Pharmaceutical companies

MHRA recommends that sildenafil is made available over the counter in the UK

Sildenafil — the prescription-only medicine branded as Viagra for the treatment of erectile dysfunction — could become a pharmacy (P) medicine if government proposals go ahead.…

EMA calls for suspension of generic drugs after concerns about quality of data

A list of generic drugs — including 41 that are available in the UK — have been recommended for suspension across the EU because of doubts over the quality of the bioequivalence data used to grant their national marketing authorisation.  The European Medicines Agency, the EU&r…

Dupilumab gets early access nod from UK regulator for atopic dermatitis

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a positive opinion for dupilumab in atopic dermatitis under the Early Access to Medicines Scheme.…

Patients in England will wait longer for expensive new drugs under NICE plans

The National Institute for Health and Care Excellence has announced plans to introduce a £20m budget impact test to slow down the introduction of the most expensive drugs.…

NICE recommends two more cancer drugs for routine NHS use

The National Institute for Health and Care Excellence (NICE), the health technology assessment body, has issued positive opinions on two bowel cancer drugs, cetuximab and panitumumab, that were previously available through the cancer drugs fund (CDF). …

Manchester could pay for medicines based on efficacy

The health service in Manchester has signed a deal with the pharmaceutical industry that could lead to the authorities paying for medicines based on their efficacy.…

FDA approves brodalumab for psoriasis with notice about risk of suicide

The US Food and Drug Administration (FDA) has approved an injectable biologic, brodalumab (Siliq), for psoriasis in adults that comes with a warning about the risk of suicide.  The monoclonal antibody, which is indicated for moderate-to-severe disease, will receive a boxed warning and wil…

FDA approves deflazacort for Duchenne muscular dystrophy but manufacturer delays launch over price concerns

The US Food and Drug Administration has approved the first corticosteroid to be made available in the United States for the treatment of patients with Duchenne muscular dystrophy.…

Superior shelf-life of Emerade

Last summer, I went into anaphylactic shock after being stung by a wasp. When I had recovered, my GP said I should carry an adrenaline auto-injector pen with me and we chose the Emerade brand rather than Epipen because, in addition to having a higher and more realistic dosage (500μg) i…

President Trump demands lower drug prices but vows to overhaul drug approvals process

The US president has told pharmaceutical company executives that they must reduce drug prices in the United States, but promised them he will streamline US Food and Drug Administration (FDA) processes to speed up new drug approvals.…