Good morning, everyone, and nice to see you again. We hope the long weekend respite was relaxing and invigorating, because the familiar routine of meetings, deadlines, and whatnot has now returned. But you knew this would happen, yes? Well, what can you do, except to pour another cup of stimulation and get on with it. So to help you along, here are some tidbits. Hope you survive and, of course, do keep in touch …
Sun Pharmaceutical, which is India’s largest drug maker, received a subpoena from the US Department of Justice seeking information about the pricing and marketing of generic drugs sold in the US, the Economic Times says. The agency’s antitrust division also asked for documents related to employee and corporate records and communications with competitors.
GlaxoSmithKline won European approval for Strimvelis, the world’s first life-saving gene therapy to treat ADA severe combined immunodeficiency, News18 reports. The disease is sometimes called “bubble baby” disease, because the children born with the affliction have immune systems so weak they must live in germ-free environments. The price has not yet been announced.
Jazz Pharmaceuticals agreed to pay $1.5 billion for Celator Pharmaceuticals, Bloomberg News writes, adding that Celator recently announced positive study results for a leukemia drug. Earlier this month, the US Food and Drug Administration granted breakthrough therapy designation for the Celator drug, which is called Vyxeos. Jazz, by the way, would pay about double Celator’s market value of roughly $740 million.
The FDA warned CordenPharma about manufacturing operations at a plant in Italy that was approved to make injectable cancer drugs last year, InPharma Technologist says.
Biogen and AbbVie won FDA approval for Zinbryta, a once-monthly injection for people with relapsing forms of multiple sclerosis, but it comes with a boxed warning, Pharma Times reports.
Samsung Bioepsis won European approval to sell a biosimilar version of Johnson & Johnson’s Remicade, PMLive says, noting this is the second biosimilar of the drug to be approved in the EU.
Amicus Therapeutics won European approval for the first-ever oral treatment for Fabry disease, a genetic disorder that affects about 5,000 to 10,000 people across the world.
Medivation called a $9.3 billion hostile offer from Sanofi a “devil’s bargain” and argued that the directors proposed by Sanofi are inexperienced in biopharma, TheStreet tells us.
Intercept Pharmaceuticals won FDA approval for a drug to treat primary biliary cirrhosis, an uncommon, slow-progressing liver disease, its first product to reach the US market, Bloomberg News writes.
A pair of drugs for eczema, which are potentially safer and more effective than existing steroid creams or pills, may reach the market in 2017, the Wall Street Journal tells us.
Gilead Sciences and Merck both received positive opinions from a European Union committee for two-drug, once-daily combinations for treating adults with hepatitis C, PMLive writes.
Roche received European approval for an injectable form of its MabThera therapy for people with chronic lymphocytic leukemia, Reuters says.
Granules India received an Establishment Inspection Report from the FDA following an inspection at its plant in Telangana, according to the Economic Times.