Samantha DiGrande

December 19, 2017

The way clinical trials are conducted and reported in the European Union will undergo a major change when the Clinical Trial Regulation comes into force in 2019.

December 17, 2017

How much do analysts believe the top 10 biggest-selling drugs will earn in 2018? Our latest infographic breaks down the projections.

December 16, 2017

Teva Pharmaceutical Industries, the world’s largest generic drug maker, based in Israel, unveiled its restructuring plan yesterday, which comes with big cuts to its research and development (R&D) department and staff.

December 15, 2017

Recently, the Prescription Medicines Code of Practice Authority announced in a press release that 5 pharmaceutical companies have breached the Association of the British Pharmaceutical Industry’s Code of Practice.

December 14, 2017

A recently published study explored the impact of 2 different initial doses and a cumulative 2-year dose of rituximab on drug adherence and predictors of adherence to treatment in patients with RA in an observational clinical setting.

December 13, 2017

Palivizumab (Synagis) is a monoclonal antibody that is used to help prevent respiratory syncytial virus (RSV). RSV is a common virus that can cause serious lung infections in infants who are at high risk, including premature infants or those who have certain heart and lung diseases.

December 11, 2017

Republic of Korea-based biopharma company Celltrion is looking to accelerate its momentum in Europe; analysts belive that the company could receive the European Medicines Agency’s (EMA) approval to market its biosimilar of Roche’s blockbuster cancer treatment, Herceptin (trastuzumab), by March 2018.

December 09, 2017

This week, Leah Christl, PhD, associate director for therapeutic biologics, Center for Drug Evaluation and Research (CDER), FDA, and Sue Lim, MD, medical officer at the FDA’s Office of New Drugs, held a webinar to discuss the regulatory framework for biosimilars as well as the development and approval process for these drugs.

December 07, 2017

A recent study found that Cinfa Biotech’s proposed pegfilgrastim biosimilar, B12019, has similar pharmacodynamics (PD) and immunogenicity to the reference Neulasta.

December 06, 2017

Patients can be switched from reference rituximab (MabThera) to biosimilar rituximab (Truxima) without reverting to slower infusion rates, according to a new study.