Nitrosamine

DaySavers and the Cannabis Research Coalition Want to Pay You to Smoke Joints for Science

Retrieved on: 
月曜日, 6月 10, 2024

No study to date has ever evaluated how cultivation practices or post-harvest processing impact the smokeability of the final product.

Key Points: 
  • No study to date has ever evaluated how cultivation practices or post-harvest processing impact the smokeability of the final product.
  • The SOS study has also partnered with Controlled Chemistry, experts in cannabis smoke and inhalation studies for cannabis, leveraging cutting-edge technologies and methodologies.
  • Moreover, many states are hesitant to permit smokable flower due to uncertainties about the substances produced in cannabis smoke.
  • Sponsorship proceeds for the SOS study will be reinvested into the non-profit Network of Applied Pharmacognosy and The Cannabis Research Coalition to support the evolution of cannabis research.

A Cutting-Edge Scientific Approach to Cholesterol Control, Weight Control and Disease Prevention With Less Dietary Restriction

Retrieved on: 
木曜日, 5月 2, 2024

CHICAGO, May 2, 2024 /PRNewswire-PRWeb/ -- Junk food is so loved by many. What is not loved are the associated medical conditions and weight gain. Over time, scientific studies have been conducted at various institutions across America and abroad. These studies have indicated that fiber and antioxidants can mitigate the health risks associated with junk food by counteracting the physiological effects of high-fat and other junk food, thus offering a cutting-edge approach to maintaining better health without deprivation. This does not mean that 𝑢𝑛𝑙𝑖𝑚𝑖𝑡𝑒𝑑 consumption of junk food without consequences is now possible. What it does mean is greater freedom, less restriction and a wider variety of food choices for 𝘩𝑒𝑎𝑙𝑡𝘩𝑦 individuals. These groundbreaking discoveries are uncovered in the book 𝐶𝑜𝑢𝑛𝑡𝑒𝑟𝑎𝑐𝑡 𝑡𝘩𝑒 𝐹𝑎𝑡: 𝐻𝑜𝑤 𝑆𝑐𝑖𝑒𝑛𝑡𝑖𝑓𝑖𝑐 𝑆𝑡𝑢𝑑𝑖𝑒𝑠 𝐻𝑎𝑣𝑒 𝑆𝘩𝑜𝑤𝑛 𝑇𝘩𝑎𝑡 𝐹𝑖𝑏𝑒𝑟 𝑎𝑛𝑑 𝐴𝑛𝑡𝑖𝑜𝑥𝑖𝑑𝑎𝑛𝑡𝑠 𝐶𝑎𝑛 𝐶𝑜𝑢𝑛𝑡𝑒𝑟𝑎𝑐𝑡 𝑡𝘩𝑒 𝑃𝘩𝑦𝑠𝑖𝑜𝑙𝑜𝑔𝑖𝑐𝑎𝑙 𝐸𝑓𝑓𝑒𝑐𝑡𝑠 𝑜𝑓 𝐽𝑢𝑛𝑘 𝐹𝑜𝑜𝑑 𝑎𝑛𝑑 𝑃𝑟𝑜𝑚𝑜𝑡𝑒 𝐶𝘩𝑜𝑙𝑒𝑠𝑡𝑒𝑟𝑜𝑙 𝑎𝑛𝑑 𝑊𝑒𝑖𝑔𝘩𝑡 𝐶𝑜𝑛𝑡𝑟𝑜𝑙 𝑊𝑖𝑡𝘩 𝐿𝑒𝑠𝑠 𝑅𝑒𝑠𝑡𝑟𝑖𝑐𝑡𝑖𝑜𝑛 (ISBN: 979-8398923704). The following concepts are discussed in the book:

Key Points: 
  • What it does mean is greater freedom, less restriction and a wider variety of food choices for 𝘩𝑒𝑎𝑙𝑡𝘩𝑦 individuals.
  • According to scientists, beta glucans can reduce the absorption of dietary fats and promote cholesterol control all by itself, even in a diet containing moderate amounts of saturated fat and cholesterol.
  • Scientists have reported that fiber helps to promote weight control by reducing the amount of calories the body absorbs .
  • Scientists have also reported that antioxidants help to promote weight control by providing the body with the energy that it needs to burn fat more efficiently .

A Cutting-Edge Scientific Approach to Cholesterol Control, Weight Control and Disease Prevention With Less Dietary Restriction

Retrieved on: 
水曜日, 5月 1, 2024

CHICAGO, May 1, 2024 /PRNewswire-PRWeb/ -- Junk food is so loved by many. What is not loved are the associated medical conditions and weight gain. Over time, scientific studies have been conducted at various institutions across America and abroad. These studies have indicated that fiber and antioxidants can mitigate the health risks associated with junk food by counteracting the physiological effects of high-fat and other junk food, thus offering a cutting-edge approach to maintaining better health without deprivation. This does not mean that 𝑢𝑛𝑙𝑖𝑚𝑖𝑡𝑒𝑑 consumption of junk food without consequences is now possible. What it does mean is greater freedom, less restriction and a wider variety of food choices for 𝘩𝑒𝑎𝑙𝑡𝘩𝑦 individuals. These groundbreaking discoveries are uncovered in the book 𝐶𝑜𝑢𝑛𝑡𝑒𝑟𝑎𝑐𝑡 𝑡𝘩𝑒 𝐹𝑎𝑡: 𝐻𝑜𝑤 𝑆𝑐𝑖𝑒𝑛𝑡𝑖𝑓𝑖𝑐 𝑆𝑡𝑢𝑑𝑖𝑒𝑠 𝐻𝑎𝑣𝑒 𝑆𝘩𝑜𝑤𝑛 𝑇𝘩𝑎𝑡 𝐹𝑖𝑏𝑒𝑟 𝑎𝑛𝑑 𝐴𝑛𝑡𝑖𝑜𝑥𝑖𝑑𝑎𝑛𝑡𝑠 𝐶𝑎𝑛 𝐶𝑜𝑢𝑛𝑡𝑒𝑟𝑎𝑐𝑡 𝑡𝘩𝑒 𝑃𝘩𝑦𝑠𝑖𝑜𝑙𝑜𝑔𝑖𝑐𝑎𝑙 𝐸𝑓𝑓𝑒𝑐𝑡𝑠 𝑜𝑓 𝐽𝑢𝑛𝑘 𝐹𝑜𝑜𝑑 𝑎𝑛𝑑 𝑃𝑟𝑜𝑚𝑜𝑡𝑒 𝐶𝘩𝑜𝑙𝑒𝑠𝑡𝑒𝑟𝑜𝑙 𝑎𝑛𝑑 𝑊𝑒𝑖𝑔𝘩𝑡 𝐶𝑜𝑛𝑡𝑟𝑜𝑙 𝑊𝑖𝑡𝘩 𝐿𝑒𝑠𝑠 𝑅𝑒𝑠𝑡𝑟𝑖𝑐𝑡𝑖𝑜𝑛 (ISBN: 979-8398923704). The following concepts are discussed in the book:

Key Points: 
  • What it does mean is greater freedom, less restriction and a wider variety of food choices for 𝘩𝑒𝑎𝑙𝑡𝘩𝑦 individuals.
  • According to scientists, beta glucans can reduce the absorption of dietary fats and promote cholesterol control all by itself, even in a diet containing moderate amounts of saturated fat and cholesterol.
  • Scientists have reported that fiber helps to promote weight control by reducing the amount of calories the body absorbs .
  • Scientists have also reported that antioxidants help to promote weight control by providing the body with the energy that it needs to burn fat more efficiently .

IFF to Showcase Science-backed Low Nitrite Excipients at Excipient World 2024

Retrieved on: 
月曜日, 4月 29, 2024

NEW YORK, April 29, 2024 /PRNewswire/ -- IFF's Pharma Solutions division will highlight innovative solutions to help pharmaceutical manufacturers seeking science-backed excipients with effective strategies to support their nitrosamine risk mitigation plans at Excipient World 2024, May 13-15, Gaylord Palms Resort and Convention Center, Kissimmee, Florida at booth 214.

Key Points: 
  • "As the pharmaceutical landscape evolves, it is important to address and solve any challenges associated with nitrosamine risk," said Angela Strzelecki, president, Pharma Solutions, IFF.
  • "Collaborating with an excipient manufacturer with vital expertise, and robust formulation and analytical capabilities enables drug developers to confidently and efficiently incorporate low nitrite excipients into their formulations."
  • Register here to schedule a meeting at Excipient World 2024.
  • IFF, the IFF Logo, and all trademarks and service marks denoted with ™, SM or ® are owned by IFF or affiliates of IFF unless otherwise noted.

Vaping now more common than smoking among young people – and the risks go beyond lung and brain damage

Retrieved on: 
木曜日, 4月 25, 2024

This echoes research that has found the popularity of vaping among young people in the UK has surged in recent years.

Key Points: 
  • This echoes research that has found the popularity of vaping among young people in the UK has surged in recent years.
  • But vaping comes with many risks to young people, including harm to the lungs and brain.
  • Young people who vape may be more likely to start smoking and find it harder to quit any nicotine use at all.
  • And using vaping products alongside other products containing nicotine, like cigarettes, for example, may be even worse for their health.

Hidden risks

  • There are many less obvious risks to vaping too.
  • The chemicals in vape liquids – including various toxins, heavy metals and possibly even radioactive polonium – may be harmful.
  • This could be because of the specific mix of ingredients different brands put in the vape liquid.
  • Even if a vape liquid is advertised as being nicotine-free, it might still contain chemicals called nitrosamines, which are known to cause cancer.

Is a ban on disposable vapes enough?

  • The forthcoming ban on disposable vapes in England, Scotland and Wales may not be enough to deal with the problem.
  • With more than 400 vape brands already on the market, a more comprehensive approach is needed.


Amira Guirguis 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.

ARS Pharmaceuticals Submits Response to FDA Complete Response Letter for neffy® (Epinephrine Nasal Spray)

Retrieved on: 
水曜日, 4月 3, 2024

In February 2024, ARS Pharma announced the successful completion of the repeat dosing study of neffy in seasonal allergic rhinitis under NAC conditions.

Key Points: 
  • In February 2024, ARS Pharma announced the successful completion of the repeat dosing study of neffy in seasonal allergic rhinitis under NAC conditions.
  • ARS Pharma also completed the nitrosamine testing requested with no measurable levels of nitrosamines detected.
  • In May 2023, the FDA Advisory Committee (PADAC) determined a favorable benefit-risk profile for neffy (16:6 for adults and 17:5 for children).
  • ARS Pharma anticipates an FDA review period of up to six months, and the PDUFA date is anticipated to be October 2, 2024, based on the submission receipt date of April 2, 2024.

ARS Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
木曜日, 3月 21, 2024

SAN DIEGO, March 21, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today reported business updates and financial results for the fourth quarter and full year 2023.

Key Points: 
  • In February 2024, ARS Pharma announced the successful completion of the repeat dosing study of neffy in seasonal allergic rhinitis under nasal allergen challenge conditions.
  • R&D Expenses: Research and development expenses were $3.4 million and $20.3 million for the quarter and year ended December 31, 2023, respectively.
  • G&A Expenses: General and administrative expenses were $6.8 million and $47.3 million for the quarter and year ended December 31, 2023, respectively.
  • Net Loss: Net loss was $7.2 million and $54.4 million for the quarter and year ended December 31, 2023, respectively.

ARS Pharma Announces Favorable Topline Results from Repeat Dosing Study of neffy® (Epinephrine Nasal Spray) Under Nasal Allergen Challenge Conditions, Readies Data for Response to FDA’s Complete Response Letter

Retrieved on: 
火曜日, 2月 20, 2024

SAN DIEGO, Feb. 20, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQ: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today announced topline results from its clinical study comparing repeat doses of neffy (epinephrine nasal spray) to repeat doses of epinephrine intramuscular (IM) injection, as requested by the FDA with and without nasal allergen challenge (NAC) conditions.

Key Points: 
  • “The study objective was to compare twice dosing with epinephrine injection and twice dosing with neffy under normal conditions and after nasal allergen challenge.
  • With these results, we are completing the necessary work to submit our response to FDA in the next couple of months.
  • The repeat dose study under NAC conditions was designed with the FDA to address the Agency’s outstanding questions regarding neffy as described in the Complete Response Letter (CRL) from September 2023.
  • In addition, multiple PADAC members highlighted the favorable profile of neffy in our single dose NAC study.

Eight Nitrosamine Implementation Oversight Group (NIOG) meeting, European Medicines Agency, Amsterdam, the Netherlands, 7 September 2022

Retrieved on: 
日曜日, 3月 10, 2024

Eight Nitrosamine Implementation Oversight Group (NIOG) meeting

Key Points: 
  • Eight Nitrosamine Implementation Oversight Group (NIOG) meeting
    EventHumanCorporate
    Date
    Location
    The Nitrosamine Implementation Oversight Group (NIOG) was set up by the European medicines regulatory network to oversee the harmonised implementation of the Article 5(3) CHMP opinion on nitrosamines in human medicinal products.
  • The NIOG will be the main interface between regulators and industry to agree on topics requiring further scientific discussion.

Human medicines European public assessment report (EPAR): Entresto, sacubitril,valsartan, Date of authorisation: 19/11/2015, Revision: 19, Status: Authorised

Retrieved on: 
火曜日, 1月 2, 2024

Human medicines European public assessment report (EPAR): Entresto, sacubitril,valsartan, Date of authorisation: 19/11/2015, Revision: 19, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Entresto, sacubitril,valsartan, Date of authorisation: 19/11/2015, Revision: 19, Status: Authorised