Drug Safety

Introduction to Veterinary Pharmacovigilance: Training Course for Those Working on Drug Safety in the EU (London, United Kingdom - November 5-6, 2019) - ResearchAndMarkets.com

Retrieved on: 
Tuesday, October 15, 2019

A basic training course for those working on drug safety in the EU.

Key Points: 
  • A basic training course for those working on drug safety in the EU.
  • This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance.
  • This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance.
  • New entrants and support staff, as well as experienced personnel who require a better understanding of veterinary drug safety, will benefit from the practical guidance provided.

FDAnews Announces -- Labeling for Prescription Drugs, Biologics and Combination Products:Complying with FDA's Most Recent IFU Guidance Webinar, Oct. 29, 2019

Retrieved on: 
Tuesday, October 15, 2019

What implications does the recent Instructions for Use (IFU) guidance have on new drug applications and biologics license applications?

Key Points: 
  • What implications does the recent Instructions for Use (IFU) guidance have on new drug applications and biologics license applications?
  • How will the current content and format for IFUs need to be modified?
  • a partner and leader of the Food & Drug Practice Team of Arnall Golden Gregory LLP will clarify the new guidance and explain how to comply with it.
  • Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
    to learn about our special multisite discount.

ONL Therapeutics Announces First-In-Human Clinical Study with ONL1204

Retrieved on: 
Tuesday, October 8, 2019

The study is being conducted in Australia at leading clinical research centers in Sydney and Melbourne.

Key Points: 
  • The study is being conducted in Australia at leading clinical research centers in Sydney and Melbourne.
  • The study will assess four different doses of ONL1204 and is designed to demonstrate safety and tolerability of the investigational drug in patients with a macula-off rhegmatogenous retinal detachment (RRD).
  • Today marks a major milestone in the history of ONL Therapeutics as we transition into a clinical-stage pharmaceutical company, commented David Zacks, MD, PhD, Founder and Chief Scientific Officer of ONL Therapeutics.
  • ONL Therapeutics (ONL) is a clinical-stage biopharmaceutical company committed to protecting and improving the vision of patients with retinal disease.

Intersect ENT Announces Results From the ASCEND Study of Company’s Investigational Drug-Coated Balloon for Sinus Dilation

Retrieved on: 
Monday, October 7, 2019

Intersect ENT, Inc. (NASDAQ: XENT), a company dedicated to transforming care for patients with ear, nose and throat conditions, today announced results from a study of the companys ASCEND investigational drug-coated sinus balloon.

Key Points: 
  • Intersect ENT, Inc. (NASDAQ: XENT), a company dedicated to transforming care for patients with ear, nose and throat conditions, today announced results from a study of the companys ASCEND investigational drug-coated sinus balloon.
  • The ASCEND study is the first prospective, randomized, double-blind, multi-center trial designed to assess the safety and efficacy of Intersect ENTs drug-coated sinus balloon used to dilate the frontal sinus ostium.
  • We look forward to assessing the results of the study more extensively with our fellow clinical investigators and Intersect ENT.
  • The ASCEND drug-coated sinus balloon is an investigational product and is limited by federal law to investigational use only.

The Walt Disney Company Announces Expiration and Final Results of Tender Offers by The Walt Disney Company and 21st Century Fox America, Inc.

Retrieved on: 
Tuesday, October 1, 2019

The Tender Offers expired at 11:59 p.m., New York City time, on September 30, 2019 (the Expiration Date) and no tenders submitted after the Expiration Date are valid.

Key Points: 
  • The Tender Offers expired at 11:59 p.m., New York City time, on September 30, 2019 (the Expiration Date) and no tenders submitted after the Expiration Date are valid.
  • The Tender Offers were subject to the satisfaction of certain conditions as set forth in the Offer to Purchase (as defined below), all of which have been satisfied as of the Expiration Date.
  • The early results and pricing information of the Tender Offers were previously announced in the press releases dated September 17, 2019.
  • The table below identifies the principal amount of each Series of Tender Notes validly tendered and not validly withdrawn and accepted for purchase as of the Expiration Date.

Global Shelf-life Testing Market to Grow from $3.41 Billion in 2018 to $7.1 Billion by 2027, at a CAGR of 8.5%

Retrieved on: 
Friday, September 27, 2019

Dublin, Sept. 27, 2019 (GLOBE NEWSWIRE) -- The "Shelf-life Testing - Global Market Outlook (2018-2027)" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • Dublin, Sept. 27, 2019 (GLOBE NEWSWIRE) -- The "Shelf-life Testing - Global Market Outlook (2018-2027)" report has been added to ResearchAndMarkets.com's offering.
  • The Global Shelf-life Testing market accounted for $3.41 billion in 2018 and is expected to reach $7.1 billion by 2027 growing at a CAGR of 8.5% during the forecast period.
  • Moreover, the Advancement of novel technologies and approach to track the untapped markets by prominent manufacturers is providing opportunities for market growth.
  • However, lack of standardization and improper regulations in developing countries is one of the restraining factors for the market.

Global Shelf-life Testing Market Outlook Report, 2018-2027 - Analysis on Rancidity, Organoleptic Properties, Nutrient Stability, Microbial Contamination, and Other Parameters - ResearchAndMarkets.com

Retrieved on: 
Friday, September 27, 2019

The "Shelf-life Testing - Global Market Outlook (2018-2027)" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Shelf-life Testing - Global Market Outlook (2018-2027)" report has been added to ResearchAndMarkets.com's offering.
  • The Global Shelf-life Testing market accounted for $3.41 billion in 2018 and is expected to reach $7.1 billion by 2027 growing at a CAGR of 8.5% during the forecast period.
  • Moreover, the Advancement of novel technologies and approach to track the untapped markets by prominent manufacturers is providing opportunities for market growth.
  • However, lack of standardization and improper regulations in developing countries is one of the restraining factors for the market.

IntelGenx Announces Resubmission of RIZAPORT® New Drug Application

Retrieved on: 
Thursday, September 26, 2019

SAINT LAURENT, Quebec, Sept. 26, 2019 (GLOBE NEWSWIRE) -- IntelGenx Corp.(TSX-V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx"), a leader in pharmaceutical films, today announced that it has resubmitted its 505(b)(2) New Drug Application (NDA) for RIZAPORT VersaFilm for the treatment of acute migraines to the U.S. Food and Drug Administration (FDA).

Key Points: 
  • SAINT LAURENT, Quebec, Sept. 26, 2019 (GLOBE NEWSWIRE) -- IntelGenx Corp.(TSX-V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx"), a leader in pharmaceutical films, today announced that it has resubmitted its 505(b)(2) New Drug Application (NDA) for RIZAPORT VersaFilm for the treatment of acute migraines to the U.S. Food and Drug Administration (FDA).
  • The issues cited in the CRL relate to the Chemistry, Manufacturing and Controls section of the application.
  • IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.
  • Each of the TSX Venture Exchange and OTCQX has neither approved nor disapproved the contents of this press release.

Rosemarie Riddell Bogdan, Esq. Appointed to Plaintiffs' Steering Committee in National Valsartan NDMA Products Liability Litigation

Retrieved on: 
Wednesday, September 25, 2019

NISKAYUNA, N.Y., Sept. 25, 2019 /PRNewswire-PRWeb/ -- On May 6th, 2019, Martin, Harding & Mazzotti, LLP partner, RosemarieRiddell Bogdan , was appointed to a leadership position on the Plaintiffs' Personal Injury Steering Committee in the National Valsartan NDMA contamination litigation (IN RE: Valsartan Products Liability Litigation, MDL No.

Key Points: 
  • NISKAYUNA, N.Y., Sept. 25, 2019 /PRNewswire-PRWeb/ -- On May 6th, 2019, Martin, Harding & Mazzotti, LLP partner, RosemarieRiddell Bogdan , was appointed to a leadership position on the Plaintiffs' Personal Injury Steering Committee in the National Valsartan NDMA contamination litigation (IN RE: Valsartan Products Liability Litigation, MDL No.
  • The IN RE: Valsartan Products Liability Litigation, MDL No.
  • 2875centers around the FDA recalls of Valsartan which began in July of 2018 and have continued throughout 2019.
  • On February 14, 2019, the Judicial Panel on Multidistrict Litigation (JPML) issued a transfer order consolidating valsartan products liability lawsuits in the District of New Jersey.

Tarsius Pharma Announces FDA Acceptance of IND Application for TRS01

Retrieved on: 
Tuesday, September 24, 2019

TEL-AVIV, Israel, Sept. 24, 2019 /PRNewswire/ -- Tarsius Pharma today announced the acceptance of its Investigational New Drug (IND) application for TRS01 by the U.S. Food and Drug Administration (FDA).

Key Points: 
  • TEL-AVIV, Israel, Sept. 24, 2019 /PRNewswire/ -- Tarsius Pharma today announced the acceptance of its Investigational New Drug (IND) application for TRS01 by the U.S. Food and Drug Administration (FDA).
  • TRS was developed to 're-engineer' the immune system, and approaches inflammatory diseases from within the system.
  • This IND acceptance will enable Tarsius to initiate enrollment in its planned Phase I/II clinical trial of TRS01.
  • This study is designed to determine the safety profile of TRS01, the recommended dose, and preliminary evaluation of the potential effect of TRS01 in ocular inflammation.