Drug Safety

CrazyMothers to Host November 14 Event on National Mall to Honor Unsung Victims of Vaccine Injury

Wednesday, November 13, 2019 - 9:34pm

Thousands will gather on the National Mall on November 14 to raise awareness for vaccine injury and honor those whose lives have been impacted by vaccine reactions, injury and death.

Key Points: 
  • Thousands will gather on the National Mall on November 14 to raise awareness for vaccine injury and honor those whose lives have been impacted by vaccine reactions, injury and death.
  • The event marks the day that the National Childhood Vaccine Injury Act (NCVIA) was enacted 33 years ago, ultimately removing manufacturer liability for vaccine injury and death and creating a government compensation program for those affected.
  • Organized by CrazyMothers, a nonprofit advocacy group, the event seeks to honor those whose lives have been harmed by government-licensed and recommended vaccines.
  • is twofold: to illustrate that vaccine injury is prevalent not one in a million as is commonly cited and to give a voice to the voiceless.

Children's Health Advocates Gather to Demand Truth and Justice for the Vaccine-Injured

Tuesday, November 12, 2019 - 12:00pm

The rally on Nov. 14th will spotlight the devastating impact NCVIA has had upon the state of children's health.

Key Points: 
  • The rally on Nov. 14th will spotlight the devastating impact NCVIA has had upon the state of children's health.
  • RFK, Jr. will address the ramifications of NCVIA and honor those whose lives have been forever changed by vaccines.
  • "There is no crisis more urgent than the epidemics of chronic health conditions among our nation's children."
  • The Department of Justice and the NVICP are accused of fraud and obstruction of justice in the Autism Omnibus Proceeding.

MabPlex Congratulates Encure Biopharma with FDA IND Clearance of YH001 for the Treatment of a Broad Range of Cancers

Monday, November 11, 2019 - 9:30am

MabPlex also assisted Encure in submitting an Investigational New Drug application (IND) to the United States Food and Drug Administration (FDA) and confirmed that the FDA has cleared Encure's IND application.

Key Points: 
  • MabPlex also assisted Encure in submitting an Investigational New Drug application (IND) to the United States Food and Drug Administration (FDA) and confirmed that the FDA has cleared Encure's IND application.
  • This approval is the third FDA IND application MabPlex has secured for its clients in 2019.
  • MabPlex led the IND filing on behalf of Encure, for the company's lead drug candidate, YH001, an innovative, proprietary, antibody-based drug molecule with an initial indication for the treatment of cancer.
  • As a fully integrated international CDMO service provider, MabPlex has been able to help Encure to successfully secure a U.S. FDA IND for the company's YH001 Project.

Audentes Therapeutics Reports Third Quarter 2019 Financial Results and Provides Corporate Update

Thursday, November 7, 2019 - 9:01pm

Presented positive data from the ASPIRO dose escalation cohorts at the 24th International Annual Congress of the World Muscle Society.

Key Points: 
  • Presented positive data from the ASPIRO dose escalation cohorts at the 24th International Annual Congress of the World Muscle Society.
  • Submitted a US Investigational New Drug application (IND) for AT845 in the third quarter of 2019; application is currently undergoing review with the U.S. Food & Drug Administration (FDA).
  • At 4:30 p.m. Eastern Time today, Audentes management will host a conference call and a simultaneous webcast to discuss its third quarter 2019 financial results and provide a corporate update.
  • Audentes Therapeutics (Nasdaq: BOLD) is a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases.

Global Over-the-Counter (OTC) Drugs and Dietary Supplements Market Opportunities, 2025 - Focus on Consumer Goods Distributors

Wednesday, October 30, 2019 - 6:45pm

DUBLIN, Oct. 30, 2019 /PRNewswire/ -- The "Over-the-Counter (OTC) Drugs and Dietary Supplements: Opportunities for Consumer Goods Distributors" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Oct. 30, 2019 /PRNewswire/ -- The "Over-the-Counter (OTC) Drugs and Dietary Supplements: Opportunities for Consumer Goods Distributors" report has been added to ResearchAndMarkets.com's offering.
  • Over-the-counter (OTC) drugs and dietary supplements will change the landscape of primary healthcare in the coming years.
  • Stakeholders in the healthcare industry understand the benefits of self-care and the importance of making drugs for minor illness available without a prescription.
  • Some nations have allowed self-selection of drugs for common illnesses such as low-grade fever, headache, cough and cold, and digestive issues.

Tetra Bio-Pharma Provides Management Update on Tetra Natural Health’s Commercial Activities

Wednesday, October 30, 2019 - 12:00pm

The portfolio of OTC drug products that Tetra is preparing to commercialize are at an advanced stage (i.e., DIN submission).

Key Points: 
  • The portfolio of OTC drug products that Tetra is preparing to commercialize are at an advanced stage (i.e., DIN submission).
  • Tetra has developed several other non-prescription drug products for the Canadian and USA Over-the-Counter (OTC) drug markets.
  • Tetra has created this product line to bring self-care therapies, that act on the CB2 receptor, to pharmacies and their consumers.
  • In addition, Tetra is in commercial agreement discussions with other pharmaceutical and natural product companies for the sale and distribution of several other approved natural health products containing beta-caryophyllene.

Cara Therapeutics to Announce Third Quarter 2019 Financial Results on November 5, 2019

Tuesday, October 29, 2019 - 8:01pm

ET to report third quarter 2019 financial results and provide a corporate update.

Key Points: 
  • ET to report third quarter 2019 financial results and provide a corporate update.
  • To participate in the conference call, please dial (855) 445-2816 (domestic) or (484) 756-4300 (international) and refer to conference ID 9284479.
  • An archived webcast recording will be available on the Cara website beginning approximately two hours after the call.
  • CR845/difelikefalin is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

OTC Drugs & Dietary Supplements Market Report | Worldwide Opportunities for Consumer Goods Distributors, 2019-2025

Tuesday, October 22, 2019 - 3:36pm

Dublin, Oct. 22, 2019 (GLOBE NEWSWIRE) -- The "Over-the-Counter (OTC) Drugs and Dietary Supplements: Opportunities for Consumer Goods Distributors" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • Dublin, Oct. 22, 2019 (GLOBE NEWSWIRE) -- The "Over-the-Counter (OTC) Drugs and Dietary Supplements: Opportunities for Consumer Goods Distributors" report has been added to ResearchAndMarkets.com's offering.
  • regulations on selling OTC medicines in outlets other than pharmacies, and how these changing regulatory landscapes can influence the FMCG market
    Over-the-counter (OTC) drugs and dietary supplements will change the landscape of primary healthcare in the coming years.
  • Stakeholders in the healthcare industry understand the benefits of self-care and the importance of making drugs for minor illness available without a prescription.
  • Some nations have allowed self-selection of drugs for common illnesses such as low-grade fever, headache, cough and cold, and digestive issues.

Over-the-Counter (OTC) Drugs and Dietary Supplements Opportunities for Consumer Goods Distributors, 2019-2025 Report - ResearchAndMarkets.com

Tuesday, October 22, 2019 - 2:53pm

The "Over-the-Counter (OTC) Drugs and Dietary Supplements: Opportunities for Consumer Goods Distributors" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Over-the-Counter (OTC) Drugs and Dietary Supplements: Opportunities for Consumer Goods Distributors" report has been added to ResearchAndMarkets.com's offering.
  • Over-the-counter (OTC) drugs and dietary supplements will change the landscape of primary healthcare in the coming years.
  • Stakeholders in the healthcare industry understand the benefits of self-care and the importance of making drugs for minor illness available without a prescription.
  • Some nations have allowed self-selection of drugs for common illnesses such as low-grade fever, headache, cough and cold, and digestive issues.

QPPV Online Training 2019: A Technical Training Program to be a Qualified Pharmacovigilance Professional (QPPV) - ResearchAndMarkets.com

Thursday, October 17, 2019 - 5:01pm

This will be a perfect learning opportunity in all areas of drug safety, pharmacovigilance, regulatory and quality compliance and will be a great addition to your knowledge in pharmacovigilance.

Key Points: 
  • This will be a perfect learning opportunity in all areas of drug safety, pharmacovigilance, regulatory and quality compliance and will be a great addition to your knowledge in pharmacovigilance.
  • QPPV stands for Qualified Person Responsible for Pharmacovigilance and is a Qualified and experienced professional in all aspects of Pharmacovigilance.
  • QPPV is required in Pharmacovigilance system as per the legal obligations in EU per GVP Module I which states that all marketing authorization holders to have one qualified person for pharmacovigilance (QPPV) with responsibility for establishing and maintaining all aspects of the company's global pharmacovigilance system.
  • The QPPV is responsible for all Pharmacovigilance related activities like risk management including detection, assessment, understanding and communication of safety information.