CHMP recommend Shire’s rare disease treatment for use in EU

EMA’s CHMP committee has recommended Shire’s Lanadelumab, a new rare disease treatment which has blockbuster potential. Lanadelumab has been endorsed for prevention of recurrent attacks of hereditary angioedema (HAE) a rare, genetic disorder that results in recurring attacks of oedema in parts of the body, including the abdomen, face, feet, genitals, hands and throat. Laryngeal

Continue Reading

NHS approves combination skin cancer therapy from Novartis

NHS has three months to ensure that Novartis’ combination therapy dabrafenib/trametinib is routinely available to eligible skin cancer patients, after cost regulators published guidance backing funds for the treatment. NICE recommended the combination for use in patients with stage III BRAF V600 mutation-positive melanoma that has spread to lymph vessels, or lymph glands close to

Continue Reading

Novartis seeks approval for Multiple Sclerosis drug in EU and US

Novartis is seeking approval from EU and US for use of experimental multiple sclerosis therapy, siponimod, to treat secondary progressive forms of MS. Secondary progressive multiple sclerosis (SPMS) is where the disease causes continuous worsening of neurological function over time, independent of relapses. Most people with relapsing remitting forms of MS will eventually go on

Continue Reading

European Commission approved AZ’s treatment for locally advanced, unresectable NSCLC

AstraZeneca’s durvalumab has been approved in Europe for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC). The decision enables doctors to prescribe the drug for adults with stage III NSCLC whose tumours express PD-L1 on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT). The

Continue Reading

Regulatory Professionals to attend TOPRA 2018 Symposium in Sweden

Regulatory Professionals employees Sarah Goddard, Divisional Director and Kirsty Calow, Divisional Manager will be exhibiting at the 2018 TOPRA Symposium, which is taking place in Sweden October 1-3rd. The Symposium features the following: Information on the latest regulatory developments Insight provided directly from Regulatory experts Opportunity for delegates to expand on their existing knowledge of

Continue Reading