The biosimilar pathway permits licensure based on less than full clinical data.

The proliferation of counterfeit medicines is nothing new to pharma; however, the scale of the problem seems to be escalating.

TraceLink launched the EU-hosted early access program to reduce the time, cost, and risk of achieving regulatory compliance for global requirements.

Douglas C. Throckmorton, MD, provides some key facts about abuse-deterrent opioids.

US and Chinese pharmacopeial standards groups commit to collaboration on standards for drug safety.

Oxford Genetics has secured a GBP1 million capital from investment group Mercia Technologies to support its growth strategy in delivering new services for cancer-fighting gene-therapy technologies.

Interactive Coding Equipment has produced a detailed guide to help pharmaceutical manufacturers make informed choices in the selection of suitable coding equipment for their applications.

Pharmapack Europe is inviting pharmaceutical packaging and drug-delivery experts to apply for the 2017 Pharmapack Awards.

Teva and IBM expanded their partnership to focus on drug development and chronic disease management.

Caribou and JAX entered into a license agreement for Caribou’s CRISPR-Cas9 gene editing technology.

The technical center is a new addition to Ashland’s Shanghai facility.

Kaléo announced on Oct. 26, 2016 that the company will reintroduce the AUVI-Q (epinephrine injection) to the United States market during the first half of 2017. AUVI-Q is a prescription epinephrine autoinjector used to treat anaphylaxis. The autoinjector includes an automatically retractable needle and a voice prompt system that guides the user through delivery.

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

Ashland opened a new pharmaceutical excipient manufacturing facility in Nanjing, China.

Heat Biologics will collaborate with the University of Miami on the development of a Zika vaccine using the company’s gp96 platform.

GENCO, a FedEx Company, introduces a multi-tenant warehouse model in Milton, Ontario, and Memphis, Tennessee.

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

IDT Biologika will provide fill/finish services of live-vectored virus products in clinical development through licensure.

Catalent invests $34 million to add a 2 x 2000-L single-use bioreactor system and laboratory space in Madison, WI.

Horizon announces new bioproduction outlicense deal with an unnamed partner for a minimum value of £500,000.

Datwyler is channelling more than CHF 100 million into building a new plant in the US state of Delaware, which will be used to manufacture elastomer components for injectable drug-delivery systems.

BASF announced that steamcrackers are slowly being restarted at the company’s plant in Ludwigshafen.

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 patented desiccant stoppers improve the opening of tablet tubes used to contain lozenges, effervescent, and chewable tablets.

Merck is providing WHO with approximately 10 million tablets for Ivory Coast.

Prefilled syringes for commercial supply of the etanercept biosimilar will be produced at Catalent’s Brussels facility in Belgium.

Designing loss-in-weight feeders for accurate and consistent refill is crucial to a continuous solid-dosage process.