BioCentury | Jul 10, 2020
Product Development

IQVia’s Dreyer on how real-world data are poised to break new ground

Real-world data isn’t just about post-market analysis of new drugs and vaccines. With the pandemic putting the benefits on display, epidemiologists are finding new ways to use the data, and new data sources, to support...
BioCentury | Feb 14, 2020
Regulation

Controversy over stretching expanded access to off-label uses

Compassionate use is no exception to the axiom that sooner or later, someone will find an unexpected and controversial way to bend any law or regulation for unanticipated purposes. FDA’s expanded access, or compassionate use,...
BioCentury | Feb 5, 2020
Politics, Policy & Law

FDA’s Pazdur supports expanded access for approved drugs

Richard Pazdur, director of FDA’s Oncology Center of Excellence, Wednesday said he supports authorizing expanded access requests for unapproved uses of approved medicines. Although physicians can prescribe drugs for off-label indications, it can be difficult...
BioCentury | Sep 26, 2019
Tools & Techniques

Biotechs propose solutions to impending shortage of AI talent

Competition for AI talent is about to get fierce as companies across biopharma, and every other sector, begin to deploy machine learning in house. Right now, biotechs are aiming to fill their talent needs through...
BioCentury | Aug 26, 2019
Company News

Simone Fishburn announced as BioCentury’s new Editor in Chief

BioCentury Inc. has announced the promotion of Simone Fishburn, Ph.D., to the position of Editor in Chief. She is only the third person to hold the Editor’s title in BioCentury’s 27-year history. In addition to...
BioCentury | Aug 5, 2019
Company News

Aug. 5 Company Quick Takes: Briefing docs for Descovy cast doubt on full PrEP approval; plus Alnylam, Provention and more

FDA questions Descovy as PrEP in cis women Briefing documents released ahead of the Aug. 7 Antimicrobial Drugs Advisory Committee meeting for Descovy emtricitabine/tenofovir alafenamide from Gilead Sciences Inc. (NASDAQ:GILD) indicate that FDA is uncertain...
BioCentury | Apr 19, 2019
Politics, Policy & Law

Thin U.S. biosimilars market fuels proposals to regulate biologics prices

Frustration over the failure of biosimilars to slash the costs of decades-old biologics has prompted a group of policy analysts to suggest abandoning attempts to copy biologics. Because the sole purpose of biosimilars is to...
BioCentury | Oct 31, 2018
Distillery Therapeutics

Renal

...INDICATION: Renal Patient sample and mouse studies suggest inhibiting DAB2 could help treat chronic kidney disease...
...83 CKD risk loci previously identified by genome-wide association studies (GWAS) yielded 27 genes, including DAB2...
...DAB2 and validating the other 26 genes as therapeutic targets for CKD. TARGET/MARKER/PATHWAY: Disabled homolog 2 (DAB2; DOC2...
BioCentury | Dec 23, 2017
Regulation

Prioritizing preferences

The realization that patients have distinct preferences about the trade-offs and risks inherent in medical decisions -- and that their choices are frequently different from those physicians or regulators would make -- has mobilized FDA,...
BioCentury | Oct 16, 2017
Company News

Retinopathy a mild concern in semaglutide briefing docs

In briefing documents issued ahead of an advisory committee meeting for subcutaneous semaglutide (NN9353) from Novo Nordisk A/S (CSE:NOVOB; NYSE:NVO), FDA reviewers acknowledged that the candidate poses a risk of diabetic retinopathy, but noted that...
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