Laryngeal papillomatosis

Orphan designation: Gorilla adenovirus vector expressing HPV6 and HPV11 antigens Treatment of recurrent respiratory papillomatosis, 12/01/2024 Positive

Retrieved on: 
Thursday, April 18, 2024

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of recurrent respiratory papillomatosis on 12 January 2024.
  • Orphan designation does not mean the medicine is available or authorised for use.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • 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:

Orphan designation: doruxapapogene ralaplasmid Treatment of recurrent respiratory papillomatosis, 22/05/2023 Positive

Retrieved on: 
Sunday, February 4, 2024

EU/3/23/2785 - orphan designation for treatment of recurrent respiratory papillomatosis

Key Points: 
  • EU/3/23/2785 - orphan designation for treatment of recurrent respiratory papillomatosis
    doruxapapogene ralaplasmid
    OrphanHuman
    PHARA
    For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
    European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
  • The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:
    EMA list of opinions on orphan medicinal product designation
    EMA publishes information on orphan medicinal product designation adopted by the Committee for Orphan Medicinal Products (COMP) on the IRIS online platform:

Whispp to Debut New Real-Time Assistive Voice Technology, Helping Millions with Voice Disabilities Speak in Their Natural Voice

Retrieved on: 
Wednesday, December 6, 2023

LEIDEN, Netherlands, Dec. 6, 2023 /PRNewswire-PRWeb/ -- Whispp, an AI-powered assistive speech and phone-calling app, today announced plans to debut its newest phone-calling feature that seamlessly converts whispered and vocal cord-impaired speech into a user's healthy, natural voice in real-time at the 2024 Consumer Electronics Show (CES). A 2024 CES Innovation Award honoree in the Accessibility and Aging Tech category, Whispp will showcase its technology at CES Unveiled Las Vegas on Sunday evening, January 7, 2024, and as part of the NL Tech Pavilion in Eureka Park at the Venetian Expo, Booth 62100 from January 9 - 12, 2024. View a short video about Whispp here.

Key Points: 
  • "Voice disabilities and speech disorders like stuttering significantly impact a person's life and happiness," said Whispp founder and CEO Joris Castermans.
  • "Whispp isn't just transforming voices; it's advancing communication by making it accessible to all and enhancing quality of life."
  • "Voice disabilities and speech disorders like stuttering significantly impact a person's life and happiness," said Whispp co-founder and CEO Joris Castermans.
  • Unlike conventional speech-to-text (STT) approaches with noticeable latency and an uneven conversational flow, Whispp provides real-time speech conversion, eliminating barriers to natural communication.

Europe Human Papillomavirus Vaccine Market Report 2022: Growing Number of HPV Awareness Programs Presents Opportunities - ResearchAndMarkets.com

Retrieved on: 
Thursday, January 26, 2023

The Europe human papillomavirus (HPV) vaccine market is expected to grow at a good CAGR during the forecast period.

Key Points: 
  • The Europe human papillomavirus (HPV) vaccine market is expected to grow at a good CAGR during the forecast period.
  • The Europe human papillomavirus (HPV) vaccine market is segmented based on type, dosage, age, application, end user, and country.
  • Based on type, the Europe human papillomavirus (HPV) vaccine market is segmented into 9-valent HPV vaccine, quadrivalent HPV vaccine, and bivalent HPV vaccine.
  • Ltd; Vaccitech; and Walvax Biotechnology Co., Ltd. are among the leading companies in the Europe human papillomavirus (HPV) vaccine market.

Europe Human Papillomavirus Vaccine Market Report 2022: Sector to Reach $1.59 Billion by 2028 at a 4.9% CAGR

Retrieved on: 
Friday, January 27, 2023

The Europe human papillomavirus (HPV) vaccine market is expected to grow at a good CAGR during the forecast period.

Key Points: 
  • The Europe human papillomavirus (HPV) vaccine market is expected to grow at a good CAGR during the forecast period.
  • The Europe human papillomavirus (HPV) vaccine market is segmented based on type, dosage, age, application, end user, and country.
  • Based on type, the Europe human papillomavirus (HPV) vaccine market is segmented into 9-valent HPV vaccine, quadrivalent HPV vaccine, and bivalent HPV vaccine.
  • Ltd; Vaccitech; and Walvax Biotechnology Co., Ltd. are among the leading companies in the Europe human papillomavirus (HPV) vaccine market.

Precigen Receives FDA Orphan Drug Designation for PRGN-2012 AdenoVerse™ Immunotherapy in Patients with Recurrent Respiratory Papillomatosis (RRP)

Retrieved on: 
Thursday, March 18, 2021

In January 2021, Precigen announced the clearance of the IND to Initiate a Phase I study of PRGN-2012 AdenoVerse immunotherapy in adult patients with RRP (clinical trial identifier: NCT04724980 ).

Key Points: 
  • In January 2021, Precigen announced the clearance of the IND to Initiate a Phase I study of PRGN-2012 AdenoVerse immunotherapy in adult patients with RRP (clinical trial identifier: NCT04724980 ).
  • Orphan drug designation is granted by the FDA to drugs intended to treat rare diseases or disorders that affect fewer than 200,000 people in the US.
  • "As the first regulatory designation for our proprietary AdenoVerse platform, this orphan drug designation will help to advance PRGN-2012 with important incentives that support delivery of this medicine as rapidly as possible to patients suffering from RRP."
  • "Human papillomavirus infection in papillomas and nondiseased respiratory sites of patients with recurrent respiratory papillomatosis using the polymerase chain reaction."

Precigen Announces Clearance of IND to Initiate Phase I Study of PRGN-2012 AdenoVerse™ Immunotherapy in Patients with Recurrent Respiratory Papillomatosis (RRP)

Retrieved on: 
Tuesday, January 5, 2021

ThePhase I study will follow 3+3 dose escalation of PRGN-2012 as an adjuvant immunotherapy following standard-of-care surgical removal of visible papillomatosis disease.

Key Points: 
  • ThePhase I study will follow 3+3 dose escalation of PRGN-2012 as an adjuvant immunotherapy following standard-of-care surgical removal of visible papillomatosis disease.
  • The primary objective of the study is to determine safety and tolerability and recommended Phase II dose (RP2D) of PRGN-2012.
  • The study will enroll 3 to 6 subjects at each dose level, and 12 patients will be treated at the maximum tolerated dose.
  • "Human papillomavirus infection in papillomas and nondiseased respiratory sites of patients with recurrent respiratory papillomatosis using the polymerase chain reaction."

INOVIO Receives Orphan Drug Designation From U.S. FDA for DNA Medicine INO-3107 To Treat Rare Disease Recurrent Respiratory Papillomatosis (RRP)

Retrieved on: 
Wednesday, July 29, 2020

PLYMOUTH MEETING, Pa., July 29, 2020 /PRNewswire/ --INOVIO (NASDAQ: INO) today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation for INO-3107, its DNA medicine being evaluated in a Phase 1/2 trial for treatment of recurrent respiratory papillomatosis (RRP).

Key Points: 
  • PLYMOUTH MEETING, Pa., July 29, 2020 /PRNewswire/ --INOVIO (NASDAQ: INO) today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation for INO-3107, its DNA medicine being evaluated in a Phase 1/2 trial for treatment of recurrent respiratory papillomatosis (RRP).
  • Orphan drug designation is intended to advance drug development for rare diseases.
  • FDA grants orphan drug status to medicines intended for the prevention, diagnosis, and treatment of rare diseases or conditions.
  • In the United States, an orphan disease is defined as a disease or condition with a prevalence of less than 200,000 patients in the United States annually.