The US Food and Drug Administration (FDA) has approved Brineura (cerliponase alfa) as a treatment for a specific form of Batten disease. Brineura is the first FDA-approved treatment to slow loss of walking ability (ambulation) in symptomatic paediatric patients three years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also [...]
Global pharmaceutical company, Mylan, has announced the US launch of Perphenazine Tablets USP, 2 mg, 4 mg, 8 mg and 16 mg, a generic version of the reference listed drug, Trilafon Tablets 2 mg, 4 mg, 8 mg and 16 mg, originally marketed by Schering. Mylan received final approval from the US Food and Drug [...]
The US Food and Drug Administration (FDA) has approved Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia. This is the first drug approved by the FDA for this condition. Tardive dyskinesia is a neurological disorder characterized by repetitive involuntary movements, usually of the jaw, lips and tongue, such as grimacing, sticking out the tongue [...]
Pfizer has confirmed that the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has launched a public consultation on the reclassification of sildenafil 50mg to non-prescription, pharmacist-supplied (P) status for the treatment of erectile dysfunction. Erectile dysfunction is a common, self-recognisable condition, and research has estimated that half of men between the ages [...]
The Care Quality Commission (CQC) has taken further action to protect people in England who are using websites to obtain prescription medicines. The quality regulator has published inspection reports on four more providers, which detail examples of people being put at risk of harm, with insufficient checks on their identity, poor recording of their medical [...]
In a new snapshot survey of leading pharmaceutical businesses in the UK, companies have said that changes to the way the National Institute for Health & Care Excellence (NICE) and NHS England (NHSE) assess new medicines, which came into effect on 1st April, will decrease access to the latest treatments, with new medicines for cancer [...]
Actavis UK has rebranded to become Accord Healthcare. This follows its acquisition by Intas Pharmaceuticals, through its wholly owned subsidiary Accord Healthcare in January 2017. The combination of the two organisations facilitates the aim for Accord to become the largest generic pharmaceutical business in the UK and a leading player in the industry at European [...]
The US Food and Drug Administration (FDA) has approved Odactra, the first allergen extract to be administered under the tongue (sublingually) to treat house dust mite (HDM)-induced nasal inflammation (allergic rhinitis), with or without eye inflammation (conjunctivitis), in people 18 through 65 years of age. ‘House dust mite allergic disease can negatively impact a person’s [...]
The US Food and Drug Administration (FDA) has approved Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two times per night to urinate due to a condition known as nocturnal polyuria (overproduction of urine during the night). Noctiva is the first FDA-approved treatment for this condition. ‘Today’s approval provides adults who overproduce [...]
Now in its seventh year, the Pharmaceutical Innovation Index (PII) celebrates the pharmaceutical companies that are most successful at developing and commercialising innovation. The Index can be summarised by the question: if you gave the same molecule to two different companies in early phase, which would make the best of it? Based on systematic, objective [...]
