US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and NIH Director Francis Collins testified on Thursday before the House Energy & Commerce Committee on how their agencies have worked to implement provisions from the 21st Century Cures Act passed and signed by President Barack Obama a month before he left office.
CPhI India was held from November 28th to November 30th, 2017 at the Bombay Exhibition Centre in Mumbai, India.
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.
Biogen (Nasdaq:BIIB) and Alkermes plc (Nasdaq:ALKS) today announced that they have entered into a global license and collaboration agreement to develop and commercialize ALKS 8700, a novel, oral, monomethyl fumarate (MMF) small drug molecule in Phase 3 development for the treatment of relapsing forms of multiple sclerosis (MS).
Medeor Therapeutics announced it had closed on an oversubscribed Series B financing worth $57 million. The round was led by RA Capital Management. New investors included Sofinnova Ventures and 6 Dimensions Capital. They were joined by existing investors Vivo Capital and WuXi Healthcare Ventures.
Janssen-Cilag International NV announced that the European Commission (EC) has approved TREMFYA® (guselkumab) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. Guselkumab is the first biologic that selectively blocks interleukin (IL)-23, a key driver of the immune inflammatory response in psoriasis.
Gilead Sciences, Inc. (NASDAQ: GILD) announced that the China Food and Drug Administration (CFDA) has approved Sovaldi® (sofosbuvir 400mg), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. Sovaldi was approved for the treatment of adults and adolescents (aged 12 to 18 years) infected with HCV genotype 1, 2, 3, 4, 5 or 6 as a component of a combination antiviral treatment regimen. Sovaldi is the first Gilead HCV medicine approved in China.
On Friday, November 17, Genentech, a Roche company, sued Pfizer in a federal court in Wilmington, Delaware, over Pfizer’s biosimilar for Genentech’s Herceptin. Genentech is claiming that Pfizer’s proposed biosimilar infringes 40 of its patents. Genentech also is demanding compensation for lost sales if Pfizer launches its copycat version before the Herceptin patents expire.
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.
Maintaining sufficient vitamin D levels may help to prevent the onset of inflammatory diseases like rheumatoid arthritis, research led by the University of Birmingham has discovered.
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