CDER

EQS-News: Rentschler Biopharma contributes to nearly 25% of FDA approved biopharmaceuticals in 2023

Retrieved on: 
Wednesday, March 13, 2024
Therapy, Senior, Caregiver, DCAT, SVP, FDA, Technology transfer, Food, Business development, CDMO, CDER, Monoclonal antibody, Patient, Cancer

Laupheim, Germany, Milford (MA), USA, and Stevenage, UK, March 6, 2024 – In 2023, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 55 new drugs, 17 of which were biopharmaceuticals.

Key Points: 
  • Laupheim, Germany, Milford (MA), USA, and Stevenage, UK, March 6, 2024 – In 2023, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 55 new drugs, 17 of which were biopharmaceuticals.
  • Rentschler Biopharma SE, a leading contract development and manufacturing organization (CDMO) for biopharmaceuticals, including advanced therapy medicinal products (ATMPs), contributed to four, which equals nearly 25%, of these biopharmaceuticals.
  • For the four newly approved products, Rentschler Biopharma provided support with integrated capabilities, including consulting, regulatory services, process development, technology transfer and manufacturing.
  • Benedikt von Braunmühl, CEO of Rentschler Biopharma, said: “At Rentschler Biopharma, we strive to create value sustainably, together with our client partners, for patients with serious and rare diseases worldwide.

Rentschler Biopharma contributes to nearly 25% of FDA approved biopharmaceuticals in 2023

Retrieved on: 
Wednesday, March 6, 2024
Therapy, Senior, Caregiver, DCAT, SVP, FDA, Food, Technology transfer, Business development, CDMO, CDER, Monoclonal antibody, Patient, Cancer

and STEVENAGE, United Kingdom, March 06, 2024 (GLOBE NEWSWIRE) -- In 2023, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 55 new drugs, 17 of which were biopharmaceuticals.

Key Points: 
  • and STEVENAGE, United Kingdom, March 06, 2024 (GLOBE NEWSWIRE) -- In 2023, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 55 new drugs, 17 of which were biopharmaceuticals.
  • Rentschler Biopharma SE, a leading contract development and manufacturing organization (CDMO) for biopharmaceuticals, including advanced therapy medicinal products (ATMPs), contributed to four, which equals nearly 25%, of these biopharmaceuticals.
  • For the four newly approved products, Rentschler Biopharma provided support with integrated capabilities, including consulting, regulatory services, process development, technology transfer and manufacturing.
  • Benedikt von Braunmühl, CEO of Rentschler Biopharma, said: “At Rentschler Biopharma, we strive to create value sustainably, together with our client partners, for patients with serious and rare diseases worldwide.

PDA India Chapter Annual Meeting – Maintaining Quality & Compliance in Pharmaceutical Drug Manufacturing and Regulatory Expectations – Being Held March 11-15, in Hyderabad, India

Retrieved on: 
Monday, March 4, 2024
Health, Medical Devices, Health Technology, Other Health, General Health, Pharmaceutical, Biotechnology, Chairperson, Senior, Risk management, FDA, US FDA, EDQM, Environmental monitoring, CDER, Drug, Operation, Medical device

PQE Group is excited to join the 2024 PDA India Chapter Annual Meeting in Hyderabad from March 11-15, focusing on key issues in the pharmaceutical and medical device industries.

Key Points: 
  • PQE Group is excited to join the 2024 PDA India Chapter Annual Meeting in Hyderabad from March 11-15, focusing on key issues in the pharmaceutical and medical device industries.
  • In addition, Stephen Tyrpak will lead sessions on Quality Culture, risk management, and visual inspections with case studies and demos.
  • "We're thrilled to take part, present, and support this significant event, which has become increasingly valuable for the pharmaceutical and medical device industries in India.
  • Since PQE Group's launch in India in 2019, we've grown to over 110 professionals dedicated to compliance across the region.

New Pacific Research Institute Brief: Regulatory Roadblocks Hinder Development of New COVID-19 Treatments for the Immunocompromised

Retrieved on: 
Wednesday, March 6, 2024
Innovation, Health, Freedom, Food and Drug Administration, FDA, Food, Immunodeficiency, Government, Vaccine, CDER, COVID-19, Policy, Patient, Hook effect, Pacific Research Institute, PRI

Monoclonal antibodies, or mAbs, work by mimicking the body's natural antibodies, which is why they are so valuable to treating the immunocompromised. Six different mAbs were authorized by the federal Food and Drug Administration (FDA) early on during the COVID-19 pandemic. However, the predominant COVID-19 strain -- the JN.1 variant -- shows numerous mutations all at once. As a result, the FDA has pulled authorization for current treatments as the current virus continues to mutate.

Key Points: 
  • "That's why it is so important that only scientific constraints limit patient access to mAb treatments, not misguided government policy or regulatory inefficiencies."
  • Monoclonal antibodies, or mAbs, work by mimicking the body's natural antibodies, which is why they are so valuable to treating the immunocompromised.
  • Winegarden argues that the federal regulatory environment should promote a wider array of treatment options, including the continued development of potentially efficacious mAbs.
  • The Pacific Research Institute ( www.pacificresearch.org ) champions freedom, opportunity, and personal responsibility through free-market policy ideas.

Limb-Girdle Muscular Dystrophy Leaders Advance Collaborative Dialogue to Accelerate Drug Development to Address the Urgent Unmet Need in Limb-Girdle Muscular Dystrophy

Retrieved on: 
Tuesday, February 27, 2024
LGMD, Nationwide Children's Hospital, Analysis Group, OND, FDA, Clinical trial, Food, Drug development, Sarepta Therapeutics, Virginia Commonwealth University, Hospital, Treatment, Senior advisor, Documentation, University, CDER, Therapy, Keynote, Patient, Science, Limb–girdle muscular dystrophy

The meeting focused on six LGMD subtypes: 2A/R1, 2B/R2, 2C/R5, 2D/R3, 2E/R4, and 2I/R9.

Key Points: 
  • The meeting focused on six LGMD subtypes: 2A/R1, 2B/R2, 2C/R5, 2D/R3, 2E/R4, and 2I/R9.
  • We are thrilled that the workshop advanced a collaborative dialogue and brought people together from every facet of the drug development process to drive progress for patients.
  • This was truly a monumental event for the LGMD community and a model for others to follow in the future."
  • In-depth documentation of the workshop's findings and next steps is in progress and will be shared when available.

Chemify Partners with Prepaire Labs to Apply Ground-breaking Chemistry AI-Robotics to Radically Accelerate the Discovery of Non-Addictive Opioids

Retrieved on: 
Thursday, January 18, 2024
Technology, Pharmaceutical, Optical, Oncology, Other Science, Artificial Intelligence, Mental Health, Research, Infectious Diseases, Hospitals, Genetics, Fitness & Nutrition, Dental, Clinical Trials, Cardiology, Biotechnology, Alternative Medicine, AIDS, Health, Managed Care, Nanotechnology, Science, FDA, Other Health, CDER, Architecture, Biology, Cell, Multimedia, Partnership, Deep learning, University, Drug discovery, LAAS, NIH, Labs, Methamphetamine, BSL3, Machine learning, Medicine, Pharmaceutical industry

View the full release here: https://www.businesswire.com/news/home/20240118500713/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240118500713/en/
    Prepaire Labs is a pioneering healthcare technology company focused on revolutionizing drug discovery and precision medicine.
  • Through the integration of deep learning and biology, Prepaire Labs builds predictive models grounded in genetic, phenotypic, and clinical data.
  • Under the terms of this partnership, Chemify will design and discover novel compounds to identify Opioid-derived hits and develop them further into candidates.
  • There aren't any approved treatments to help address addiction to opioids, whose use has surged in recent years.

CDISC is Proud to Announce a Research Collaboration to Incorporate FDA Business Rules into CDISC’s Open Rules Engine (CORE)

Retrieved on: 
Tuesday, January 16, 2024
Data Management, Biotechnology, Technology, FDA, Health, General Health, Health Technology, Other Science, Research, Science, Clinical Trials, CDER, Computational science, Food, Clinical trial

CDISC is proud to announce a research collaboration with the U.S. Food and Drug Administration’s Office of Translational Sciences in the Center for Drug Evaluation and Research and Office of Regulatory Operations in the Center for Biologics Evaluation and Research to incorporate FDA Business Rules into CDISC’s Open Rules Engine (CORE).

Key Points: 
  • CDISC is proud to announce a research collaboration with the U.S. Food and Drug Administration’s Office of Translational Sciences in the Center for Drug Evaluation and Research and Office of Regulatory Operations in the Center for Biologics Evaluation and Research to incorporate FDA Business Rules into CDISC’s Open Rules Engine (CORE).
  • CDISC’s CORE project provides an open-source version of the CDISC Conformance Rules in a machine-executable format.
  • These rules, published and managed by CDISC, create a single source for conformance rules and allow external vendors and sponsor companies to implement and extend these rules within their tools.
  • FDA Business Rules are currently written in a plain text, non-machine executable format and describe the business requirements for regulatory review to help ensure that clinical trial study data is compliant and useful and supports meaningful review and analysis.

Qnovia, Inc. announces positive results from first-in-human pharmacokinetic and safety study of lead asset QN-01, a prescription inhaled smoking cessation therapy

Retrieved on: 
Wednesday, November 29, 2023
Science, Other Science, Pharmaceutical, Health, Tobacco, Health Technology, Clinical Trials, Retail, Smoker, IND, Plasma, MHRA, Patient, Multimedia, Smoke, Nicotine, Tmax, Initial, Pharmacokinetics, CDER, Medication, Therapy, NRT, Cmax, CTA, Smoking cessation, Smoking, Pharmaceutical industry, Research

Qnovia, Inc., a pharma company developing inhaled therapeutics across a variety of indication areas leveraging its proprietary inhaled drug delivery platform, the RespiRxTM, today announced positive results from its first in-human study of QN-01, the company’s lead asset.

Key Points: 
  • Qnovia, Inc., a pharma company developing inhaled therapeutics across a variety of indication areas leveraging its proprietary inhaled drug delivery platform, the RespiRxTM, today announced positive results from its first in-human study of QN-01, the company’s lead asset.
  • QN-01 is an inhaled smoking cessation therapy that is currently being evaluated in the U.S. under FDA’s Center for Drug Evaluation and Research (CDER) and in the U.K. by the Medicines and Healthcare Products Regulatory Agency (MHRA).
  • “We are delighted to share that QN-01 demonstrated a superior pharmacokinetic profile compared to an existing inhaled NRT and was well tolerated.
  • The drug-device combination was well tolerated with no severe adverse events and few minor adverse events typical of inhaled nicotine.

Limb-Girdle Muscular Dystrophy Scientific Leaders - Together With the FDA - Will Come Together for a Drug Development Workshop on February 8, 2024

Retrieved on: 
Wednesday, December 13, 2023
Food, OND, Therapy, Hospital, CBER, Patient, Nationwide Children's Hospital, Virginia Commonwealth University, FDA, CDER, Caregiver, Limb–girdle muscular dystrophy, University, Muscular dystrophy, Drug development, Pharmaceutical industry, Medical device, LGMD, Research

ROCKVILLE, Md., Dec. 13, 2023 /PRNewswire/ -- On February 8, 2024, The Speak Foundation, a patient-led 501(c)(3) organization for Limb-Girdle Muscular Dystrophy (LGMD), will be convening a multi-stakeholder LGMD Scientific Drug Development Workshop in Rockville, Maryland.

Key Points: 
  • ROCKVILLE, Md., Dec. 13, 2023 /PRNewswire/ -- On February 8, 2024, The Speak Foundation, a patient-led 501(c)(3) organization for Limb-Girdle Muscular Dystrophy (LGMD), will be convening a multi-stakeholder LGMD Scientific Drug Development Workshop in Rockville, Maryland.
  • The workshop will continue to drive the momentum for the sense of urgency needed by the patient community to accelerate LGMD drug development.
  • "This workshop is a continuing step to work with the FDA and LGMD scientific leaders on pushing critical drug development forward.
  • The LGMD Scientific Workshop will be a focused discussion with clinicians, scientific researchers, drug developers, regulators, patients and patient advocates on the characteristics of LGMD that drive drug development programs.

Sarah McGarry, M.D., Senior FDA Official in CDER and CBER, Joins Greenleaf Health

Retrieved on: 
Wednesday, November 8, 2023
FDA, COVID-19, Public Policy, Consulting, Pharmaceutical, Professional Services, Medical Devices, Infectious Diseases, Government, Science, Biotechnology, AIDS, Other Science, Health, Research, Georgetown University School of Medicine, Bioinformatics, CBER, Center for Biologics Evaluation and Research, Policy, Food, Infection, Duke University, SARS-CoV-2, Center for Drug Evaluation and Research, OND, HIV, CDER, Ritonavir, Senior, Marketing, Internal medicine, China Biologic Products, Associate, Food and Drug Administration, Pharmaceutical industry

Greenleaf Health, Inc. (Greenleaf), a leading consulting firm for companies regulated by the Food and Drug Administration (FDA), is pleased to announce that Sarah McGarry, M.D., has joined as Senior Vice President, Drug and Biological Products.

Key Points: 
  • Greenleaf Health, Inc. (Greenleaf), a leading consulting firm for companies regulated by the Food and Drug Administration (FDA), is pleased to announce that Sarah McGarry, M.D., has joined as Senior Vice President, Drug and Biological Products.
  • Throughout her 18-year FDA service, Sarah held multiple leadership, review, and advisory positions within the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
  • Her knowledge of the FDA review process and regulatory policy will enrich the strategic and scientific guidance that Greenleaf provides to clients.
  • from Georgetown University Medical School and completed a residency in internal medicine and a fellowship in infectious diseases at Duke University.