After an ongoing battle, the United States Court of Appeals for the Federal Circuit recently held in Amgen's favor on the validity of two patents that describe and claim Enbrel (etanercept)...
Allergan, an AbbVie company, recently announced that the FDA accepted its supplemental biologics license application (sBLA) to expand BOTOX prescribing information for bladder (detrusor) overactivity...
Medicaid spent an estimated $761 million in excess costs over seven years due to delayed generic drug entry costs, according to a recent study.
Delayed generic drug entry is common,...
US taxpayers and the healthcare sector may save nearly $7 billion annually with a stronger, more competitive biosimilars market, which is a significant increase from the current annual cost-savings of...
Biogen, the Broad Institute of MIT and Harvard, and Partners HealthCare recently launched a consortium that will build and share a COVID-19 biobank, according to a press release.
For more coronavirus...
Eli Lilly and Company recently announced that it partnered with the National Institutes of Allergy and Infectious Diseases (NIAID) to study baricitinib as part of NIAID’s Adaptive COVID-19...
In response to an FDA and FTC open docket regarding biosimilar marketplace competition, Premier submitted comments and recommendations to further promote a robust biosimilars marketplace.
The...
When matched for all characteristics, two biosimilars showed significant cost savings for large US employers, according to researchers from the Bloomberg School of Public Health at Johns Hopkins...
Mylan recently announced that the proposed pharmaceutical merger with Upjohn, a division of Pfizer, is delayed due to the COVID-19 pandemic.
For more coronavirus updates, visit our resource page,...
Biosimilar reviews confirm any differences between a potential biosimilar and its reference product, but new research shows that these reviews may need to provide more information about efficacy to...
The Bill and Melinda Gates Foundation, Wellcome, and Mastercard recently launched an initiative to boost drug discovery and biologics to treat patients with COVID-19.
For more coronavirus updates,...
The Food and Drug Administration (FDA) recently published a final rule and additional resources to provide useful information to healthcare providers to ensure smooth regulatory transition of insulin...
A new Congressional Research Service report on Wednesday delved into the deluge of proposals that have been set forth to address drug pricing and drug patenting practices.
The report is a high-level...
A machine learning algorithm can predict whether an individual is likely to benefit from sertraline treatment using a neural signature, findings published Monday in Nature Biotechnology...
The Trump administration put out a proposed rule on Wednesday that aims to foster access to generics and biosimilars through a push for price transparency around pharmaceutical drugs administered under...
The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) on Monday issued a set of four joint goals to support a competitive US marketplace for approved biological products,...
The Food and Drug Administration issued updates to its policy on prioritization of generic drug applications to make better use of the agency's limited resources.
The Manual of Policies and...
US Food and Drug Administration (FDA) recently issued six final guidances and draft guidance to advance gene therapy development by clarifying the policy framework for development and...
The Senate’s January 16 approval of the US-Mexico-Canada (USMCA) Agreement was well-received by industry groups who argued for it to serve as a template for ongoing trade deal negotiations to...
Study sponsors will be subject to a new requirement for pediatric investigations beginning August 18, with new Food and Drug Administration draft guidance offering transitional information.
The...
