US FDA

Quotient Sciences Announces Successful US FDA Inspection of Alnwick, UK Facility

Retrieved on: 
Thursday, October 5, 2023
Quotient, Insulin, Food, GLP, US, Good laboratory practice, US Foods, MHRA, FDA, GMP, Patient safety, Head, Patient, US FDA, Pharmaceutical industry, Generic drug, Medical device

NOTTINGHAM, England, Oct. 5, 2023 /PRNewswire/ -- Quotient Sciences, a leading global pharmaceutical drug development and manufacturing accelerator, is proud to announce the successful completion of a US Food and Drug Administration (FDA) inspection of its bioanalytical facility in Alnwick, UK.

Key Points: 
  • NOTTINGHAM, England, Oct. 5, 2023 /PRNewswire/ -- Quotient Sciences, a leading global pharmaceutical drug development and manufacturing accelerator, is proud to announce the successful completion of a US Food and Drug Administration (FDA) inspection of its bioanalytical facility in Alnwick, UK.
  • The US FDA inspection of Quotient Sciences' Alnwick facility is a significant achievement for the organization, highlighting its commitment to upholding the highest standards of quality and regulatory compliance.
  • MARK EGERTON, CEO of Quotient Sciences, "By successfully completing the US FDA inspection for these studies, Quotient Sciences has achieved another milestone in its mission to support the development of innovative medicines for patients worldwide.
  • "The results of the inspection further strengthen our track record for outstanding regulatory compliance at our Alnwick facility.

Quotient Sciences Announces Successful US FDA Inspection of Alnwick, UK Facility

Retrieved on: 
Thursday, October 5, 2023
Quotient, Insulin, Food, GLP, US, Good laboratory practice, US Foods, MHRA, FDA, GMP, Patient safety, Head, Patient, US FDA, Pharmaceutical industry, Generic drug, Medical device

NOTTINGHAM, England, Oct. 5, 2023 /PRNewswire/ -- Quotient Sciences, a leading global pharmaceutical drug development and manufacturing accelerator, is proud to announce the successful completion of a US Food and Drug Administration (FDA) inspection of its bioanalytical facility in Alnwick, UK.

Key Points: 
  • NOTTINGHAM, England, Oct. 5, 2023 /PRNewswire/ -- Quotient Sciences, a leading global pharmaceutical drug development and manufacturing accelerator, is proud to announce the successful completion of a US Food and Drug Administration (FDA) inspection of its bioanalytical facility in Alnwick, UK.
  • The US FDA inspection of Quotient Sciences' Alnwick facility is a significant achievement for the organization, highlighting its commitment to upholding the highest standards of quality and regulatory compliance.
  • MARK EGERTON, CEO of Quotient Sciences, "By successfully completing the US FDA inspection for these studies, Quotient Sciences has achieved another milestone in its mission to support the development of innovative medicines for patients worldwide.
  • "The results of the inspection further strengthen our track record for outstanding regulatory compliance at our Alnwick facility.

Cell and Gene Therapy Clinical Trials' Regulatory Strategies and Safety Considerations, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Wednesday, October 4, 2023
US Foods, Doctor of Pharmacy, Marketing, ICH, Doctor of Philosophy, Associate, US, Risk, FDA, Monitoring, Safety, Environment, US FDA, Food, Pharmaceutical industry, Medical device, Vaccine, Pharmacovigilance, EMMS International, Regulation

TORONTO, Oct. 4, 2023 /PRNewswire-PRWeb/ -- As the somatic cell and gene therapy platforms continue to advance, so do the US Food and Drug Administration (FDA) and international council for harmonisation of technical requirements for pharmaceuticals for human use (ICH) regulatory guidelines and the competent authority requirements associated with these product classes. Successful preclinical to clinical transition requires careful consideration of these agency guidance documents to minimize the risk of avoidable delays in the development of cell and gene therapy clinical trials in a regulated environment.

Key Points: 
  • Attendees will effectively manage unique safety considerations such as the timing of initial assessment to long-term follow up.
  • The featured speakers will address the timing of efficacy endpoints assessment in early-phase vs late-phase clinical trials.
  • Many cell and gene therapy clinical trials come with their own challenges and have unique safety and efficacy considerations before they can be approved for marketing.
  • Join this webinar to get insights on the US FDA guidelines and the managing of safety considerations and efficacy endpoints of these cell and gene therapy products.

Global COVID-19 Vaccines Strategic Business Analysis Report 2023-2025 - ResearchAndMarkets.com

Retrieved on: 
Monday, October 2, 2023
Pharmaceutical, Health, COVID-19, Vaccination, African, Ageing, Dawn, US, Death, Deaths due to the Chernobyl disaster, FDA, Vaccine, COVID-19 vaccination in mainland China, US FDA, IMF, Pharmaceutical industry, Mutation

The "COVID-19 Vaccines: Global Strategic Business Report" has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "COVID-19 Vaccines: Global Strategic Business Report" has been added to ResearchAndMarkets.com's offering.
  • The COVID-19 Vaccines Market Report is your essential resource for data, insights, and strategic decision-making.
  • This report provides an in-depth analysis of current market dynamics, dissecting intricate trends, and offering comprehensive competitor insights to shape your strategic choices.
  • Evaluate the vaccine value's stability in major contributors like China and anticipate global vaccination rates in the upcoming years.

Triastek Completes USD 20.4 Million Pre-C Funding Round to Accelerate Commercialization of 3D Printing Pharmaceutical Technology and Products

Retrieved on: 
Thursday, September 28, 2023
GMP, Medicine, Drug development, 3D, 5Y Capital, Merck Group, Micro injection molding, Goldmine, Eli Lilly, Tablet, Boehringer Ingelheim, Tasly, Patent, MED, FDA, Matrix Partners, Hand, IND, NMPA, US FDA, CPE, Pharmaceutical industry, 3D printing, Diao Guoxin, China Renaissance

Nanjing, Sept. 28, 2023 (GLOBE NEWSWIRE) -- Triastek, Inc. (" Triastek ") today announced the completion of a USD 20.4 million Pre-C financing round.

Key Points: 
  • Nanjing, Sept. 28, 2023 (GLOBE NEWSWIRE) -- Triastek, Inc. (" Triastek ") today announced the completion of a USD 20.4 million Pre-C financing round.
  • Triastek’s proprietary technology, the Melt Extrusion Deposition (MED®) 3D printing process, combined with digital formulation development methods, enables complex drug delivery and programmed release.
  • Triastek, as a leading provider of digital pharmaceutical process technology, is continuously advancing applications of 3D printing technology to produce novel pharmaceutical products that improve patient outcomes.
  • The company has engaged in extensive business collaborations with global pharmaceutical companies, focusing on novel products and advanced technical solutions.

New to The Street Announces Episodes 510 and 511 Six Corporate Interviews, airings on Newsmax and FOX Business Network, Broadcastings Begin Saturday, September 16, 2023, at 3:30 PM ET

Retrieved on: 
Friday, September 15, 2023
Sustainability, Medicine, Self-directed IRA, Diabetes, Internet, Fox Business, Vegetable, Privacy, Wood, Long COVID, Soil, MD, Patient, VRM, Hacks, Mining, Fatigue, Semaglutide, Diet, Interview, Atmosphere, OTCQB, SL, Email spoofing, Administration, JD, Tonix Pharmaceuticals, Virtual private network, FDA, Vaccine, CSE, HHS, COVID-19, Health, Nasdaq MarketSite, FRA, VPN, Gold, Social Security, Water, LG, BEC, United States Department of Health and Human Services, Biopharmaceutical, Obesity, Q&A, Metal, Infection, Weight loss, Silver, Nutrient, BCE, IRA, Environmental policy of the Joe Biden administration, PROMO, Associate, Novo Nordisk, OTCQX, CPA, US FDA, Television, Cryptocurrency, Newsmax, Street

NEW YORK, Sept. 15, 2023 (GLOBE NEWSWIRE) -- FMW Media's New to The Street announces their corporate interviews for episodes 510 and 511 that will air on Newsmax and the FOX Business Network.

Key Points: 
  • NEW YORK, Sept. 15, 2023 (GLOBE NEWSWIRE) -- FMW Media's New to The Street announces their corporate interviews for episodes 510 and 511 that will air on Newsmax and the FOX Business Network.
  • Sustainable Solutions - The Sustainable Green Team, Ltd.'s (OTCQX: SGTM) ($SGTM) interview with Brian Rivera, Director of Administration, and Brian Meier, Chief Operating Officer.
  • Dr. Lederman tells viewers that data from its FDA Phase 2 proof-of-concept PREVAIL study of TNX-102 SL shows top-line results in combating fatigue.
  • Alain invites everyone to join their online chat sessions, Monday-Friday, 9 AM-6 PM ET, to learn more through a comprehensive Q&A platform.

ELREXFIO™ (elranatamab-bcmm), Now Available from Onco360

Retrieved on: 
Wednesday, September 13, 2023
FDA, Health, Pharmaceutical, Clinical Trials, Oncology, REMS, Cytokine release syndrome, Malignancy, US FDA, Mitigation, CD3, CRS, Multiple myeloma, Immunomodulatory imide drug, Cancer, Bone marrow, National Cancer Institute, Cohort study, Pharmacy, CAR, US, Specialty pharmacy, Patient, B cell, SEER, ADC, Diagnosis, RRMM, Caregiver, Phase, ORR, BCMA, Pfizer, Disease, Vaccine, Pharmaceutical industry, Epidemiology

Onco360®, the nation’s leading independent Specialty Pharmacy will be a pharmacy provider for Elrexfio™ (elranatamab-bcmm).

Key Points: 
  • Onco360®, the nation’s leading independent Specialty Pharmacy will be a pharmacy provider for Elrexfio™ (elranatamab-bcmm).
  • This indication is approved under accelerated approval based on response rate and durability of response.
  • Multiple myeloma, a rare malignancy, accounts for 1.8% of all new cancer cases in the United States.
  • The five-year overall survival (OS) for patients with multiple myeloma is 59.8%.3
    ELREXFIO is commercialized by Pfizer.

Mesoblast Reports Financial Results and Operational Update for Fiscal Year Ended June 30, 2023

Retrieved on: 
Thursday, August 31, 2023
MESO, BM, SR, Regenerative Medicine Advanced Therapy, Research and development, Blood, FINANCIAL, STI, Marketing, Clinical trial, International University of Management and Administration, Degenerative disc disease, Research, LVAD, CMO, Mesoblast, EDT, Pain, Administration, Data analysis, Patient, Survival, Heart, Pivotal, Mortality, Ageing, MSB, Transplant, FDA, BLA, US FDA, Inflammation, Rare-earth element, Pharmaceutical industry, Cryptocurrency, Palladium, Vaccine, Renewable energy, Fine chemical, Takeda, LTI – Lingua Tertii Imperii

NEW YORK, Aug. 30, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today reported financial results and an operational update for the period ended June 30, 2023, and provided an overview of upcoming milestones.

Key Points: 
  • NEW YORK, Aug. 30, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today reported financial results and an operational update for the period ended June 30, 2023, and provided an overview of upcoming milestones.
  • Net cash usage for operating activities was US$63.3 million for FY2023, a 37% reduction compared with FY2021 and 4% reduction compared with FY2022.
  • DETAILS OF FINANCIAL RESULTS FOR THE PERIOD ENDED JUNE 30, 2023 (FY2023)
    Research & Development expenses reduced by US$5.6 million (17%), down to US$27.2 million for FY2023 compared to US$32.8 million for FY2022.
  • It can be accessed via: https://webcast.openbriefing.com/msb-fyr-2023/
    The archived webcast will be available on the Investor page of the Company’s website: www.mesoblast.com

Todos Announces Notice of Allowance From USPTO for Patent Application Covering Use of Compositions In Tollovid™ and Tollovir™ Ingredients

Retrieved on: 
Wednesday, August 30, 2023
Coronavirus, Autophagy, COVID-19, OTCQB, COVID, Inflammation, Science, TEL, US, Patent, Patient, NLC, Diagnosis, US FDA, Disease, Pharmaceutical industry, Long COVID

NEW YORK, NY, ALPHARETTA, GA and TEL AVIV, ISRAEL, Aug. 30, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire - Todos Medical, Ltd. (OTCQB: TOMDF), a medical diagnostics and related solutions company, today announced that the United States Patent & Trademark Office (USPTO) has issued a Notice of Allowance for NLC Pharma’s patent application entitled "Compounds for Treating a Coronavirus Infection” prosecuted from the groundbreaking work of Dr. Dorit Arad. The Notice of Allowance covers the use of key compounds contained in the ingredients in Tollovid™ and Tollovir™ (NLC-V-01, NLC-001 or 3CL-001).  The allowed claims are directed, among other things, to the administration of compounds to a subject to inhibit activity of the 3CL protease, inflammation and autophagy, and to treat coronavirus infection. 

Key Points: 
  • The Notice of Allowance covers the use of key compounds contained in the ingredients in Tollovid™ and Tollovir™ (NLC-V-01, NLC-001 or 3CL-001).
  • I am gratified by the patent allowance which validates the patentability of these crucial aspects inherent in the Tollovid and Tollovir compounds."
  • “The USPTO granting of this Notice of Allowance marks a major milestone for the Tollovid and Tollovir programs,” said Gerald Commissiong, President & CEO of Todos Medical.
  • For more information on the Company’s dietary supplement that provides immune support with 3CL protease inhibition, please visit www.mytollovid.com .

Zealand Pharma announces designation of priority review by the US FDA for dasiglucagon in congenital hyperinsulinism

Retrieved on: 
Wednesday, August 30, 2023
CGM, Glucose, New Drug Application, NDA, Part, Hypoglycemia, MD, Patient, PDUFA, FDA, US FDA, Safety, Congenital hyperinsulinism, Pharmaceutical industry, CHI, Zealand Pharma

To ensure the most efficient regulatory process, the review by the US FDA will be conducted in two parts under the same New Drug Application (NDA).

Key Points: 
  • To ensure the most efficient regulatory process, the review by the US FDA will be conducted in two parts under the same New Drug Application (NDA).
  • Part 1 relates to dosing for up to 3 weeks, whereas Part 2 relates to use beyond 3 weeks.
  • Copenhagen, Denmark, August 30, 2023 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no.
  • To ensure the most efficient regulatory review process, the US FDA has recommended reviewing the NDA submission in two parts.