Nitrosamine

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

Retrieved on: 
Wednesday, April 3, 2024
Nitrosamine, Anaphylaxis, Symantec Endpoint Protection, Entrepreneurship, ARS, Caregiver, NAC, PD, New Drug Application, Patient, Adrenaline, CRL, Allergy, NDA, Food, FDA, PDUFA, Pharmaceutical industry

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: 
Thursday, March 21, 2024
Research, Nitrosamine, Anaphylaxis, Symantec Endpoint Protection, Absorption, Human, ARS, MAA, Patent, Caregiver, PD, New Drug Application, SAN, Patient, Adrenaline, Journal, CRL, NDA, American Academy, EMA, Quality of life, Trial of the century, Flare, American College, Investment, Clinical trial, Erythema, Lower respiratory tract infection, Asthma, Body surface area, Itch, Allergy, FDA, AAAAI, Total, Food, Pharmaceutical industry

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: 
Tuesday, February 20, 2024
Allergy, Epinephrine autoinjector, SAN, EMA, PD, Caregiver, Committee, CRL, Doctor of Philosophy, RN, ARS, Absorption, FDA, Food, File, Anaphylaxis, Heart rate, NAC, PDUFA, Agency, Entrepreneurship, Complete Response Letter, FARE, Symantec Endpoint Protection, Safety, Health, Lower respiratory tract infection, University, Rhinitis, Nasal mucosa, CHMP, European Medicines Agency, Nitrosamine, Patient, Pediatrics, IM, Adrenaline, Translational research, Trial of the century, Pharmaceutical industry

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: 
Sunday, March 10, 2024
Nitrosamine, CHMP, Medical device

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: 
Tuesday, January 2, 2024
Blood pressure, Urine, Patient, Medical Subject Headings, Heart failure, Marketing, Nitrosamine, Quality of life, Kidney, Sacubitril, INN, Pediatrics, Natriuresis, Death, Valsartan, Woman, Failure, Hypotension, ATC, System, Blood, International, Sodium, European, Disease, Angioedema, Diabetes, Tissue, Profile, Language, Ageing, Mouth, Heart, Enalapril, Hyperkalemia, Angiotensin, Water, European Medicines Agency, ACE, Tablet, Select, Liver disease, Anatomy, Medicine, Fibrosis, IIA, Science, Pharmaceutical industry

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

Human medicines European public assessment report (EPAR): Neparvis, sacubitril,valsartan, Date of authorisation: 26/05/2016, Revision: 19, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Blood pressure, Urine, Patient, Medical Subject Headings, Heart failure, Marketing, Nitrosamine, Quality of life, Kidney, Sacubitril, INN, Pediatrics, Natriuresis, Death, Valsartan, Woman, Failure, Hypotension, ATC, System, Blood, International, Sodium, European, Disease, Angioedema, Tissue, Profile, Diabetes, Language, Ageing, Heart, Enalapril, Angiotensin, Hyperkalemia, Water, European Medicines Agency, ACE, Tablet, Select, Liver disease, Anatomy, Medicine, Fibrosis, IIA, Science, Medical device

Human medicines European public assessment report (EPAR): Neparvis, sacubitril,valsartan, Date of authorisation: 26/05/2016, Revision: 19, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Neparvis, sacubitril,valsartan, Date of authorisation: 26/05/2016, Revision: 19, Status: Authorised

Individuals and Entities who Consumed and/or Paid for Valsartan or Valsartan‐Containing Drugs, a Class Action Lawsuit Could Affect Your Rights

Retrieved on: 
Monday, December 4, 2023
Nitrosamine, Migliaccio, Clerk, Plaintiff, Notice, LLP, Subclass, Class, District court, Active ingredient, NDEA, NDMA, Judgement, PO, Ritalin class-action lawsuits, Kanner, Court, TPP, Third party, Pharmaceutical industry, Defendant, Losartan, Lawsuit, Valsartan

The Court has not decided whether the Defendants did anything wrong or whether the Plaintiffs' claims have merit.

Key Points: 
  • The Court has not decided whether the Defendants did anything wrong or whether the Plaintiffs' claims have merit.
  • If you qualify as a member of a Class, you have the right to participate as a class member or to opt out.
  • You may visit the Case Website to register for case updates regarding the Lawsuit and any potential recovery or benefits to class members.
  • Opt-Out: All individuals and entities that satisfy a Class definition will be automatically included in the Class unless they choose to opt-out from the Class and Lawsuit entirely.

Zydus receives USFDA approval for ZITUVIO™ to treat adult patients with type 2 diabetes mellitus

Retrieved on: 
Friday, October 20, 2023
FDA, DPP-4, Food, USFDA, Diabetes, Nitrosamine, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Research, Exercise, Tablet, Type, Zydus Lifesciences, New Drug Application, Diet, MAT, NDA, Patient, Dietary supplement, Pharmaceutical industry, Sitagliptin

AHMEDABAD, India, Oct. 20, 2023 /PRNewswire/ -- Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as 'Zydus') today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for ZITUVIO™ (Sitagliptin) tablets, 25 mg, 50 mg, and 100 mg.

Key Points: 
  • The approval of ZITUVIO™ is based on research, development, regulatory and manufacturing work performed by Zydus teams.
  • ZITUVIO™ has undergone quality testing for Nitrosamines and potential genotoxic impurities as per current USFDA standards.
  • "The ZITUVIO™ approval builds on Zydus' long-term commitment to offer healthcare professionals a new affordable treatment option in connection with diabetes management," said Dr. Sharvil Patel, Managing Director of Zydus Lifesciences Limited.
  • "We are pleased to be able to receive such a milestone approval for Zydus.

2023 RAPS Article of The Year: Addressing the Risks of Nitrosamine Contamination in Pharmaceuticals, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Monday, October 9, 2023
Nitrosamine, FDA, Risk, News, Food and Drug Administration, Risk assessment, Food, Medical device, Pharmaceutical industry

TORONTO, Oct. 9, 2023 /PRNewswire-PRWeb/ -- Discover an informative webinar delving into nitrosamine contamination in drug manufacturing and the current scientific and regulatory landscape. Nitrosamines in pharmaceuticals became a topic of special concern when their presence at unacceptable levels in common medicines hit the news in 2018. Drug substance and drug product manufacturers have since been required to conduct risk assessments and, when necessary, perform confirmation tests and recall products to address the risks of nitrosamine contamination and potential genotoxicity.

Key Points: 
  • Attendees will learn about recent scientific developments that have enhanced the requirements for risk assessment, testing and mitigation.
  • The featured speakers will discuss regulatory guidance on assessing the risk of — and identifying the root cause for — potential nitrosamine impurities.
  • Attendees will also gain insights into the recent Food and Drug Administration (FDA) guidance on nitrosamine drug substance-related impurities (NDSRIs) and implementation requirements.
  • TORONTO, Oct. 9, 2023 /PRNewswire-PRWeb/ -- Discover an informative webinar delving into nitrosamine contamination in drug manufacturing and the current scientific and regulatory landscape.

AB Science today reports its revenues for the first half of 2023 and provides an update on its activities

Retrieved on: 
Friday, September 29, 2023
Acceleration, Science, Failure, Neutrophil, Prostate cancer, Bank statement, Veterinary medicine, European Medicines Agency, Bone marrow, AND, Toxicity, Research, Alzheimer's disease, ADPC, IP, Multiple sclerosis, Marketing, Acute myeloid leukemia, MECOM, EMA, Nitrosamine, Sarcoma, AML, Azacitidine, Euronext, HIV disease progression rates, COVID-19, Investment, Patent, Patient, Risk, FIRST, NOA, Financial toxicity, Mastocytosis, MDA, FDA, ALS, Family, MCAS, CHMP, Video game, Pharmaceutical industry, Cryptocurrency, Management, Vaccine

However, the milestones reached at this stage are essential factors that contribute to the feasibility of this strategy.

Key Points: 
  • However, the milestones reached at this stage are essential factors that contribute to the feasibility of this strategy.
  • As a result of the focus strategy, AB Science has decided to adapt its organization, which lead to a significant reduction in costs.
  • This strategic focus reinforces and sustains the existing agreement between certain shareholders of AB Science and Alain Moussy.
  • The following table summarizes the consolidated financial statements for the first half of 2023 prepared in accordance with IFRS, and comparative information with the first half of 2022: