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TFF Pharmaceuticals Reports First Quarter Financial Results and Provides Corporate Update

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tisdag, maj 14, 2024
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FORT WORTH, Texas, May 14, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today reported financial results for the first quarter 2024 and provided a corporate update.

Key Points: 
  • FORT WORTH, Texas, May 14, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today reported financial results for the first quarter 2024 and provided a corporate update.
  • We expect to receive feedback from the FDA this quarter that will help guide our next steps in the clinical development pathway for TFF TAC.
  • I am also pleased to note that we were able to secure additional financing following the close of the quarter to help us further advance TFF TAC toward registrational testing.
  • The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

Ascendis Pharma Announces Extension of U.S. Food and Drug Administration Review Period for TransCon™ PTH for Adults with Hypoparathyroidism

Retrieved on: 
tisdag, maj 14, 2024
New Drug Application, Patient, Microsoft Access, EAP, Food, NDA, FDA, PDUFA, Hypoparathyroidism, Pharmaceutical industry

COPENHAGEN, Denmark, May 14, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food and Drug Administration (FDA) notified the Company that information submitted in response to the FDA’s ongoing review of the New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for adults with hypoparathyroidism constituted a major amendment to the NDA. Accordingly, the FDA has extended the PDUFA target action date by three months, to August 14, 2024, to provide time for a full review of the submission.

Key Points: 
  • Accordingly, the FDA has extended the PDUFA target action date by three months, to August 14, 2024, to provide time for a full review of the submission.
  • “We have responded to all requests received to date from FDA and will work with the agency as they continue their review of our NDA,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer.
  • “Adults with hypoparathyroidism in the United States, who are receiving TransCon PTH in our clinical trials and our Expanded Access Program (EAP) will continue to receive their medication, and the EAP remains open for enrollment for eligible patients.
  • We remain committed to bringing TransCon PTH to adults with hypoparathyroidism in the United States, who face an urgent need for new treatments.”

Pharming Group reports first quarter 2024 financial results and provides business update

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onsdag, maj 8, 2024
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“Pharming delivered a strong first quarter, increasing quarterly revenues by 31% year-over-year to US$55.6 million and keeping the Company on track for our 2024 total revenue guidance of US$280 - US$295 million.

Key Points: 
  • “Pharming delivered a strong first quarter, increasing quarterly revenues by 31% year-over-year to US$55.6 million and keeping the Company on track for our 2024 total revenue guidance of US$280 - US$295 million.
  • Pharming made continued progress in the first quarter of 2024 on leniolisib regulatory filings for APDS patients 12 years of age and older in key global markets.
  • Pharming filed regulatory submissions in Canada and Australia in the third quarter of 2023, and Israel in the second quarter.
  • Pharming announced completion of enrollment in the clinical trial for children ages 4 to 11 years old on April 8, 2024.

US Medical Innovations Secures FDA Clearance for Canady Helios Cold Plasma™ Ablation System

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tisdag, maj 7, 2024
Research, Robotics, Oncology, Medical Devices, Technology, Artificial Intelligence, Clinical Trials, Science, Surgery, Biotechnology, FDA, Health, Risk, Innovation system, Doctor of Philosophy, SMC, RNS, Sheba Medical Center, Medicine, RMC, Oncology nursing, Purdue University, Canady, ROS, Surgical oncology, Entrepreneurship, Plasma, Johns Hopkins University, Patient, Multi, Argon, Safety, George Washington University, Microsoft Access, Cell death, Survival, IDE, University of Massachusetts, Treatment, Multimedia, Reactive nitrogen species, Engineer, CHCP, University, Apoptosis, FACS, Field line, Airline, Rush University Medical Center, Reactive oxygen species, Nursing

US Medical Innovations, LLC (USMI) announced today it has received FDA 510k Clearance (K240297) for the Canady Helios Cold Plasma™ (CHCP) Ablation System for the ablation of soft tissue during surgery.

Key Points: 
  • US Medical Innovations, LLC (USMI) announced today it has received FDA 510k Clearance (K240297) for the Canady Helios Cold Plasma™ (CHCP) Ablation System for the ablation of soft tissue during surgery.
  • The CHCP system consists of the Canady Helios Cold Plasma XL-1000 CP Smart Electrosurgical Generator, Canady Helios Cold Plasma Ablators, Foot Pedal and Trolley Cart.
  • The Canady Helios Cold Plasma™ System introduces a novel approach to soft tissue ablation using plasma.
  • For more information on US Medical Innovation’s products and technology please visit: www.usmedinnovations.com .

Blues and Arduino Partner to Boost Arduino Opta Connectivity with Launch of Affordable 'Wireless for Opta' Expansion Module

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måndag, maj 6, 2024
Cloud, Operational technology, Organization, Ethernet, Ecosystem, Communication, Partnership, Wi-Fi, Water, AUX, RS485, Automation, LTE, Lotus, Senior, Front page, PC, GCP, Opta, Azure, PLC, Arduino, Index card, CAT1, Wireless, Fourth Industrial Revolution, Microsoft Access, AWS, LoRa, Industrial internet of things, Note, Video game

BOSTON, May 6, 2024 /PRNewswire/ -- Blues, in collaboration with Arduino, has unveiled the Blues Wireless for Arduino Opta, a groundbreaking Expansion Module that enhances connectivity options for the Arduino Opta micro-PLC, at Automate in Chicago today.

Key Points: 
  • BOSTON, May 6, 2024 /PRNewswire/ -- Blues, in collaboration with Arduino, has unveiled the Blues Wireless for Arduino Opta, a groundbreaking Expansion Module that enhances connectivity options for the Arduino Opta micro-PLC, at Automate in Chicago today.
  • The Expansion will be available in the Blues Shop and the Arduino Store this Summer.
  • With the Opta and Blues' Wireless Expansion, Blues and Arduino are fueling a similar revolution, empowering OT teams with a direct path to cloud-connected PLC systems."
  • The Blues Wireless for Arduino Opta expansion can quickly and inexpensively add Cellular or LoRa connectivity to any Arduino Opta micro-PLC.

Tiziana Life Sciences Announces Additional Clinical Improvements Among Multiple Sclerosis Patients in its Expanded Access Program

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måndag, april 22, 2024
EAP, Mass, Hospital, EDSS, Patient, MFIS, Fatigue, Neurology, Harvard Medical School, Multiple sclerosis, Central nervous system, Microsoft Access, Nursing

NEW YORK, April 22, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced additional positive clinical results from its intermediate sized Expanded Access Program (EAP) for non-active secondary progressive multiple sclerosis (na-SPMS) patients.

Key Points: 
  • NEW YORK, April 22, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced additional positive clinical results from its intermediate sized Expanded Access Program (EAP) for non-active secondary progressive multiple sclerosis (na-SPMS) patients.
  • The data demonstrate multiple improvements in foralumab-treated patients, with 70% showing an improvement in fatigue after six months of follow-up.
  • Fatigue is a debilitating symptom for many MS patients and is measured by the Modified Fatigue Impact Scale (MFIS).
  • The findings, which are summarized in Table 1 below, show broad-based six-month improvements across various key measures for multiple sclerosis.

Tiziana Life Sciences Announces New Quantitative PET Imaging Data on Foralumab at the Annual Meeting of the American Academy of Neurology

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torsdag, april 18, 2024
American Academy, Mass, Hospital, Stabilizer, White matter, PET, EDSS, Human, Patient, MFIS, Fatigue, DSM-IV codes, Harvard Medical School, Biomarker, Annual general meeting, Associate, Microsoft Access, Neuro, PIRA, Medical imaging

The presentation includes new, encouraging quantitative imaging data from foralumab’s intermediate- size patient population Expanded Access Program.

Key Points: 
  • The presentation includes new, encouraging quantitative imaging data from foralumab’s intermediate- size patient population Expanded Access Program.
  • Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences, commented, “Tiziana is taking a leadership role in focusing on this subset of progressive MS where there are no effective treatments.
  • The study is designed to be open-label and part of the Expanded-Access Program evaluating foralumab in na-SPMS patients that is currently underway.
  • This trial ( NCT06292923 ) is important because if the potential to slow disease progression is demonstrated this would align with early treatment intervention.

Feinstein Institutes’ Daniel A. Grande Named President-Elect of the International Cartilage Regeneration & Joint Preservation Society (ICRS)

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torsdag, april 18, 2024
Health, Hospitals, Other Health, Other Science, General Health, Research, Science, Education, FDA, Rheumatology, EVS, Microsoft Exchange Server, Intervertebral disc, Regenerative medicine, Seminal vesicles, Cartilage, Doctor of Philosophy, B cell, Meniscus, ICRS, Patient, Tissue engineering, Molecular medicine, 3D bioprinting, Medical research, Microsoft Access, Multimedia, Regeneration, Stem cell, Credit, Journal, Medical device

The International Cartilage Regeneration & Joint Preservation Society (ICRS) has named Daniel A. Grande, PhD, assistant vice president of research services and professor of molecular medicine and orthopedic surgery at The Feinstein Institutes for Medical Research , its new President-Elect.

Key Points: 
  • The International Cartilage Regeneration & Joint Preservation Society (ICRS) has named Daniel A. Grande, PhD, assistant vice president of research services and professor of molecular medicine and orthopedic surgery at The Feinstein Institutes for Medical Research , its new President-Elect.
  • View the full release here: https://www.businesswire.com/news/home/20240418363701/en/
    Feinstein Institutes’ Dr. Daniel A. Grande has been named the new president-elect of International Cartilage Repair Society.
  • (Credit: Feinstein Institutes)
    Dr. Grande, renowned for his significant contributions to cartilage repair and regeneration, will lead the ICRS in its mission to advance science and education in preventing and treating cartilage injuries.
  • "I am honored and excited to serve as the President-Elect of the International Cartilage Regeneration & Joint Preservation Society.

Zevra Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Updates

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torsdag, mars 28, 2024
Narcolepsy, Exercise, Somnolence, New Drug Application, Patient, Visual analogue scale, Sale, NDA, G&A, Arimoclomol, Nature, IND, Bank statement, Microsoft Access, Investment, Therapy, Priority review, Corporation, Audit committee, Research, Niemann–Pick disease, Medical science liaison, Sleep disorder, Brain, Trial of the century, Safety, Interim, Food, Sleep, QuickStart, Disease, FY, Acquisition, Emetine, UCD, COL3A1, Celiprolol, Syndrome, FDA, Marketing, Conference call, Conference, EAP, SDX, NPC, Epworth Sleepiness Scale, Idiopathic hypersomnia, Physician, PDUFA, Pharmaceutical industry

CELEBRATION, Fla., March 28, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the fourth quarter and year ended December 31, 2023. 

Key Points: 
  • ET
    CELEBRATION, Fla., March 28, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the fourth quarter and year ended December 31, 2023.
  • “We made solid progress on our key priorities in 2023,” said Neil F. McFarlane, President and Chief Executive Officer of Zevra.
  • Overview of Q4 2023 and FY 2023 Financial Results:
    Net revenue for Q4 2023 was $13.2 million, compared to prior year Q4 net revenue of $2.2 million.
  • ET, to discuss its corporate and financial results for Q4 and FY 2023.

TFF Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
torsdag, mars 28, 2024
Research, TFF, Administration, Conference, Patient, IPA, EAP, Mortality, G&A, Lung transplantation, Insurance, AAAM, Microsoft Access, Research and development, Infection, Safety, FDA, Heart, Corporation, Pharmaceutical industry

FORT WORTH, Texas, March 28, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today reported financial results for the fourth quarter and full year 2023.

Key Points: 
  • FORT WORTH, Texas, March 28, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today reported financial results for the fourth quarter and full year 2023.
  • For TFF TAC, the Company presented data showing that eight out of eight patients successfully transitioned from oral Tacrolimus to TFF TAC in the Phase 2 study.
  • TFF TAC continues to demonstrate favorable safety results with no mortality or discontinuations due to adverse events.
  • In the fourth quarter 2023, the Company announced the appointment of three new members of its Board of Directors, including Thomas B.