USFDA

FDA gives thumbs-up to Balversa The U.S. FDA has granted approval of Balversa (erdafitinib) to Belgium-based Janssen Pharmaceutica, for the treatment of advanced or metastatic bladder cancer. This drug is the first ever approved target-specific medication targeting susceptible FGFR genetic mutations, and for can...

Gordon and Betty Moore Foundation gives USD 85 Million to stop delayed, erroneous diagnostics The Gordon and Betty Moore Foundation is putting up money for improving diagnostics. The Foundation focuses on a plethora of areas, including those outside of healthcare, such as environmental conservation. It has an annua...

Gene Therapy is now touted as a new revolution for cancer treatment. If the list of new cancer treatment methodologies is traversed, then the end seems to be farther and farther away. As a sequel to the relentless efforts by researchers across the world to formulate therapies better than the existing ones, new prosp...

Merck and Eisai has entered into an Oncology Pact worth Up to USD 5.76 Billion Two major pharmaceutical companies (Merck & Eisai) has entered into a USD 5.76 Billion pact to develop and commercialize Lenvima (lenvatinib mesylate) both as a monotherapy and an in-combination therapy for treating multiple types of ...

Familial Amyloid Polyneuropathy (also known as transthyretin amyloidosis, TTR, and FAP) is a group of endangering multisystem disorders which are transmitted as an autosomal dominant trait. It is caused by the excessive accumulation of amyloid in the organs and tissues. The first identified cause of FAP is the Val30...

Gene therapy is back into play after a decade-long failed deliveries. 2017 was a golden year in gene therapy arena, various companies are aggressively developing gene therapy based treatments targeting life-threatening indications. Spark therapeutics got USFDA approval for the first-ever gene therapy based blindness...

Novo petitions FDA to require copies of Victoza to conduct clinical trials With one drugmaker already trying to pry patent protection off of Novo Nordisk’s blockbuster Victoza before its 2022 expiration, the insulin specialist has taken new steps to deter copies. The Danish drugmaker has filed a citizen petition arg...

Samsung and Merck launch Remicade biosim at 35% discount After the first biosimilar of Johnson & Johnson’s big-selling immunology drug Remicade hit the market last year at a modest discount, another has come along with a much deeper pricing slash. Samsung and marketing partner Merck & Co. Monday launched the...

Roche, Boehringer tout new idiopathic pulmonary fibrosis analyses to boost their rival medications The idiopathic pulmonary fibrosis (IPF) market-share battle between Roche’s Esbriet and Boehringer Ingelheim’s Ofev hasn’t let up since the FDA green-lighted the medications in October 2014. And this week, both drugmak...

The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co.) for adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and...