Medicines licensing

New drug for chronic constipation approved by US Food and Drug Administration

The US Food and Drug Administration has approved plecanatide (Trulance; Synergy Pharmaceuticals) as another option for the treatment of chronic idiopathic constipation (CIC) in adults. Plecanatide, which should be taken daily, supports regular bowel function by stimulating the upper gastr…

One in three new cancer drugs brings no overall survival benefit

One in three newly approved cancer medicines is not associated with any overall survival benefit, according to new research. And one in five new oncology drugs neither extends life nor improves patient safety or quality of life, the analysis found. …

Return on investment falls for pharmaceutical industry

The return on investment in drug research and development being achieved by the pharmaceutical industry fell to 3.7% in 2016 – the lowest figure in the past six years, according to an industry analysis published by Deloitte.…

FDA approves nusinersen for use in rare genetic condition

The first drug approved to treat patients with the potentially fatal genetic disease spinal muscular atrophy has been approved for use in the United States.…

EMA recommends approval for oral rheumatoid arthritis drug

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended that baricitinib (Olumiant; Eli Lilly), an oral therapy for rheumatoid arthritis (RA), is granted a marketing authorisation in the EU.…

FDA approves rucaparib for ovarian cancer

The US Food and Drug Administration (FDA) has approved rucaparib (Rubraca) for ovarian cancer in women with BRCA mutations.…

FDA approves treatment for postmenopausal sexual dysfunction

The US Food and Drug Administration has approved dehydroepiandrosterone for the treatment of vulvovaginal atrophy in postmenopausal women.…

New treatment option for Parkinson’s disease launched in the UK

Drug company BIAL Pharm UK has launched opicapone (Ongentys), a new drug to improve mobility in some adult patients with Parkinson’s disease, for use in the UK. …

European conditional approval given for rare liver disease drug

The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended a new drug to treat a rare and potentially lethal liver disease for conditional marketing approval across the EU.  Obeticholic acid (Ocaliva; Intercept Pharma) has been re…

European medicines regulator sets out plans for revamped drug database

An electronic database containing information about all human medicines approved across Europe that will be accessible to the public as well as health professionals is being developed by the European Medicines Agency.…