Inhalation

REMSleep Holdings Shareholder Update

Retrieved on: 
Monday, March 4, 2024

CLEARWATER, FL, March 04, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire - REMSleep Holdings, Inc. (OTC PINK: RMSL) gives an update on FDA process and REMSleep status.

Key Points: 
  • CLEARWATER, FL, March 04, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire - REMSleep Holdings, Inc. (OTC PINK: RMSL) gives an update on FDA process and REMSleep status.
  • We have had numerous inquiries asking for REMSleep regulatory status update.
  • REMSleep consultants are confident we will receive our 510(K) and we will never give up until we are successful.
  • REMSleep has addressed this problem by developing a novel CPAP nasal pillow interface that has been engineered to reduce pressure and enable better airflow.

Nocion Therapeutics Announces $62 Million Series B Financing to Advance Lead Program in Cough into Later Stage Development

Retrieved on: 
Monday, March 4, 2024

Nocion Therapeutics, a clinical-stage biopharmaceutical company, today announced that it has raised $62 million in Series B funding.

Key Points: 
  • Nocion Therapeutics, a clinical-stage biopharmaceutical company, today announced that it has raised $62 million in Series B funding.
  • Proceeds from the financing will be used to evaluate the lead program, Taplucanium Dry Powder for Inhalation, in a Phase 2b study in Chronic Cough patients.
  • With this financing, Nocion has raised $122 million since the company was founded in 2018.
  • “We are grateful to our new and existing investors for their commitment to our lead program in this challenging disease,” said Dr. Richard Batycky, Chief Executive Officer of Nocion.

Questions and answers on the European Union framework for (traditional) herbal medicinal products, including those from a ‘non-European’ tradition

Retrieved on: 
Sunday, March 10, 2024

1

Key Points: 
    • 1
      Committee on Herbal Medicinal Products (HMPC)

      Questions & Answers on the European Union framework
      for (traditional) herbal medicinal products, including those
      from a ?non-European? tradition

      Table of Content
      1.

    • European Pharmacopoeia

      SAWP

      Scientific Advice Working Party

      SmPC

      Summary of Product Characteristics

      THMP

      Traditional Herbal Medicinal Product

      TUR

      Traditional Use Registration

      WEU

      Well-Established Use

      Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

    • Terminology of herbal medicinal products (Q&A 1-4)

      Question 1
      What are herbal substances, herbal preparations, and herbal medicinal products?

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Question 4
      Are food supplements regulated under the European Union (EU) pharmaceutical legislation
      for (traditional) herbal medicinal products ((T)HMPs)?
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Regulation of herbal medicinal products in the European Union (Q&A 511)

      Question 5
      Where to find the pharmaceutical legislation and dossier requirements for herbal medicinal
      products (HMPs), including traditional herbal medicinal products (THMPs), in the European
      Union (EU)?

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • These countries have,
      through the EEA agreement, adopted the complete Union acquis on medicinal products and are
      consequently parties to the Union procedures.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Specific provisions for traditional herbal medicinal products (Q&A 1221)

      Question 12
      Which indications can be granted for traditional herbal medicinal products (THMPs)?

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Nov. 2023
      Answer 17

      Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Question 29
      Does the Committee on Herbal Medicinal Products (HMPC) hold a specific database on
      (registered) authorised (traditional) herbal medicinal products ((T)HMPs)?
    • Discussion with Member States intended to be

      Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

Government of Canada releases 2024-2030 Action Plan on Sexually Transmitted and Blood-Borne Infections

Retrieved on: 
Tuesday, February 27, 2024

OTTAWA, ON, Feb. 27, 2024 /CNW/ - Sexually transmitted and blood-borne infections (STBBI) are largely preventable, treatable, and in many cases curable.

Key Points: 
  • OTTAWA, ON, Feb. 27, 2024 /CNW/ - Sexually transmitted and blood-borne infections (STBBI) are largely preventable, treatable, and in many cases curable.
  • However, rates of sexually transmitted infections in Canada have increased over the last decade—gonorrhea rates have doubled since 2012, and syphilis rates are five times what they were.
  • That is why today, the Honourable Mark Holland, Minister of Health, launched the Government of Canada's sexually transmitted and blood-borne infections (STBBI) action plan 2024-2030 and announced $2.45 million in funding to address STBBI in Canada.
  • The Action Plan will continue to work towards reducing STBBI related stigma, to prevent new and reoccurring infections and connect people to testing, prevention, treatment and care."

Herbal medicinal product: Plantaginis ovatae semenArray, C: ongoing call for scientific data

Retrieved on: 
Friday, February 16, 2024

Herbal medicinal product: Plantaginis ovatae semenArray, C: ongoing call for scientific data

Key Points: 


Herbal medicinal product: Plantaginis ovatae semenArray, C: ongoing call for scientific data

Herbal medicinal product: Plantaginis ovatae seminis tegumentumArray, C: ongoing call for scientific data

Retrieved on: 
Friday, February 16, 2024

Herbal medicinal product: Plantaginis ovatae seminis tegumentumArray, C: ongoing call for scientific data

Key Points: 


Herbal medicinal product: Plantaginis ovatae seminis tegumentumArray, C: ongoing call for scientific data

Scinai Welcomes Liat Halpert as Head of Business Development and Sales

Retrieved on: 
Tuesday, February 13, 2024

JERUSALEM, Feb. 13, 2024 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI), a biopharmaceutical company focused on developing inflammation and immunology (I&I) biological products and providing CDMO services through its Scinai Bioservices business unit, today announced the appointment of Liat Halpert as Head of Business Development and Sales.

Key Points: 
  • JERUSALEM, Feb. 13, 2024 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI), a biopharmaceutical company focused on developing inflammation and immunology (I&I) biological products and providing CDMO services through its Scinai Bioservices business unit, today announced the appointment of Liat Halpert as Head of Business Development and Sales.
  • Scinai's broad pharmaceutical development experience, along with its end-to-end biologics drug development and GMP manufacturing facility, drove the Q3 2023 launch of Scinai Bioservices, a boutique end-to-end CDMO business unit, to assist biotech companies efficiently bring their products to market.
  • In addition to expanding the CDMO's business development and sales activities, Halpert will support partnering and out-licensing activities with mid and large cap pharma companies with which Scinai plans on bringing the NanoAbs through clinical trials and towards commercialization.
  • Halpert commented, "I am thrilled to join Scinai where I'll be leading business development and sales of our state-of-the-art end-to-end CDMO services in the global biotech arena.

ResMed’s New AirCurve™ 11 Bilevel Devices Enable Healthcare Providers to Make Informed Decisions about Care, Deliver Personalized Support, and Drive Positive Therapy Outcomes for Patients with Sleep Apnea

Retrieved on: 
Monday, February 12, 2024

AirCurve 11 devices are built on ResMed’s market-leading AirSense 11 platform and enhance the suite of offerings available for healthcare providers and clinicians when determining the best care for sleep apnea patients.

Key Points: 
  • AirCurve 11 devices are built on ResMed’s market-leading AirSense 11 platform and enhance the suite of offerings available for healthcare providers and clinicians when determining the best care for sleep apnea patients.
  • This design allows the device to align more closely with the patient’s natural breathing pattern.
  • myAir3, a patient engagement app that tracks sleep and therapy progress with a daily sleep score, now with support for bilevel patients.
  • AirView, a secure, cloud-based system that helps providers monitor and manage patients’ therapy remotely, enabling an informed pathway to optimal care.

In Chile, huge wildfires have killed at least 131 people – but one village was almost untouched

Retrieved on: 
Thursday, February 8, 2024

Existing diseases have been exacerbated by service interruptions, and people have lost their homes and livelihoods.

Key Points: 
  • Existing diseases have been exacerbated by service interruptions, and people have lost their homes and livelihoods.
  • It is a disaster mainly caused by our decisions and lack of preparation to deal with a more extreme climate hazard.
  • As an academic disaster researcher from Chile, I think there are lessons we can learn from these fires.

Fire-prone conditions

  • Meteorological conditions have made Chile very prone to fires this summer, especially in this long-and-thin country’s central region, where it is warm enough for fires yet wet enough for there to be vegetation to burn.
  • Conditions were dry on top of a longer-term mega-drought, and relative humidity was low.
  • It is very likely that these conditions have been influenced by El Niño, on top of human-induced climate change.

Formula for a (not natural) perfect disaster

  • This is exactly what happened in Chile: a deadly combination of an extreme climate hazard and inadequate social preparation.
  • Several antennas were affected by the fires and not properly working, so many people did not receive the message on time.
  • This led to traffic jams and bottlenecks, some of which became engulfed in the middle of the fires.

Climate-related hazards shouldn’t turn disastrous

  • However, the human health risks this poses can be reduced by adequate preparedness and response plans.
  • Villa Botania, near the city of Quilpué in central Chile, emerged from these fires as an interesting example to learn from.
  • This can save lives, as shown by the success since the 1970s of anti-seismic building regulations in this earthquake-prone country.


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Yasna Palmeiro Silva does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

Fragrance ingredient exposure is orders of magnitude below thresholds of concern, study shows

Retrieved on: 
Tuesday, February 6, 2024

MAHWAH, N.J., Feb. 6, 2024 /PRNewswire/ -- The Research Institute for Fragrance Materials, Inc. (RIFM), in collaboration with scientific modeling, data analytics, and computing company Creme Global, compared the fragrance exposure of the highest-end product users to the Threshold of Toxicological Concern (TTC) and Dermal Sensitization Threshold (DST) to determine a realistic understanding of consumer exposure to fragrance. The TTC is based on the U.S. Food and Drug Administration's Threshold of Regulation, which it expands upon to include consideration of an ingredient's molecular structure in conjunction with its toxicity data. The TTC approach is internationally recognized by regulators including the European Food Safety Authority (EFSA).

Key Points: 
  • The TTC approach is internationally recognized by regulators including the European Food Safety Authority (EFSA) .
  • The study authors compared exposure to the approximately 3,000 in-use fragrance-producing ingredients to their respective TTCs and DSTs.
  • Representative fragrance ingredients were randomly selected and analyzed for exposure distribution by product type (i.e., personal, household, oral, and air care) and route of exposure.
  • Exposure calculations were performed by the Creme-RIFM Aggregate Exposure model, which provides realistic exposure estimates that consider all fragrances the population is exposed to across all products used.