NDA Submitted for Novel, Targeted Antibiotic Iclaprim

NDA Submitted for Novel, Targeted Antibiotic Iclaprim

June 18, 2018 Iclaprim, a diaminopyrimidine antibiotic, has also received Qualified Infectious Disease Product designation as well as Fast Track designation. The New Drug Application (NDA) for iclaprim (Motif Bio), a targeted, Gram-positive investigational antibiotic for the […]

Valeant's Rebound Falters After Key Drug Is Rejected

Valeant's Rebound Falters After Key Drug Is Rejected

Print Valeant Pharmaceuticals International Inc.’s rebound from this year’s low in March was stopped in its tracks after U.S. regulators rejected its application for a plaque psoriasis lotion, Duobrii, that management saw as the first of many new drugs to hit the market in the next few years. The shares, which peaked last week at […]

Detox Center Plan In Downtown Highlands Meets Resistance

Detox Center Plan In Downtown Highlands Meets Resistance

Located a less than a half mile north of the Chubby Pickle and less than third of a mile south of The Claddagh, the abandoned Highlands Methodist Church at 181 Bay Ave. is the proposed site of a new drug and alcohol detox center. An application for the development of the site came before the […]

Myriad's BRACAnalysis CDx® Supplementary PMA Accepted by FDA for Review as a Companion Diagnostic for …

Myriad's BRACAnalysis CDx® Supplementary PMA Accepted by FDA for Review as a Companion Diagnostic for …

SALT LAKE CITY, June 18, 2018 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplementary premarket approval (sPMA) application for BRACAnalysis CDx® to be used as a companion diagnostic with Pfizer’s PARP (poly ADP ribose polymerase) inhibitor, […]

Global Cardiology Surgery, Devices and Drugs Market Overview, Segmentation, Application and Competitive …

Global Cardiology Surgery, Devices and Drugs Market Overview, Segmentation, Application and Competitive …

A new market study, titled “Global Cardiology Surgery, Devices and Drugs Market Research and Forecast, 2018-2023”, has been featured on WiseGuyReports. The report covers three major segments of interventional cardiology market which include surgeries, devices, and drugs. As per WHO more than 17 million people died due to CVD in 2015 which makes is the […]

2 Clinical-Stage Biotech Stocks That Could Soar Next Week

2 Clinical-Stage Biotech Stocks That Could Soar Next Week

Although it’s never a good idea to try to time the market, there are undoubtedly better times than others when it comes to buying clinical-stage biotech stocks. If you buy too early, for instance, you can end up having to wait years before a company reaches an important clinical milestone, and that could mean enduring […]

Gottlieb sets a new standard for FDA commissioner

Gottlieb sets a new standard for FDA commissioner

Dr. Scott Gottlieb, FDA commissioner Dr. Scott Gottlieb has taken industry skeptics
 by surprise. When the Trump administration tapped Gottlieb to lead the U.S. Food and Drug Administration last year, branded-drug manufacturers and their investors celebrated. Others were less exuberant. Industry observers expected Gottlieb, who advised GlaxoSmithKline and was a board member for several other […]

Big data targets drug resistance

Big data targets drug resistance

Daly, who, before becoming dean directed the pediatric bone marrow program at Boston Children’s Hospital and the Dana-Farber Cancer Institute, said physicians there — concerned about infection because bone marrow transplants weaken the immune system — could see that the tools they had at their disposal were weakening. “The fact is that the diminishing potency […]