Industry News

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.

A new study proposes a new way to potentially treat congenital diseases in utero.

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.

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.

CPhI outlines trends from the conference in Seoul.

EMA has recommended halting supply of non-critical drugs from Pharmaceutics International Inc. because of GMP failures.

In response to the EpiPen pricing scandal, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, clarifies FDA’s role in drug pricing.

Industry concerns have generated efforts by FDA to streamline the system for designating the lead center to regulate a new combination product.

The organization announced the winners of the 2016 awards at a dinner on Sept. 13 in Washington DC.