Industry News

The agency will lead an international team to create a Supply Chain Security Toolkit of resources to educate the pharmaceutical and healthcare industries on supply chain vulnerabilities.

Catalent Applied Drug Delivery Institute announced a partnership with Rutgers University to examine the challenges of pediatric drug formulation and delivery.

Contract manufacturers await a promising pipeline of drug products to jump-start stagnant growth.

Updated ISPE guidance offers risk assessment guidance to avoid cross contamination in multiproduct pharmaceutical manufacturing facilities.

The agency recommended a total of 11 drugs at its July meeting, including five orphan drugs.

The Bridgewater facility will provide a range of contract services for biopharmaceutical and pharmaceutical manufacturers, and also serve electronics chemicals suppliers.

Researchers have demonstrated how an investigational drug currently in testing works against Niemann-Pick type C1, which may lead to treatments for other similar disorders.

The agency cited the Italian company for aseptic processing failures.

The National Academies of Sciences, Engineering, and Medicine released a report on its findings on the opioid abuse epidemic, citing the need for a prescribing culture change.

BIO and PhRMA issued statements expressing the groups’ approval of the continuation of user fee programs.

The National Institutes of Health says researchers have found a way to block a step in the HIV invasion process that may lead to the development of new drugs.

The agency sent a warning letter to Vista Pharmaceuticals Limited for CGMP failures related to equipment cleaning and process control.

One day after Ocular Therapeutix sent FDA a detailed response highlighting manufacturing improvements, FDA rejected its application for Dextenza, a new drug designed to alleviate post-operative eye pain.

The 2017 CPhI Pharma Awards program features 20 categories covering achievements in the pharma industry.

In an FDAVoice blog post, the CDER director highlighted two recent scientific advances.

The assay assesses the ability of antibodies to neutralize the Ebola virus.

The National Institutes of Health says a new study showed that hydroxychloroquine reduced the transmission of Zika in pregnant mice.

The agency’s Pharmacovigilance Risk Assessment Committee made recommendations on the risk of multiple sclerosis treatments, injectable methylprednisolone medicines, and the use of gadolinium contrast agents.

FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.

A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.

A new study predicts a potential disconnect between regulatory science and biotechnology product development, unless regulators scan the horizon for new developments and consider new potential risk pathways.

The agency announced a plan to eliminate its existing orphan designation request backlog.

The conference will return to the EU and is featuring its Start-Up Hub and Pharmapack Awards.

The directorate highlights its 2016 achievements.

An NIH study examined a dissolving microneedle technology as a way to deliver the influenza vaccine to patients.

BIO report measures decade-long investment and acquisition trends for emerging biotech companies.

Drug sales forecasts fall for first time in 10 years, thanks to pressures to reduce drug prices and the advent of biosimilars.

The agency announced it is taking steps to increase competition within the prescription drug market.

Fagron Sterile Services has voluntarily recalled three lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level.

The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.