PRES

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 2024

Retrieved on: 
Sunday, February 4, 2024
Civil service commission, Pneumonia, Febrile neutropenia, Eli Lilly, Triprolidine, International, Bacteria, Schizophrenia, Myelopathy, Incidence, ALD, Cefepime, Allergic rhinitis, Nasal congestion, Neutrophil, Agency, COMP, Fever, HAP, EEIG, Headache, Static pressure, Medicine, Committee, Conditional, Spinal cord, Hospital-acquired pneumonia, PTC, Neutropenia, Public, CHMP, European, AMD, Patient, Diagnosis, Marketing, RCVS, European Commission, Brain, Disease, Infection, Inflammation, Male, PRES, PRAC, Pain, Pyelonephritis, Urinary tract infection, VAP, Ageing, EMA, Geographic atrophy, Adrenoleukodystrophy, Therapy, News, INN, Duchenne muscular dystrophy, Common, Fungal infection, Vaccine

Three new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended three medicines for approval at its January 2024 meeting.The committee recommended…, Positive recommendations on new medicines, Exblifep International non-proprietary name (INN)cefepime / enmetazobactam Marketing-authorisation applicantAdvanz Pharma LimitedTherapeutic indicationTreatment of: 1)…, Ryzneuta INNefbemalenograstim alfaMarketing-authorisation applicantEvive Biotechnology Ireland LimitedTherapeutic indicationReduction in the duration of neutropenia and…, Positive recommendations on new generic medicines, Niapelf INNpaliperidoneMarketing-authorisation applicantNeuraxpharm Pharmaceuticals S.L.Therapeutic indicationTreatment of schizophreniaMore informationNiapelf: Pending…, Negative recommendations on new medicines, Nezglyal INNleriglitazoneMarketing-authorisation applicantMinoryx Therapeutics S.L.Therapeutic indicationTreatment of cerebral progression and myelopathy in male…, Syfovre INNpegcetacoplanMarketing-authorisation applicantApellis Netherlands B.V.Therapeutic indicationTreatment of geographic atrophy (GA) secondary to age-related…, Positive recommendations on extensions of indications, Abecma INNidecabtagene vicleucel Marketing-authorisation holderBristol-Myers Squibb Pharma EEIGMore informationAbecma: Pending EC decision, Prevenar 20 (previously Apexxnar) Common namepneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)Marketing-authorisation holderPfizer Europe MA EEIGMore…, Aspaveli INNpegcetacoplanMarketing-authorisation holderSwedish Orphan Biovitrum AB (publ)More informationAspaveli: Pending EC decision, Retsevmo INNselpercatinibMarketing-authorisation holderEli Lilly Nederland B.V.More informationRetsevmo: Pending EC decision, Outcome of re-examination of recommendation on non-renewal of Conditional Marketing Authorisation, Translarna INNataluren Marketing-authorisation holderPTC Therapeutics International LimitedNewsEMA confirms recommendation for non-renewal of authorisation of Duchenne…, Outcome of referral, Pseudoephedrine Marketing-authorisation holderVarious companiesMore informationPseudoephedrine-containing medicinal products, Re-examination of conclusion of referral, Synapse Labs Pvt.

Key Points: 
  • Three new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended three medicines for approval at its January 2024 meeting.The committee recommended…, Positive recommendations on new medicines, Exblifep International non-proprietary name (INN)cefepime / enmetazobactam Marketing-authorisation applicantAdvanz Pharma LimitedTherapeutic indicationTreatment of: 1)…, Ryzneuta INNefbemalenograstim alfaMarketing-authorisation applicantEvive Biotechnology Ireland LimitedTherapeutic indicationReduction in the duration of neutropenia and…, Positive recommendations on new generic medicines, Niapelf INNpaliperidoneMarketing-authorisation applicantNeuraxpharm Pharmaceuticals S.L.Therapeutic indicationTreatment of schizophreniaMore informationNiapelf: Pending…, Negative recommendations on new medicines, Nezglyal INNleriglitazoneMarketing-authorisation applicantMinoryx Therapeutics S.L.Therapeutic indicationTreatment of cerebral progression and myelopathy in male…, Syfovre INNpegcetacoplanMarketing-authorisation applicantApellis Netherlands B.V.Therapeutic indicationTreatment of geographic atrophy (GA) secondary to age-related…, Positive recommendations on extensions of indications, Abecma INNidecabtagene vicleucel Marketing-authorisation holderBristol-Myers Squibb Pharma EEIGMore informationAbecma: Pending EC decision, Prevenar 20 (previously Apexxnar) Common namepneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)Marketing-authorisation holderPfizer Europe MA EEIGMore…, Aspaveli INNpegcetacoplanMarketing-authorisation holderSwedish Orphan Biovitrum AB (publ)More informationAspaveli: Pending EC decision, Retsevmo INNselpercatinibMarketing-authorisation holderEli Lilly Nederland B.V.More informationRetsevmo: Pending EC decision, Outcome of re-examination of recommendation on non-renewal of Conditional Marketing Authorisation, Translarna INNataluren Marketing-authorisation holderPTC Therapeutics International LimitedNewsEMA confirms recommendation for non-renewal of authorisation of Duchenne…, Outcome of referral, Pseudoephedrine Marketing-authorisation holderVarious companiesMore informationPseudoephedrine-containing medicinal products, Re-examination of conclusion of referral, Synapse Labs Pvt.
  • Ltd. Marketing-authorisation holderVarious companiesMore informationSynapse

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2023

Retrieved on: 
Monday, December 18, 2023
Medicine, Vomiting, Brain, Liraglutide, European Commission, Pseudoephedrine, Semaglutide, RCVS, PRES, Headache, Dulaglutide, Allergy, Kidney disease, State, EMA, Civil service commission, Signal, Patient, DSM-IV codes, Exenatide, Association, RMP, Vaccine, CHMP, Reversible cerebral vasoconstriction syndrome, Marketing, Data, COVID-19, Seizure, Diagnosis, Communication, Direct, Health care, Review, Failure, PRAC, Confusion, Public, Pharmaceutical industry, Hospital, Dietary supplement, Medical device, Safety

EMA’s safety committee, PRAC, has recommended new measures for medicines containing pseudoephedrine to minimise the risks of posterior reversible encephalopathy syndrome (PRES)…, Agenda Agenda of the PRAC meeting 27-30 November 2023DraftFirst published: 27/11/2023Reference Number: EMA/PRAC/477373/2023…, PRAC statistics: December 2023, Glossary:Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between a medicine…, Ongoing referralsProcedureStatusUpdateHydroxyprogesterone-containing medicinal products – Article-31 referralUnder evaluationPRAC continued its assessment

Key Points: 


EMA’s safety committee, PRAC, has recommended new measures for medicines containing pseudoephedrine to minimise the risks of posterior reversible encephalopathy syndrome (PRES)…, Agenda Agenda of the PRAC meeting 27-30 November 2023DraftFirst published: 27/11/2023Reference Number: EMA/PRAC/477373/2023…, PRAC statistics: December 2023, Glossary:Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between a medicine…, Ongoing referralsProcedureStatusUpdateHydroxyprogesterone-containing medicinal products – Article-31 referralUnder evaluationPRAC continued its assessment

VEGZELMA® (bevacizumab-adcd) receives preferred formulary status with Ventegra® for commercially insured patients

Retrieved on: 
Monday, December 11, 2023
Urine, Reproduction, Skeleton, Headache, PSA, Kidney, Erythroderma, Patient, Pharmacy, Birth, Nephrotic syndrome, MBA, Cancer, Miscarriage, Safety, Incidence, VTE, Bevacizumab, Corneal opacity, Wound healing, VEGFR2, Gastrointestinal perforation, Hemoptysis, Female, Fetus, CHF, Celltrion, Pharming, Necrotizing fasciitis, Heart failure, Fistula, Risk, Tracheoesophageal fistula, Bleeding, Organogenesis, Partnership, Rhinitis, Hypertension, Primary ovarian insufficiency, Back pain, Pregnancy, Glioblastoma, PRES, Nosebleed, Skull, FDA, ATE, VEGF, MBM, Hypertensive encephalopathy, Toxicity, Nursing, Pharmaceutical industry, Birth control, Dietary supplement, Proteinuria

Ventegra's proprietary formulary program (which includes Formulary Shield and the Ventegra Specialty Inclusion Program) is available for access by more than 400 clients and 13 million members/patients that are enrolled with Ventegra.

Key Points: 
  • Ventegra's proprietary formulary program (which includes Formulary Shield and the Ventegra Specialty Inclusion Program) is available for access by more than 400 clients and 13 million members/patients that are enrolled with Ventegra.
  • Gastrointestinal Perforations and Fistula: Discontinue for gastrointestinal perforations, tracheoesophageal fistula, grade 4 fistula, or fistula formation involving any organ.
  • Surgery and Wound Healing Complications: In patients who experience wound healing complications during VEGZELMA treatment, withhold VEGZELMA until adequate wound healing.
  • Do not administer VEGZELMA for at least 28 days following a major surgery, and until adequate wound healing.

Akari Therapeutics Announces Presentation of a Case Study from Phase 3 Part A Clinical Trial of Nomacopan in Pediatric HSCT-TMA as a Late-Breaker at The Transplantation & Cellular Therapy Tandem Meetings

Retrieved on: 
Tuesday, February 21, 2023
DSM-IV codes, Royal Manchester Children's Hospital, AML, PRES, CH50, Thrombocytopenia, Hope, HSCT, Viremia, LTB4, Diagnosis, Leukotriene B4, NHS foundation trust, Thrombotic microangiopathy, Maintenance, GVHD, Division, Hematopoietic stem cell transplantation, Patient, Hospital, Clinical trial, Inflammation, Center for International Blood and Marrow Transplant Research, TMA, University, Research, Therapy, Male, Hypertension, TCA, Death, University of Manchester, Thiotepa, End organ damage, Manchester University NHS Foundation Trust, Cytomegalovirus, System, Transplant, Society, Syndrome, Hot game, Rosenthal, CMV, Pharmaceutical industry, Dentistry, Pediatrics

The case study, Clinical Response to Nomacopan in the Pediatric HSCT-TMA Setting, was presented on Thursday February 16, at 5:45 pm ET at the Transplantation & Cellular Therapy Tandem Meetings in Orlando, Florida.

Key Points: 
  • The case study, Clinical Response to Nomacopan in the Pediatric HSCT-TMA Setting, was presented on Thursday February 16, at 5:45 pm ET at the Transplantation & Cellular Therapy Tandem Meetings in Orlando, Florida.
  • The patient received 7 granulocyte infusions peri-transplant as part of an experimental protocol to augment the graft-versus-leukemia effect.
  • His immediate post-transplant course was complicated by engraftment syndrome, acute gut graft-versus-host disease (GVHD) grade 3 and cytomegalovirus (CMV) viraemia.
  • Nomacopan was stopped for 3 days and restarted after the diagnosis was deemed to be unrelated to nomacopan treatment.

BOTS, Inc. Opens President Trump Coin $Pres to Ownership on the Binance Smart Chain and Trading on the Popular Decentralized Exchange, Pancakeswap

Retrieved on: 
Monday, October 25, 2021
Omni, President Trump, President Clinton, Bitcoin, Digital, Big Tech, Republican National Committee, Trump, ISO/IEC 27001:2013, Twitter, NEWS, Bitcoin ATM, Insurance, SPAC, BOTS, Public policy, PRES, Republican, Life, Social media, COIN, DWAC, Company, Forward-looking statement, OTC, CNBC, Solution, Bloomberg, Roman Catholic Diocese of La Crosse, Acquisition, The Company, Wanderland, GLOBE, Mining, Investment Technology Group, Cryptocurrency, Public relations, Financial services, Video game, Security (finance)

Current owners of $PRES on the Omni and potential crypto traders may find information about President Trump (COIN: PRES) on the Binance Smart Chain Explorer here:

Key Points: 
  • Current owners of $PRES on the Omni and potential crypto traders may find information about President Trump (COIN: PRES) on the Binance Smart Chain Explorer here:
    The historically commemorative $PRES coin was first listed on CoinMarketCap before the 2016 elections.
  • Those who wish to swap out their Omni $PRES for Binance, $PRES, should contact [email protected] for further instructions.
  • Trump has managed to gain access to hundreds of millions of dollars to launch a social media company through a SPAC bearing the symbol DWAC.
  • New York Times article "Trump Takes Advantage of Wall Street Fad to Bankroll New Venture" described the deal.

Astellas Receives Positive CHMP Opinion for XTANDI® (enzalutamide) for Adult Men with High-Risk Non-Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
Monday, September 24, 2018
Chemistry, Organic chemistry, Prostate cancer, Progonadotropins, Cancer, Nitriles, Nonsteroidal antiandrogens, Lactams, Enzalutamide, Androgen receptor, PRES, Posterior reversible encephalopathy syndrome

About XTANDI (enzalutamide) capsules in the U.S.

Key Points: 
  • About XTANDI (enzalutamide) capsules in the U.S.
    XTANDI (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with castration-resistant prostate cancer.
  • Important Safety Information for XTANDI in the U.S.
    Seizureoccurred in 0.4% of patients receiving XTANDI in clinical studies.
  • Posterior Reversible Encephalopathy Syndrome (PRES)In post approval use, there have been reports of PRES in patients receiving XTANDI.
  • Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in clinical trials.