News

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.

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

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

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.

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

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

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.

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

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

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.

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

Insulin has been shown to improve the production of viruses and viral vectors.

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

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

Oxford Genetics increased its laboratory space to 5700 sq. ft. with a move to a new location at Oxford Science Park.

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

The company announced plans to begin shipping Inflectra to the US market in late November 2016.