Industry News

The £14-million research project aims to better understand adverse drug reactions through a variety of modeling approaches.

Local manufacturing, regulatory strategies, market entry, and harmonization to be featured at CPhI Istanbul.

Trump met with pharma manufacturers and makes a statement focused on domestic manufacturing, FDA approvals, and drug pricing.

The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.

PAT, quality by design, process controls, and analytical advances for small- and large-molecule drugs are on agenda for IFPAC 2017.

The company issues a voluntary nationwide recall due to the presence of particulate matter in a single vial.

The agency finds repeated CGMP violations at Porton Biopharma, Limited.

FDA’s Office of Regional Affairs aims to implement Program Alignment initiative by May 15, 2017.

In a recent deal with the Federal Trade Commission, Endo agreed to refrain from entering into future pay-for-delay patent settlements for ten years.

A new report says that failure to account for rebates, discounts, and price concessions leads to an “overstatement of payments realized by manufacturers” in most annual industry drug spend reports.

A study by EMA shows that drugs that received conditional marketing authorization gave patients earlier access to needed medications.

FDA cites Sato Yakuhin Kogyo Co., Ltd. with data integrity violations after a June 2016 inspection of its Kashihara City facility.

A new report from HBM Partners said FDA new molecular entity approvals have dropped to 19 in 2016 from 45 in 2015.

The agency published an overview of marketing authorizations made in 2016.

EDQM outlines the steps it will take to implement the ICH Q3D guideline on elemental impurities.

In a blog post, Robert Califf and Rita Nalubola discuss the agency’s approach to the use of genome-edited products.

An FDA guidance on biosimilar naming garnered mixed responses from the Biosimilars Forum, the American College of Rheumatology, and Pfenex.

FDA published a flurry of guidance documents in late 2016.

Industry experts identify the future focus of the biopharma industry in a new survey.

The agency plans on publishing more than 100 new or revised guidance documents in 2017.

The partnership will focus on providing practical information to clients on the development of biologics and vaccines.

The company was cited by FDA for violations of sterile processing GMPs.

A study of 53 cancer drugs found that new treatments extended patient life an average of 3.43 months when compared with treatments available in 2003.

According to a Deloitte report, the industry’s return on its research investment has been steadily slipping for the past six years. The conclusion? Fundamental change may no longer be a given, but a necessity for the industry

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.