Health Canada

Government of Canada announces draft rules to cut pollutants that cause smog in communities across Canada

Retrieved on:

Friday, February 23, 2024

Today, Environment and Climate Change Canada and Health Canada announced the draft regulations to further reduce emissions from the petroleum sector of harmful volatile organic compounds (VOCs), which are airborne pollutants that contribute to smog.

Key Points:

Today, Environment and Climate Change Canada and Health Canada announced the draft regulations to further reduce emissions from the petroleum sector of harmful volatile organic compounds (VOCs), which are airborne pollutants that contribute to smog.
These changes would improve air quality in neighbourhoods and communities across the country that are close to oil and gas facilities.
The draft regulations reflect an on-going commitment to environmental justice and the need to address disproportionate environmental harms on communities near industrial sites.
Exposure levels are higher in communities near large emission sources, including Indigenous and low-income communities already facing increased health burdens.

Government of Canada announces first steps in its Action Plan to support Black public servants

Retrieved on:

Wednesday, February 21, 2024

As a result, nearly $50 million is supporting the creation and development of the Action Plan for Black Public Servants (Action Plan) to establish career development programs and mental health supports for Black public servants.

Key Points:

As a result, nearly $50 million is supporting the creation and development of the Action Plan for Black Public Servants (Action Plan) to establish career development programs and mental health supports for Black public servants.
Today, the Honourable Anita Anand, President of the Treasury Board, announced the first initiatives of the Action Plan, which will continue to be refined through meaningful input from Black public servants.
The Public Service Commission (PSC) is receiving funding to provide individualized assessment, counselling and coaching services to Black public servants.
- The Honourable Ya'ara Saks, Minister of Health and Addictions and Associate Minister of Health
For more information about the Action Plan, public servants can contact the Task Force for Black Public Servants at [email protected] .

Public advisory - APO-Mometasone nasal spray: Two lots recalled due to possible risk of infection

Retrieved on:

Monday, February 19, 2024

Pharmacy, Sepsis, Health Canada, Infection, Polyp (medicine), Sneeze, Sinusitis, BCC, Chronic pain, Burkholderia cepacia complex, Fever, Risk, Bacteria, Death, Child, Inc., Pressure, Immune system

Apotex Inc. is recalling two lots of APO-Mometasone nasal spray due to possible bacterial contamination with Burkholderia cepacia complex (Bcc).

Key Points:

Apotex Inc. is recalling two lots of APO-Mometasone nasal spray due to possible bacterial contamination with Burkholderia cepacia complex (Bcc).
APO-Mometasone nasal spray is a prescription drug used to treat seasonal and year-round nasal allergy symptoms (such as itchy, stuffy or runny nose and sneezing) in children 3-11 years old.
It is also used to treat sinusitis (sinus inflammation) in adults and children 12 years of age and older, and nasal polyps in adults.
The effects of Bcc vary widely, ranging from no symptoms at all to serious infections.

Momentum Health receives FDA 510K Clearance for Momentum Spine, a Pioneering AI-Enabled Mobile Application for Monitoring Scoliosis, Available for Download Now!

Retrieved on:

Thursday, February 15, 2024

After receiving their Health Canada class 1 medical device clearance, Momentum Spine continues to gain traction with FDA clearance and the launch of their mobile app.

Key Points:

After receiving their Health Canada class 1 medical device clearance, Momentum Spine continues to gain traction with FDA clearance and the launch of their mobile app.
MONTREAL, Feb. 15, 2024 /CNW/ - Momentum Health Inc. is excited to announce that its innovative mobile application, Momentum Spine, has received U.S. Food and Drug Administration (FDA) clearance.
With the recent FDA clearance, Momentum Health is progressing to the commercialization phase for the Momentum Spine technology.
Dr. Jean Ouellet, a Pediatric Spine Surgeon and the Chief Medical Officer of Momentum Health Inc., shared his enthusiasm: "Receiving FDA clearance is a monumental achievement for Momentum Health.

CEL-SCI Corporation Reports First Quarter Fiscal 2024 Financial Results

Retrieved on:

Thursday, February 15, 2024

CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended December 31, 2023, as well as key recent clinical and corporate developments.

Key Points:

CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended December 31, 2023, as well as key recent clinical and corporate developments.
In October 2023, the new data were presented at the 2023 European Society for Medical Oncology (ESMO) Congress.
CEL-SCI plans to submit the target population data to the U.S. Food and Drug Administration (FDA) this quarter.
CEL-SCI raised $5 million in November 2023 and $7.75 million in February 2024, both through public offerings of common stock.

Animal Protection Party of Canada: Good for Remilk, for Canada, for Animals, and for Us. Boo to Italy.

Retrieved on:

Wednesday, February 14, 2024

TORONTO, Feb. 14, 2024 (GLOBE NEWSWIRE) -- “We are happy to see recent technological developments that bode well for ecological health, human health, food security, and compassion for animals,” says Barry MacKay, Animal Protection Party’s General Manager.

Key Points:

TORONTO, Feb. 14, 2024 (GLOBE NEWSWIRE) -- “We are happy to see recent technological developments that bode well for ecological health, human health, food security, and compassion for animals,” says Barry MacKay, Animal Protection Party’s General Manager.
It was announced on February 5th that Health Canada has sent a “letter of no objection” to Remilk, a company specializing in food technology.
While able to produce cheese, yogurt, milk, and ice cream indistinguishable from that derived from lactating cows, the new product does not require cattle.
Adaptation is not merely the key to species survival, it is the only means by which survival can occur.

Draft revised consolidated 3-year work plan for the Methodology Working Party (MWP)

Retrieved on:

Wednesday, February 14, 2024

Real-World Evidence, ACT, Data science, CMD, Toxicity, Budesonide, Paliperidone palmitate, Drug development, E20, RWE, ETF, Human, Pharmacology, Machine learning, Quantitative systems pharmacology, Register, Radiopharmaceutical, Legislation, QST, M12, CAT, Salt, Pharmacoepidemiology, Dasatinib, Algorithm, M13, Azacitidine, Methylphenidate, Clinical trial, Health, M&S, Methodology, PBPK, HMA, Adverse drug reaction, European, CHMP, HTA, Biomarker, Big data, Digoxin, Betahistine, Multi, Therapy, Medication package insert, Simulation, LALA, ADR, US FDA, Language, RWD, Corr, PBBM, WPS, SAWP, Committee, Pharmacovigilance, Peptide, ICH, CPS, Contribution, Good, QSP, Model, Epidemiology, Artificial intelligence, RPS, Research, Reproduction, PRAC, EMA, Health Canada, AI, Cross, Gastrointestinal tract, Paliperidone, Communication, Risk, Melatonin, MWP, CP, Medicine, Patient, Biostatistics, Pharmacokinetics, Oligonucleotide, E21, M14, Q&A, Drug, M15, Medical device

Industry level .................................................................................................. 13

Key Points:

Industry level .................................................................................................. 13
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023

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1.
A reflection paper
(RP) on the clinical pharmacology package for oligonucleotides is a prioritised activity in the MWP work
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023

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plan, and it is envisaged that something similar may be needed for other emerging treatment
modalities (e.g., peptides).
Guideline work led by other working parties
?
Revision of the guideline on the requirements for clinical documentation for orally inhaled
products (CPMP/EWP/4151/00 Rev.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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The planned concept papers (CPs) will formulate problem statements for potential workshops and
subsequent guidance documents will be informed and enriched by the outcome of discussions of
workshops to be held in 2024.
Guideline work led by other working parties and committees
?
Revision of Guidance on the investigation of medicinal products in the term and preterm
neonate (EMEA/536810/2008).
There is a need for
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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new guidance in these areas to ensure these novel approaches meet the required evidentiary
standards and facilitate their evaluation.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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?

Revision of Guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98/Rev.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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?

Provide appropriate support to the EU network for generic and hybrid medicines including
product-specific requirements.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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2.3.
?
Cross disciplinary work with Quality Working Party and other stakeholders on physiologically
based biopharmaceutics modelling (PBBM).
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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?

In order to support adequate evaluation of all methodology MWP will aim to facilitate an
increase in presence and visibility in relevant committees of methodological expertise from
across the EU network such as CHMP, PRAC, PDCO, CMD(h), ETF and CAT.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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?

Product Specific Bioequivalence Guidelines (PSBGLs) (multiple) in liaison with CMD(h): for
2024, azacitidine, budesonide (LALA GIT), trametinib, dabrafenib, paliperidone palmitate (3M
depot) and melatonin have been prioritised as the next in series for drafting.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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4.2.
?
Cross disciplinary work with Quality Working Party and other stakeholders on PBBM model
assessment.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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?

To deliver an improved access to raw data (e.g.
?
Propose regulatory research priorities for funders in across the activities of Methodology
Working Party, including in the big data area.
?
Establish key communication points in national competent authorities and build a resource of
key messages and communication materials on regulation and methodology.
The timing of workshops may need to be arranged according to the
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023

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specific needs of the guidance ? either before the guidance is finalised to gather views and
expertise; or once it is finalised for training purposes.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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ELREXFIO™ is authorized by Health Canada for adults with relapsed or refractory multiple myeloma in Canada

Retrieved on:

Tuesday, February 13, 2024

Bone marrow, Health Canada, Multiple myeloma, RRMM, News, Pfizer, B cell, Myeloma Canada, Patient, Disease, Cancer, Pharmaceutical industry

KIRKLAND, QC, Feb. 13, 2024 /CNW/ - Today, Pfizer Canada announced that Health Canada has granted a Notice of Compliance with conditions (NOC/c) to ELREXFIO (elranatamab solution for injection).

Key Points:

KIRKLAND, QC, Feb. 13, 2024 /CNW/ - Today, Pfizer Canada announced that Health Canada has granted a Notice of Compliance with conditions (NOC/c) to ELREXFIO (elranatamab solution for injection).
"The approval of ELREXFIO is good news for patients and their healthcare teams as it offers a new treatment possibility for those living with the disease."
Multiple myeloma is the second-most common type of blood cancer, with an estimated 11 Canadians being diagnosed with myeloma every day.iii It is estimated that in 2023, 3,900 Canadians were diagnosed with multiple myeloma and 1,700 Canadians died from the disease.iv
"Multiple myeloma can be an incredibly challenging cancer to live with and manage," said Martine Elias, Executive Director at Myeloma Canada.
This is why it's so important that people living with the disease have access to many and new options even more so when they have relapsed."

PharmaTher Provides Update of its Priority Original Abbreviated New Drug Application for Ketamine

Retrieved on:

Monday, February 12, 2024

Hospital, Anxiety, Mental health, Health Canada, FDA, Ketamine, Food, Pain, Quality, Suicidal ideation, DSM-IV codes, Anesthesia, Depression, Pharmaceutical industry

TORONTO, Feb. 12, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, provides an update of its Priority Original Abbreviated New Drug Application (“ANDA”) for Ketamine that was accepted by the U.S. Food and Drug Administration (the “FDA”) and assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of April 29, 2024.

Key Points:

TORONTO, Feb. 12, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, provides an update of its Priority Original Abbreviated New Drug Application (“ANDA”) for Ketamine that was accepted by the U.S. Food and Drug Administration (the “FDA”) and assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of April 29, 2024.
The Company aims to respond to satisfy the preliminary thoughts on possible deficiencies before the goal date.
The Company received a waiver from the FDA for bioequivalence studies and has not identified any deficiencies.
A recently published new peer-reviewed study on the real-world effectiveness of ketamine intravenous therapy demonstrated significant patient improvement for depression, anxiety and suicidal ideation.

Optimi Health Congratulates Lykos Therapeutics on FDA Priority Review of New Drug Application And Releases MDMA Production Video

Retrieved on:

Monday, February 12, 2024

Health Canada, MAPS, FDA, Food, FRA, HPLC, GMP, PDUFA, MDMA, Safety, Therapy, Lycus, PTSD, NDA, Chromatography, Pharmaceutical industry

Additionally, Optimi is pleased to unveil a six-minute video showcasing its end-to-end GMP MDMA encapsulation and production process.

Key Points:

Additionally, Optimi is pleased to unveil a six-minute video showcasing its end-to-end GMP MDMA encapsulation and production process.
The FDA's priority review designation underscores the significance of this potential breakthrough in providing effective treatment options for those impacted by this debilitating condition.
Bill Ciprick, CEO of Optimi Health, stated, "We commend Lykos Therapeutics and MAPS founder, Rick Doblin, for their unwavering dedication to advancing innovative therapies for PTSD.
Stevens stated, "The ability to showcase our GMP MDMA production process is a testament to our commitment to excellence and transparency.