Regulation of food and dietary supplements by the U.S. Food and Drug Administration

Dermavant to Present Data from Multiple Studies of VTAMA® (tapinarof) cream, 1% at the 2023 Winter Clinical Dermatology Conference

Retrieved on: 
Thursday, January 12, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Cream, Disease, Swelling, Atopic dermatitis, Common, Headache, Quality of life, Stinger, Body surface area, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pharmacokinetics, Folliculitis, Safety, FDA, Grande Ballroom, Irritation, Psoriasis, Dermatology Life Quality Index, Treatment, Plasma, Conference, Rash, Food, Therapy, Itch, Patient, Pivotal, QD, Incidence, Nose, PASI, Pain, Pharmaceutical industry, Dietary supplement, Vaccine

The company anticipates announcing topline results from its pivotal Phase 3 clinical trial program in atopic dermatitis, ADORING 1 and ADORING 2, in the first half of this year.

Key Points: 
  • The company anticipates announcing topline results from its pivotal Phase 3 clinical trial program in atopic dermatitis, ADORING 1 and ADORING 2, in the first half of this year.
  • The following posters will be on display in the Grande Ballroom at the Fairmont Orchid Hotel, as well as digitally throughout the conference.
  • The specific mechanisms by which VTAMA cream exerts is therapeutic action in psoriasis and atopic dermatitis are unknown.
  • Visit fda.gov/medwatch or call 1-800-FDA-1088 or report side effects to Dermavant Sciences at 1-8 DERMAVANT (1-833-762-8268).

Testicular Cancer - Global Pipeline Insights, 2022: Featuring Sanofi, Seagen, BioNTech, Context Therapeutics & Leadartis - ResearchAndMarkets.com

Retrieved on: 
Wednesday, January 11, 2023
Consumer, Health, Men, Clinical Trials, Oncology, Physical examination, Testicular cancer, News, Prednisone, Ageing, Tubulin, Survival rate, Prognosis, Route, Prostate cancer, Sanofi, European Medicines Agency, Complex, Microtubule, Cell cycle, II, Administration, BioNTech, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Cryptorchidism, Discovery, Epidemiology, Interphase, FDA, Cancer, SE, Knowledge, Carlos Roa, CLDN6, Route of administration, CAR, Risk, Metaphase, History, Food, Apoptosis, Therapy, Patient, RNA, Cabazitaxel, Clinical trial, EMA, Docetaxel, Dietary supplement, Vaccine, Pharmaceutical industry, Testicle

This "Testicular Cancer - Pipeline Insight, 2022" report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in Testicular Cancer pipeline landscape.

Key Points: 
  • This "Testicular Cancer - Pipeline Insight, 2022" report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in Testicular Cancer pipeline landscape.
  • Testicular cancer is one of the most common malignancies in men aged 15 to 45 years.
  • Complex environmental and genetic factors are involved in the development of testicular cancer; common risk factors include cryptorchidism, family history of testicular cancer, personal history of testicular cancer in the contralateral testis, age, and ethnicity.
  • Testicular Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

Exactech and JointMedica Announce First Hip Resurfacing Procedure with Polymotion® Hip Implant

Retrieved on: 
Tuesday, January 10, 2023
Technology, Surgery, Medical Devices, Other Technology, Health Technology, Software, Biotechnology, Health, General Health, McMinn, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pathology, Metal-insulator-metal, Surgeon, Food, Patient, FRCS, Acquisition, Multimedia, Invention, Powder metallurgy, Medical device, MD

Exactech , a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, is pleased to announce the first hip resurfacing surgery was successfully completed using the novel JointMedica Polymotion® hip implant that is based on a metal-on-polyethylene articulation.

Key Points: 
  • Exactech , a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, is pleased to announce the first hip resurfacing surgery was successfully completed using the novel JointMedica Polymotion® hip implant that is based on a metal-on-polyethylene articulation.
  • View the full release here: https://www.businesswire.com/news/home/20230110005732/en/
    Exactech and JointMedica Announce First Hip Resurfacing Procedure with Polymotion® Hip Implant (Photo: Business Wire)
    This surgery was performed by hip resurfacing specialist Jim MacKenzie, MD, in Calgary, Canada, who is also celebrating a milestone accomplishment of 20 years of completing hip resurfacing procedures.
  • The Polymotion hip implant addressed the unique pathology of the patient’s hip that could not be addressed with legacy, metal-on-metal hip resurfacing implants.
  • In fact, Sir John Charnley, the credited inventor of the modern total hip replacement, intuitively performed hip resurfacing in his initial cohort of hip arthritis patients [rather than total hip arthroplasty].

Can-Fite Submits Market Registration Plan to European Medicines Agency for Piclidenoson in the Treatment of Psoriasis; FDA Submission to Follow

Retrieved on: 
Tuesday, January 10, 2023
Managed Care, Biotechnology, Pharmaceutical, Health, Connective tissue disease, European Medicines Agency, CMC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, Institute of Liver and Biliary Sciences, FDA, Psoriasis, NYSE, Food, CSO, Patient, Cancer, Clinical trial, Chemistry, CANF, Phase, EMA, TASE, Pharmaceutical industry, Apremilast

A submission to the U.S. Food and Drug Administration (FDA) will follow.

Key Points: 
  • A submission to the U.S. Food and Drug Administration (FDA) will follow.
  • Registration plans for both the EMA and FDA include final efficacy and safety results from Can-Fite’s successful COMFORT™ Phase III study and the protocol for the Company’s upcoming Phase III pivotal trial together with a request for registration advice from the regulators.
  • Current chemistry, manufacturing, and controls (CMC), nonclinical data, and human pharmacokinetic data are also included.
  • “This submission represents an important step toward the pivotal Phase III study and subsequent marketing approval of Piclidenoson,” said Dr. Pnina Fishman, CEO & CSO of Can-Fite BioPharma.

Glaukos Announces Positive Clinical Updates for Several Corneal Health Pipeline Programs

Retrieved on: 
Tuesday, January 10, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Ilut, New Drug Application, Duane syndrome, Standard of care, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Keratoconus, Corporation, Safety, Dermis, FDA, Pilocarpine, Glaucoma, Eyelid, NYSE, NDA, Food, Patient, GKOS, DED, Eye, Retina, BID, Pharmaceutical industry, 1870 Glaukos

“These clinical updates represent meaningful milestones for two of our key Corneal Health pipeline programs and we look forward to continuing to advance both of these important programs forward in 2023,” said Thomas Burns, Glaukos chairman and chief executive officer.

Key Points: 
  • “These clinical updates represent meaningful milestones for two of our key Corneal Health pipeline programs and we look forward to continuing to advance both of these important programs forward in 2023,” said Thomas Burns, Glaukos chairman and chief executive officer.
  • Glaukos plans to randomize approximately 290 subjects in this trial and is targeting enrollment completion by the end of 2023.
  • Glaukos also announced promising topline results from its Phase 2a first-in-human clinical trial for GLK-301 (iLution – Dry Eye Disease (DED)) for the signs and symptoms of DED.
  • Based on these encouraging observations, Glaukos plans to advance GLK-301 into a Phase 2b clinical trial targeted to begin in 2023.

Lecanemab Receives Priority Review Status in Japan

Retrieved on: 
Monday, January 30, 2023
Disease, The New England Journal of Medicine, Alzheimer's disease, European Medicines Agency, PMDA, National Medical Products Administration, Amyloid beta, Priority review, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, MHLW, FDA, AD, Medication, Marketing, Pharmaceuticals and Medical Devices Agency, Food, Neurotoxicity, Medicines and Healthcare products Regulatory Agency, Eisai, BLA, Co-promotion, NMPA, Clarity, Phase, MAA, EMA, Pharmaceutical industry, Health, Biogen

Priority Review in Japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for Priority Review, the target total review period is shortened.

Key Points: 
  • Priority Review in Japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for Priority Review, the target total review period is shortened.
  • In Japan, Eisai submitted the manufacturing and marketing approval for lecanemab to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023.
  • Lecanemab selectively binds and eliminates soluble, toxic Abeta aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.

Eisai: Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer's Disease Accepted by European Medicines Agency

Retrieved on: 
Friday, January 27, 2023
Free agent, Brain, European Medicines Agency, PMDA, National Medical Products Administration, Amyloid beta, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, PMID, Medication, Pharmaceuticals and Medical Devices Agency, Food, Medicines and Healthcare products Regulatory Agency, BLA, Eisai, PLOS One, Co-promotion, NMPA, Phase, Alzheimer's disease, MAA, EMA, Pharmaceutical industry, Biogen

In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023.

Key Points: 
  • In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023.
  • On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway based on the results from the Phase III Clarity AD confirmatory study.
  • In Japan, Eisai submitted a marketing authorization application to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023.
  • In China, Eisai has initiated submission of data for a BLA to the National Medical Products Administration (NMPA) of China in December 2022.

Eisai Files Marketing Authorization Application for Anti-Amyloid-Beta Protofibril Antibody Lecanemab for Early Alzheimer's Disease in Japan

Retrieved on: 
Monday, January 16, 2023
PET, Brain, Brand, European Medicines Agency, PMDA, Headache, National Medical Products Administration, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, FDA, Superficial siderosis, AD, Siderosis, Medication, Pharmaceuticals and Medical Devices Agency, Food, Medicines and Healthcare products Regulatory Agency, BLA, Eisai, Co-promotion, NMPA, MCI, Clarity, ADCS, Phase, Alzheimer's disease, EMA, MAA, Medical imaging, Medical device, Pharmaceutical industry, Biogen

Prior to submitting this application, Eisai utilized the prior assessment consultation system of PMDA, with the aim of shortening the review period for lecanemab.

Key Points: 
  • Prior to submitting this application, Eisai utilized the prior assessment consultation system of PMDA, with the aim of shortening the review period for lecanemab.
  • On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway.
  • In Europe, Eisai submitted marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023.
  • Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer's Disease in Europe

Retrieved on: 
Wednesday, January 11, 2023
Memory, Problem solving, The New England Journal of Medicine, Alzheimer's disease, Brand, European Medicines Agency, Judgement, Headache, National Medical Products Administration, Amyloid beta, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BIIB, Hobby, FDA, Superficial siderosis, AD, Food, BLA, Co-promotion, NMPA, Clarity, Dementia, Phase, MAA, EMA, Orientation, Medical device, Pharmaceutical industry, Biogen, Eisai

In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023.

Key Points: 
  • In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023.
  • Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway on the same day.
  • In Japan, Eisai plans to submit a marketing authorization application by the end of Eisai's fiscal year 2022, which ends March 31, 2023.
  • Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

Eisai Submits Supplemental Biologics License Application to FDA for Traditional Approval of LEQEMBI (lecanemab-irmb) for the Treatment of Alzheimer's Disease

Retrieved on: 
Monday, January 9, 2023
Disease, The New England Journal of Medicine, Brain, National Medical Products Administration, Amyloid beta, Trial of the century, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pathology, FDA, AD, Accelerated approval (FDA), Marketing, Food, BLA, Plaque, Patient, File, Amyloid-related imaging abnormalities, ARIA, Co-promotion, NMPA, Immunoglobulin G, Medicine, Clarity, Incidence, Pharmaceutical industry, Biogen, Eisai, Alzheimer's disease, EU

This sBLA is subject to validation of whether the FDA accepts the application for review.

Key Points: 
  • This sBLA is subject to validation of whether the FDA accepts the application for review.
  • Treatment with LEQEMBI should only be initiated in patients with the mild cognitive impairment or mild dementia stage of disease and confirmed presence of Aβ pathology.
  • Accelerated Approval of LEQEMBI was based on Phase 2 data that demonstrated LEQEMBI reduced the accumulation of Aβ plaque in the brain, a defining feature of AD.
  • The sBLA for LEQEMBI is based on the data from the Phase 3 confirmatory Clarity AD clinical trial.