IV

4DMT Gains Alignment with FDA on Plan to Lift Clinical Hold on Phase 1/2 INGLAXA Clinical Trial for 4D-310 for Fabry Disease Cardiomyopathy

Retrieved on: 
Monday, October 30, 2023
FDA, AAV, Chelsea Handler, Food, IV, Therapy, Fabry, Risk, Atypical hemolytic uremic syndrome, Safety, Patient, Pharmaceutical industry

“We are delighted to have reached an agreement with the FDA on our proposed plan to address the clinical hold and continue trial development,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT.

Key Points: 
  • “We are delighted to have reached an agreement with the FDA on our proposed plan to address the clinical hold and continue trial development,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT.
  • Consistent with the Company’s plans, the FDA subsequently notified the Company of a clinical hold in the U.S.
  • The Asia-Pacific clinical trial program was not placed on clinical hold by any regulatory agency.
  • In addition, the INGLAXA clinical trial protocol has been amended to minimize the risk of aHUS following IV 4D-310 dosing, including requiring the R/S immunosuppressive regimen.

Republic Bancorp and Norcross Braca Group Announce $35 Million Investment

Retrieved on: 
Friday, October 27, 2023
Toronto-Dominion Bank, Ballard Spahr, III, Appointment, IV, Sullivan & Cromwell, Oliver Cromwell, Chair, Risk-weighted asset, Republic, Republic First Bancorp, Vinson & Elkins, Republic Bank, LLP, TD, Cryptocurrency, Management

PHILADELPHIA, Oct. 27, 2023 (GLOBE NEWSWIRE) -- Republic First Bancorp, Inc. (OTCEM: FRBK) (“Republic” or the “Company”), the parent company of Republic First Bank d/b/a Republic Bank, and George E. Norcross, III, Gregory B. Braca, Philip A. Norcross, Lexie Norcross, other Norcross family members and affiliates (collectively, the “Norcross Braca Group”), today announced that they have signed a Securities Purchase Agreement to effectuate a $35 million investment by the Norcross Braca Group. As part of the agreement, the Company’s Board of Directors (the “Board”) will be reconstituted, with former TD Bank U.S. CEO Gregory B. Braca and two other highly qualified individuals joining as Directors and Philip A. Norcross becoming the Chair. Upon closing of the new investment, which is subject to regulatory approval and other conditions related to the Company, the remainder of the previously announced $75 million to $100 million capital raise will commence.

Key Points: 
  • Investment Will Improve Capital Ratios and Result in Reconstitution of Republic Board, with Appointment of Philip A. Norcross as Chair as well as Gregory B. Braca and Two New Independent Directors
    PHILADELPHIA, Oct. 27, 2023 (GLOBE NEWSWIRE) -- Republic First Bancorp, Inc. (OTCEM: FRBK) (“Republic” or the “Company”), the parent company of Republic First Bank d/b/a Republic Bank, and George E. Norcross, III, Gregory B. Braca, Philip A. Norcross, Lexie Norcross, other Norcross family members and affiliates (collectively, the “Norcross Braca Group”), today announced that they have signed a Securities Purchase Agreement to effectuate a $35 million investment by the Norcross Braca Group.
  • Upon closing of the new investment, which is subject to regulatory approval and other conditions related to the Company, the remainder of the previously announced $75 million to $100 million capital raise will commence.
  • Legacy Directors Andrew B. Cohen, Harry D. Madonna, Harris Wildstein and Lisa Jacobs will all depart the Board.
  • Sullivan & Cromwell LLP and Ballard Spahr are serving as legal advisors to the Norcross Braca Group.

In Honor of the Most Iconic Night in Music, GBK Brand Bar Produces & Curates the 'Backstage Artist Lounge' During Rehearsals of the 38th Annual Rock & Roll Hall of Fame Induction Ceremony

Retrieved on: 
Sunday, November 5, 2023
Plata, H.E.R, Foo Fighters, Rhythm, 2007 College Football Hall of Fame inductees, Human, Poetry, LL Cool J, Jukebox, Jennie (singer), Rage Against the Machine, Spinners, IV, Barclays Center, Rage, 2 Girls, Multimedia, LoveSac, Rock, Common, Immunity, Special, Cotopaxi, Deodorant, Sleep, Travel, Citrus, Bakery, Electrolyte, Turks and Caicos Islands, Hotel, Nightclub, New Edition

View original content to download multimedia:https://www.prnewswire.com/news-releases/in-honor-of-the-most-iconic-nig...

Key Points: 
  • NEW YORK, Nov. 4, 2023 /PRNewswire/ -- GBK Brand Bar hosted a three-day luxury gifting and charitable experience to celebrate music's highest honor.
  • During the backstage rehearsals, artists signed a Vespa Sprint 50cc in all-white, a Foo Fighters Pro Stern pinball machine and a custom mixed media painting by Jennifer Contini to be auctioned off for the Rock & Roll Hall of Fame Foundation.
  • Rock & Roll Hall of Fame Inductee, Chaka Khan unveiled "Chaka by Chaka Khan," her debut unisex fragrance personally curated to capture essence from within.
  • In the spirit of giving back, GBK Brand Bar auctioned off a backstage experience for three lucky guests to be treated like a celebrity for the day to benefit the Rock & Roll Hall of Fame Foundation.

BD Advances "One-Stick Hospital Stay" Vision with Launch of Next-Generation Needle-Free Blood Draw Technology

Retrieved on: 
Thursday, November 2, 2023
FDA, Becton, Standard of care, NYSE, Food, IV, Needlestick injury, Fear, Regulation of tobacco by the U.S. Food and Drug Administration, Health, Maintenance, BD, Clinical, BDX, Risk, Hospital, Workflow, Anxiety, Becton, Dickinson and Company headquarters, Patient, Medical imaging, Medical device

FRANKLIN LAKES, N.J., Nov. 2, 2023 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today launched new needle-free blood draw technology compatible with integrated catheters, helping to further enable the company's vision of a "One-Stick Hospital Stay."  

Key Points: 
  • New Peripheral Line Draw Solution Delivers First and Only Compatibility with Integrated Catheters, Bringing Elevated Standard of Care to More U.S.
  • Hospitals
    FRANKLIN LAKES, N.J., Nov. 2, 2023 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today launched new needle-free blood draw technology compatible with integrated catheters, helping to further enable the company's vision of a "One-Stick Hospital Stay."
  • **Clinical studies were done on previous generations of the PIVO™ Blood Collection Device and Nexiva™ Catheter System.
  • PIVO™ Pro and Nexiva™ with NearPort IV Access are the next generations of their respective product families.

Hydration Room: IV and Injection Therapy Celebrates Milestone with 25th Location

Retrieved on: 
Monday, October 30, 2023
NAD, Patient, Health, IV, SAN, Hospital

SAN DIEGO, Oct. 30, 2023 /PRNewswire/ -- Hydration Room ®, California's leading provider of intravenous (IV) hydration and injection therapy, is excited to announce the grand opening of its 25th location, marking a significant achievement in the brand's journey since its inception in 2014.

Key Points: 
  • SAN DIEGO, Oct. 30, 2023 /PRNewswire/ -- Hydration Room ®, California's leading provider of intravenous (IV) hydration and injection therapy, is excited to announce the grand opening of its 25th location, marking a significant achievement in the brand's journey since its inception in 2014.
  • With its unwavering commitment to health and wellness, Hydration Room has been at the forefront of revolutionizing the field of IV hydration therapy.
  • "We are absolutely thrilled to reach this milestone," said Dr. Brett Florie, founder and Chief Executive Officer of Hydration Room.
  • "We are excited to continue our journey, bringing health, wellness, and IV hydration therapy to even more people."

NKGen Biotech Presented Phase I Clinical Trial Data at the 16th Annual Clinical Trials on Alzheimer’s Disease (CTAD) Conference

Retrieved on: 
Thursday, October 26, 2023
Week, Research, MRI, AD, IND, Mini–Mental State Examination, IV, Glial fibrillary acidic protein, Therapy, CSF, ADAS, Dispute board, Cell, Protein, Clinical trial, PET, Poster, ADAS-Cog, Traffic barrier, Cerebrospinal fluid, NK, Alzheimer's disease, GFAP, MMSE, Classification, Safety, Patient, Medical device, Pharmaceutical industry, Medical imaging, Hospital Angeles Tijuana

SANTA ANA, Calif., Oct. 26, 2023 (GLOBE NEWSWIRE) -- NKGen Biotech Inc. (Nasdaq: NKGN) (NKGen or the Company), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK natural killer cell therapeutics, today presented a poster with Phase I trial data on the use of its investigational NK cell therapy, SNK01, to treat patients with Alzheimer’s disease (AD) at the Clinical Trials on Alzheimer’s Disease (CTAD) Annual Meeting in Boston, MA.

Key Points: 
  • The severity of AD was based on the baseline Clinical Dementia Rating-Sum of Boxes, or CDR-SB score.
  • The primary endpoint was safety and secondary endpoints included changes in cognitive assessments and biomarker levels.
  • We are very excited to begin this next phase in hopes of establishing an entirely new treatment paradigm for more advanced patients."
  • *Data at Week 22 was only obtained for nine of the ten patients.

Cybin Announces Grant of European Patent Protecting its Proprietary Deuterated Programs

Retrieved on: 
Thursday, October 26, 2023
Alternative Medicine, Mental Health, Health, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Patent, NYSE, IV, DSM-IV codes, Psilocybin, Inc., European Patent Office, DMT, NEO, European Patent Convention, Patient, Pharmaceutical industry

Cybin Inc. (NYSE American:CYBN) (NEO:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative psychedelic-based treatment options, today announced that the European Patent Office (“EP”) has granted a patent protecting Cybin’s proprietary deuterated psilocybin analog and N, N-dimethyltryptamine (“DMT”) programs.

Key Points: 
  • Cybin Inc. (NYSE American:CYBN) (NEO:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative psychedelic-based treatment options, today announced that the European Patent Office (“EP”) has granted a patent protecting Cybin’s proprietary deuterated psilocybin analog and N, N-dimethyltryptamine (“DMT”) programs.
  • 4,031,529 provides composition of matter protection for certain deuterated tryptamine compounds, including deuterated psilocybin analogs within the CYB003 program and deuterated analogs of DMT within Cybin’s DMT program, as well as their medical use.
  • “Following quickly on from the two recently announced U.S. patents granted in respect of our deuterated DMT program, this European patent further strengthens our intellectual property protection around our deuterated DMT and deuterated psilocybin programs.
  • The Company expects to report topline data from its deuterated psilocybin and DMT programs in the fourth quarter of 2023.

Recce Pharmaceuticals Announces Safety Committee Approves Faster Infusion Rate in Phase I/II Trial of RECCE® 327 for Urinary Tract Infections and Urosepsis

Retrieved on: 
Wednesday, October 25, 2023
ASX, Pyelonephritis, Urinary tract infection, IV, Mortality, SCC, Pharmacokinetics, Phase, ID, Clinical trial, Genetically modified bacteria, FSE, Safety, Sepsis, Patient, RCE, Pharmaceutical industry

The next cohort of subjects has been recruited, with dosing to begin imminently.

Key Points: 
  • The next cohort of subjects has been recruited, with dosing to begin imminently.
  • “We are pleased to receive approval from the Independent Safety Committee to commence dosing of R327 at 15 minutes, a faster infusion rate than what has been administered in previous doses at 1-hour and 30-minute infusion rates,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals.
  • Antibiotics administered as an IV infusion, usually over 30 minutes, have benefits such as savings in nursing time, reduced costs, and improved safety.
  • More information on this trial can be found at the Australia New Zealand Clinical Trial Registry (ANZCTR) under the trial ID ACTRN12623000448640 .

Iterum Therapeutics Announces Completion of Enrollment in its REASSURE Phase 3 Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections

Retrieved on: 
Tuesday, October 24, 2023
FDA, Food, ITRM, IV, Probenecid, Renewable Fuels Agency, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Urinary tract infection, Clinical trial, New Drug Application, Woman, NDA, Therapy, Infection, Pharmaceutical industry, Sulopenem

DUBLIN, Ireland and CHICAGO, Oct. 24, 2023 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced the completion of patient enrollment in its REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales) clinical trial comparing oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) to oral Augmentin® (amoxicillin/clavulanate) in adult women with uncomplicated urinary tract infections (uUTI).

Key Points: 
  • DUBLIN, Ireland and CHICAGO, Oct. 24, 2023 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced the completion of patient enrollment in its REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales) clinical trial comparing oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) to oral Augmentin® (amoxicillin/clavulanate) in adult women with uncomplicated urinary tract infections (uUTI).
  • “We are extremely pleased to have completed enrollment in our REASSURE trial well ahead of schedule.
  • We now expect topline results early in the first quarter of 2024, and subject to our analysis of the data, plan to resubmit our NDA to the FDA in the second quarter of 2024,” said Corey Fishman, Chief Executive Officer.
  • Provided that the resubmitted NDA addresses all of the deficiencies identified in the complete response letter Iterum received from the FDA in July 2021, Iterum expects that the FDA will complete its review and take action six months from the date the FDA receives the resubmitted NDA (or during the second half of 2024).

SCYNEXIS Presents New Preclinical Data on Second Generation Fungerp SCY-247 at the 11th Congress on Trends in Medical Mycology (TIMM)

Retrieved on: 
Tuesday, October 24, 2023
Yeast, TIMM, European Confederation, IV, Antimalarial medication, Auris, Candida albicans, Biotechnology, Congress, Professor, ECMM, Mouse, Candida auris, University of Graz, University, Medical Mycology, Fungal infection, Patient, Associate, Mycology, Pharmaceutical industry

JERSEY CITY, N.J., Oct. 24, 2023 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced the presentation of preclinical data on its second generation fungerp candidate, SCY-247, against a broad panel of fungal pathogens.

Key Points: 
  • JERSEY CITY, N.J., Oct. 24, 2023 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced the presentation of preclinical data on its second generation fungerp candidate, SCY-247, against a broad panel of fungal pathogens.
  • “We are excited to see the progress in the development of this novel compound from the fungerp family,” said Dr. Martin Hoenigl, FECMM, Associate Professor of Translational Mycology at University of Graz, Austria and president of the European Confederation of Medical Mycology (ECMM).
  • Results illustrated the potent and broad-spectrum in vitro activity of SCY-247, including against a large array of yeasts, molds and dimorphic fungi.
  • Results also demonstrated SCY-247’s extensive tissue distribution in mice, including brain penetration.