Industry News

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.

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.

FDA puts Beijing Taiyang Pharmaceutical Industry Co. on import alert after company refuses access to inspectors.

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

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.

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

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

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

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.