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Regulators in the EU have cleared the way for Amgen to market its cholesterol-lowering drug Repatha, marking the world’s first approval of a PCSK9 inhibitor. Read More
Excipient makers preparing for the new GMP standard NSF/IPEC/ANSI 363 should be aware they are expected to police themselves to determine if they are meeting manufacturing requirements for their products. Read More
The UK’s healthcare costs regulator is recommending Daiichi Sankyo’s oral anticoagulant Lixiana as a cost-effective drug that causes less disruption to patients’ lives while treating blood clots in deep veins that could lead to fatal blockages. Read More
Otsuka and H. Lundbeck expect to launch once-daily Rexulti as a treatment for schizophrenia and add-on therapy for major depressive disorder in early August, following FDA approval Monday. Read More