BC Extra | Jan 23, 2020
Politics & Policy

MNCs lead price cuts in China’s second round of centralized procurement

MNC originators took the deepest price cuts in the second round of China’s expanded centralized procurement program for generic and off-patent drugs. A list released Tuesday by China’s Joint Procurement Office showed that 77 winning...
BC Innovations | Oct 31, 2018
Distillery Therapeutics

Cancer; infectious disease

INDICATION: Cancer; melanoma; cervical cancer; influenza virus Mouse and monkey studies suggest simvastatin could be used as an adjuvant to boost the efficacy of cancer and influenza vaccines. In mice, immunization with the antigen ovalbumin...
BC Extra | Jul 6, 2018
Preclinical News

New uses for marketed drugs in tough-to-treat indications

Two studies in Science Translational Medicine suggest three generics could be repurposed for difficult to treat indications. A paper from University of Edinburgh researchers showed that endothelial cell-targeted drugs simvastatin and perindopril could help treat...
BioCentury | Jul 7, 2017
Product Development

One small CETP for Merck

Merck & Co. Inc. ’s massive cardiovascular outcomes trial for anacetrapib finally may have shown a CETP inhibitor provides a benefit. But the question remains whether the relative risk reduction is large enough for it...
BC Week In Review | Feb 22, 2016
Clinical News

Vytorin regulatory update

Merck said FDA issued a complete response letter for sNDAs that were seeking to add claims of cardiovascular benefit to the labels of Vytorin ezetimibe/simvastatin and Zetia ezetimibe. The pharma markets the drugs to reduce...
BC Week In Review | Feb 22, 2016
Clinical News

Zetia ezetimibe regulatory update

Merck said FDA issued a complete response letter for sNDAs that were seeking to add claims of cardiovascular benefit to the labels of Vytorin ezetimibe/simvastatin and Zetia ezetimibe. The pharma markets the drugs to reduce...
BC Extra | Feb 17, 2016
Top Story

FDA rejects CV benefit claim for Vytorin, Zetia

Merck & Co. Inc. (NYSE:MRK) said FDA issued a complete response letter for sNDAs that were seeking to add claims of cardiovascular benefit to the labels of Vytorin ezetimibe/simvastatin and Zetia ezetimibe. The pharma markets...
BC Innovations | Feb 4, 2016
Distillery Therapeutics

Therapeutics:Proprotein convertase subtilisin/kexin type 9 (PCSK9)

Endocrine/metabolic disease INDICATION: Hypercholesterolemia Rat and monkey studies suggest virus-like particles (VLPs) displaying a human PCSK9 peptide could help treat hypercholesterolemia. In rats, a vaccine based on VLPs displaying peptide PCSK9(207-223) decreased total cholesterol by...
BioCentury | Feb 1, 2016
Strategy

Results may vary

The first handful of outcomes-based deals notched by Amgen Inc. and Novartis AG for new drugs in the U.S. provide early lessons for companies thinking about testing similar pricing models. The first is that companies...
BC Extra | Dec 15, 2015
Company News

FDA panel rebuffs Vytorin, Zetia CV benefit claim

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 10-5 that data did not show that adding Zetia ezetimibe to a statin reduced risk of CV events compared with a statin alone. The panel convened to...
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