PDUFA

Ipsen receives new FDA PDUFA date for investigational palovarotene for the treatment of people with FOP

Retrieved on: 
Thursday, March 16, 2023
ADR, New Drug Application, Committee for Medicinal Products for Human Use, Palovarotene, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Committee, Patient, Fibrodysplasia ossificans progressiva, FOP, FDA, Committee on Herbal Medicinal Products, MOVE, IPN, European Medicines Agency, Food, CHMP, NDA, Medical device, Pharmaceutical industry, Euronext, Ipsen, PDUFA

Additional information on palovarotene clinical trial data, requested in a complete response letter to Ipsen in December 2022, will be reviewed as part of this resubmission process.

Key Points: 
  • Additional information on palovarotene clinical trial data, requested in a complete response letter to Ipsen in December 2022, will be reviewed as part of this resubmission process.
  • Furthermore, Ipsen has requested a re-examination of the European Medicines Agency’s January 2023 Committee for Medicinal Products for Human Use (CHMP) opinion on palovarotene.
  • Palovarotene is authorized for use in appropriate patients in Canada where it is marketed as SohonosTM (palovarotene capsules).
  • Investigational palovarotene is under review with several regulatory authorities.

FDA Advisory Committee Votes in Support of Favorable Benefit-Risk Profile for Pfizer’s PAXLOVID™

Retrieved on: 
Thursday, March 16, 2023
Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Oncology, Cancer, PFE, New Drug Application, Smoking, EPIC, EC, Prescription Drug User Fee Act, Patient, Hospital, U.S. FDA, NYSE, Risk, Obesity, Death, SARS-CoV-2, Senior, EUA, European Commission, COVID-19, Disease, Evaluation, Internal medicine, Safety, CDC, Clinical trial, Vaccination, PDUFA, Omicron, Inc., Food, Diabetes, Rusyns, Ageing, NDA, Virulence, Civil service commission, Pharmaceutical industry, Vaccine, Pfizer

The AMDAC's vote, while not binding, will be considered by the FDA when making its decision regarding the potential approval of PAXLOVID.

Key Points: 
  • The AMDAC's vote, while not binding, will be considered by the FDA when making its decision regarding the potential approval of PAXLOVID.
  • “We are encouraged by the AMDAC’s positive vote today.
  • The data showed an 86% reduction in risk of COVID-19-related hospitalization or death from any cause through Day 28 in patients treated with PAXLOVID within 5 days of symptoms onset, compared to placebo.
  • The target Prescription Drug User Fee Act (PDUFA) action date for a decision by the FDA is May 2023.

U.S. Veterans' Health Administration (VHA) Provides Coverage of LEQEMBI (lecanemab-Irmb) Two Months After LEQEMBI's FDA Accelerated Approval for Veterans Living with Early Stages of Alzheimer's Disease

Retrieved on: 
Tuesday, March 14, 2023
The New England Journal of Medicine, Tradition, Brain, Veteran, Pathology, Co-promotion, Priority review, VHA, Lecanemab, Patient, Clarity, FDA, Clinical trial, PDUFA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, AD, Plaque, Immunoglobulin G, Pharmaceutical industry, Alzheimer's disease, Biogen, Disease, Eisai

The VHA's careful consideration and timely action to make LEQEMBI available approximately two months after the FDA approved LEQEMBI under the accelerated approval pathway shows its continued commitment to veterans living with AD.

Key Points: 
  • The VHA's careful consideration and timely action to make LEQEMBI available approximately two months after the FDA approved LEQEMBI under the accelerated approval pathway shows its continued commitment to veterans living with AD.
  • If approved under the traditional pathway, the FDA will update the label for LEQEMBI, which will include new data that has been evaluated by the FDA.
  • The FDA has determined that the results of Clarity AD will serve as the confirmatory study to verify the clinical benefit of LEQEMBI.
  • On the same day that LEQEMBI received its Accelerated approval, Eisai submitted the supplemental Biologics License Application (sBLA) to the FDA for approval under the Traditional pathway.

FDA Accepts Eisai's Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBITM (lecanemab-irmb) for the Treatment of Alzheimer's Disease

Retrieved on: 
Monday, March 6, 2023
The New England Journal of Medicine, Brain, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Co-promotion, Pathology, Priority review, BIIB, Lecanemab, Patient, Clarity, FDA, Clinical trial, Oncology Drug Advisory Committee, PDUFA, Prescription Drug User Fee Act, Food, Advisory Committee, AD, Plaque, Immunoglobulin G, Pharmaceutical industry, Medical imaging, Alzheimer's disease, Biogen, Eisai

The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.

Key Points: 
  • The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.
  • The FDA is currently planning to hold an Advisory Committee to discuss this application but has not yet publicly announced the date of the meeting.
  • On the same day that LEQEMBI received its accelerated approval, Eisai submitted the sBLA to the FDA for approval under the traditional pathway.
  • The sBLA is based on the findings from Eisai's recently published large, global confirmatory Phase 3 clinical trial, Clarity AD.

Tarsus Reports Full-Year 2022 Financial Results and Recent Business Achievements

Retrieved on: 
Monday, March 13, 2023
Rosacea, New Drug Application, Prescription Drug User Fee Act, Galatea, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Optometry, Medicare, Patient, Science, TARS, MGD, FDA, Disease, Diagnosis, ECP, PDUFA, Ophthalmology, Food, NDA, Pharmaceutical industry, Demodex

IRVINE, Calif., March 13, 2023 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced financial results for the full-year ended December 31, 2022, and recent business achievements.

Key Points: 
  • Engaging with more than two-thirds of key optometrists and/or ophthalmologists, and top payers on Demodex blepharitis in anticipation of TP-03 August 25, 2023 PDUFA
    IRVINE, Calif., March 13, 2023 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced financial results for the full-year ended December 31, 2022, and recent business achievements.
  • “In 2022 we had a clear vision to transform eyelid health, starting with the development of our novel investigational treatment for Demodex blepharitis, a disease that impacts millions of Americans.
  • This year, we continue to focus on this unique opportunity, and we are actively educating the market on the disease as we move closer to our PDUFA target action date,” said Bobak Azamian, M.D., Ph.D., Chief Executive Officer and Chairman of Tarsus.
  • “Alongside our efforts in Demodex blepharitis, we’re working to advance our pipeline, including the initiation of our Phase 2 trial in rosacea, and our planned Phase 2a data readouts from our Lyme disease prevention and MGD-related trials in the second half of 2023.

Innoviva Announces FDA Advisory Committee Meeting to Review Sulbactam-Durlobactam (SUL-DUR), an Investigational Targeted Antibiotic

Retrieved on: 
Monday, March 13, 2023
Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Infectious Diseases, Clinical Trials, Priority review, CDC, Nephrotoxicity, Infection, WHO, Acinetobacter, Disease, Patient, Food, Committee, Therapy, Safety, Incidence, NDA, Colistin, Public, Mortality, PDUFA, Pharmaceutical industry

Innoviva, Inc. (Nasdaq: INVA) (“Innoviva”), a diversified holding company with a portfolio of royalties and other healthcare assets, today announced that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee will convene April 17, 2023 to review data supporting the new drug application (NDA) for sulbactam-durlobactam (SUL-DUR).

Key Points: 
  • Innoviva, Inc. (Nasdaq: INVA) (“Innoviva”), a diversified holding company with a portfolio of royalties and other healthcare assets, today announced that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee will convene April 17, 2023 to review data supporting the new drug application (NDA) for sulbactam-durlobactam (SUL-DUR).
  • SUL-DUR is an investigational targeted antibiotic for the treatment of infections due to Acinetobacter baumannii-calcoaceticus complex (Acinetobacter).
  • Infections caused by drug-resistant Acinetobacter are serious and life-threatening conditions associated with high morbidity and mortalityi.
  • The Committee will review data from studies involving SUL-DUR, including data from the landmark Phase 3 trial evaluating the safety and efficacy of SUL-DUR versus colistin in patients with infections caused by Acinetobacter.

Intercept Announces FDA Advisory Committee Meeting Date for Obeticholic Acid as a Treatment for Pre-Cirrhotic Liver Fibrosis due to NASH

Retrieved on: 
Friday, March 10, 2023
Clinical trial, OCA, Intercept, Prescription Drug User Fee Act, Committee, Liver transplantation, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Intercept Pharmaceuticals, Fatty liver disease, NDA, PDUFA, Advisory Committee, NASH, Therapy, Oncology Drug Advisory Committee, Pharmaceutical industry

MORRISTOWN, N.J., March 10, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that the Gastrointestinal Drugs Advisory Committee (GIDAC) of the U.S. Food and Drug Administration (FDA) will discuss Intercept’s new drug application (NDA) for obeticholic acid (OCA) as a treatment for pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH) on May 19, 2023. The Advisory Committee Meeting will be hosted as a virtual meeting.

Key Points: 
  • The Advisory Committee Meeting will be hosted as a virtual meeting.
  • “There are currently no approved treatment options for people living with NASH, a devastating disease and the most rapidly growing cause of liver transplantation in the U.S.,” said Jerry Durso, President and Chief Executive Officer of Intercept.
  • “We look forward to the opportunity to discuss with the Advisory Committee our clinical trial data demonstrating the strong and confirmed antifibrotic effect of OCA, as well as its manageable safety profile in NASH.”
    As previously reported, the Prescription Drug User Fee Act (PDUFA) target action date is June 22, 2023.
  • The timeline for review of the NDA by FDA remains subject to change.

Galera Announces Presentation of Supplemental Analysis of Phase 3 ROMAN Trial at European Congress on Head and Neck Oncology

Retrieved on: 
Friday, March 10, 2023
European Medicines Agency, Quality of life, Head, Breakthrough therapy, Therapy, SOM, RT, Food and Drug Administration, EMA, Patient, FDA, File, Cancer, Food, NDA, PDUFA, Mucositis, Radiation, Congress, Pharmaceutical industry, European

The analysis further demonstrates the overall impact of avasopasem manganese (avasopasem) in reducing the burden of severe oral mucositis (SOM).

Key Points: 
  • The analysis further demonstrates the overall impact of avasopasem manganese (avasopasem) in reducing the burden of severe oral mucositis (SOM).
  • We believe the results reinforce avasopasem’s first-in-class potential to reduce SOM, a common and debilitating effect of radiotherapy in patients with head and neck cancer.
  • The Company believes that the supplemental net treatment benefit analysis being presented at ECHNO further supports the avasopasem clinical benefit observed in those trials.
  • Head and neck cancers are a global problem, as is SOM caused by the standard-of-care RT.

FDA Accepts Mesoblast’s Resubmission of the Biologic License Application for Remestemcel-L In Children with Steroid-Refractory Acute Graft Versus Host Disease as a Complete Response and Sets Goal Date of August 2, 2023

Retrieved on: 
Wednesday, March 8, 2023
MSB, Bone marrow, PDUFA, Australia New Zealand Therapeutic Products Authority, Biomarker, OTP, FDA, MESO, Safety, Agency, Survival, Priority review, BLA, Mesoblast, Inflammation, Pharmaceutical industry

FDA considers the resubmission to be a complete response and has set a Prescription Drug User Fee Act (PDUFA) goal date of August 2, 2023.

Key Points: 
  • FDA considers the resubmission to be a complete response and has set a Prescription Drug User Fee Act (PDUFA) goal date of August 2, 2023.
  • “Over the last two years we have worked tirelessly to address the issues previously raised by FDA.
  • We look forward to working closely with the Agency over the review period with the aim to make remestemcel-L available as a therapy for children suffering from SR-aGVHD,” said Mesoblast Chief Executive Silviu Itescu.
  • If remestemcel-L receives FDA approval, it will be the first allogeneic “off-the-shelf” cellular medicine to be approved in the United States, and the first therapy for children under 12 years old with SR-aGVHD.

Galera Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Corporate Updates

Retrieved on: 
Wednesday, March 8, 2023
Sale, PDUFA, New Drug Application, Literature, HNC, AESOP, NSCLC, Investment, Letter, GPC, SOM, FDA, NDA, Therapy, Chemoradiotherapy, University, Radiation therapy, SBRT, Survival, Cancer, Research, Incidence, Priority review, Mucositis, Head, Patient, File, Esophagitis, MD, Food, LAPC, Lung cancer, Pharmaceutical industry, Medical imaging, Cryptocurrency

MALVERN, Pa., March 08, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced financial results for the fourth quarter and year ended December 31, 2022 and provided recent corporate updates.

Key Points: 
  • On February 15, 2023, the Company announced that the FDA accepted for filing and granted priority review to the NDA for avasopasem.
  • Research and development expenses were $8.1 million in the fourth quarter of 2022, compared to $9.2 million for the same period in 2021.
  • General and administrative expenses were $5.0 million in the fourth quarter of 2022, compared to $5.3 million for the same period in 2021.
  • As of December 31, 2022, Galera had cash, cash equivalents and short-term investments of $31.6 million.