Eight medicines have been backed for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use, including new therapies to treat hepatitis C, multiple sclerosis and cancer.
News
US approval for Portola’s BevyxXa
Portola Pharmaceuticals’ BevyxXa has been cleared by the US Food and Drug Administration for preventing blood clots in hospitalised patients.
EU regulators reviewing Shire’s bleeding disorder drug
European regulators have validated the marketing authorisation application for Shire’s experimental von Willebrand Disease therapy Veyvondi.
Roche’s haemophilia drug cut bleeds by 87 percent in trial
Roche has presented a new batch of data showing that its experimental bispecific monoclonal antibody emicizumab significantly reduced bleeds in patients with haemophilia A and inhibitors to factor VIII.
ABPI suspends Astellas UK for a further year
Astellas UK’s membership of the Association of the British Pharmaceutical Industry has been suspended for a further 12 months because of a number of “serious breaches” of the Code of Practice.
NICE turnaround for AstraZeneca’s COPD drug Daxas
AstraZeneca’s Daxas is now likely to be routinely available on the NHS to patients with chronic obstructive pulmonary disease (COPD), after new evidence helped persuade cost regulators that the drug is value for money in this setting.
US nod for CSL Behring’s HAE prevention therapy
US regulators have approved CSL Behring’s Haegarda, the first C1 esterase inhibitor for subcutaneous administration to prevent hereditary angioedema (HAE) attacks in adolescent and adults
Green light for Novartis’ lung cancer combination therapy
Novartis’ combination therapy Tafinlar + Mekinist has won approval from the US Food and Drug Administration to treat patients with metastatic non-small cell lung cancer (NSCLC) carrying the BRAF V600E mutation.
NHS England re-opens innovation accelerator scheme
NHS England is again issuing a call for the world’s “best healthcare innovations” to improve frontline patient care in a further round of the NHS Innovation Accelerator programme.
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Novartis drug cuts cardiovascular risk in heart attack survivors
An experimental antibody being developed by Novartis has cut cardiovascular risk in patients who have survived a heart attack in a late-stage study.
DMD patients in the UK win early access to Santhera’s Raxone
Santhera Pharmaceuticals’ Raxone has become the first drug for Duchenne Muscular Dystrophy (DMD) to join the UK’s Early Access to Medicines Scheme (EAMS).
Shire secures US nod for once-daily ADHD drug
Shire has finally bagged approval in the US for its long-acting attention deficit hyperactivity disorder drug (ADHD) Mydayis.
EU regulators review Novartis’ migraine drug
An experimental therapy being developed by Amgen and Novartis to prevent migraine has been accepted for review in the European Union.
Charity sets eight new ‘grand challenges’ to combat cancer
Earlier detection of cancer through interrogation of medical and non-medical data sets using machine and deep-learning is one of eight new key quests set by Cancer Research UK in the second phase of its Grand Challenge Fund.
