The US Food and Drug Administration has approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate-to-severe kidney disease and those who are on dialysis. Mavyret is also approved for adult patients with HCV genotype 1 infection [...]

The US Food and Drug Administration has approved Endari (L-glutamine oral powder) for patients age five years and older with sickle cell disease to reduce severe complications associated with the blood disorder. ‘Endari is the first treatment approved for patients with sickle cell disease in almost 20 years,’ commented Richard Pazdur, MD, Acting Director of [...]

Sanofi and its specialty care global business unit, Sanofi Genzyme, have announced that the European Commission (EC) has granted marketing authorisation for Kevzara® (sarilumab) in combination with methotrexate (MTX) for the treatment of moderately-to-severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease [...]

The US Food and Drug Administration has approved Haegarda, the first C1 Esterase Inhibitor (Human) for subcutaneous (under the skin) administration to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients. The subcutaneous route of administration allows for easier at-home self-injection by the patient or caregiver, once proper training is received. HAE is caused [...]

LEO Pharma has announced that the first patients have been dosed in a phase three clinical study of tralokinumab. Tralokinumab is an investigational human monoclonal antibody that specifically targets the cytokine IL-13, which plays an important role in the development of moderate-to-severe atopic dermatitis. Tralokinumab is not currently licensed in any indication. ECZTRA 1, the [...]

In drug development, the body can be something of a black box. We take medicine and observe the overall effects, but what happens inside the body largely remains a mystery. To help clear up this picture, researchers are turning to imaging techniques in tissue and animal testing. The step has gained ground in the drug [...]

The 2017 Welsh Pharmacy Awards once again cast a spotlight on the sector’s key players and innovators, commending and celebrating their stories of success. The prestigious annual event is dedicated to honouring those whose exceptional expertise and contribution have transformed the provision of pharmaceutical care for the better. This year, The Vale Resort, Glamorgan, was [...]

The US Food and Drug Administration has expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis. This new indication provides the first FDA-approved therapy, specific to this type of vasculitis. ‘We expedited the development and review of this application because this drug fulfills a critical need for patients with [...]

A study of how policies restricting pharmaceutical promotion to physicians affect medication prescribing found that physicians in academic medical centres (AMCs) prescribed fewer of the promoted drugs, and more non-promoted drugs in the same drug classes, following policy changes to restrict marketing activities at those medical centres. The analysis encompassed 16.1 million prescriptions; while the [...]

The US Food and Drug Administration has approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease. ‘After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer about filing a marketing application in the United States,’ explained Eric [...]