Formulation and Drug Delivery

Alvotech, Prestige Biopharma Form New Manufacturing Partnership

August 30, 2019

Alvotech and Prestige Biopharma, have announced the formation of a new contract manufacturing partnership for the commercial production of a biosimilar.

Australian Researchers Successfully Develop New Tuberculosis Vaccine

August 30, 2019

Medical researchers from the Centenary Institute and the University of Sydney in Australia have managed to successfully develop and test a new vaccine targeting tuberculosis.

FDA Expands Scope of API Impurity Investigation

August 29, 2019

While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.

Industry Stresses Importance of Tackling Vaccine Hesitancy

August 23, 2019

ABPI has issued a statement of support in response to the United Kingdom’s Prime Minister’s recent order of urgent action to boost the numbers of children receiving vaccinations.

Biosimilar Teriparatide Launches Across Europe

August 23, 2019

A biosimilar to Eli Lilly’s Forsteo, biosimilar teriparatide, has been launched across Europe by Gedeon Richter following the patent expiration of the reference product.

Generics: Getting Beyond “File First, Figure it Out Later”

August 20, 2019

A GAO report analyzes some of the reasons why so few generics are approved the first time around. NIPTE has proposed a program that would address these issues

Majority of High-Containment CMO Facilities Located in 5EU and Switzerland, Notes GlobalData

August 15, 2019

The latest research from GlobalData has revealed that more than two-thirds (69%) of CMOs high-containment facilities are based in the top five European Union countries and Switzerland.

Nemera Acquires Chicago Consulting Firm

August 15, 2019

Nemera has acquired a healthcare focused design and innovation consulting firm in Chicago, IL, Insight Product Development, strengthening its presence in North America.

European Commission Extends Use of Dupixent to Include Adolescents

August 15, 2019

The European Commission has approved an extension of the use of Dupixent (dupilumab) within the EU to include patients aged 12 to 17 years old with moderate-to-severe atopic dermatitis.

Amgen Wins Enbrel Patent Case, Sandoz to Appeal Ruling

August 13, 2019

A New Jersey court upheld the validity of patent claims for Amgen’s anti-inflammatory blockbuster biologic, Enbrel (etanercept).