The European Commission have announced that they have granted regulatory approval to Alcon’s (Novartis’ ophthalmology division) Simbrinza, the only fixed-combination therapy for patients with glaucoma that doesn’t involve a beta-blocker. The European regulators have approved Simbrinza (brinzolamide / brimonidine tartrate) to decrease elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension, where
Amag Pharmaceuticals have received a setback for their anaemia drug, Feraheme, after the US Food and Drug Administration (FDA) rejected Amag’s application to expand the drug’s label. The regulatory agency issued a complete response letter for the supplemental New Drug Application to increase use of Feraheme (ferumoxytol) beyond the current chronic kidney disease indication, to
Merck & Co have unveiled plans to cut around 8,500 jobs, in addition to previously-announced cuts of 7,500 roles, in an attempt to decrease costs and improve competitiveness. Merck are expecting to make $2.50 billion in yearly cost savings by the end of 2015 and the majority of this will come from a reduction of
It’s perhaps fair to say that the changes within pharmaceutical outsourcing over recent years have led to a level of disruption for talent strategies. As organisations have moved from solely internal teams of clinical professional and researchers, to fully outsourced divisions, right up to the mix we see today, there’s one key audience that have
Advisors to the European Medicines Agency (EMA) have voted in support of approving GlaxoSmithKline/ Theravance’s Relvar Ellipta for both asthma and chronic obstructive pulmonary disease (COPD). The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has delivered a response recommending marketing authorisation for Relvar Ellipta, a combination of the inhaled corticosteroid fluticasone
Scottish regulatory body, the Scottish Medicines Consortium (SMC), have approved Roche’s MabThera (rituximab) for the National Health Service (NHS) in Scotland. MabThera has been approved to treat two potentially life-threatening illnesses, GPA and MPA.
GlaxoSmithKline’s (GSK) Tafinlar has been given the green light by the European Commission to be used as an oral treatment for unresectable or metastatic melanoma in adults with a BRAF V600 mutation. Tafinlar (dabrafenib) is an orally bioavailable inhibitor of BRAF, part of the pathway that regulates the normal growth and death of cells. Mutations
Roche have posted positive clinical trial Phase II results for lampalizumab when treating age-related macular degeneration (AMD). The clinical trial demonstrated that patients with the dry form of AMD had a 20% reduction in geographic atrophy after 18 months’ treatment.
US regulators have granted Novartis’ experimental muscle wasting drug, bimagrumab, ‘breakthrough’ status, potentially granting it fast-track to being approved. The US Food and Drug Administration (FDA) has decided to grant BYM338 (bimagrumab) a potential breakthrough because, if it is approved, it could become the first treatment for patients with sporadic inclusion body myositis, a rare
It is looking unlikely that Pfizer’s Bosulif (also known as Bosutinib) will be made available on the NHS, after cost regulator, NICE, released preliminary draft guidance rejecting the drug’s use in patients with chronic myeloid leukaemia (CML). Bosulif has already been approved in Europe as well as the US for use after treatment with one
