An agreement on the full mutual recognition of pharmaceutical factory inspections was reached on 1 November when the US Food and Drug Administration and the European Commission confirmed that they can now accept one another’s standards.
Novartis has announced plans to begin a tender for all of the shares of Advanced Accelerator Applications (AAA) SA, a radiopharmaceutical company that has an approved product for the treatment of gastroenteropancreatic neuroendocrine tumours. The offer is valued at $3.9 billion.
Shire Plc delivered a 7% increase in product sales to $3.5 billion in the third quarter, which was heavily weighted by revenue from its haematology and immunology franchises, acquired following the company’s takeover of Baxalta Inc in 2016.
With a strategic refocus underway, GlaxoSmithKline Plc delivered revenue growth of 4% in the third quarter and a higher operating margin of 23.9%. The company is forecasting earnings per share growth of 3% to 5% for the year as a whole, expressed in constant exchange rates.
Novartis AG reported a 2% increase in sales and a 4% rise in operating profit for the third 2017 quarter while maintaining its forecast of little change in sales for the year and possibly a decline in operating profit. Over nine months, sales were about unchanged at $36.2 billion while operating profit dipped 4% to $6.56 billion.
Genomics England has taken the next step towards sequencing the genomes of a large number of patients in the National Health Service (NHS) with the appointment of industry partners to help it explore the potential of liquid biopsy tests to manage cancer.
The Roche group expects to see core earnings per share grow in line with a mid-single digit percentage rise in sales this year on the back of a steady increase in demand for its legacy and new pharmaceutical products. The US remains a key market for the Swiss multinational.
The US Food and Drug Administration has approved a second gene therapy to treat cancer, giving a further boost to developers of the new technologies. The approval is for Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T cell therapy to treat adults with certain types of large B-cell lymphoma.
Eli Lilly and Co has obtained the services of CureVac AG for the discovery and development of up to five cancer vaccines, all of which will make use of the German company’s messenger RNA (mRNA) technology to target tumour neoantigens and fight the cancers.
GlaxoSmithKline Plc, which has a gene therapy on the market, is broadening its portfolio of advanced therapy medicinal products to include potential new treatments derived from induced pluripotent stem cells (iPSC). iPSCs are a type of pluripotent stem cell that can be generated directly from adult cells.