NICE recommended eribulin for the treatment of patients with breast cancer, reversing its 2012 decision.

CFDA granted Pfizer China approval for the company’s Prevenar 13 vaccine.

Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to prepare for an inspection by a foreign regulatory agency.

CPhI Pharma Award winners were recognized for sweating the details for the bigger picture.

Pharma industry event in Mumbai will host 40,000 visitors on Nov. 17-23.

Recipharm is investing more than EUR1.2 million to enhance its small-scale GMP API development and manufacturing capabilities in Paderno Dugnano, Italy.

The company announce its plans to invest $7 million in the expansion of the Westborough, MA facility.

Astellas will acquire Ganymed and its portfolio of ideal monoclonal antibody candidates.

Bellicum and Ospedale Pediatrico Bambino Gesù will collaborate on preclinical and clinical development of CAR-T and TCR therapeutics.

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.

The collaboration follows the signing of a cooperative research agreement between Sanofi Pasteur, Fiocruz, and WRAIR.

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.