Novartis has received a new cancer indication for its chimeric antigen receptor T (CAR-T) cell therapy Kymriah (tisagenlecleucel) enabling the gene therapy to be administered to a broader group of patients. The new indication is for large B cell lymphoma, including diffuse large B cell lymphoma (DLBCL).
Subject to approval from US regulators, Bayer AG hopes to conclude its $66 billion takeover of Monsanto Co in the second quarter. The transaction would be the third merger of its kind in just under 12 months, illustrating the global consolidation of the agrochemical and seed businesses. This is being enabled by biotechnology, which makes it possible for crops to be engineered to resist insects, and digital technology which gives farmers new tools for managing their fields.
If everything goes according to plan, member states of the European Union will in future use a common methodology to decide whether a new medicine or medical device is clinically effective, relative to certain benchmarks, and therefore be considered for reimbursement. This is the scenario envisioned by the European Commission under a proposed Regulation on Health Technology Assessment, which was unveiled earlier this year.
With new evidence showing that the biological changes associated with Alzheimer’s disease start earlier than expected, the European Medicines Agency has revised its guideline for companies developing drugs for the disease.
Citing the urgent need for new drugs to treat neurological diseases, the US Food and Drug Administration has shaken up its review teams to encourage experts to work across disciplines and identify new opportunities for treatment.
After one volunteer died and four others were seriously injured during a clinical study in France in 2016, the European Medicines Agency revised its rules for first-in-human studies to tighten the requirements for the dosing of experimental drugs in humans. Introducing the changes in 2017, the agency said that clinical trial protocols are now more complex than ever before and sponsors will need to work harder to exercise oversight.
AstraZeneca Plc has won a new indication for its checkpoint antibody Imfinzi (durvalumab) from the US Food and Drug Administration to reduce the risk of non-small cell lung cancer progressing. Imfinzi targets the programmed death ligand-1 (PD-L1).
The US Food and Drug Administration has used a novel endpoint to approve a new drug for prostate cancer. Measuring metastasis-free survival, the agency decided that the Janssen Pharmaceutical drug Erleada (apalutamide) is effective.
After Amazon, Berkshire Hathaway Inc and JP Morgan Chase & Co announced on 30 January that they will take steps to reduce the rising cost of US health insurance, shares of health insurance companies and pharmacies declined.
A decades’ long discussion in the EU about how to establish common rules for assessing the value of new medicines has come to a conclusion with a proposal from the European Commission on 31 January to regulate health technology assessment (HTA).