News

The European Medicines Agency has published a guide to help industry and regulatory authorities implement safety-monitoring standards.

Cosentyx (secukinumab) is the first IL-17A inhibitor for moderate-to-severe plaque psoriasis patients.

Catalent announced that it would partner with Mitsubishi Gas Chemical Company, and its subsidiary MGC Pharma, to promote GPEx technology, a high-titer vector for stable mammalian cell lines.

FDA aims is to collect data regularly from manufacturers that will indicate the ability of a firm and its facilities to produce high-quality therapies on a continual, error-free basis.

The European Medicines Agency plans on sharing generic-drug assessment reports with regulators outside the European Union.

Eli Lilly collaborates with Bristol-Myers Squibb and Merck on clinical trials of oncology treatments.

Boehringer Ingelheim announced that it would partner with Vanderbilt University to research and develop Ras inhibitors for the treatment of cancers affected by Ras mutation.

Sanofi will tap into Boehringer Ingelheim’s therapeutic monoclonal antibody manufacturing capabilities.

USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.

The move represents Hospira’s first biosimilar submission in the United States.

The new partnership between NeoStem and Invetech focuses on the development of a closed processing system for cell-based therapy manufacturing.

Shire adds rare-disease portfolio with acquisition of NPS Pharma.

Bristol-Myers Squibb announced that it stopped its study of Opdivo for the treatment of 2nd line squamous cell lung cancer due to superior overall survival of study participants.

The decision to skip an FDA panel advisory may allow the medication to be approved more quickly.

Single-use components aid efficiency in automated personalized therapy manufacturing.

A guidance document published just before the Jan. 1, 2015 deadline adds a four-month grace period.

Biogen Idec’s investigational monoclonal antibody met its primary endpoints in a recent Phase II for the treatment of acute optic neuritis.

An FDA panel unanimously recommended the agency approve EP2006, Sandoz’s biosimilar for filgrastim.

The FDA center released a list of the guidance documents it plans to publish in 2015.

The exclusivity deal mirrors that of the recent deal between Express Scripts and AbbVie for Viekira Pak.

Isis Pharmaceuticals announced that it entered into an agreement with Janssen Biotech to discover and develop antisense drugs for autoimmune disorders of the GI tract.

In 2014, FDA approved 41 new molecular entities, which is the highest number since 1996.

The Parenteral Drug Association report addresses prevention and communication of drug shortages caused by manufacturing and quality related disruptions.

Improving efficiency, value chain, quality, and protein complexity with advanced bioprocess development.

FDA delays enforcement of product tracing requirements to May 1, 2015, providing trading partners more time to comply.

Roivant Neurosciences acquired GlaxoSmithKline’s selective 5-HTC receptor antagonist for the treatment of various neurological disorders, specifically Alzheimer’s disease.

Although competing therapies will continue to be released in the immune-oncology space, efficacy profiles, combination regimens, and administration setting may influence a drug’s preferred status more than price.

Hospira issued a voluntary worldwide recall due to confirmed subpotency and elevated impurity levels.