Health Canada

Public advisory - Unlabelled Herbaland brand gummy vitamins and supplements sold in bulk may pose serious health risks

Retrieved on: 
Saturday, November 11, 2023
Folate, Vomiting, Health Canada, Drug, Safety, Mineral, Allergy, Pregnancy, Pharmacy, Vitamin A, Candy, Health, Birth, Hazardous waste, Vitamin, Anaphylaxis, Nausea, Fetus, Vitamin D, Dietary supplement, Medical device

Herbaland Naturals Inc. is recalling all Herbaland gummy vitamins and supplements sold in bulk because they may pose serious health risks if misused, particularly for children and pregnant people.

Key Points: 
  • Herbaland Naturals Inc. is recalling all Herbaland gummy vitamins and supplements sold in bulk because they may pose serious health risks if misused, particularly for children and pregnant people.
  • Some products may also not be appropriate for certain groups such as children, pregnant people and people taking other health products.
  • All natural health products must follow Health Canada's labelling requirements to protect consumers' health and safety.
  • Health Canada is monitoring the recall and will inform the public if any new health risks are identified.

Public advisory - Sabril (vigabatrin) 500 mg sachets and tablets found to contain trace amounts of another drug

Retrieved on: 
Thursday, November 9, 2023
Health Canada, Seizure, Risk, Tablet, Tic, Allergy, Patient, Agitation, Child, Spasm, Throat, Mouth, Aggression, Dyskinesia, Psychosis, Pharmacy, Pharmaceutical industry, Nursing, Dietary supplement, Medical device, Vigabatrin

Further to the advisory below, in discussion with Health Canada, Lundbeck Canada Inc. is releasing one lot of Sabril (vigabatrin) 500 mg tablets on the Canadian market found to contain trace amounts of another prescription drug, tiapride.

Key Points: 
  • Further to the advisory below, in discussion with Health Canada, Lundbeck Canada Inc. is releasing one lot of Sabril (vigabatrin) 500 mg tablets on the Canadian market found to contain trace amounts of another prescription drug, tiapride.
  • To help mitigate the ongoing shortage, Health Canada is working with stakeholders to monitor the supply of sachets and tablets.
  • Further to the advisory below, in discussion with Health Canada, Lundbeck Canada Inc. is releasing an additional lot Sabril (vigabatrin) 500 mg in sachet format on the Canadian market found to contain trace amounts of another prescription drug, tiapride.
  • Original Advisory – August 18, 2023:
    Lundbeck Canada Inc. has informed Health Canada that two lots of Sabril (vigabatrin) 500 mg powder for oral solution, in sachet format, were found to contain trace amounts of another prescription drug, tiapride.

World’s First Observational Trial to Assess Real-World Efficacy of MDMA Treatment

Retrieved on: 
Thursday, November 9, 2023
Knowledge, Post-traumatic stress disorder, University of Calgary, MDMA, Veterans Affairs Canada, UC, Physician, OTC, Health Canada, Ethics, Special access program, Party, Research, RWE, CSE, Trauma, Nature, PTSD, Trial, Real, Clinical trial, Partnership, SAP, University, LOI, GMP, Safety, Collection, Patient, DSM-IV codes, Mental health, Senate, Pharmaceutical industry, Veteran

The University of Calgary, under the direction of Dr. Leah Mayo, Parker Research Chair in Psychedelics, will assess data pertaining to efficacy of MDMA in the treatment of PTSD under real-world circumstances.

Key Points: 
  • The University of Calgary, under the direction of Dr. Leah Mayo, Parker Research Chair in Psychedelics, will assess data pertaining to efficacy of MDMA in the treatment of PTSD under real-world circumstances.
  • This trial will generate Real World Evidence (“RWE”) on the efficacy of MDMA in the treatment of Post-Traumatic Stress Disorder which may be submitted to Health regulators, including Health Canada and Veterans Affairs Canada.
  • As the trial is Observational in nature, no patients will be dosed as part of the trial’s protocol.
  • The goal of the trial is to gather data on the efficacy of treatment for patients who are already qualified for treatment under the Special Access Program.

Canadian Psychedelic Trade Association Endorses Senate Report Calling for Research into Psychedelic-Assisted Therapy

Retrieved on: 
Wednesday, November 8, 2023
Psilocybin, Science, Government, Post-traumatic stress disorder, Parliament, Anxiety, MDMA, Veterans Affairs Canada, MDD, Chronic pain, Public, DND, Treatment, Health Canada, Veteran, Government of Canada, Doctor of Philosophy, Research, National security, Equitable Access to Care and Health Act, Canadian Institutes of Health Research, PTSD, OUD, CIHR, Atypical depression, DSM-IV codes, AUD, Partnership, VAC, TUD, House, Safety, Nicotine, Veterans' affairs, TRD, Mental health, Senate, Pharmaceutical industry, Nursing

OTTAWA, Nov. 08, 2023 (GLOBE NEWSWIRE) -- PsyCan — the not-for-profit trade association of legally-operating Canadian psychedelic companies — enthusiastically endorses a new report by the Senate of Canada Subcommittee on Veteran Affairs urging federal, provincial, and territorial governments to launch and fund a large-scale research program into psychedelic-assisted therapy.

Key Points: 
  • OTTAWA, Nov. 08, 2023 (GLOBE NEWSWIRE) -- PsyCan — the not-for-profit trade association of legally-operating Canadian psychedelic companies — enthusiastically endorses a new report by the Senate of Canada Subcommittee on Veteran Affairs urging federal, provincial, and territorial governments to launch and fund a large-scale research program into psychedelic-assisted therapy.
  • While Canada is a leader in developing these innovative treatments, many barriers remain to patient access, and government must play an active role.
  • “This report echoes our calls for government funding into psychedelic-assisted therapy,” said PharmAla Biotech CEO and PsyCan Chair Nick Kadysh.
  • “Research on these subjects is constantly evolving and will continue to do so.

PepGen Reports Third Quarter 2023 Financial Results and Recent Corporate Developments

Retrieved on: 
Wednesday, November 8, 2023
DM1, FDA, Research, EDO, Clinical trial, Food, Three Months, Therapy, Health Canada, News, Conference, CTA, MAD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Development, Clinical, BioCompute Object, PGN, Myotonia, Biology, Duchenne muscular dystrophy, Research and development, Letter, Safety, DMD, Patient, Administration, NHP, Investigational New Drug, Neuromuscular disease, Pharmaceutical industry, Cryptocurrency, Rare-earth element

BOSTON, Nov. 08, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today reported financial results for the third quarter ended September 30, 2023 and highlighted recent corporate developments.

Key Points: 
  • Orphan Drug Designation granted to PGN-EDODM1: In September 2023, the FDA granted Orphan Drug Designation to PGN-EDODM1 for the treatment of DM1.
  • PepGen expects to report initial results from this study in 2024.
  • Financial Results for the Three Months Ended September 30, 2023
    Cash and cash equivalents were $129.5 million as of September 30, 2023, which is anticipated to fund currently planned operations into 2025.
  • PepGen had approximately 23.8 million shares outstanding on September 30, 2023.

MITSUBISHI TANABE PHARMA CANADA ANNOUNCES THAT COMPANY'S ORAL TREATMENT FORMULATION FOR AMYOTROPHIC LATERAL SCLEROSIS (ALS) HAS BEEN ADDED TO THE PROVINCIAL DRUG PLANS IN PRINCE EDWARD ISLAND, NEWFOUNDLAND AND LABRADOR

Retrieved on: 
Tuesday, November 7, 2023
Government, MTPA, Veterans Affairs Canada, PEI, ALS, Life, Indigenous Services Canada, Neurology, Health Canada, Face, News, ALS Society of Canada, Disease, Pharmacare, Memorial University of Newfoundland, Brain, Patient, Diagnosis, Edaravone, Pharmaceutical industry, Health insurance, Dentistry

"To date, RADICAVA® Oral Suspension is listed on the majority of provincial public drug plans.

Key Points: 
  • "To date, RADICAVA® Oral Suspension is listed on the majority of provincial public drug plans.
  • MTP-CA will continue to work with the remaining provincial, territorial and federal drug plans to help ensure that RADICAVA® Oral Suspension is listed on all public formularies across the country."
  • To date, it is estimated that the majority of private insurance plans in the country cover RADICAVA® Oral Suspension.
  • MTP-CA continues to have discussions with the territories and federal agencies regarding the listing of RADICAVA® Oral Suspension under additional publicly funded drug programs.

Health Canada Approves DOPTELET (avatrombopag) for Two Indications in Thrombocytopenia

Retrieved on: 
Monday, November 6, 2023
Abdominal pain, Headache, Food, Vancouver, Thrombocytopenia, Physician, Health Canada, MD, FRCPC, Hemostasis, Edema, Bleeding, Nausea, Platelet transfusion, Vancouver General Hospital, Chronic liver disease, Risk, Swedish Orphan Biovitrum, ITP, Blood, University, CLD, Woman, Safety, Patient, Hospital, Platelet, Fatigue, Medical imaging, Birth control, Pharmaceutical industry, Avatrombopag, Fever

”The current treatment landscape for immune thrombocytopenia in Canada has left certain patients with limited options.

Key Points: 
  • ”The current treatment landscape for immune thrombocytopenia in Canada has left certain patients with limited options.
  • With today’s approval of Doptelet, patients now have an effective oral treatment option with no food-type restrictions or need for liver function monitoring,” said Dr. Charles H. Li, MD, FRCPC, Consultant Hematologist at Vancouver General Hospital and Clinical Associate Professor at the University of British Columbia.
  • For Sobi Media contacts, click here.
  • Pooled safety data for 128 patients with ITP support the safety and tolerability of DOPTELET.

Anavex Life Sciences Appoints Senior VP of Regulatory Affairs

Retrieved on: 
Monday, November 6, 2023
Alzheimer's disease, FDA, Therapy, Medicine, Health Canada, Psychiatry, Rutgers University, Doctor of Philosophy, CNS, Senior, DSM-IV codes, Rett syndrome, MLS, Parkinson's disease, Central nervous system, EMA, MS, Neurology, NDA, Pharmacy, Patient, Regulatory affairs, Pharmaceutical industry, Pharmacist

Mr. Goldberger will succeed retiring Senior Vice President Regulatory Affairs, Emmanuel O Fadiran, RPh, MS, PhD.

Key Points: 
  • Mr. Goldberger will succeed retiring Senior Vice President Regulatory Affairs, Emmanuel O Fadiran, RPh, MS, PhD.
  • “We are delighted to welcome Mr. Goldberger to the Anavex team,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.
  • Prior to Otsuka he held senior level positions in Global Regulatory Affairs for Johnson and Johnson (J&J) Pharmaceutical Research and Development in Global Regulatory Affairs.
  • In addition, he led CMC Regulatory Affairs, Labeling, Regulatory Operations/Technology and Medical Writing areas.

Blender Bites Signs Definitive Agreement to Acquire Advanced Sports Nutrition Inc. and Targets Athletic Recovery with NFL-Funded Clinical Trial

Retrieved on: 
Saturday, November 4, 2023
Acquisition, NFL, Health Canada, Clinical trials publication, Clinical trial, Sport, Multilateral, Administrative share, MI, Blender, CSE, Athlete, FWB, BITE, Growth, Date, Canadian Securities Exchange, Marketing, WKN, Retail, Pharmaceutical industry, CBD

Chelsie Hodge, CEO of Blender Bites, stated, “Our goal at Blender Bites has always been to innovate and enhance the wellness of our customers.

Key Points: 
  • Chelsie Hodge, CEO of Blender Bites, stated, “Our goal at Blender Bites has always been to innovate and enhance the wellness of our customers.
  • Targeting a distinct demographic, it could set the stage for additional sales generation through Blender Bites’ existing distribution network.
  • The Clinical Trial will allow Blender Bites to develop unique proprietary beverage formulations, ensuring long-term protection against competition and fostering future innovations.
  • With the Acquisition, Blender Bites intends to diversify its revenue streams by venturing into the athletic recovery and CBD wellness market.

Thunder Bay teen honoured for saving father’s life with CPR

Retrieved on: 
Thursday, November 2, 2023
ACT, Knowledge, Science, The Act, Education, Health, Life, Health Canada, Hydro One, Sibling, St. Patrick's High School, Student, CPR, School, AED, Firefighter, Safety, Literacy, Secondary school, Nursing

She was honoured during an awards ceremony at St. Patrick High School.

Key Points: 
  • She was honoured during an awards ceremony at St. Patrick High School.
  • Their mother, Clare Caza, had already started performing CPR and was on the phone with the 911 operator.
  • Madeleine was trained through the ACT High School CPR and AED Program, which aims to see all students empowered to save lives.
  • With the 911 operator’s guidance, Madeleine and Luke quickly placed Michel on the floor, and Madeleine took over performing CPR until firefighters arrived.