The recent announcement of two vertical mergers — the $52 billion acquisition of Express Scripts, the largest pharmacy benefit manager (PBM) in the country, by Cigna, and the $69 billion purchase of Aetna by CVS Health — raise significant antitrust concerns over how these megacompanies will impact patient access and pharmaceutical pricing.
With the FDA’s approval of three new gene therapies, researchers and manufacturers must now figure out how streamline the development process.
AmpliPhi Biosciences is pushing bacteriophage-therapy development for drug-resistant infections — not to replace, but possibly to augment antibiotics.
Not much has changed in pharma cybersecurity since the NotPeyta ransomware attacked Merck last summer. Many biotech execs think they are too small to be targeted. They’re wrong.
With the General Data Protection Regulation (GDPR) going into effect in May, it is important that all EU companies and their global business partners comply with the guidelines.
The CEO and founder of Seattle Genetics, Clay Siegall, discusses one of the company’s new technologies, sugar-engineered antibodies (SEAs).
The founder and CEO of Seattle Genetics discusses a number of interesting topics, including how he was able to get the founders of Microsoft as early investors in his company.
Clay Siegall, the founder of Seattle Genetics, explains how his company became an unintentional-startup incubator for Alder BioPharmaceuticals.
The CEO of Seattle Genetics discusses the past, present, and future of some of his company’s partnerships.
This article posits that the orphan market is actually a collection of seven distinct business model archetypes that are driven by key disease, patient, and market characteristics. By disaggregating and characterizing these business models and their key success factors/risks, readers may be able to focus their corporate strategies to optimize the value and impact of their orphan therapies.
Only 12 therapeutics were approved for CNS indications between 2012 and 2016, as compared with 19 during the prior five-year period. Experts note that what is known about pathophysiology is more advanced in cancer than in CNS indications. The explanation for these developments differs across CNS indications. Here, we will focus on four CNS indications: AD, MDD, migraine, and schizophrenia.
Based on our research, the European Union (EU) is 10 years ahead of the United States with respect to biosimilar adoption. It is therefore unsurprising that the EU’s actions and policy decisions are having an impact on the U.S. market. In this two-part series, we will consider multiple facets of the EU’s influence. Part 1 will focus on payer coverage of biosimilars and the role of discounting and contracting. Part 2 will highlight the effects of the NOR-SWITCH trial results and how the EU’s view of biosimilars as therapeutic alternatives, rather than generics, has influenced U.S. policy.
In addition to understanding what influences employers’ health plan decision-making, it’s important to note employers' growing demands for greater pricing transparency and the complexity posed by the lack of an integrated benefits system.
The FDA Center for Devices and Radiological Health (CDRH) has proposed a reorganization that will collapse the Center’s seven offices into four, combining siloes of expertise into a new office that aligns talent into teams by product type and technology. Find out how this change may affect you.
Of the 17 biosimilar products litigated under BPCIA to date, in most cases (about 70 percent), the applicants engaged in and completed the patent dance before the lawsuits (setting aside allegations of noncompliance with the disclosure requirements). So far, in three instances, the biosimilar applicants have declined to dance outright.
Despite the challenges of maintaining an aseptic environment and producing a sterile drug product, I believed that someday science and technology would allow manufacturers to have the same level of confidence in aseptically processed products as they had in terminally sterilized products.
Excitement around the potential for blockchain platforms continues to build. This parallels the surge in popularity of blockchain-based cryptocurrencies such as Bitcoin. Meanwhile, “critics argue it’s all hype — a technological hammer looking for a nail — and that the complexities of health information prevent practical use of blockchain technology.”