Explore some interesting things going on with pharma and biotech in regulatory intelligence this week!
- FDA grants accelerated approval for AstraZeneca’s immunotherapy, Durvalumab, for the treatment of advanced bladder cancer. It is the first approved indication for a product the company hopes will become a blockbuster. (Reuters)
- Altor BioScience announced that it has received Fast Track designation from the FDA for ALT-803, its investigational bladder cancer drug. ALT-803, an interleukin-15 (IL-15) agonist complex, is being evaluated for the treatment of non-muscle invasive bladder cancer. Altor will present results from its Phase 1b study at the American Urological Association Annual Meeting on May 12. (Business Wire)
- Novo Nordisk reached a settlement in a whistleblower lawsuit alleging that the company ran a “white-coat marketing scheme”. The suit claims that the company partnered with a clinical education company to hire and train certified diabetes educators & provide free services to gain access to physician practices. (FiercePharma)
- Takeda has received accelerated approval for Alunbrig, a second-line treatment for patients with a specific type of lung cancer. Takeda acquired Ariad, the drug’s developer, in mid-February. (Reuters)
- Home blood pressure monitors are under scrutiny. A recent study indicates that home blood pressure monitors may be too inaccurate to be useful in managing the disease of patients with hypertension, the “number one cause of death and disability in the world”. (Reuters)