Center for Drug Evaluation and Research

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

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星期三, 十一月 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.

Marinus Pharmaceuticals Provides Business Update and Reports Third Quarter 2023 Financial Results

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星期二, 十一月 7, 2023
Professional Services, Health, FDA, Finance, Clinical Trials, Pharmaceutical, Biotechnology, Biomedical Advanced Research and Development Authority, Research, Security (finance), NMPA, Therapy, Medication, Ganaxolone, SG, Human services, G&A, Marinus, Administration for Strategic Preparedness and Response, National Medical Products Administration, GAAP, Center for Drug Evaluation and Research, BARDA, MAD, Lennox–Gastaut syndrome, Administration, R, Development, RAISE, CDE, Epilepsy, RSE, API, TSC, NDA, U.S. Department of Defense Strategy for Operating in Cyberspace, Office of Inspector General, U.S. Department of Health and Human Services, Investment, Patient, Status epilepticus, Pharmaceutical industry, Fine chemical, Cryptocurrency, CDD

Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today reported business highlights and financial results for the third quarter ended September 30, 2023.

Key Points: 
  • Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today reported business highlights and financial results for the third quarter ended September 30, 2023.
  • Dr. Braunstein continued, “We remain acutely focused on advancing our Phase 3 clinical trials in refractory status epilepticus and tuberous sclerosis complex.
  • Net product revenue consists of ZTALMY product sales, which was launched in the U.S. in the third quarter of 2022.
  • Selected Financial Data (in thousands, except share and per share amounts)

Cytokinetics Reports Third Quarter 2023 Financial Results

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星期四, 十一月 2, 2023
Randomness, FDA, National Medical Products Administration, Standard of care, Research, Heart failure, Manuscript, American College, NMPA, Food, Center for Drug Evaluation and Research, Pivotal, LVEF, OND, Symantec Endpoint Protection, Safety, Cytokinetics, Organization, MAD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Journal of Cardiac Failure, Obstruction, SAD, Journal, Cardiology, CRL, Disopyramide, ALS, Clinical trial, CDE, EMA, Șaeș, Assessment, NDA, Investment, LVOT, Plasma protein binding, Pharmaceutical industry, Medical device, Patient, Pharmacokinetics, Pharmacology, HCM, EU

SOUTH SAN FRANCISCO, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the third quarter of 2023. Net loss for the third quarter was $129.4 million, or $1.35 per share, compared to net loss for the third quarter of 2022 of $142.3 million, or $1.52 per share. Cash, cash equivalents and investments totaled $554.7 million on September 30, 2023.

Key Points: 
  • On Track for Topline Results from SEQUOIA-HCM,
    a Pivotal Phase 3 Clinical Trial of Aficamten in Obstructive HCM,
    the Open-Label Extension Study of Aficamten,
    SOUTH SAN FRANCISCO, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the third quarter of 2023.
  • Net loss for the third quarter was $129.4 million, or $1.35 per share, compared to net loss for the third quarter of 2022 of $142.3 million, or $1.52 per share.
  • “During the third quarter we made considerable progress across our specialty cardiology franchise, with aficamten remaining our top priority.
  • During the quarter we also started ACACIA-HCM, a pivotal Phase 3 clinical trial of aficamten in patients with non-obstructive HCM.

PicnicHealth Announces Three New Advisors and Expands Expertise in Regulatory-ready Research

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星期一, 十一月 6, 2023
Software, Research, Professional Services, Pharmaceutical, Data Management, Oncology, Consumer, Technology, Data Analytics, Science, Other Consumer, Biotechnology, Health, Food, Johns Hopkins University, Public health, Life, Registry, Merck, Brody, Acquisition, Regulation of tobacco by the U.S. Food and Drug Administration, Harvard University, Professional degrees of public health, Aetion, UnitedHealth Group, University of North Carolina at Pembroke, Cerner Enviza, Faculty of Management Studies – University of Delhi, Disease, Medicine, Health policy, University, Public, Harvard T.H. Chan School of Public Health, Cancer, Center for Drug Evaluation and Research, Health policy and management, Doctor of Philosophy, IQVIA, Pharmaceutical industry, Management, Psychology, Pharmacovigilance, New York University, Epidemiology

PicnicHealth , a leading patient-centered healthcare evidence generation company, appointed three advisors in clinical research design – Nancy Dreyer, Solomon Iyasu, and Jeremy Brody.

Key Points: 
  • PicnicHealth , a leading patient-centered healthcare evidence generation company, appointed three advisors in clinical research design – Nancy Dreyer, Solomon Iyasu, and Jeremy Brody.
  • These new advisors are joining PicnicHealth in an advisory capacity to support the company’s expansion into regulatory use cases.
  • Dr. Dreyer is an internationally recognized expert in the use of real-world evidence for regulatory purposes.
  • Dr. Dreyer holds a Ph.D. in epidemiology and Master of Public Health from the University of North Carolina, Chapel Hill.

FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases

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星期二, 十月 31, 2023
Abdominal pain, FDA, Research, Psoriasis, Headache, Biosimilar, Inflammation, Food, Itch, Vomiting, Center for Drug Evaluation and Research, Upper respiratory tract infection, Diarrhea, Bronchitis, Light, Infection, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Posterior reversible encephalopathy syndrome, Ulcerative colitis, Nausea, Fever, Crohn's disease, Disease, Risk, Pharmacy, Malignancy, Medication, Urinary tract infection, China Biologic Products, Safety, Hospital, Immunology, Patient, Sinusitis, Fatigue, Pharmaceutical industry, Vaccine, Generic drug, Ustekinumab, Common

SILVER SPRING, Md., Oct. 31, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases.

Key Points: 
  • SILVER SPRING, Md., Oct. 31, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases.
  • An interchangeable biosimilar is a biosimilar that has been shown to meet other requirements under the law and may be substituted for the reference product without consulting the prescriber.
  • This means health care providers and patients can expect the same safety and effectiveness from both a biosimilar and an interchangeable biosimilar, just as they would for a reference product.
  • Biosimilar and interchangeable biosimilar products may cost less than the brand-name medicine.

ICON's World Children's Day; access and inclusion for every child, upcoming Webinar Hosted by Xtalks

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星期一, 十月 30, 2023
Penta, Children's Day, FDA, Maternal health, DO, Food, ICON, Therapy, Center for Drug Evaluation and Research, MD, Bureau of Oceans and International Environmental and Scientific Affairs, Rights, Doctor of Philosophy, Drug development, UN General Assembly Resolution 60/147, Food and Drug Administration, Caregiver, University of Padua, Convention, University, Declaration of the Rights of the Child, Patient, UN, MS, Pharmaceutical industry, Research, Child

TORONTO, Oct. 30, 2023 /PRNewswire-PRWeb/ -- ICON's Centre for Paediatric Clinical Development invites you to celebrate World Children's Day virtually with us on November 13, 2023. World Children's Day is recognised as an international coming together to advocate for, promote, and celebrate the rights and welfare of children and create dialogue and action plans to build a better world for children. First established in 1954, it also commemorates the day when the UN General Assembly adopted the Declaration of the Rights of the Child in 1959 and when the UN General Assembly adopted the Convention on the Rights of the Child in 1989.

Key Points: 
  • Attendees will learn about increasing awareness of the needs and effort behind providing access to safe and accurate dosage forms of medicines for every child.
  • The featured speakers will discuss how drug development can be expedited for children and their families to provide access to adapted medicines and innovative medicines.
  • TORONTO, Oct. 30, 2023 /PRNewswire-PRWeb/ -- ICON's Centre for Paediatric Clinical Development invites you to celebrate World Children's Day virtually with us on November 13, 2023.
  • For more information, or to register for this event, visit ICON's World Children's Day .

Qilu Pharmaceutical announces the latest results from its clinical study on QL1706, in combination with chemotherapy, as a first-line treatment for recurrent or metastatic cervical cancer

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星期三, 十月 25, 2023
CR, Response evaluation criteria in solid tumors, Bevacizumab, Survival, Patient, PD-L1, Carboplatin, New Drug Application, Cervical cancer, Incidence, ESMO, Progression-free survival, Trae tha Truth, Center for Drug Evaluation and Research, DOR, DCR, Squamous-cell carcinoma, Cisplatin, The New England Journal of Medicine, Neoplasm, Treatment, European Society for Medical Oncology, PFS, PD-1, American Society of Clinical Oncology, HIV disease progression rates, CC, Chinese, CPS, Paclitaxel, Immunotherapy, CDE, Diagnosis, Oncology, ORR, Anemia, RECIST, NDA, Safety, Ira Pastan, OS, Toxicity, Cohort, Performance, CI, Pharmaceutical industry, Medical imaging

This trial studied the use of QL1706 (iparomlimab and tuvonralimab) in combination with chemotherapy, with or without bevacizumab, as a first-line treatment of recurrent or metastatic cervical cancer (r/mCC).

Key Points: 
  • This trial studied the use of QL1706 (iparomlimab and tuvonralimab) in combination with chemotherapy, with or without bevacizumab, as a first-line treatment of recurrent or metastatic cervical cancer (r/mCC).
  • Moreover, the treatment exhibited a manageable safety profile without any new safety signals observed, making it a potential new first-line treatment option for r/mCC patients.
  • Currently, the preferred standard first-line treatment for r/mCC patients is cisplatin or carboplatin and paclitaxel plus bevacizumab, and efficacy and safety of the treatment also need to be considered.
  • For r/mCC patients with positive PD-L1 expression, the PD-1 inhibitor pembrolizumab, administered with chemotherapy and with or without bevacizumab, is recommended as the standard first-line treatment.

Qilu Pharmaceutical announces the latest results from its clinical study on QL1706, in combination with chemotherapy, as a first-line treatment for recurrent or metastatic cervical cancer

Retrieved on: 
星期三, 十月 25, 2023
CR, Response evaluation criteria in solid tumors, Bevacizumab, Survival, Patient, PD-L1, Carboplatin, New Drug Application, Cervical cancer, Incidence, ESMO, Progression-free survival, Trae tha Truth, Center for Drug Evaluation and Research, DOR, DCR, Squamous-cell carcinoma, Cisplatin, The New England Journal of Medicine, Neoplasm, Treatment, European Society for Medical Oncology, PFS, PD-1, American Society of Clinical Oncology, HIV disease progression rates, CC, Chinese, Multimedia, CPS, Paclitaxel, Immunotherapy, CDE, Diagnosis, Oncology, ORR, Anemia, RECIST, NDA, Safety, Ira Pastan, OS, Toxicity, Cohort, Performance, CI, Pharmaceutical industry, Medical imaging

This trial studied the use of QL1706 (iparomlimab and tuvonralimab) in combination with chemotherapy, with or without bevacizumab, as a first-line treatment of recurrent or metastatic cervical cancer (r/mCC).

Key Points: 
  • This trial studied the use of QL1706 (iparomlimab and tuvonralimab) in combination with chemotherapy, with or without bevacizumab, as a first-line treatment of recurrent or metastatic cervical cancer (r/mCC).
  • Moreover, the treatment exhibited a manageable safety profile without any new safety signals observed, making it a potential new first-line treatment option for r/mCC patients.
  • Currently, the preferred standard first-line treatment for r/mCC patients is cisplatin or carboplatin and paclitaxel plus bevacizumab, and efficacy and safety of the treatment also need to be considered.
  • For r/mCC patients with positive PD-L1 expression, the PD-1 inhibitor pembrolizumab, administered with chemotherapy and with or without bevacizumab, is recommended as the standard first-line treatment.

North America - Healthcare Logistics Market size to grow by USD 18.4 billion from 2022 to 2027, Legislative and regulatory changes supporting pharma growth to drive the growth - Technavio

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星期一, 十月 2, 2023
Vaccine, CDER, Industrial internet of things, Data wrangling, CMA, Biopharmaceutical, Center for Drug Evaluation and Research, Augmented reality, Intelligent automation, United Van Lines, AmerisourceBergen, DSV, Automation, YOY, USD, FedEx, Government, Free, Digital electronics, Air Canada, Nippon Yusen, Investment, Nature, United Parcel Service, Fourth Industrial Revolution, Deutsche Bahn, Virtual reality, Local government in Canada, Artificial intelligence, Growth, Transport, FDA, Industrial, R, Criticism of the Food and Drug Administration, Food, NME, Deutsche Post DHL Group, Pharmaceutical industry, Beauty salon, Fine chemical, Research

NEW YORK, Oct. 2, 2023 /PRNewswire/ -- The North America healthcare logistics market is expected to grow by USD 18.4 billion from 2022 to 2027.

Key Points: 
  • NEW YORK, Oct. 2, 2023 /PRNewswire/ -- The North America healthcare logistics market is expected to grow by USD 18.4 billion from 2022 to 2027.
  • The adoption of legislative and regulatory changes supporting pharma growth is the key factor driving the market growth.
  • The report analyses the market size and growth and provides accurate predictions on the growth of the market.
  • The healthcare logistics market is estimated to grow at a CAGR of 11.67% between 2022 and 2027.

FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies

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星期五, 九月 29, 2023
Well, China Biologic Products, CDER, Communication, Drug development, START, Life, Register, CBER, Marketing, Center for Drug Evaluation and Research, New Drug Application, Disability, Center for Biologics Evaluation and Research, ARC, Rare, Adequate Yearly Progress, Federal, Biologics license application, Request for information, Investigational New Drug, Federal Register, Patient, Learning, Effectiveness, FDA, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Support, Education, Food, Safety, Disease, Pharmaceutical industry, Medical device, Research

"These are complex products and we recognize the importance of sponsor communication with the FDA to facilitate development of products for patients with unmet medical needs."

Key Points: 
  • "These are complex products and we recognize the importance of sponsor communication with the FDA to facilitate development of products for patients with unmet medical needs."
  • The FDA has undertaken additional efforts to further enhance and expedite the availability of therapies intended to treat rare diseases.
  • The agency additionally published a docket for stakeholder feedback as part of the Learning and Education to Advance and Empower Rare Disease Drug Developers (LEADER 3D) program under the CDER Accelerating Rare disease Cures (ARC) program .
  • Feedback will be used for the identification of knowledge gaps in rare disease drug development and the development of publicly available resources to inform stakeholders who design and conduct rare disease drug development programs on regulatory considerations surrounding clinical trial design.