TRH

Orphan designation: rovatirelin Treatment of spinocerebellar ataxia, 11/11/2022 Positive

Retrieved on: 
Tuesday, April 9, 2024
Community, Civil service commission, Spinocerebellar ataxia, Diagnosis, Brain, Prevalence, Disease, BBB, Clinical, Locus coeruleus, Patient, Committee, Thyrotropin-releasing hormone, Spinocerebellar tract, Traffic barrier, EMA, IRIS, Neuron, TRH, Agency, European, COMP, European Commission, Marketing, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of spinocerebellar ataxia in the European Union on 11 November 2022.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • The full list of orphan designations is available in the Community register of orphan medicinal products for human use.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

Xeris Biopharma Announces Plans for a Phase II Dose-Finding Study for Its Investigational Subcutaneous (SC) Levothyroxine (XP-8121) as Replacement Therapy for Hypothyroidism

Retrieved on: 
Thursday, December 15, 2022
Health, FDA, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Hormone, Doctor of Pharmacy, Levothyroxine, Medical Affairs Bureau, Congenital hypothyroidism, Phase, Perception, Person, Food, Hypothalamus, TRH, Thyroid hormones, Patient, Communication, Type, Digestion, Hypothyroidism, Solubility, FDA, Neck, Absorption, Quality of life, COVID-19, Administration, Nature, Heart rate, Safety, Risk, Hypoglycemia, TSH, Food and Drug Administration Amendments Act of 2007, Temperature, Thyroid, Pharmaceutical industry

We received very productive feedback from the FDA on our proposed clinical plan for our once weekly subcutaneous levothyroxine and are in the process of clarifying some aspects of the Phase II and Phase III recommendations.

Key Points: 
  • We received very productive feedback from the FDA on our proposed clinical plan for our once weekly subcutaneous levothyroxine and are in the process of clarifying some aspects of the Phase II and Phase III recommendations.
  • We are excited to commence our Phase II dose-finding study of XP-8121 in 2023.
  • In October, Xeris reported positive topline Phase I data of XP-8121.
  • Hypothyroidism, or underactive thyroid, happens when your thyroid gland doesn't make enough thyroid hormones to meet your body's needs.

Xeris Biopharma Announces Positive Topline Phase 1 Clinical Data of Its Investigational Subcutaneous (SC) Levothyroxine (XP-8121); Hosts Conference Call and Webcast

Retrieved on: 
Thursday, October 20, 2022
Biotechnology, General Health, Health, Pharmaceutical, Clinical Trials, Thyroid hormones, LinkedIn, Doctor of Pharmacy, Hypothyroidism, Heart rate, TSH, Private Securities Litigation Reform Act, Hypothalamus, Solubility, Perception, Instagram, Congenital hypothyroidism, Administration, Hypoglycemia, Pharmacokinetics, CEO, Absorption, Hormone, Solution, Prescription, Quality of life, Communication, PO, Population, Person, Levothyroxine, Thyroid, Twitter, Access, Medical Affairs Bureau, Company, Industry, Nature, FDA, TRH, Neck, Volunteering, Technology, Temperature, AUC, Digestion, Risk, U.S. Securities and Exchange Commission, Webcast, Patient, SC, Nasdaq, Adult, Safety, Forward-looking statement, COVID-19, Pharmaceutical industry

The Phase 1 study was a randomized, open-label, crossover study conducted in 60 healthy adults.

Key Points: 
  • The Phase 1 study was a randomized, open-label, crossover study conducted in 60 healthy adults.
  • We have requested a meeting with the FDA and expect feedback by the end of the year.
  • We are very encouraged with the results of the Phase 1 study of XP-8121, our subcutaneous injection of levothyroxine.
  • Xeris will host a conference call and webcast today, Thursday, October 20, 2022, at 8:30 a.m. Eastern Time.

Quantum Genomics (ALQGC): Initiation — A fresh take on cardiovascular medicine

Retrieved on: 
Wednesday, August 31, 2022
Genomics, NDA, NPV, Research, FDA, Pharmaceutical industry, Thomas Edison, TRH

Quantum Genomics is focused on the development of new classes of cardiovascular medicines.

Key Points: 
  • Quantum Genomics is focused on the development of new classes of cardiovascular medicines.
  • We value Quantum Genomics at 701.3m or 20.3 per share, with 92% of this attributable to firibastat in TRH.
  • In the near term, readouts from two Phase III trials in TRH are the main catalyst for the company.
  • In our view, firibastats unique mechanism of action offers the potential for significant differentiation in the sizeable cardiovascular drug market.

Heart Failure Pipeline Research Report 2021: Comprehensive Insights on 100+ Companies & Respective Pipeline Drugs - ResearchAndMarkets.com

Retrieved on: 
Wednesday, August 11, 2021
Pharmaceutical, Health, Cardiology, LICA, TRH, Heart, Therapy, News, Patient, Route of administration, Angiotensin, Heart failure, Clinical trial, Kidney, Finerenone, Bayer, BAY, Discovery, Route, II, III, MRA, Blood pressure, ROA, Administration, Medical device, Pharmaceutical industry

This Heart failure - Pipeline Insight, 2021 provides comprehensive insights for approx 100+ companies and 100+ pipeline drugs in Heart failure pipeline landscape.

Key Points: 
  • This Heart failure - Pipeline Insight, 2021 provides comprehensive insights for approx 100+ companies and 100+ pipeline drugs in Heart failure pipeline landscape.
  • The companies and academics are working to assess challenges and seek opportunities that could influence Heart failure R&D.
  • This segment of the report provides insights about the different Heart failure drugs segregated based on following parameters that define the scope of the report, such as:
    There are approx.
  • Heart failure pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.