European Commission approves Amgen’s Repatha for reducing cardiovascular risk

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

Continue Reading

Praluent and Repatha backed by NICE

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allows NICE to back Praluent and Amgen’s rival Repatha (evolucumab), which had already been discounted in the new final draft guidance.

Continue Reading

Teva’s Version of Neupogen Approved by FDA

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

Continue Reading

Amgen Requests Biosimilars Clinical Trial Clarification

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 In February, the US Food and Drug Administration (FDA) presented three initial draft guidance documents on the regulation of biosimilars.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

Continue Reading

Amgen and Watson Pharmaceuticals Announce Cancer Biosimilars Agreement

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

Continue Reading

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

Continue Reading