Scientific Advisory Group

Procedural advice to applicants/marketing authorisation holders on re-examination of CVMP opinions (according to Regulation (EU) 2019/6)

Retrieved on: 
Friday, February 16, 2024
Steps, European Commission, EMA, Committee, Marketing, Calendar, CVMP, Scientific Advisory Group, Documentation, Letter, European, MAH, Prayut Chan-o-cha, Civil service commission, Element, European Medicines Agency, SAG, Legislation, Commission, Reproduction, Audit

6 February 2024

Key Points: 
    • 6 February 2024
      EMA/CVMP/321528/2017 ? Rev.3
      Committee for Veterinary Medicinal Products (CVMP)

      Procedural advice to applicants/marketing authorisation
      holders on re-examination of CVMP opinions

      Table of contents
      1.

    • Assessment of the applicant?s/marketing authorisation holder?s detailed grounds for reexamination of the CVMP opinion ................................................................................ 5
      4.4.1.
    • Timetable for re-examination of opinions for work-sharing procedures, variations
      requiring assessment, referrals and establishment of maximum residue limits ................... 7
      4.4.3.
    • This document describes the procedure and gives guidance for the re-examination of
      different types of opinions of the Committee for Veterinary Medicinal Products (CVMP).
    • The conclusions reached and the reasons for those conclusions shall be annexed to its
      opinion and shall form an integral part thereof.
    • Within 15 days of the re-examination of its opinion, the Agency shall forward its opinion to the
      Commission and the applicant.
    • The re-examination procedure is not applicable for CVMP opinions on procedures according to
      Articles 54(8), 130(4), 141(1)(c) or (e) of Regulation (EU) 2019/6 as this is not foreseen in the
      legislation.
    • Applicant?s/marketing authorisation holder?s request for reexamination
      Within 15 calendar days of receipt of the CVMP opinion (date of receipt by applicant/MAH as
      documented by Eudralink), the applicant/MAH may request a re-examination of the CVMP opinion.
    • For further
      details see CVMP rules on appointment and responsibilities of the CVMP rapporteur and co-rapporteur
      in accordance with Article 140(6) of Regulation (EU) 2019/6, and peer reviewer.
    • Day 80
      Day 90

      Adoption of final CVMP opinion and assessment report (following an oral
      explanation by applicant to the CVMP, if applicable).

    • Day 50
      Day 60

      Adoption of final CVMP opinion and assessment report (following an oral
      explanation by applicant/MAH to the CVMP, if applicable).

    • Oral explanation at CVMP meeting
      The applicant/MAH has the right to be heard by the CVMP in an oral explanation.
    • CVMP final opinion on re-examination
      The procedure for adoption of the final CVMP opinion at the CVMP meeting follows the principles
      described in the CVMP rules of procedure.
    • Information to be made available to the public
      The start of a re-examination procedure will be mentioned in the CVMP meeting highlights.
    • summary of opinion, EPAR,
      refusal EPAR, questions and answers on referrals, all annexes of the CVMP opinion, etc.).

Eisai: The Scientific Advisory Group (SAG) to Convene to Discuss the Marketing Authorization Application for lecanemab in the EU

Retrieved on: 
Thursday, January 11, 2024
CHMP, European Medicines Agency, SAG, European Commission, Scientific Advisory Group, EMA, Eisai, Biogen, Committee, MAA

TOKYO, Jan 11, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that the Scientific Advisory Group (SAG) will convene to discuss the marketing authorization application (MAA) of lecanemab (generic name, brand name: LEQEMBI), which is currently under review by the European Medicines Agency (EMA).

Key Points: 
  • TOKYO, Jan 11, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that the Scientific Advisory Group (SAG) will convene to discuss the marketing authorization application (MAA) of lecanemab (generic name, brand name: LEQEMBI), which is currently under review by the European Medicines Agency (EMA).
  • The meeting of the SAG is expected to take place during FY2023, which ends on March 31, 2024.
  • Eisai expects the European Commission's decision for the MAA of lecanemab in the first quarter of FY2024 ending June 30, 2024, if the opinion from the CHMP is received by March 31, 2024, following discussion by the SAG.
  • Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen Inc. (U.S.) co-commercializing and co-promoting the product and Eisai having final decision-making authority.

The European Medicines Agency's Scientific Advisory Group (SAG) to discuss the Marketing Authorisation Application for lecanemab: BioArctic

Retrieved on: 
Thursday, January 11, 2024
CHMP, European Medicines Agency, SAG, European Commission, Scientific Advisory Group, EMA, Eisai, Committee, Marketing, MAA, Vaccine

STOCKHOLM, Jan. 11, 2024 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the Scientific Advisory Group (SAG) will convene to discuss the Marketing Authorisation Application (MAA) of lecanemab (generic name, brand name: Leqembi®), which is currently under review by the European Medicines Agency (EMA).

Key Points: 
  • STOCKHOLM, Jan. 11, 2024 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the Scientific Advisory Group (SAG) will convene to discuss the Marketing Authorisation Application (MAA) of lecanemab (generic name, brand name: Leqembi®), which is currently under review by the European Medicines Agency (EMA).
  • The meeting of the SAG is expected to take place during the first quarter of 2024.
  • BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region.
  • This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation.

The European Medicines Agency's Scientific Advisory Group (SAG) to discuss the Marketing Authorisation Application for lecanemab: BioArctic

Retrieved on: 
Thursday, January 11, 2024
CHMP, European Medicines Agency, SAG, European Commission, Scientific Advisory Group, EMA, Eisai, Committee, Marketing, MAA, Vaccine

STOCKHOLM, Jan. 11, 2024 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the Scientific Advisory Group (SAG) will convene to discuss the Marketing Authorisation Application (MAA) of lecanemab (generic name, brand name: Leqembi®), which is currently under review by the European Medicines Agency (EMA).

Key Points: 
  • STOCKHOLM, Jan. 11, 2024 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the Scientific Advisory Group (SAG) will convene to discuss the Marketing Authorisation Application (MAA) of lecanemab (generic name, brand name: Leqembi®), which is currently under review by the European Medicines Agency (EMA).
  • The meeting of the SAG is expected to take place during the first quarter of 2024.
  • BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region.
  • This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation.

Pathway to Cures Announces Venture Investment in Five Liters

Retrieved on: 
Monday, October 16, 2023
Research, General Health, Pharmaceutical, Philanthropy, Fund Raising, Foundation, Clinical Trials, Science, Biotechnology, Other Philanthropy, Other Science, Health, VNS, MBA, Doctor of Philosophy, Litre, Indian Council of Medical Research, Bleeding, Anemia, Sickle cell disease, MD, Northwell Health, Injury, Von Willebrand disease, VWD, Electricity, Vagus nerve stimulation, Medical research, Desmopressin, Feinstein Institutes for Medical Research, Coagulopathy, Haemophilia, Scientific Advisory Group, Tan, Hemostasis, Nature Communications, Cyclic permutation, Blood, Vagus nerve, Patient, Pharmaceutical industry, Medical device, The New York Times, Cure, Pathway

Pathway to Cures (P2C) announced today its investment of $500,000 in Five Liters, a subsidiary of Spark Biomedical, to develop therapies for treating inheritable blood and bleeding disorders.

Key Points: 
  • Pathway to Cures (P2C) announced today its investment of $500,000 in Five Liters, a subsidiary of Spark Biomedical, to develop therapies for treating inheritable blood and bleeding disorders.
  • Pathway to Cures, an affiliate of the National Bleeding Disorders Foundation, is a venture philanthropy fund focused on early-stage companies developing cures, therapies, or enabling technologies in support of the inheritable blood and bleeding disorders community.
  • This significant milestone is made possible through Five Liters' collaboration with Northwell Health’s Feinstein Institutes for Medical Research in New York.
  • Dr. Recht is Chief Medical and Scientific Officer at both Pathway to Cures and the National Bleeding Disorders Foundation (NBDF) and chairs the Pathway to Cures Scientific Advisory Group.

Pathway to Cures Announces First Venture Investment

Retrieved on: 
Tuesday, September 5, 2023
Other Health, Research, General Health, Pharmaceutical, Philanthropy, Genetics, Foundation, Science, Biotechnology, Other Philanthropy, Other Science, Health, Database, Therapy, Haemophilia, Scientific Advisory Group, Coagulopathy, RNA, Transcriptome, Metabolic syndrome, Patient, Algorithm, Blood, Anemia, Sickle cell disease, Biology, Knowledge, Disease, Pharmaceutical industry, Vaccine

Pathway to Cures (P2C) announced today its inaugural investment of $250,000 in Anvesana to develop therapies for treating inheritable blood and bleeding disorders.

Key Points: 
  • Pathway to Cures (P2C) announced today its inaugural investment of $250,000 in Anvesana to develop therapies for treating inheritable blood and bleeding disorders.
  • Pathway to Cures, an affiliate of the National Bleeding Disorders Foundation, is a venture philanthropy fund focused on early-stage companies developing cures, therapies, or enabling technologies in support of the inheritable blood and bleeding disorders community.
  • “Anvesana is delighted to be working with Pathway to Cures to develop therapeutics that will bring life altering cures to individuals suffering from the devastating effects of inheritable blood and bleeding disorders,” said Eric Ekland, PhD., CEO of Anvesana.
  • “Being able to support Anvesana in its early-stage research is an incredible step in launching our investment strategy to attract the best science and technology to the inheritable blood and bleeding disorder space,” said Teri Willey, Managing Director for Pathway to Cures.

Pathway to Cures Names First Members to Scientific Advisory Group

Retrieved on: 
Tuesday, July 18, 2023
Philanthropy, Health, Genetics, Fund Raising, Foundation, Pharmaceutical, Biotechnology, National Hemophilia Foundation, Bleeding, NHF, Gene editing, United States Air Force Scientific Advisory Board, Scientific Advisory Group, MBA, Scientific Advisory Group for Emergencies, Doctor of Philosophy, Science, Anemia, Blood, Sickle cell disease, Coagulopathy, Knowledge, Haemophilia, Pharmaceutical industry, MD, Pathway

Pathway to Cures (P2C), a venture philanthropy fund focused on early-stage companies developing cures, therapies, or enabling technologies in support of the inheritable blood and bleeding disorders community, has named Katherine High, MD; Haiyan Jiang, PhD; Glenn Pierce, MD, PhD and Steven Pipe, MD, to its Scientific Advisory Group.

Key Points: 
  • Pathway to Cures (P2C), a venture philanthropy fund focused on early-stage companies developing cures, therapies, or enabling technologies in support of the inheritable blood and bleeding disorders community, has named Katherine High, MD; Haiyan Jiang, PhD; Glenn Pierce, MD, PhD and Steven Pipe, MD, to its Scientific Advisory Group.
  • Leonard Valentino, MD, P2C’s Chief Executive Officer and NHF President and CEO, also serves on the Scientific Advisory Group.
  • Dr. Recht is Chief Medical and Scientific Officer at both Pathway to Cures and the National Hemophilia Foundation (NHF) and chairs the Pathway to Cures Scientific Advisory Group.
  • P2C’s Scientific Advisory Board makes recommendations to the P2C Investment Committee regarding promising opportunities.

Center for Asbestos Related Disease (CARD) Forms Scientific Advisory Group

Retrieved on: 
Monday, June 19, 2023
CARD, Asbestos-related diseases, University, Epidemiology, COVID-19, Scientific Advisory Group, Research, Montana State University, Autoimmunity, Creativity, Radiology, SAG, Outline, Asbestos, Center of excellence, The Humble Guys, Mortality, ARD, Cornell University, Montana House of Representatives, Pharmaceutical industry

LIBBY, Mont., June 19, 2023 /PRNewswire/ -- The Center for Asbestos Related Disease (CARD) was designated a Center of Excellence by the Montana House of Representatives Resolution HR-2 in April and, in response, CARD has established a Scientific Advisory Group (SAG) to assist in guiding the organization as it moves forward.

Key Points: 
  • LIBBY, Mont., June 19, 2023 /PRNewswire/ -- The Center for Asbestos Related Disease (CARD) was designated a Center of Excellence by the Montana House of Representatives Resolution HR-2 in April and, in response, CARD has established a Scientific Advisory Group (SAG) to assist in guiding the organization as it moves forward.
  • The group includes radiologists, a pulmonologist, occupational medicine specialists, epidemiologists, an immunotoxicologist, and a medical imaging analyst.
  • At the SAG formation session held in April, the group came together to outline what it hoped to accomplish over the next 24 months.
  • CARD is humbled and excited to enter this new chapter and expand its expertise through collaboration with these highly respected individuals.

Amylyx Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results

Retrieved on: 
Monday, March 13, 2023
Biotechnology, General Health, Neurology, Health, Pharmaceutical, Aureus, Fidelity Investments, Marketing, Webcast, Investment, European Medicines Agency, Research, AMX0035, Fidelity, Regulation Fair Disclosure, ALS, EMA, CHMP, Scientific Advisory Group for Origins of Novel Pathogens, Neurodegenerative disease, European Directive on Traditional Herbal Medicinal Products, National Defense Authorization Act, U.S. FDA, Health Canada, Committee for Medicinal Products for Human Use, Medication, Committee, MAA, Physician, FDA, Marketing Authorisation Application, Regulation, Scientific Advisory Group, Risk management, Disclosure, Cryptocurrency, Pharmaceutical industry, Amylyx Pharmaceuticals, PHOENIX

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the fourth quarter and full year ended December 31, 2022.

Key Points: 
  • Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the fourth quarter and full year ended December 31, 2022.
  • Amylyx received U.S. FDA approval for RELYVRIO in September 2022 with the first commercial product being available in October 2022.
  • Financial Results for the Fourth Quarter and Year Ended December 31, 2022
    For the three months ended December 31, 2022, net product revenue was $21.9 million and cost of sales were $2.8 million.
  • Cash, cash equivalents, and short-term investments were $346.9 million at December 31, 2022, compared to $162.6 million at September 30, 2022.

COVID-19 Origins Investigation Must Continue, says AHF

Retrieved on: 
Thursday, February 16, 2023
Public Policy, Government, Advocacy Group Opinion, Health, COVID-19, Nature, Origin, AHF, Human, Scientific Advisory Group for Origins of Novel Pathogens, World Health Organization, AIDS Healthcare Foundation, Scientific Advisory Group, WHO, Global health, Pharmaceutical industry

Following reporting by Nature that the World Health Organization planned to abandon the second phase of its COVID-19 origins investigation and a quick rebuttal by WHO that it was still a go, AHF calls for the global health institution to continue its investigation and make its position unequivocally clear.

Key Points: 
  • Following reporting by Nature that the World Health Organization planned to abandon the second phase of its COVID-19 origins investigation and a quick rebuttal by WHO that it was still a go, AHF calls for the global health institution to continue its investigation and make its position unequivocally clear.
  • We have not, and we will not.”
    “Delaying or canceling the investigation into the origins of COVID-19 would be a catastrophic decision by the WHO and a huge detriment to global health security and future efforts to foster cooperation on pandemic prevention, preparedness, and response,” said AHF President Michael Weinstein.
  • “How COVID-19 started is still a big question, with many credible experts supporting the hypothesis that a laboratory accident is more likely than a zoonotic event.
  • To learn more about AHF, please visit our website: www.aidshealth.org , find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare and Instagram: @aidshealthcare .