Gilead recently announced that it submitted a request to FDA to rescind the orphan drug status it was granted for the investigational antiviral remdesivir, which is currently a potential COVID-19...
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...
Vizient recently announced it has sent recommendations to the White House Coronavirus Task Force and FDA to improve access for two potential COVID-19 drugs: chloroquine and hydroxychloroquine.
For...
Global specialist HIV company ViiV Healthcare, owned by GSK, and UNC-Chapel Hill recently announced a five-year, $20 million renewal of a public-private partnership to discover a possible HIV...
Globally, companies manufacturing gene therapy, cell therapy, and other regenerative medicines raised nearly $10 billion in 2019, the second-highest year on record, according to a recent analysis from...
Patients will now have access to a cheaper version of the drug at the center of a recent price gouging case. In an announcement on Feb. 28, the FDA reported that it has approved the first generic drug...
Biopharmaceutical companies spent an estimated $985 million on new drug development and research over a decade, counting expenditures on failed trials, according to researchers from the London School...
Law firm Lieff Cabraser, Heimann & Bernstein recently filed a wrongful death lawsuit against biopharmaceutical manufacturer Alkermes, for its alleged misrepresentation of an opioid dependence drug,...
Germany-based pharmaceutical company, Stada, announced it acquired 15 well-established local and regional consumer over-the-counter (OTC) products from GlaxoSmithKline (GSK).
The proposed...
Tying drug prices to those in other developed countries may be a useful strategy for lowering US prescription drug spending, but international reference pricing may not be ideal, according to...
Biotechnology and pharmaceutical stakeholders largely supported guidance from the FDA on patient-focused drug development, but some sought some clarification about FDA decision-making.
The agency held...
HHS launched on Monday the nation’s first Foundry for American Biotechnology for producing technological solutions that help protect against and respond to health security threats, as well as...
A chronic disease management drug used to treat type 2 diabetes showed real-world efficacy, even working slightly better among patients who would have been considered ineligible to participate in phase...
Biogen recently won an ongoing patent dispute over its multiple sclerosis (MS) drug, Tecfidera, which pulled in nearly $4.4 billion in revenue in 2019, according to a decision from the US Patient 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 Coalition for Epidemic Preparedness Innovations launched three programs to develop vaccines for the coronavirus, including through partnerships with US-based biotechnology companies Inovio...
The Government Accountability Office unveiled a report on Tuesday that identifies challenges and opportunities with the use of machine learning throughout the drug development lifecycle.
Machine...
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...
A new study published Tuesday in JAMA suggests that the evolution of drugs and biologics’ regulatory approval programs at the US Food and Drug Administration has resulted in a system that...
As the Food and Drug Administration looks to reorganize its Office of New Drugs (OND) this year, drugmakers and industry trade groups have recommendations to inform OND’s...
