Remove Licensing Remove Presentation Remove Virus
article thumbnail

Navigating Regulatory Hurdles in Drug Development

DrugBank

Once a drug completes Phase III trials, companies prepare a New Drug Application or Biologics License Application (BLA) for final review. Many agencies offer pre-IND meetings where companies can present their research plans, discuss potential challenges, and receive guidance on the type of data required for approval.

article thumbnail

k kh,h,,h, jjgm gmm

Twist Bioscience

Human Comprehensive Exome Human Core Exome Human Methylome Panel Human RefSeq Panel Mitochondrial Panel Mouse Exome Panel Respiratory Virus Research Panel Comprehensive Viral Research Panel Twist's Whole Exome Library Preparation Workflow.

RNA 52
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules

BioPharma Drive: Drug Pricing

Published June 27, 2025 By BioPharma Dive staff post share post print email license Daniel Tadevosyan via Getty Images Today, a brief rundown of news involving Biocryst and Peter Marks, as well as updates from UCB and Altimmune that you may have missed. An oral solution of fenfluramine is already cleared in the U.S.

Vaccine 130
article thumbnail

Aridis Pharmaceuticals to Present at the ROTH Capital Partners 2020 MedTech Innovation Forum on a COVID-19 Panel

The Pharma Data

(Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, today announced the Company will present at the ROTH Capital Partners 2020 MedTech Innovation Forum on Wednesday, October 28, 2020. AR-711 (COVID-19). AR-201 (RSV infection).

article thumbnail

Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir

The Pharma Data

The companies today reported findings on one secondary objective from the Phase 2a study, showing a reduction in time (days) to negativity of infectious virus isolation in nasopharyngeal swabs from participants with symptomatic SARS-CoV-2 infection, as determined by isolation in Vero cell line culture. This press release features multimedia.

Trials 69
article thumbnail

Crescita Announces Licensing Agreement for Pliaglis; in China

The Pharma Data

Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”). million and US$1.8

article thumbnail

What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Law Blog: Drug Discovery

This product was developed by uniQure prior to being licensed to CSL Behring. However, there are many treatment goals that patients and their caregivers have that fall short of a cure, not only improvements but, for progressive conditions, a slowing or halting of worsening.

Therapies 119