New drug approvals all but screeched to a halt in 2016, with a measly 22 new OKs after a pair of bountiful years. But the FDA wasted no time in 2017, signing off on 12 drugs in the first quarter alone—besting its record for the same period of any year in recent history.
A new drug developed by Merck & Co and Pfizer Inc won U.S. approval on Wednesday to treat type II diabetes, the Food and Drug Administration(FDA) said, adding another competitor to a growing class of treatments.
AbbVie’s investigational JAK1-inhibitor upadacitinib yielded positive top-line results in a Phase III trial as a monotherapy for rheumatoid arthritis patients. But the drug shows that it is still plagued by some safety concerns.
Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) has initiated the United States Phase I bridging clinical trial of fruquintinib. Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors (“VEGFR”) 1, 2 and 3, that has met its primary endpoint in several Phase II and III clinical trials in China for the treatment of colorectal, lung and gastric cancers. The clinical study in the U.S. is a multi-center, open-label, Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of fruquintinib in U.S. patients with advanced solid tumors. The first drug dose was administered earlier this month. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT03251378.
Pfizer has won a first approval for OTC Viagra. Viagra Connect, the Pfizer OTC name for its blockbuster erectile dysfunction drug, has been approved for sale in the U.K.
The frontrunner in the race to commercialize CGRP migraine medications just picked up some added momentum. Amgen $AMGN has published promising Phase III data that might lend to its approval, keeping the company — and its partner Novartis — ahead of its many competitors in the crowded space.
Chinese biotech groups are on target to raise about $10bn this year from venture capital funding, initial public offerings and licensing deals with overseas pharma companies, in what is partly a bet that Chinese-developed drugs can compete globally.
Encouraged by evidence of the impact that its diabetes drug semaglutide can have on obesity, with patients shedding an average of 16% of their weight in a mid-stage study, top researchers at Novo Nordisk today unveiled an ambitious late-stage strategy to make their mark in a tough, but potentially blockbuster market.
Peptidream Inc. has scored another billion dollar-plus agreement to develop peptide-based therapies aimed at the treatment multiple disease targets.
New data presented today showed that Jardiance® reduced the risk of cardiovascular death compared with placebo when added to standard of care in adults with type 2 diabetes and peripheral artery disease.
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