Drug Safety

American College of Medical Toxicology Reports Data on Adverse Effects and Toxicity from Unapproved Use of Ivermectin for the Prevention or Treatment of COVID-19

Retrieved on: 
Friday, August 20, 2021
Onchocerciasis, Toxicity, COVID-19, Human, FACT, Tremor, Ivermectin, Vomiting, Program, Rosacea, Physician, Medicine, GLOBE, Hallucination, Pharmacovigilance, Association, Seizure, Nausea, Horse, Coma, Panel, Animal, Fatigue, Drug, Abdominal pain, Dizziness, Disease, Patient, Diarrhea, Cattle, American College of Medical Toxicology, Drug Safety, FDA, Headache, National Institute, American College, Pharmaceutical industry

These incidents were reported through ToxICs FDA ACMT COVID-19 ToxIC (FACT) Pharmacovigilance Project Sub-registry between October 2020 and August 2021.

Key Points: 
  • These incidents were reported through ToxICs FDA ACMT COVID-19 ToxIC (FACT) Pharmacovigilance Project Sub-registry between October 2020 and August 2021.
  • Ivermectin is FDA-approved for prescription use in humans as an antiparasitic drug to treat conditions including intestinal strongyloidiasis and onchocerciasis or river blindness.
  • Physicians specialized in medical toxicology oversee this program at 15 designated medical centers across various geographic regions in the United States.
  • The American College of Medical Toxicology (ACMT) is a professional, nonprofit association of physicians with recognized expertise and board certification in medical toxicology.

Finch Therapeutics Reports Second Quarter 2021 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, August 10, 2021
Autism, Private Securities Litigation Reform Act, Clostridioides difficile infection, Patient, Food, Patent, COVID-19, Research, Inflammatory bowel disease, Public expenditure, GI, Marketing, FNCH, Hepatitis, HBeAg, U.S. Securities and Exchange Commission, Recurrence, HBV, Continuous Progress Mathematics, KOL, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, Breakthrough therapy, Leadership, Biomarker, DO, Growth, SEC, Drug Safety, JD, MPH, GLOBE, Therapy, IBD, Partnership, IRB, DNA, Board, Ulcerative colitis, ASD, CDI, Board of directors, Doctor of Philosophy, Security (finance), Medicine, Pharmaceutical industry

Continued progress advancing development programs, with clinical data across multiple programs anticipated in 2022

Key Points: 
  • Continued progress advancing development programs, with clinical data across multiple programs anticipated in 2022
    SOMERVILLE, Mass., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Finch Therapeutics Group, Inc. (Finch or Finch Therapeutics) (Nasdaq: FNCH), a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery platform to develop a novel class of orally administered biological drugs, today reported financial results for the second quarter ended June 30, 2021 and provided a business update.
  • Finch reported a net loss of $15.2 million for the second quarter of 2021 as compared to a net loss of $8.3 million for the same period in 2020.
  • Research and development expenses for the second quarter of 2021 were $14.0 million, compared with $8.1 million for the same period in 2020.
  • Finch Therapeutics is a clinical-stage microbiome therapeutics company leveraging its Human-First Discoveryplatform to develop a novel class of orally administered biological drugs.

Knipper's New SamplicitySA Is the Next Generation of Sample Management

Retrieved on: 
Tuesday, August 3, 2021
Pharmaceuticals policy, Drugs, Drug Safety, Over-the-counter drug

SamplicitySA Sample Management is an integral component of Samplicity, Knipper's fully-integrated sample management platform.

Key Points: 
  • SamplicitySA Sample Management is an integral component of Samplicity, Knipper's fully-integrated sample management platform.
  • Sales personnel can spend their time selling rather than managing their sample orders, or the sample requests of their customers.
  • Knipper is currently scheduling demonstrations of the new SamplicitySA Sample Accountability program.
  • Named for its simple approach to sample management, Samplicity revolutionizes sample management for prescription and over-the-counter (OTC) pharmaceutical products with an exclusive suite of technology, services, and support.

Dr. Sabine Hazan Conducts ProgenaBiome's First Fecal Transplant for The Purposes of Studying Autism

Retrieved on: 
Tuesday, August 3, 2021
Branches of biology, Health, Medical specialties, Clinical research, Drug Safety, Food and Drug Administration, Investigational New Drug, Autism

It was completed as part of a clinical research study with FDA approval through an individual Investigational New Drug (IND) Application.

Key Points: 
  • It was completed as part of a clinical research study with FDA approval through an individual Investigational New Drug (IND) Application.
  • "I founded ProgenaBiome to continue the legacy work of world-famous infectious disease specialist Dr. Sydney Finegold," says Dr. Hazan, renowned gastroenterologist, leader in microbiome research, and co-author of Let's Talk S**t .
  • "Dr. Finegold dedicated his life to studying the gut flora and its relationship to disease, particularly Autism.
  • With the success of this procedure, Dr. Hazan hopes to find new data on the potential connection between Autism and the microbiome.

SCYNEXIS Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Monday, August 2, 2021
Life sciences, Health care, Health sciences, Drug Safety, Pharmaceutical industry, Food and Drug Administration, United States Public Health Service, New Drug Application

The stock options were granted as material inducements to the new employees to accept SCYNEXIS offers of employment.

Key Points: 
  • The stock options were granted as material inducements to the new employees to accept SCYNEXIS offers of employment.
  • The stock options were granted pursuant to SCYNEXIS 2015 Inducement Award Plan, as amended, which was adopted by SCYNEXIS board of directors under Rule 5635(c)(4) for equity grants to induce new employees to enter into employment with SCYNEXIS.
  • SCYNEXIS, Inc.(NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant.
  • The New Drug Application (NDA) for BREXAFEMME (ibrexafungerp tablets) was approved by the U.S. Food and Drug Administration (FDA) on June 1, 2021.

BioStem Technologies, Inc., Announces the Engagement of Biologics Consulting To Support FDA Strategies and Submissions.

Retrieved on: 
Tuesday, July 27, 2021
Life sciences, Biotechnology, Pharmaceutical industry, Health sciences, Food and Drug Administration, Drug Safety, Biopharmaceutical, Pharmacy, Biologics license application, BLA

Biologics Consulting will help BioStem navigate through the FDAs Biologics License Application (BLA) process.

Key Points: 
  • Biologics Consulting will help BioStem navigate through the FDAs Biologics License Application (BLA) process.
  • Biologics Consulting will provide education and support, best practices, and assist with the necessary communications with the relevant regulatory agency groups.
  • Jason Matuszewski, CEO of BioStem Technologies, states, "We are excited to announce our engagement of Biologics Consulting.
  • BioStem Technologies offers a comprehensive portfolio of high-quality brands that include RHEO, OROPRO, VENDAJE, VENDAJE AC, and VENDAJE OPTIC.

Idorsia announces financial results for the first half 2021 – Building momentum towards becoming a fully-fledged biopharmaceutical company

Retrieved on: 
Tuesday, July 27, 2021
Food and Drug Administration, Drugs, Pharmaceutical industry, Health sciences, Health care, Drug Safety, GABAA receptor positive allosteric modulators, Lactams, PMDA, New Drug Application, Flunitrazepam

In April and July of 2020, Idorsia reported positive results in each of the two pivotal Phase 3 studies of daridorexant in patients with insomnia.

Key Points: 
  • In April and July of 2020, Idorsia reported positive results in each of the two pivotal Phase 3 studies of daridorexant in patients with insomnia.
  • Should approval be received, the company anticipates launch in the US in the second quarter of 2022, followed by other regions thereafter.
  • A New Drug Application (NDA) to the Japanese PMDA for clazosentan was submitted on March 1, 2021.
  • Based on initial clinical pharmacology investigation with ACT-541478, the company has decided not to pursue the development of this CNS compound further.

PolarityTE Submits Investigational New Drug Application for SkinTE® in Chronic Cutaneous Ulcers

Retrieved on: 
Monday, July 26, 2021
Medical devices, FDA, Health, Surgery, Clinical trials, Biotechnology, Drug Safety, Food and Drug Administration, Health sciences, Health, Pharmaceutical industry, Clinical research, Investigational New Drug, New Drug Application

PolarityTE, Inc. (Nasdaq: PTE) today announced the submission of an investigational new drug application (IND) to the United States Food and Drug Administration (FDA) seeking authorization to commence a clinical trial to evaluate its SkinTE product for the proposed indication of treatment of chronic cutaneous ulcers.

Key Points: 
  • PolarityTE, Inc. (Nasdaq: PTE) today announced the submission of an investigational new drug application (IND) to the United States Food and Drug Administration (FDA) seeking authorization to commence a clinical trial to evaluate its SkinTE product for the proposed indication of treatment of chronic cutaneous ulcers.
  • Wounds closed with SkinTE have exhibited significant improvement after SkinTE application (e.g., avoidance of amputation after failure of treatment alternatives).
  • Thus, PolarityTE believes that preliminary clinical evidence suggests SkinTE could ameliorate a number of serious conditions caused by chronic cutaneous ulcers.
  • POLARITYTE, the POLARITYTE logo, SKINTE, WHERE SELF REGENERATES SELF and WELCOME TO THE SHIFT are registered trademarks of PolarityTE, Inc.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210726005157/en/

The Veterinary Drug Approval Process and FDA Regulatory Oversight Seminar (October 20-22, 2021) - ResearchAndMarkets.com

Retrieved on: 
Friday, July 23, 2021
Veterinary, Health, Health sciences, Food and Drug Administration, Health, Drug Safety, Veterinary medicine in the United States, Veterinary drugs, United States Public Health Service, Center for Veterinary Medicine, Animal drug, Criticism of the Food and Drug Administration, New Drug Application

The "The Veterinary Drug Approval Process and FDA Regulatory Oversight" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "The Veterinary Drug Approval Process and FDA Regulatory Oversight" training has been added to ResearchAndMarkets.com's offering.
  • The U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) is responsible for the approval of veterinary drug products intended for family pets, food-producing animals, and other animal species.
  • This three-day interactive seminar will provide attendees with an understanding of FDA's veterinary drug approval process.
  • Key goals of the seminar will include learning:
    How the U.S. Food and Drug Administration (FDA) regulates animal drug products.

Antares Pharma Announces FDA Acceptance of IND Application for ATRS-1902 for Adrenal Crisis Rescue

Retrieved on: 
Thursday, July 22, 2021
Health sciences, Health care, Health, Food and Drug Administration, Glucocorticoids, Drug Safety, Corticosteroids, Alcohols, Hydrocortisone, New Drug Application, Investigational New Drug, Pharmaceutical industry

EWING, N.J., July 22, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (the Company), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug Application (IND) for ATRS-1902 for adrenal crisis rescue.

Key Points: 
  • EWING, N.J., July 22, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (the Company), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug Application (IND) for ATRS-1902 for adrenal crisis rescue.
  • The FDA acceptance of this IND is an important milestone in the development of a novel formulation and delivery of hydrocortisone in a crisis situation.
  • Current standard of care for the management of acute adrenal crises includes Solu-Cortef, which is an anti-inflammatory glucocorticoid.
  • Robert F. Apple, President and Chief Executive Officer of Antares Pharma, added, We are pleased to be able to advance the development of our proprietary pipeline with the FDA acceptance of this IND.