Here are the latest stories being discussed in biopharma today:
1. Grail has ambitious plans for its blood cancer tests; however, its first step is finding a new owner. Grail’s test can detect pancreatic cancer early, but costs $949 and is not covered by Medicare or the majority of insurers. The company hopes to get FDA approval by 2027, but it will need to win over payers in order to reach a wider audience. Grail also plans on selling or spinning out the business after US and European regulators challenged the unfortunate $8 billion acquisition.
2. AbbVie has filed a trade secrets suit against Adcentrx and a former AbbVie employee. The suit alleges that the former employee stole trade secrets about AbbVie’s antibody-drug conjugate programs and used this information to help Adcentrx quickly develop its own ADC program. AbbVie demands compensation for the lost trade secret information.
3. The FDA is encouraging developers of Covid-19 monoclonal antibodies to collaborate in their efforts to target emerging Covid variants. This initiative aims to improve the fast development of monoclonal antibodies. Companies like Inivvyd are leveraging this push, with positive phase III data for their monoclonal antibody announced recently.
4. Bristol Myers Squibb has gained regulatory clearance to finalize its $4.8 billion takeover of Mirati. The finalized acquisition is expected to occur within the first half of 2024 and will give Bristol Myers access to Kraza, the second approved KRAS drug following Lumakras.
5. The FDA plans to establish a new Office of the Chief Medical Officer to coordinate cross-agency operations. The office will be set up within the Office of the Commissioner, with increased staffing being sourced from various other FDA offices. This is part of larger reshuffling efforts within the FDA that also includes the establishment of an Office of Enterprise Transformation.
6. Genentech’s food allergy medication, Xolair, has received a priority review from the FDA. The priority review will hasten the decision-making process, with the FDA expected to make a decision by early 2024. If approved, Xolair would become the first medication to abate allergic reactions to multiple types of food.
