Industry News

The agency put Baoying County Fukang Medical Appliance Co., Ltd. on import alert after observing violations at the company’s Yangzhou City facility.

A pilot project, beginning in 2017, will support the development of biosimilars.

The agency announces that 81 medicines overall were recommended in 2016.

The commission concluded its P4Bio pilot phase with the adoption of the monograph for etanercept.

FDA’s Center for Drug Evaluation and Research makes plans for implementation of the 21st Century Cures Act that include patient-focused drug development.

PDA is conducting a survey of industry members challenged by the complexity of making post-approval changes.

DuPont received a grant from the Bill & Melinda Gates Foundation to produce pharmaceutical proteins.

Congress enacted the 21st Century Cures legislation, which shores FDA operations and supports biomedical research at the National Institutes of Health.

QuintilesIMS forecasts global spending on medicine will reach $1.5 trillion by 2021.

Dara Corrigan examines the Mutual Reliance Initiative as a method for expanding FDA’s inspection capabilities in Europe and beyond.

Researchers test the efficacy of a new polymer that is an alternative to PEG for drugs used to treat type 2 diabetes.

The UK’s NICE recommended pembrolizumab for the treatment of patients with advanced lung cancer, reversing the institute’s earlier decision.

The House-approved 21st Century Cures legislation supports initiatives for medical research, drug development, and faster approvals, but comes up short on actual appropriations.

The commission approved future plans, appointed members, and adopted texts during its November 2016 session.

Wockhardt Limited received a warning letter from FDA for CGMP violations.

FDA issued a warning letter to Srikem Laboratories Pvt. Ltd. for data integrity violations

Biopharma proponents argue for FDA resources, Cures legislation, and science-based drug regulation.

CDER is asking manufacturers to participate in the Experiential Learning Site Visit Program to educate OPQ staff about pharmaceutical manufacturing processes.

The agency published guidance to help pharma companies in the clinical development of treatments for bacillus Calmette-Guerin (BCG)-unresponsive nonmuscle invasive bladder cancer.

At ICH’s November 2016 meeting, the council announced new members and new guidelines.

Research by agency scientists may help speed development of Zika virus vaccines.

Despite some progress, pharmaceutical companies have a long way to go in making their products accessible and affordable, this year's study finds.

Nine fellows recognized for research ranging from cancer treatment to improved vaccines.

The agency recommended nine drugs including treatments for diabetes, hepatitis B, and HIV.

NIH researchers developed a test to identify existing drugs that might be able to combat drug-resistant bacteria.

The Broad Institute and IBM Watson Health will collaborate on a $50 million project to study how cancers become resistant to therapies.

What’s ahead for the healthcare and pharmaceutical industries?

GS1 US published new guidelines in preparation for the serialization and traceability requirements associated with DSCSA.

PMMI, The Association for Packaging and Processing Technologies, released a report on trends opportunities in packaging of pharmaceuticals and medical devices that predicts increased spending on capital equipment for processing and packaging.

Researchers in the University of Dundee have discovered a new method of activating drugs to combat visceral leishmaniasis. The discovery could lead to better treatments for neglected tropical diseases.