AstraZeneca’s Calquence has been given a speedy green light in the US as a treatment for adults with mantle cell lymphoma.
News
GW completes Epidiolex submission
GW Pharmaceuticals and its US subsidiary Greenwich Biosciences have completed the rolling submission of Epidiolex as adjunctive treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, two difficult-to-treat forms of childhood-onset epilepsy.
AZ farms out rare disease therapy to Mereo
AstraZeneca has licensed an experimental rare disease therapy to UK-based Mereo BioPharma, as it continues to shed products outside of its area of strategic focus.
Pfizer, Celltrion say data backs switch to Remicade biosimilar
Pfizer and Celltrion Healthcare have unveiled new data showing that switching patients with Crohn’s disease from Remicade to biosimilar Inflectra showed comparable efficacy, safety and tolerability over a 24-week period.
Bayer files long-acting haemophilia therapy in the US
US regulators are reviewing Bayer’s BAY94-9027, a longer-acting Factor VIII therapy designed to reduce the number of infusions necessary to prevent bleeds in patients with Haemophilia A.
Concept buys Scottish CRO Aquila
Manchester, UK-based Concept Life Sciences, an integrated drug discovery, development and analytical services company, has acquired Scottish contract research organisation Aquila BioMedical.
MSD pulls EU filing for Keytruda combo
MSD has pulled back its application to market Keytruda (pembrolizumab) in the European Union in combination with pemetrexed and carboplatin as a first-line treatment for metastatic nonsquamous non-small cell lung cancer (NSCLC).
Novartis bolsters oncology offering with $3.9bn deal
Novartis has unveiled plans to buy Advanced Accelerator Applications (AAA) for $3.9 billion in cash, beefing up its oncology portfolio.
2016 saw jump in complaints to UK pharma regulator
The number of complaints to the Prescription Medicines Code of Practice Authority, which polices adherence to the Association of the British Pharmaceutical Industry’s Code of Practice, jumped significantly last year.
UK pharma contributes £190m to NHS meds bill
The UK pharmaceutical industry has paid the Department of Health £190 million during the first two quarters of 2017 under the 2014 Pharmaceutical Price Regulation Scheme (PPRS).
EU regulators to review Sandoz’ Neulasta biosimilar
The European Medicines Agency has accepted for review Novartis unit Sandoz’ biosimilar of Amgen’s Neulasta.
NHS could have prevented WannaCry attack
The NHS could have prevented the WannaCry cyber attack earlier this year if it followed basic IT security best practice, an investigation by the National Audit Office has found.
Shire’s HAE drug Firazyr cleared for children
European regulators have approved a label extension for Shire’s Firazyr, broadening its use include adolescents and children aged two years and older with a particular type of HAE.
New analysis backs benefit-risk profile of Merck’s Mavenclad
Merck has released new data showing a positive benefit-risk profile for its multiple sclerosis drug Mavenclad.
FDA considers Avastin as first-line ovarian cancer therapy
US regulators are reviewing a potential new indication for Avastin as a first-line option for advanced ovarian cancer, filed by Roche group Genentech.
