Pharmaceuticals and Medical Devices Agency

Eisai to Present Full Findings from Lecanemab Confirmatory Phase 3 Clinical Trial (Clarity AD) and Other Alzheimer's Disease Research at The 15th Clinical Trials on Alzheimer's Disease (CTAD) Conference

Retrieved on: 
Monday, November 21, 2022
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Additionally, other important research from the lecanemab clinical development program and Eisai's AD pipeline, including the company's investigational anti-microtubule binding region (MTBR) tau antibody (E2814), will be presented in four oral and ten poster presentations.

Key Points: 
  • Additionally, other important research from the lecanemab clinical development program and Eisai's AD pipeline, including the company's investigational anti-microtubule binding region (MTBR) tau antibody (E2814), will be presented in four oral and ten poster presentations.
  • - Clarity AD: Full results from the Phase 3 confirmatory Clarity AD clinical trial of lecanemab in patients with early AD will be presented in a scientific session on November 29 at 4:50 p.m. PT.
  • Eisai will host a live webcast of presentations in the session and can be viewed live on the investors section of the Eisai Co., Ltd. website.
  • The FDA has agreed that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab.

THORNE HEALTHTECH'S ONEDRAW DEVICE USED IN DEPARTMENT OF DEFENSE'S CANCER MOONSHOT 2.0 PROJECT, PROMETHEUS, AS PART OF PRESIDENT BIDEN INITIATIVE

Retrieved on: 
Thursday, November 17, 2022
Cancer, CE marking, National Institute of Environmental Health Sciences, Diabetes, United States Department of Defense, Department of Defense Serum Repository, Partnership, FDA, Medication, Mayo Clinic, Education, Research, Thorne, Multimedia, Medicines and Healthcare products Regulatory Agency, National Toxicology Program, Uniformed Services University of the Health Sciences, Glycated hemoglobin, Outline of health sciences, PMDA, Blood, Division, USU, Association of British HealthTech Industries, Glucose, Engineering, Pharmaceuticals and Medical Devices Agency, White House, Sabotage (2014 film), Pharmaceutical industry, Medical device, Dietary supplement, Health, Defense

"As health and wellness continues to evolve and demands for reliable and convenient testing grow, our OneDraw device showcases that next-gen multi-omics testing can be performed on patient-friendly platforms," said Paul Jacobson, CEO of Thorne HealthTech.

Key Points: 
  • "As health and wellness continues to evolve and demands for reliable and convenient testing grow, our OneDraw device showcases that next-gen multi-omics testing can be performed on patient-friendly platforms," said Paul Jacobson, CEO of Thorne HealthTech.
  • "At Thorne HealthTech, we believe in the power of scientific wellness and taking a preventative approach to health and wellness, which is exactly what President Biden's Cancer Moonshot Project is doing with our OneDraw device."
  • This research is critical to developing new tools for the early detection and possible prevention of cancer."
  • Arising out of President Biden's White House Cancer Moonshot 2.0 initiative in 2022, PROMETHEUS is a project of the Department of Defense's Uniformed Services University of the Health Sciences (USU) Murtha Cancer Center Research Program (MCCRP).

BioCardia Reports Third Quarter 2022 Business Highlights and Financial Results

Retrieved on: 
Wednesday, November 9, 2022
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Our team has delivered solid progress on our programs and business development initiatives this past quarter, said Peter Altman, Ph.D., President, and CEO.

Key Points: 
  • Our team has delivered solid progress on our programs and business development initiatives this past quarter, said Peter Altman, Ph.D., President, and CEO.
  • Throughout the third quarter, efforts developing the submission to PMDA for a third formal consultation continued and are substantially complete.
  • In October 2022, an update to www.CardiAMP.com , a website to educate patients and physicians about the clinical trial sponsored by BioCardia, went live.
  • The IND for this program was filed with FDA CBER in early November 2022 and the Company anticipates FDA approval in December 2022.

Establishment Labs Announces Japanese Regulatory Approval and Reimbursement for Motiva Implants and the Motiva Flora Tissue Expander for Use in Post-Mastectomy Reconstruction

Retrieved on: 
Thursday, November 10, 2022
General Health, Health, Telemedicine, Virtual Medicine, Medical Devices, Establishment, Motiva, Implant, 21 CFR 820, Nasdaq, Diversified Specialty Institute Holdings, Inc., IDE, Pharmaceuticals and Medical Devices Agency, RFID, ESTA, Medicines and Healthcare products Regulatory Agency, PMDA, Clinical trial, MDSAP, Woman, U.S. FDA, Spanish National Health System, Medication, FDA, Pharmaceutical industry, Medical imaging, Medical device

The products have also received reimbursement for post-mastectomy reconstruction under the Japanese National Health System.

Key Points: 
  • The products have also received reimbursement for post-mastectomy reconstruction under the Japanese National Health System.
  • The first reconstruction patient in Japan was successfully treated with Motiva in early November at Nagoya University Hospital.
  • Launching Motiva Flora with Motiva Implants in the Japanese market is a significant step in changing the global standard in breast reconstruction, said Juan Jos Chacn-Quirs, Founder and Chief Executive Officer.
  • Motiva Implants and the Motiva Flora tissue expander are currently not approved for commercial distribution in the United States.

Dong-A ST Signs License-out Deal with Polifarma of Türkiye for NESP® Biosimilar DA-3880

Retrieved on: 
Wednesday, November 9, 2022
Biotechnology, Health, Science, Pharmaceutical, Research, Chronic kidney disease, Medication, KRX, Medicines and Healthcare products Regulatory Agency, PMDA, CSO, Pharmaceuticals and Medical Devices Agency, Patient, CEO, Decision-making, Airline, Pharmaceutical industry

According to the agreement, Dong-A ST will license out the exclusive rights for the development and commercialization of DA-3880 in Trkiye, Brazil, and Mexico to Polifarma.

Key Points: 
  • According to the agreement, Dong-A ST will license out the exclusive rights for the development and commercialization of DA-3880 in Trkiye, Brazil, and Mexico to Polifarma.
  • Dong-A ST will receive upfront and developmental/commercial milestone payments and will exclusively supply the finished product through STgen Bio, an affiliated Bio CDMO of Dong-A Socio Holdings.
  • Meanwhile, Polifarma will be responsible for the development and commercialization in Trkiye, Brazil, and Mexico.
  • Dong-A ST will commit to expanding its global market presence by showcasing our biosimilar R&D and overseas business capabilities.

Inspection Machines Market is Set to Surpass US$ 1 Bn Revenue by 2032 end at a Steady CAGR Owing to Latest Rise in Regulatory Compliances with GMP | Data Analysis by Future Market Insights, Inc.

Retrieved on: 
Wednesday, November 2, 2022
Carbon, OEM, Pharmaceuticals and Medical Devices Agency, Growth, European Medicines Agency, Food and Drug Administration, Traction, Medication, Health, CMOS, Adoption, Cros, Good manufacturing practice, Research, Industry, Risk, Poverty, R, GMP, CAGR, Investment, Compliance, Miniature, CNT, Omron, FDA, CGMP, Food, Original equipment manufacturer, Medicines and Healthcare products Regulatory Agency, Projection, Fine chemical, Medical imaging, Vaccine

NEWARK, Del., Nov. 2, 2022 /PRNewswire/ -- The global inspection machines market is expected to bolster over the projection with a robust CAGR of 5.1% over the forecast period from 2022 to 2032. The global market is anticipated to be appraised at US$ 1,053.5 Mn by 2032, up from US$ 643.1 Mn in 2022. It has been observed that a surging number of inspection checkpoints are present throughout the production line. This is likely to drive the sales of inspection machines. Although, integrating inspection equipment into the manufacturing and packaging line is difficult because of the complexity of machines and the heightened end-use environment. Conversely, increasing investments in biotech and pharma research and development (R&D) activities are anticipated to generate remunerative opportunities for the market.

Key Points: 
  • Conversely, increasing investments in biotech and pharma research and development (R&D) activities are anticipated to generate remunerative opportunities for the market.
  • Several research studies, along with various product development and launches are anticipated to surge the growth of the inspection machines market trends.
  • Therefore, the inspection machines market growth is anticipated to propel attributing to such research to emphasize the importance of GMP.
  • With the help of carbon nanotube-based miniature x-ray tubes, such devices are gaining traction in the global inspection machines market.

Inspection Machines Market is Set to Surpass US$ 1 Bn Revenue by 2032 end at a Steady CAGR Owing to Latest Rise in Regulatory Compliances with GMP | Data Analysis by Future Market Insights, Inc.

Retrieved on: 
Wednesday, November 2, 2022
Carbon, OEM, Pharmaceuticals and Medical Devices Agency, Growth, European Medicines Agency, Food and Drug Administration, Traction, Medication, Health, CMOS, Adoption, Cros, Good manufacturing practice, Research, Industry, Risk, Poverty, R, GMP, CAGR, Investment, Compliance, Miniature, CNT, Omron, FDA, CGMP, Food, Original equipment manufacturer, Medicines and Healthcare products Regulatory Agency, Projection, Fine chemical, Medical imaging, Vaccine

NEWARK, Del., Nov. 2, 2022 /PRNewswire/ -- The global inspection machines market is expected to bolster over the projection with a robust CAGR of 5.1% over the forecast period from 2022 to 2032. The global market is anticipated to be appraised at US$ 1,053.5 Mn by 2032, up from US$ 643.1 Mn in 2022. It has been observed that a surging number of inspection checkpoints are present throughout the production line. This is likely to drive the sales of inspection machines. Although, integrating inspection equipment into the manufacturing and packaging line is difficult because of the complexity of machines and the heightened end-use environment. Conversely, increasing investments in biotech and pharma research and development (R&D) activities are anticipated to generate remunerative opportunities for the market.

Key Points: 
  • Conversely, increasing investments in biotech and pharma research and development (R&D) activities are anticipated to generate remunerative opportunities for the market.
  • Several research studies, along with various product development and launches are anticipated to surge the growth of the inspection machines market trends.
  • Therefore, the inspection machines market growth is anticipated to propel attributing to such research to emphasize the importance of GMP.
  • With the help of carbon nanotube-based miniature x-ray tubes, such devices are gaining traction in the global inspection machines market.

THORNE HEALTHTECH AND GENTEGRA COLLABORATE TO DEVELOP A NEXT-GENERATION WHOLE BLOOD DNA COLLECTION AND EXTRACTION KIT

Retrieved on: 
Tuesday, October 25, 2022
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The collaboration paves the way for Thorne and GenTegra to introduce a product that will be inclusive of Thorne's OneDraw DNA cartridges and GenTegra's GenSolve technology for highly efficient DNA extraction.

Key Points: 
  • The collaboration paves the way for Thorne and GenTegra to introduce a product that will be inclusive of Thorne's OneDraw DNA cartridges and GenTegra's GenSolve technology for highly efficient DNA extraction.
  • In a recent study, GenTegra demonstrated that its Active Chemical Protection technology could be applied to the cold-chain-free blood storage matrix of OneDraw's blood collection device to further preserve DNA at room temperature.
  • Additionally, GenTegra's proprietary reagent kit, GenSolve for laboratories, allowed for the extraction of greater amounts of high-quality DNA from whole blood collection matrices.
  • "Sample collection is a critical component of delivering accurate test results to the end user," said Paul Jacobson, CEO of Thorne HealthTech.

Domain Therapeutics to progress into clinical trials with its EP4R antagonist DT-9081 in solid tumors

Retrieved on: 
Wednesday, October 19, 2022
News, Neoplasm, Agence nationale de sécurité du médicament et des produits de santé, Patient, Gq alpha subunit, IO, G protein-coupled receptor, Standard of care, Cancer, ANSM, Immune system, Drug discovery, EP4, Pharmaceuticals and Medical Devices Agency, CEO, Immunosuppression, CTA, PGE2, Clinical trial, Pharmaceutical industry

The first-in-human clinical trial is on track to initiate by the end of the year.

Key Points: 
  • The first-in-human clinical trial is on track to initiate by the end of the year.
  • Given the high concentrations of PGE2 exhibited by a range of different solid tumors, Domain Therapeutics has developed an extensive biomarker strategy, enabling optimal selection of tumor types and patient subpopulations and monitoring the target engagement in future clinical trials.
  • Dr. Pascal Neuville, CEO of Domain Therapeutics, commented: Todays news marks a pivotal moment for Domain as we progress our first fully-owned immuno-oncology drug candidate towards the clinic.
  • Dr. Asmaa Boudribila,Medical Director at Domain Therapeutics, commented: DT-9081 is a promising new candidate with the potential to treat a wide range of cancers.

Caladrius Biosciences Reports Second Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Thursday, August 4, 2022
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BASKING RIDGE, N.J., Aug. 04, 2022 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company developing innovative therapies designed to treat or reverse disease, today reported financial results for the three and six months ended June 30, 2022 and provided a business update.

Key Points: 
  • The second quarter of 2022 was a transformative and energizing quarter for Caladrius with the announcement of our proposed merger with Cend Therapeutics (Cend).
  • The Company treated the first patient in April 2022 and completed treatment for all six subjects during the third quarter of 2022.
  • Caladrius will hold a live conference call today, August 4, 2022, at 4:30 p.m. (EDT) to discuss financial results, provide a business update and answer questions.
  • Caladrius Biosciences, Inc. is a clinical-stage biopharmaceutical company dedicated to the development of innovative therapies designed to treat or reverse disease.