Samantha DiGrande

In 2017, the FDA more than doubled the number of drugs it approved compared with the previous year, with 46 novel medicines receiving the FDA’s endorsement in 2017.

The Psoriasis Stratification to Optimize Relevant Therapy (PSORT) study assessed real-world levels of self-reported non-adherence to traditional systemic and biologic therapies used for psoriasis, and evaluated psychological and biomedical factors associated with non-adherence using multivariable analyses.

There are a variety of biologics available for the treatment of psoriasis; our latest infographic provides examples of each type.

In 2008, tbo-filgrastim (Granix) was approved as a biosimilar in Europe. In 2012, it was approved in the United States as a follow-on biologic product to filgrastim. Tbo-filgrastim was less expensive than filgrastim, and clinical information and expert opinion supported similarity between the products. This led the pharmacy and therapeutics committee of a major US health system to approve tbo-filgrastim as the preferred granulocyte-colony stimulating factor (G-CSF) product in March 2014.

Elan Rubinstein, PharmD, MPH, voiced his frustration with the lack of presence the pharmacy profession has had in the negotiations of repealing and replacing the Affordable Care Act.

A recently published review appearing in the International Journal of Molecular Sciences, looks at the factors influencing psoriasis severity and the indications for systematic treatments.

Biologics are the most expensive drug category in the United States. A recent study, published in the Journal of Managed Care and Specialty Pharmacy, investigated how American health systems are reacting to the introduction of biosimilars into the marketplace, and described real-world implementation strategies.

JHL Biotech, a biopharmaceutical startup based in Taiwan, announced yesterday that it has submitted a phase 1 clinical trial application to the Dutch Healthcare Authority for its proposed dornase alfa biosimilar, JHL1922, to improve pulmonary function in patients with cystic fibrosis.

Hikma Pharmaceuticals Plc. announced yesterday that it has reached a licensing agreement with Republic of Korea-based Celltrion for its rituximab biosimilar, Truxima, referenced on MabThera.

Fresenius Kabi, a subsidiary of the German-based Fresenius SE and Co. KFaA, announced yesterday that its Marketing Authorization Application for MSB11022, an adalimumab (Humira) biosimilar candidate, was submitted and accepted for review by the European Medicines Agency (EMA).

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.

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

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.

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.

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.

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.

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.

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.

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

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

At the American Society of Hematology’s 59th Annual Meeting and Exposition in Atlanta, Georgia, Sanjeeev Balu, PhD, will present results of a study that examines expanded access to the drug obinutuzumab (Gazyva) made possible on a budget-neutral basis through savings obtained from using biosimilar filgrastim-sndz (Zarxio).

Since Novex’s commercial launch, the first national pharmacovigilance plan for a biosimilar monoclonal antibody has been implemented, and data from this post-marketing surveillance show that, in terms of tolerability, this biosimilar has a similar safety profile to that of the reference product.

Yesterday, community oncology leaders flooded the Hill to meet with Congress and the administration to warn them of the impact the Medicare sequester’s increased cuts and extension will have on cancer care nationwide.

HHS has rescinded its approval of a major charity, Caring Voice Coalition, after the charity allowed pharma donors improper influence over the nonprofit.

A recent report by the World Health Organization (WHO) showed that nearly 1 in every 10 drugs is falsified or substandard, and estimates the net worth of the industry for such drugs at nearly $30 billion.

A recent study was conducted to determine whether the concurrent use of denosumab with a biologic disease-modifying antirheumatic drug (bDMARD), such as adalimuab, etanercept, or infliximab, increases the risk of infection.

Trastuzumab has been used to manage both early and metastatic HER2-postive breast cancer and has significantly improved the survival of these patients and become the standard of care, according to Arlene Chan, MB BS, FRACP, MMed, writing in Chinese Clinical Oncology.

A new study, the phase 3 IMpower150, demonstrated Genentech’s atezolizumab (Tecentriq) and innovator bevacizumab (Avastin) plus paclitaxel and carboplatin chemotherapy significantly reduced the risk of disease worsening or death in the treatment of advanced lung cancer.

Health Canada looks to lower the maximum price for drugs, but doing so could delay patient access, warns Montreal Economic Institute.

This past week, the FDA began the long-awaited process of adding a 4-letter suffix devoid of meaning, to the end of newly approved biologics’ nonproprietary names.