Industry News

The Czech Republic drug manufacturer was cited for data integrity and quality issues.

FDA’s new Office of Tissues and Advanced Therapies will oversee a growing range of cellular and genetic products.

Scientists from the Fred Hutchinson Cancer Research Center have developed a semi-automated benchtop system for the manufacture of gene therapy.

FDA leaders insist that the decision to approve Sarepta’s Exondys (eteplirsen) should not be considered a model for future development of orphan drugs.

The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers.

The agency awarded 21 new clinical trial research grants to boost the development of treatments for rare diseases.

FDA is working with EMA to treat rare diseases and keep patients involved in healthcare.

Wallace Cameron International was cited for not registering its Wishaw, Scotland facility with FDA.

Laboratoire Sintyl S.A. received an FDA warning letter for CGMP quality violations.

HHS entered into a contract with BioProtection Systems Corp. for commercial manufacturing tests of an Ebola vaccine.

The agency’s Patient-Focused Drug Development program completed its commitment ahead of schedule.

A report from the European Union Intellectual Property Office shows that the EU loses approximately €10.2 billion a year due to counterfeit medicines.

The time and resources required to finalize post-approval changes may be preventing manufacturers from modernizing facilities, or even scouting for new technology.

Value assessment initiatives are expected to have a major impact on drug use and reimbursement.

The hospital received a five-year $5 million grant from CDC to survey for communicable diseases in children and evaluate vaccine effectiveness.

FDA’s Center for Drug Evaluation and Research provides an update on its safety initiatives.

EDQM and the Japanese Pharmacopoeia will improve the sharing of information on therapeutic products that are common in both Europe and Japan.

The company is voluntarily recalling all unexpired lots of 50-mm, 0.2-micron filters.

he guidance addresses the good manufacturing practice for managing quality in APIs.

Ravi Limaye gives an overview of the biosimilar industry and projects for 2020.

The most recent PharmSource report says bio/pharma companies have spent more than $150 billion for new plant equipment in the past five years.

FDA and EMA set up new working group on the development of treatments for rare diseases.

HHS entered into a $43.18 million contract with Sanofi Pasteur for the development of a Zika vaccine candidate.

Hebei Yuxing Bio-Engineering Co. Ltd. was cited for data integrity violations.

Wells Pharmacy Network is voluntarily recalling all of its products due to sterility concerns.

The agency published the guidance to help generic-drug facilities comply with the GDUFA self-identification requirement.

Researchers from the Wyss Institute explain a potential method for transporting and producing temperature-sensitive pharmaceuticals at a reduced cost.

The agency has confirmed that patients who take plasma- or urine-derived drugs are not at increased risk for Zika.