Regulatory Agencies

Naropa University Launches Pioneering Psychedelic Minor  

Retrieved on: 
Friday, March 29, 2024
Alternative Medicine, Education, Health, Other Education, Pharmaceutical, University, Interdisciplinarity, NCPS, Research, Mindfulness, Learning, Literature, Humanities, Heel, Religious studies, History, Policy, Student, Regulatory Agencies, Psychology, Autumn, Licensure, Curriculum, Outline of counseling, Art therapy, Movement, Naropa University, Nursing

Naropa University (Naropa), the birthplace of the modern mindfulness movement and one of the nation’s only higher educational institutions to offer a postgraduate certificate in psychedelic-assisted therapies , is now launching one of the first psychedelic minor programs in the country for undergraduate students of all majors.

Key Points: 
  • Naropa University (Naropa), the birthplace of the modern mindfulness movement and one of the nation’s only higher educational institutions to offer a postgraduate certificate in psychedelic-assisted therapies , is now launching one of the first psychedelic minor programs in the country for undergraduate students of all majors.
  • Launching in the Fall of 2024, the 12-credit BA Psychedelic Studies Minor provides a humanities and social science-based approach to studying psychedelics.
  • “Psychedelic minor graduates will be well prepared for a career in psychedelic-assisted therapy, with both Naropa University’s rigorous academic education and our singularly unique contemplative pedagogy woven throughout the curriculum,” said Naropa University President Charles G. Lief, J.D.
  • "The minor in psychedelic studies integrates existing contemplative coursework across diverse disciplines with the latest scholarship on psychedelic studies,” said Betsy Gonzalez Blohm, Dean of Naropa College and the Graduate Collective.

Batch Record Review and Product Release Virtual Seminar: Regulatory Requirements for GMP Documents - Batch Records and Beyond

Retrieved on: 
Wednesday, November 1, 2023
Regulatory Agencies, Medical device

DUBLIN, Nov. 1, 2023 /PRNewswire/ -- The "4-Hour Virtual Seminar on Batch Record Review and Product Release" seminar has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Nov. 1, 2023 /PRNewswire/ -- The "4-Hour Virtual Seminar on Batch Record Review and Product Release" seminar has been added to ResearchAndMarkets.com's offering.
  • In the realm of pharmaceuticals, biologics, and medical devices, Regulatory Agencies mandate the presence of meticulously crafted written procedures, known as batch records, to document production and process controls.
  • These critical records stand as a testament to compliance, providing a comprehensive account of all essential processing parameters tied to the manufacturing process.
  • Through in-depth analysis, it will explore each indispensable element of the batch record review process, empowering you to excel in regulatory compliance and elevate your industry prowess.

Annexon Highlights Recent Pipeline and Business Progress and Reports Second Quarter 2023 Financial Results

Retrieved on: 
Monday, August 7, 2023
Molecule, HD, Drug development, Geographic atrophy, ARCHER, G&A, Regulatory Agencies, Inflammation, Pivotal trial, LN, Differentiation, Complement component 1q, HIV disease progression rates, Investment, Appointment, Annual general meeting, GBS, R, Research, Visual acuity, ALS, Society, ASRS, Fine chemical, Pharmaceutical industry, EU, Patient

BRISBANE, Calif., Aug. 07, 2023 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, today highlighted recent progress across its business and portfolio of complement therapies and reported second quarter 2023 financial results.

Key Points: 
  • Together, these data demonstrate the differentiated mechanism of inhibiting C1q to provide functional benefits for patients living with complement-mediated diseases.
  • Annexon plans to provide pipeline updates and outline key milestones across its business and portfolio of complement-targeted therapies during an R&D Day in the second half of 2023.
  • Following encouraging preliminary results which showed slowing of disease progression, additional data are expected in the second half of 2023.
  • General and administrative (G&A) expenses: G&A expenses were $7.4 million for the quarter ended June 30, 2023, compared to $8.3 million for the quarter ended June 30, 2022.

Renaissance Pharma launches today and announces the in-licensing of Hu14.18K322A (Hu14.18) from St. Jude Children’s Research Hospital for the treatment of High-Risk Neuroblastoma

Retrieved on: 
Tuesday, August 1, 2023
Neuroblastoma, Maintenance, Pharma, Journal of Clinical Oncology, Survival, OS, Cancer, Record, Regulatory Agencies, Haematopoietic system, EMA, Senior, Radiation, Journal, Patient, GD2, Physician, Mab, European Journal of Oncology Nursing, EFS, Hospital, Phase, FDA, Partial-response maximum-likelihood, Pharmaceutical industry, Vaccine, Jude the Apostle, MD, Renaissance

Jude”) for Hu14.18, a humanised antibody in development by St. Jude for the treatment of newly diagnosed high-risk neuroblastoma.

Key Points: 
  • Jude”) for Hu14.18, a humanised antibody in development by St. Jude for the treatment of newly diagnosed high-risk neuroblastoma.
  • 50% of neuroblastoma patients have high-risk (HRNB) disease which has an overall survival of ~50% over 5 years3.
  • Lee Morley, Executive Chairman of Renaissance Pharma, said: “We couldn’t be more motivated by the prospect of bringing Hu14.18 to patients.
  • Renaissance Pharma now has its full attention on bringing this humanised antibody to market as expeditiously as possible.

Renaissance Pharma launches today and announces the in-licensing of Hu14.18K322A (Hu14.18) from St. Jude Children’s Research Hospital for the treatment of High-Risk Neuroblastoma

Retrieved on: 
Tuesday, August 1, 2023
Neuroblastoma, Maintenance, Pharma, Journal of Clinical Oncology, Survival, OS, Cancer, Record, Regulatory Agencies, Haematopoietic system, EMA, Senior, Radiation, Journal, Patient, GD2, Physician, Mab, European Journal of Oncology Nursing, EFS, Hospital, Phase, FDA, Partial-response maximum-likelihood, Pharmaceutical industry, Vaccine, Jude the Apostle, MD, Renaissance

Jude”) for Hu14.18, a humanised antibody in development by St. Jude for the treatment of newly diagnosed high-risk neuroblastoma.

Key Points: 
  • Jude”) for Hu14.18, a humanised antibody in development by St. Jude for the treatment of newly diagnosed high-risk neuroblastoma.
  • 50% of neuroblastoma patients have high-risk (HRNB) disease which has an overall survival of ~50% over 5 years3.
  • Lee Morley, Executive Chairman of Renaissance Pharma, said: “We couldn’t be more motivated by the prospect of bringing Hu14.18 to patients.
  • Renaissance Pharma now has its full attention on bringing this humanised antibody to market as expeditiously as possible.

NAIC Names Its 2023 Committee Leadership

Retrieved on: 
Wednesday, January 18, 2023
Colorado Division of Insurance, Consumer protection, Labour, Commerce, Pennsylvania Insurance Department, Name, Washington State Office of the Insurance Commissioner, Missouri Department of Social Services, Colorado Department of Regulatory Agencies, Division, National Association of Insurance Commissioners, Chair, Regulatory Agencies, NAIC, National Association, Regulation, Insurance commissioner, Minnesota Department of Commerce, Conduct of Employment Agencies and Employment Businesses Regulations 2003, South Dakota Department of Game, Fish, and Parks, South Carolina Department of Natural Resources, Management, Private investigator, Financial services, Insurance

KANSAS CITY, Mo., Jan. 18, 2023 /PRNewswire/ -- The National Association of Insurance Commissioners (NAIC) has named its 2023 committee chairs and vice chairs.

Key Points: 
  • KANSAS CITY, Mo., Jan. 18, 2023 /PRNewswire/ -- The National Association of Insurance Commissioners (NAIC) has named its 2023 committee chairs and vice chairs.
  • The NAIC also assigned members to its standing committees and named its 2023 task force chairs and vice chairs based on requirements established by the NAIC Bylaws .
  • "I look forward to seeing the work that the eight standing committees will produce and the lasting impact their work has on state-based regulation and the industry overall."
  • The 2023 NAIC committee leadership assignments are as follows.

Dipharma receives GMP certification from Brazilian ANVISA

Retrieved on: 
Thursday, December 1, 2022
Active ingredient, Certification, Good manufacturing practice, International Coalition of Medicines Regulatory Authorities, API, ANVISA, CDMO, CBPF, CGMP, Regulation, Regulatory Agencies, US, Plant, GMP, Yahoo Beijing Global R&D Center, Good, Intermediate 1, Fine chemical, U.S.A, Baranzate

It is the first Dipharma manufacturing facility to receive ANVISA certification.

Key Points: 
  • It is the first Dipharma manufacturing facility to receive ANVISA certification.
  • This authorization certifies the strict adherence of Dipharmas quality system to GMP requirements and allows Dipharma to be the right choice for all customers who would like to register new applications at ANVISA.
  • We are very pleased to have obtained this first successful completion of the ANVISA certification said Jorge Nogueira, Chief Executive Officer of Dipharma Francis S.r.l.
  • As a third-generation family-owned company, Dipharma has a long history of stability, commitment, and financial solidity.

CrossFirst Bankshares, Inc. Receives Regulatory Approval to Complete Acquisition of Farmers & Stockmens Bank / Central Bank & Trust

Retrieved on: 
Monday, November 7, 2022
Banking, Professional Services, Finance, Acquisition, NASDAQ, Central, Securities & Exchange Commission of Pakistan, Nature, Colorado Department of Regulatory Agencies, Securities Exchange Act of 1934, Securities Act of 1933, Forward-looking statement, Name, Central bank, Farmer, Region, Federal Deposit Insurance Corporation, Regulatory Agencies, U.S. Securities and Exchange Commission, Nasdaq, CFB, Division, Bank and Financial Institutions Division, Security (finance), Time, Bank, Retail

CrossFirst Bankshares Inc. (NASDAQ: CFB), the bank holding company for CrossFirst Bank (CrossFirst), announced today receipt of regulatory approval from the Federal Deposit Insurance Corporation to complete the previously announced acquisition of Central Bancorp, Inc.s (Central) bank subsidiary, Farmers & Stockmens Bank (F&S Bank).

Key Points: 
  • CrossFirst Bankshares Inc. (NASDAQ: CFB), the bank holding company for CrossFirst Bank (CrossFirst), announced today receipt of regulatory approval from the Federal Deposit Insurance Corporation to complete the previously announced acquisition of Central Bancorp, Inc.s (Central) bank subsidiary, Farmers & Stockmens Bank (F&S Bank).
  • F&S Bank currently has Central Bank & Trust branches in Denver and Colorado Springs and Farmers & Stockmens Bank branches in New Mexico.
  • We are pleased to have received regulatory approval to welcome Farmers & Stockmens Bank and Central Bank & Trust clients and employees to CrossFirst, said Mike Maddox, CrossFirsts Chief Executive Officer.
  • CrossFirst will build on Farmers & Stockmens and Central Bank & Trusts footprint to reach a broad range of clients and expand into new regions.

Dipharma Receives Regulatory Authorization for the New Line at Its cGMP Pilot Plant

Retrieved on: 
Thursday, October 6, 2022
Pharmaceutical, Other Manufacturing, Medical Supplies, General Health, Health, Chemicals, Plastics, Manufacturing, Other Health, Yahoo Beijing Global R&D Center, API, Italian Medicines Agency, Haynes International, CGMP, UD, Regulatory Agencies, AIFA, Contract, Intermediate 1, Multimedia, Partnership, Plant, CDMO, Active ingredient, Chemistry, European Medicines Agency, Fine chemical, U.S.A

(Dipharma), a leading Contract Development and Manufacturing Organization (CDMO) and a global manufacturer of Active Pharmaceutical Ingredients, announced today that the Italian Medicines Agency (AIFA) approved the brand-new production line at the cGMP pilot plant suite, located in its facility of Mereto di Tomba (Italy).

Key Points: 
  • (Dipharma), a leading Contract Development and Manufacturing Organization (CDMO) and a global manufacturer of Active Pharmaceutical Ingredients, announced today that the Italian Medicines Agency (AIFA) approved the brand-new production line at the cGMP pilot plant suite, located in its facility of Mereto di Tomba (Italy).
  • View the full release here: https://www.businesswire.com/news/home/20221005005738/en/
    New Dipharma cGMP pilot plant line, located in the Italian facility of Mereto di Tomba (UD).
  • With this state-of-the-art investment Dipharma doubles its capacity to process projects for customers, both in the generics and CDMO arena, while enhancing operational safety and isolation technologies.
  • We have experienced an unprecedented increase in demand for our services said Jorge Nogueira, Chief Executive Officer of Dipharma Francis S.r.l.

Batch Record Review and Product Release Virtual Seminar - ResearchAndMarkets.com

Retrieved on: 
Wednesday, September 14, 2022
Health, Pharmaceutical, Regulatory Agencies, Compliance, Medical device

The "6-Hour Virtual Seminar - Batch Record Review and Product Release" webinar has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "6-Hour Virtual Seminar - Batch Record Review and Product Release" webinar has been added to ResearchAndMarkets.com's offering.
  • This webinar will analyze each of these necessary elements of the batch record review process.
  • Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
  • A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.