The EC has decided to expand the scope of Amgen’s PCSK9 inhibitor Repatha to include the reduction of cardiovascular risk in adults with established atherosclerotic cardiovascular disease (CVD). The treatment can be used to reduce cardiovascular risk by lowering low-density lipoprotein cholesterol (LDL-C) levels – as an adjunct to correction of other risk factors. The
Amgen has announced that the Committee for Medicinal Products for Human Use, has issued a positive opinion recommending a label variation for Neulasta to include the Neulasta Onpro Kit. The Neulasta Onpro Kit combines the efficacy of Neulasta with an innovative on-body injector (OBI) delivery system. Neulasta is indicated in the EU for the reduction
NICE has reversed its rejection of Sanofi’s Praluent (alirocumab) after the manufacturer agreed to a patient access scheme for the new cholesterol-lowering drug. The scheme includes an undisclosed discount to the NHS and allows NICE to back Praluent and Amgen’s rival Repatha (evolucumab), which had already been discounted in the new final draft guidance.
Nineteen new therapies, which include an antidote to the blood thinner Pradaxa, a treatment for the rare blood cancer multiple myeloma, and a new drug for Parkinson’s disease. Have taken a leap closer to being granted entry to the EU market. The European Medicines Agency’s Committee for Medicinal Products for Human Use has endorsed approval
The US FDA (Food and Drug Administration) have approved Teva Pharmaceutical Industries’ form of Amgen’s severe neutropenia therapy, Neupogen. The FDA have approved tbo-filgrastim, which Teva noted is the first new granulocyte colony-stimulating factor (G-CSF) to be backed by the US agency in over 10 years. The drug is a copy of Neupogen (filgrastim), which
Amgen, the world’s largest biotechnology company, have replied to the US FDA’s recent draft advice on biosimilars, noting that certain “changes and additional clarity are needed.” In February, the US Food and Drug Administration (FDA) presented three initial draft guidance documents on the regulation of biosimilars. In response to these documents, Amgen commented “we appreciate
Amgen, an US biotech major, is partnering with Watson Pharmaceuticals to develop and commercialise several oncology antibody biosimilars. The new partners commented that the partnership “reflects the shared belief that the development and commercialisation of biosimilar products will not follow a pure brand or generic model, and will require significant expertise, infrastructure, and investment to
Amgen is the most recent drug maker to present data for a cholesterol drug that blocks the PCSK9 pathway. Phase I data presented at the American Heart Association meeting in Orlando showed that a single dose of Amgen’s AMG145, a monoclonal antibody, reduced levels of low density lipoprotein or ‘bad’ cholesterol by up to 64%
Amgen has been boosted by the news that regulators in the European Union have given the green light to Xgeva for cancer-related fractures.
Amgen has been boosted by the news that regulators in the European Union have given the green light to Xgeva for cancer-related fractures. Specifically, the European Commission has granted marketing authorisation for Xgeva (denosumab) for the prevention of skeletal-related events in adults with bone metastases from solid tumours. The Commission has also granted the