Food and Drug Administration Safety and Innovation Act

Innovent Presents Clinical Data of Two Ophthalmic Bispecific Antibodies IBI302 (anti-VEGF/complement) and IBI324 (anti-VEGF-A/Ang-2) at American Academy of Ophthalmology (AAO) Annual Meeting 2023

Retrieved on: 
Monday, November 6, 2023
NAMD, Neovascularization, HKEX, CFP, Trial of the century, CST, Incidence, Eye, Ophthalmology, Infrared spectroscopy correlation table, Treatment, DME, AAO, Injection, Fibrosis, MAD, SAD, Inflammation, Drug development, SAE, Retinal vasculitis, Anetoderma, Diabetic retinopathy, American Academy, American Academy of Ophthalmology, Annual general meeting, Paratriathlon, Safety, Visual acuity, Moran Eye Center, Patient, Hospital, Anti-VEGF, Pharmaceutical industry, Phosphorus, Food and Drug Administration Safety and Innovation Act

The primary endpoint was the change from baseline in best-corrected visual acuity (BCVA) in the study eye at 36 weeks.

Key Points: 
  • The primary endpoint was the change from baseline in best-corrected visual acuity (BCVA) in the study eye at 36 weeks.
  • In terms of safety, the incidence of adverse events were similar in the IBI302 2 mg group, IBI302 4 mg group, and the aflibercept 2 mg group.
  • This is a Phase 1 clinical study evaluating the safety, tolerability, and efficacy of IBI324 in the treatment of DME (ClinicalTrials.gov: NCT05489718).
  • We look forward to advancing the clinical development progress and hope Innovent's innovative medicines can benefit more patients."

Increase Access to Life Saving Cancer Treatment with Accarent Health’s Oncology and Gene Therapy Bundles

Retrieved on: 
Tuesday, October 24, 2023
American Cancer Society, Survival, FDA, CAR, Food, Bone marrow, Najib Roger Accar, Certification, Death, Institute for Clinical and Economic Review, Disease, Transport, Partnership, Cancer, Hospital, Patient, Diagnosis, Food and Drug Administration Safety and Innovation Act, Pharmaceutical industry, MD

CAR T-Cell therapy is a specific kind of gene therapy being used to treat cancer.

Key Points: 
  • CAR T-Cell therapy is a specific kind of gene therapy being used to treat cancer.
  • Currently, six CAR T-cell therapies have been approved by the Food and Drug Administration (FDA) for the treatment of blood cancers.
  • Accarent Health, a unified technology and care management platform granting access to pre-negotiated, fixed bundled prices for complex medical procedures and treatments, offers a variety of cancer treatment bundles eliminating unpredictable costs and providing increased access to quality care.
  • For more information or to access these or other behavioral health treatment options visit Accarent Health at www.accarenthealth.com.

PharmaTher Announces FDA Acceptance, As a Priority Original Abbreviated New Drug Application, for KETARX™ (Ketamine)

Retrieved on: 
Wednesday, September 27, 2023
Pain disorder, Abbreviated New Drug Application, Partnership, CSE, Depression, Anxiety, Pain, Food and Drug Administration Safety and Innovation Act, Ketamine, Hospital, ANDA, Suicidal ideation, FDA, Health Canada, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Mental health, Therapy, Food, Pharmaceutical industry

TORONTO, Sept. 27, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a commercial-focused specialty pharmaceutical company, today announced the U.S. Food and Drug Administration (“FDA”) has accepted the Abbreviated New Drug Application (“ANDA”) for KETARX™ (racemic ketamine) to the Food and Drug Administration (“FDA”). The FDA assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date for this priority original ANDA of April 29, 2024. The Company anticipates the commercial launch of KETARX™ in the U.S. after that, followed by the pursuit of international approvals to support the growing global demand for ketamine.

Key Points: 
  • The FDA assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date for this priority original ANDA of April 29, 2024.
  • The Company anticipates the commercial launch of KETARX™ in the U.S. after that, followed by the pursuit of international approvals to support the growing global demand for ketamine.
  • PharmaTher’s priority is to commercialize KETARX™ in the U.S. through its recently announced partnership with Vitruvias Therapeutics, Inc., a leading U.S. based specialty generic pharmaceutical company.
  • The Company expects to market various dosage forms of KETARX™, with the option to increase concentration and ready-to-administer applications for the U.S. and international markets.

MicuRx receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation for Contezolid and Contezolid acefosamil

Retrieved on: 
Friday, September 22, 2023
Priority review, Food and Drug Administration Safety and Innovation Act, Innovation Act, IV, Prevalence, Amputation, Diabetes, QIDP, Methicillin, S. aureus, Methicillin-resistant Staphylococcus aureus, Infection, Act, MRSA, NDA, Fast Track, Osteomyelitis, ABSSSI, GAIN, Diabetic foot infection, Patient, Ulcer, Disease, DFI, Mortality, Toxic shock syndrome, Bacteria, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Gram-positive bacteria, Food, Pharmaceutical industry, FDASIA

Oral contezolid and intravenous (IV) contezolid acefosamil are currently being studied in a global Phase 3 clinical trial in treatment of patients with DFI.

Key Points: 
  • Oral contezolid and intravenous (IV) contezolid acefosamil are currently being studied in a global Phase 3 clinical trial in treatment of patients with DFI.
  • Both products were previously granted QIDP designation and Fast Track status in 2018 for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
  • With excellent microbiological activity against common Gram-positive bacteria, contezolid and contezolid acefosamil are well positioned to benefit DFI patients, particularly due to methicillin-resistant Staphylococcus aureus (MRSA).
  • "We believe that MicuRx can offer an important new choice for DFI treatment with flexibility of oral and IV formulations."

Increase Access to Life Saving Cancer Treatment with Accarent Health’s Oncology and Gene Therapy Bundles

Retrieved on: 
Wednesday, September 6, 2023
Partnership, Survival, Bone marrow, Cancer, Certification, CAR, Death, Food and Drug Administration Safety and Innovation Act, Hospital, Patient, Institute for Clinical and Economic Review, Diagnosis, American Cancer Society, Transport, FDA, Food, Disease, Najib Roger Accar, Pharmaceutical industry, MD

CAR T-Cell therapy is a specific kind of gene therapy being used to treat cancer.

Key Points: 
  • CAR T-Cell therapy is a specific kind of gene therapy being used to treat cancer.
  • Currently, six CAR T-cell therapies have been approved by the Food and Drug Administration (FDA) for the treatment of blood cancers.
  • Accarent Health, a unified technology and care management platform granting access to pre-negotiated, fixed bundled prices for complex medical procedures and treatments, offers a variety of cancer treatment bundles eliminating unpredictable costs and providing increased access to quality care.
  • For more information or to access these or other behavioral health treatment options visit Accarent Health at www.accarenthealth.com.

NKGen Biotech, Inc. Announces First Patient Dosed in Phase I Clinical Trial of SNK02, Allogeneic NK Cell Therapy Product Candidate, for the Treatment of Solid Tumors

Retrieved on: 
Thursday, August 24, 2023
Clinical trial, NK, Malignancy, Food and Drug Administration Safety and Innovation Act, Investigational New Drug, Patient, NYSE, Food, Safety, Pharmaceutical industry

In October 2022, the Food and Drug Administration allowed NKGen’s Phase I SNK02 clinical trial to proceed per its Investigational New Drug application.

Key Points: 
  • In October 2022, the Food and Drug Administration allowed NKGen’s Phase I SNK02 clinical trial to proceed per its Investigational New Drug application.
  • This Phase I clinical trial is evaluating the safety and tolerability of SNK02 in participants with pathologically confirmed solid tumors refractory to standard of care therapy.
  • “We are excited to have dosed our first patient in the Phase I SNK02 clinical trial in refractory cancer patients with limited treatment options,” said Paul Y.
  • “SNK02 seeks to be one of the first cryopreserved allogeneic NK cell therapy for solid tumors that does not require lymphodepletion before administration.

Welldoc Receives 11th 510(k) Clearance from FDA for Award-Winning Diabetes Platform BlueStar®

Retrieved on: 
Wednesday, August 23, 2023
Technology, Medical Devices, FDA, Diabetes, Other Technology, Health Technology, Other Health, General Health, Health, Artificial Intelligence, CGM, Injection, Insulin, Heart failure, Feinberg School of Medicine, Research, Hypertension, Organization, Food and Drug Administration Safety and Innovation Act, Prediabetes, Risk, International Journal of Obesity, Regulatory affairs, Northwestern University, Food, Blue star, Medical device, Pharmaceutical industry

This clearance immediately follows Welldoc’s 10th 510(k) clearance announcement earlier this month, solidifying the company’s continued leadership in chronic care innovation.

Key Points: 
  • This clearance immediately follows Welldoc’s 10th 510(k) clearance announcement earlier this month, solidifying the company’s continued leadership in chronic care innovation.
  • This feature enhances BlueStar’s existing digital coaching capabilities, which guide dietary and lifestyle decisions and assist individuals in self-managing their diabetes.
  • Welldoc is the first company to receive clearance for a CGM-informed bolus calculator specifically designed for adults who manage their diabetes with multiple daily injections of insulin.
  • “This 11th 510(k) clearance is a remarkable achievement for Welldoc and demonstrates our steadfast commitment to transforming chronic care.

Welldoc Receives 10th 510(k) Clearance from FDA for Award-Winning Diabetes Platform BlueStar®

Retrieved on: 
Tuesday, August 15, 2023
Biotechnology, Pharmaceutical, Health, FDA, Diabetes, Medical Devices, Health Technology, Clinical Trials, Insulin, AI, Food and Drug Administration Safety and Innovation Act, Food, Caregiver, Blue star, Pharmaceutical industry, Medical device

Welldoc® , a digital health leader revolutionizing chronic care, today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar®.

Key Points: 
  • Welldoc® , a digital health leader revolutionizing chronic care, today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar®.
  • This clearance reinforces Welldoc’s position as a leader in technology in diabetes management.
  • This 10th 510(k) clearance enables BlueStar to use connected insulin dosing data in personalized bolus insulin dosing recommendations.
  • “The receipt of our 10th 510(k) clearance is another milestone demonstrating Welldoc’s commitment to leading innovation in digital health.

Senderra Specialty Pharmacy announces that HUMIRA biosimilar products are now available to patients nationwide

Retrieved on: 
Friday, August 4, 2023
Wuhan Institute of Biological Products, Adalimumab, Food and Drug Administration Safety and Innovation Act, Entrepreneurship, FDA, Fresenius (company), Patient, Food, Generic drug, Pharmaceutical industry

DALLAS, Aug. 4, 2023 /PRNewswire/ -- Senderra Specialty Pharmacy announced today that patients can access several HUMIRA biosimilar medications through Senderra's pharmaceutical manufacturing partnerships.

Key Points: 
  • DALLAS, Aug. 4, 2023 /PRNewswire/ -- Senderra Specialty Pharmacy announced today that patients can access several HUMIRA biosimilar medications through Senderra's pharmaceutical manufacturing partnerships.
  • This development allows patients to access biosimilars nationwide through Senderra Specialty Pharmacy conveniently.
  • As other adalimumab biosimilar manufacturers make their products available in the marketplace, Senderra will announce any new partnerships and product availability.
  • "We are delighted to extend our patient and provider offerings through our comprehensive relationships with pharmaceutical manufacturers," said Will Howard, Co-Founder and President of Senderra Specialty Pharmacy.

Aridis’ AR-301 Monoclonal Antibody is Among the First Biologics to Receive FDA’s Qualified Infectious Diseases Product (QIDP) Designation

Retrieved on: 
Wednesday, July 12, 2023
China Biologic Products, Biologics license application, Drug development, Food and Drug Administration Safety and Innovation Act, Innovation Act, QIDP, CAP, Infection, Omnibus spending bill, S, AMR, Staphylococcus, GAIN, Patient, Immunoglobulin G, VAP, Mab, Consolidated Appropriations Act, 2022, LOS, ICU, Saleh al Aridi, HAP, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Pneumonia, Food, Pharmaceutical industry, FDASIA

"Our AR-301 program will now benefit from the FDA's priority review, in addition to previously awarded Fast-Track status, allowing for accelerated drug development and regulatory review processes.

Key Points: 
  • "Our AR-301 program will now benefit from the FDA's priority review, in addition to previously awarded Fast-Track status, allowing for accelerated drug development and regulatory review processes.
  • This sought-after designation positions our AR-301 program extremely well as we continue to advance it through a confirmatory Phase 3 trial and license application."
  • AR-301 specifically targets S. aureus alpha-toxin, which has been implicated in the pathogenesis of pneumonia caused by S. aureus bacteria.
  • Aridis received positive feedback from the FDA in May 2023 on the Company's proposed single confirmatory Phase 3 study of AR-301.