilis™ and SEBclausii™.
  • "Our focus is on bringing effective and sought-after products to market to better serve our clients," said Vic Rathi, CEO & Founder of Specialty Enzymes & Probiotics.

XTANDI® (enzalutamide) Receives Health Canada Approval as the First and Only Treatment for High-Risk Patients with Non-Metastatic Castration-Sensitive Prostate Cancer (nmCSPC)

Retrieved on: 
Tuesday, January 30, 2024

MARKHAM, ON, Jan. 30, 2024 /CNW/ - Today, Astellas Pharma Canada, Inc. announced that Health Canada has approved a supplemental New Drug Application for XTANDI® (enzalutamide) in a new prostate cancer treatment setting.

Key Points: 
  • MARKHAM, ON, Jan. 30, 2024 /CNW/ - Today, Astellas Pharma Canada, Inc. announced that Health Canada has approved a supplemental New Drug Application for XTANDI® (enzalutamide) in a new prostate cancer treatment setting.
  • "I welcome the approval of XTANDI as a promising earlier treatment option for eligible patients.
  • This marks a significant step forward in addressing unmet needs for prostate cancer treatment."
  • With our recent acquisition of Propella Therapeutics, Inc., we strive to achieve even more in the investigation of targeted prostate cancer treatments for patients of the future."

Vitaquest International Secures USP Verification at All Manufacturing Sites

Retrieved on: 
Monday, January 22, 2024

Custom Manufacturer of Health & Wellness Consumer Products Takes Next Step in Drive to Lead Quality and Trust

Key Points: 
  • Vitaquest produces over 4,000 health and wellness consumer products at three different facilities, and all these facilities have now successfully completed the USP program.
  • To secure USP Verification, Vitaquest successfully completed a multi-step process that included GMP facility audits, and product quality control and manufacturing (QCM) process evaluation.
  • United States Pharmacopoeia (USP) Quality Systems GMP Audit Program is one of many dietary supplement programs the organization has successfully completed.
  • Vitaquest has successfully completed the United States Pharmacopoeia (USP) Quality Systems GMP Audit Program for three of its facilities, following an extensive review of its dietary supplement manufacturing systems and processes.

PharmAla granted a Controlled Drugs & Substances Dealer’s License by Health Canada

Retrieved on: 
Thursday, January 25, 2024

VANCOUVER, British Columbia, Jan. 25, 2024 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to announce that it has been granted a Controlled Drugs & Substances Dealer’s License (CDSL) by Health Canada, Canada’s federal health regulator.

Key Points: 
  • VANCOUVER, British Columbia, Jan. 25, 2024 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to announce that it has been granted a Controlled Drugs & Substances Dealer’s License (CDSL) by Health Canada, Canada’s federal health regulator.
  • The CDSL allows PharmAla to offer for sale both 3,4 Methylenedioxymethamphetamine (MDMA) and Psilocybin to those authorized to legally hold these materials.
  • “PharmAla is breaking new ground in the Canadian market.
  • “This license could drive revenue growth for the Company, and allow us to educate potential prescribers on the relevant science behind LaNeo™ and MDMA Therapy.

United Health Products Reports on FDA Application Status

Retrieved on: 
Friday, January 19, 2024

About United Health Products -- UHP develops, manufactures and markets HemoStyp™, a patented Neutralized Regenerated Cellulose hemostatic agent. HemoStyp is an all-natural product designed to control bleeding. UHP currently offers a suite of hemostatic products to the dental, veterinary and emergency medicine markets, and is seeking approval to access the human surgical market. 

Key Points: 
  • MESQUITE, NV, Jan. 19, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – United Health Products (UEEC) reports today on the receipt and review of final reports on product sterilization and stability testing for its hemostatic gauze.
  • As previously disclosed, UHP has been working with external packaging and sterilization service providers to complete various required tests for its Premarket Approval application.
  • UHP will now compile these data and proceed with final drafting of the PMA documentation to be submitted via the eSTAR platform for FDA and Health Canada review.
  • There can be no assurance that the company’s PMA or Health Canada applications will be approved.

Optimi Health Secures Amendment to Increase Quantities Of MDMA, MDA, And 2C-B Under Controlled Drugs And Substances Dealer’s Licence

Retrieved on: 
Friday, January 19, 2024

Effectively implemented on January 16, 2024, the amendment allows substantial increases in the quantities of MDMA, MDA, and 2CB under subsection J.01.059(4) of Part J of the Food and Drug Regulations.

Key Points: 
  • Effectively implemented on January 16, 2024, the amendment allows substantial increases in the quantities of MDMA, MDA, and 2CB under subsection J.01.059(4) of Part J of the Food and Drug Regulations.
  • Terms of the amendment now permit the following increases:
    N-METHYL-3,4-METHYLENEDIOXY AMPHETAMINE (MDMA) – from 2kg to 20kg.
  • It enhances our competitive advantage and perfectly aligns with our vision to be the leading global supplier of GMP MDMA and other psychedelic substances."
  • Optimi now has Health Canada approval to manufacture the following controlled substances: