FDA has recently approved GSK’s triple therapy inhaler, the news follows on shortly from an EMA CHMP positive opinion and the FDA advisory panel’s recent nod for its shingles vaccine, Shingrix. The news was highly welcomed, especially in the chronic obstructive pulmonary disease (COPD) area, as the current major seller in the area, Advair, faces
The Food and Drug Administration has approved Fast Track designation for Shire’s SHP607, a treatment used in the prevention of chronic lung disease in extremely premature infants. SHP607, which is currently in Phase 2 Clinical Development, is a recombinant human version of the naturally occurring protein complex of insulin-like growth factor 1 (IGF-1) and its
Merck Sharp & Dohme’s Keytruda has received approval in Europe for metastatic urothelial carcinoma allowing it to catch up with its immunotherapy rivals. Although, while BMS’ Opdivo and Roche’s Tecentriq beat MSD to approval in Europe earlier this year, Keytruda is the first treatment to show superior overall survival when compared to using chemotherapy in
Soliris approved by European Commission to treat adults with gMG, will be picked up by Germany first
Alexion has won new European indication for its ultra-orphan drug, Soliris, and has picked Germany to be its first launch market. Soliris received the green light from the European Commission to treat adults with generalised myasthenia gravis (gMG), who are anti-acetylcholine receptor antibody-positive. The extended indication for the first-in-class inhibitor was based on the back
Thyroid cancer patients in the UK could potentially lose access to Ipsen’s Cometriq and Sanofi Genzyme’s Caprelsa via the Cancer Drugs Fund due to NICE rejecting funding for their use. The cost regulators have published draft guidelines rejecting their routine commissioning on the NHS in England and Wales to treat unremovable, locally advanced or metastatic
Patients who have received at least one prior therapy for multiple myeloma in Scotland will soon have access to Amgen’s Kyprolis in combination with dexamethasone through the NHS, following a recommendation by the Scottish Medicines Consortium (SMC). This is a big achievement for the American biopharma, as the drug is the first and only proteasome
Regulatory Professionals, part of the Clinical Professionals Group, are always keen to be at the forefront of technology and innovation within the life science recruitment industry to provide candidates and clients with excellent service and knowledgeable insight and we are delighted to unveil our new Regulatory Professionals website! In addition to the fresh new look,
GlaxoSmithKline and Innoviva have applied in Europe to market Relvar Ellipta for extended use in patients with asthma who are already adequately controlled on inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy. The treatment, comprised of the ICS fluticasone furoate (FF) and the LABA vilanterol (VI), is currently indicated in Europe for the regular treatment of patients
European regulators have approved Gedeon Richter’s novel antipsychotic Reagila as a new option for the treatment of patients with schizophrenia. In clinical trials the drug, a potent dopamine D3/D2 receptor partial agonist atypical antipsychotic, significantly improved symptoms of the condition and reduced the risk of relapse by 55% when compared to the placebo.
Eli Lilly’s experimental breast cancer drug, abemaciclib, has been granted a priority review by US regulators for two indications, and is now on track to be filed in Europe later in 2017.