Approvals
- The FDA has cleared 23andMe’s Personal Genome Service Pharmacogenetic Reports for the inclusion of information about genetic variants that may impact a patient’s ability to metabolize some medicines. The test does not describe an association between the detected variants and any specific drug, nor whether a person will or will not respond to a particular drug. It is intended to help inform discussions with healthcare providers.
- A new gene therapy has been recommended for approval in Europe. Luxturna can be used in adults and children suffering from retinal dystrophy – an inherited disorder caused by RPE65 gene mutations, which usually leads to blindness. Novartis will be required to conduct follow ups on patients to ensure long-term safety and efficacy.
Controversy
- Abbvie is taking the UK’s National Health Service (NHS) to court, claiming a tender process for Hepatitis C drugs was unfair. The NHS is aiming to eliminate hepatitis C by 2025, and the procurement is the largest ever done by the agency. A number of companies bid for the contract, including Gilead Sciences, Abbvie and Merck Sharp & Dohme.
- After being asked by the FDA to provide more data, Sanofi has said it will no longer pursue FDA regulatory approval for its biosimilar version for Rituxan, Rixathon. Rixathon was approved in Europe in summer 2017. A number of other companies are preparing to take Rituan biosimilars to market in the US.
- UK pharma company ITH Pharma is facing criminal prosecution following contaminated products used for premature babies in the UK. Three babies died and 20 needed treatment after contracting septicemia in 2014. ITH Pharma says it will “vigorously defend the case”.
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