US FDA

PENTAX Medical receives FDA 510(k) clearance for 4K video processor, PENTAX Medical INSPIRA™ (EPK-i8020c) and the ergonomic i20c endoscopes in the United States

Retrieved on: 
Tuesday, August 8, 2023
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MONTVALE, N.J., Aug. 8, 2023 /PRNewswire/ -- PENTAX Medical America Inc., a division of HOYA Group, has obtained US FDA 510(k) clearance for two of its latest innovations: the PENTAX Medical INSPIRA™, a premier 4K video processor, and the i20c video endoscope series.

Key Points: 
  • MONTVALE, N.J., Aug. 8, 2023 /PRNewswire/ -- PENTAX Medical America Inc., a division of HOYA Group, has obtained US FDA 510(k) clearance for two of its latest innovations: the PENTAX Medical INSPIRA™, a premier 4K video processor, and the i20c video endoscope series.
  • The 4K video processor and endoscope series will become commercially available in October 2023.
  • The PENTAX Medical INSPIRA™ video processor is controlled via a customizable, state-of-the-art touch panel, equipped with innovative image enhancement functionalities and 4K image processing.
  • David Harrison, President of PENTAX Medical Americas, comments: "The PENTAX Medical INSPIRA™ video processor and i20c Endoscopes are a milestone for endoscopy in the United States.

ABVC Corporate Update and CEO's Letter to Shareholders

Retrieved on: 
Monday, August 7, 2023
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FREMONT, CA, Aug. 07, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire - ABVC BioPharma, Inc. (NASDAQ: ABVC) ("Company"), a clinical-stage biopharmaceutical company developing therapeutic solutions in ophthalmology, neurology, and oncology/hematology, today published a Corporate Update and Letter to Shareholders from recently appointed Chief Executive Officer, Dr. Uttam Patil.

Key Points: 
  • FREMONT, CA, Aug. 07, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire - ABVC BioPharma, Inc. (NASDAQ: ABVC) ("Company"), a clinical-stage biopharmaceutical company developing therapeutic solutions in ophthalmology, neurology, and oncology/hematology, today published a Corporate Update and Letter to Shareholders from recently appointed Chief Executive Officer, Dr. Uttam Patil.
  • As we move into the second half of 2023, I am delighted to speak about ABVC's recent developments and plans.
  • ABVC and BioFirst Corporation expect to complete the facility's construction in Hsinchu Biomedical Science Park, Taiwan, in 2024.
  • The product is ready for an End-of-Phase II meeting with the FDA to finalize the protocol for Phase III trials.

HUIDAGENE THERAPEUTICS RECEIVES FDA RARE PEDIATRIC DISEASE DESIGNATION FOR HG004 TO TREAT INHERITED BLINDNESS

Retrieved on: 
Monday, August 7, 2023
Acceleration, Retina, CRISPR, PRV, ODD, RPE65, Paratriathlon, US, Sarepta Therapeutics, Patient, AAV2, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, US FDA, Food, Pharmaceutical industry

For a large company launching a billion-dollar drug, the six-month acceleration in regulatory review can be of substantial economic value.

Key Points: 
  • For a large company launching a billion-dollar drug, the six-month acceleration in regulatory review can be of substantial economic value.
  • "This Rare Pediatric Disease designation from the US FDA highlights the significant unmet medical need that HuidaGene is seeking to address with HG004 for RPE65-IRDs," said Alvin Luk, Ph.D., M.B.A., C.C.R.A., Co-founder and Chief Executive Officer of HuidaGene.
  • We look forward to advancing HG004 in the clinic and remain steadfast in our commitment to answering patients worldwide."
  • We are committed to delivering transformative genetic medicines for rare genetic diseases globally."

1 Day Virtual Course: Inspection and Audit Readiness Training for Medical Device Manufacturers - Figure Out Loopholes and Bridge the Gaps Before the Final FDA or EPA Inspections - ResearchAndMarkets.com

Retrieved on: 
Tuesday, August 1, 2023
Other Manufacturing, Medical Supplies, FDA, Technology, Engineering, Chemicals, Plastics, Public Policy, Government, Manufacturing, Surgery, Training, Healthcare Reform, Legal, Medical Devices, Professional Services, Other Technology, Other Education, Software, Health, White House, Federal Government, Education, Medical device, Food, Shoulder, QMS, CGMP, Marketing, Electronics, ISO, CP, Risk management, U.S. FDA, EPA, US, Agency, QA, Associate, Title 21 CFR Part 11, Infant, R, UCLA, Internal, US FDA, Bottled water, Audit, Dietary supplement

The "Inspection and Audit Readiness Training for Medical Device Manufacturers" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Inspection and Audit Readiness Training for Medical Device Manufacturers" training has been added to ResearchAndMarkets.com's offering.
  • Recognizing what to expect during an FDA inspection enables a medical device manufacturer to effectively prepare for the inspection.
  • This webinar will focus on how to prepare domestic and foreign medical device manufacturers selling to the U.S. to recognize and prepare for FDA pre- and post-market inspections.
  • As a medical device manufacturer, you have the responsibility to adhere to the highest product standards and serve the intended purpose.

MediPharm Labs Makes First Delivery of Cannabis Clinical Trial Material to US Research Partner and Provides Update on US FDA Status

Retrieved on: 
Tuesday, August 1, 2023
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The US delivery and FDA inspection represent major milestones in MediPharm Labs being a pharmaceutical cannabis supplier of choice to the global pharmaceutical industry.

Key Points: 
  • The US delivery and FDA inspection represent major milestones in MediPharm Labs being a pharmaceutical cannabis supplier of choice to the global pharmaceutical industry.
  • On July 28, 2023, MediPharm completed a commercial shipment of cannabis clinical trial materials to the US, for use in an NIH funded clinical trial.
  • This clinical trial material is finished good cannabis oil that contains both CBD and THC.
  • This will allow MediPharm to further market cannabidiol API to pharmaceutical companies for new novel drugs, generic drugs, modified generics drugs (FDA 505(b)(2)), and clinical trial materials.

Syntekabio Inc.: Syntekabio and metaclipse sign for joint research on personalized immunotherapy for cancer

Retrieved on: 
Tuesday, August 1, 2023
Vaccine, Antigen, Biotechnology, Infection, Clinical trial, Cancer, Research, GA, Immunotherapy, MOU, Artificial intelligence, Neoplasm, Bias, US FDA, Safety, Pharmaceutical industry, KOSDAQ

Through this MOU, Syntekabio plans to support Metaclipse in conducting research on neoantigen identification for its MembrexTM personalized cancer vaccine platform.

Key Points: 
  • Through this MOU, Syntekabio plans to support Metaclipse in conducting research on neoantigen identification for its MembrexTM personalized cancer vaccine platform.
  • Metaclipse’s Membrex™ vaccine is a personalized immunotherapy for solid tumors comprising a patient tumor antigen source combined with the company’s proprietary membrane-linked biological adjuvants.
  • Michael Coleman, CEO of Metaclipse, said, “The TMV-based cancer vaccine has the advantage of presenting a broad array of potential neoantigens derived from the patient’s tumor, thereby providing a personalized immunotherapy for cancer.
  • Through the joint research, the two companies expect to be able to identify the most immunologically relevant antigens by utilizing Syntekabio's NEO-ARS® platform.

US Orphan Drugs Market Surpasses USD 150 Billion Opportunity by 2028 - Key Players Amgen, Horizon Therapeutics, and Alexion at the Forefront - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 27, 2023
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The orphan drug designation has been granted to over 6500 drugs and compounds, and around 100 of these have received regulatory approvals.

Key Points: 
  • The orphan drug designation has been granted to over 6500 drugs and compounds, and around 100 of these have received regulatory approvals.
  • Therefore, though the number is less, these drugs have been essential for improving the treatment outcomes of patients suffering from rare orphan diseases.
  • These favorable parameters resulted in more than 1000 orphan-designated drugs in clinical trials and more than 400 orphan-designated drugs being commercially available in the market.
  • Many drugs that were given the orphan designation for rare indications have already gained US FDA approval for a different, non-orphan indication.

Applied Therapeutics Provides Regulatory Update on Galactosemia Program

Retrieved on: 
Tuesday, July 25, 2023
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NEW YORK, July 25, 2023 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today provided a regulatory update on the Galactosemia program, including updates on the regulatory paths for govorestat (AT-007) in both the U.S. and Europe.

Key Points: 
  • NEW YORK, July 25, 2023 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today provided a regulatory update on the Galactosemia program, including updates on the regulatory paths for govorestat (AT-007) in both the U.S. and Europe.
  • “We look forward to advancing our regulatory submissions in both the U.S. and Europe,” said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics.
  • “We believe that govorestat offers compelling efficacy alongside a favorable safety profile and represents a transformative treatment option for patients with Galactosemia.
  • There are currently no approved treatments for Galactosemia, and we hope to bring govorestat to patients as the first treatment for Galactosemia as soon as possible.”

MCRA Expands Biocompatibility Division with Key Hire of Board-Certified Toxicologist

Retrieved on: 
Monday, July 24, 2023
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Dr. More expands MCRA's biocompatibility services to include toxicological risk assessment (TRA) and other toxicology consulting services for medical devices and combination products.

Key Points: 
  • Dr. More expands MCRA's biocompatibility services to include toxicological risk assessment (TRA) and other toxicology consulting services for medical devices and combination products.
  • MCRA has hired Sharlee L. More, PhD, DABT, a board-certified toxicologist, as its Associate Director of Toxicology to support the company's growing biocompatibility service offerings for the medical device industry.
  • Dr. More will lead MCRA's new toxicology service line within the Biocompatibility Division.
  • The launch of toxicology consulting services at MCRA is an important achievement for the Biocompatibility Division.

Advent Therapeutics Receives FDA Rare Pediatric Disease Designation for Retinol Palmitate for Prevention of Bronchopulmonary Dysplasia in Premature Infants

Retrieved on: 
Thursday, July 20, 2023
Bronchopulmonary dysplasia, Place of birth, BPD, Marketing, Food and Drug Administration, NDA, Vitamin A, EMA, Orphan drug, European, Advent, FDA, Therapy, US FDA, Food, New Drug Application, Pharmaceutical industry

FDA’s Rare Pediatric Disease Designation and Priority Voucher Program is intended to facilitate the development of new drugs for the prevention and treatment of rare pediatric diseases.

Key Points: 
  • FDA’s Rare Pediatric Disease Designation and Priority Voucher Program is intended to facilitate the development of new drugs for the prevention and treatment of rare pediatric diseases.
  • This program is intended to encourage the development of new drugs and biologics for the treatment of rare pediatric diseases.
  • “We are acutely focused on BPD as an area of high unmet medical need that presently has no FDA-approved therapies for prevention or treatment.
  • The FDA Rare Pediatric Disease Designation is an important addition to the Orphan Drug designations previously granted by the US FDA and the European EMA for our vitamin A metabolic and reparative respiratory drugs,” said Dave L. Lopez, CEO of Advent Therapeutics.