Here are the latest stories being discussed in biopharma today:
Eli Lilly Loses Case Against Florida Compounding Pharmacy
Eli Lilly has suffered a loss in its lawsuit against a Miami compounding pharmacy, which is creating modified versions of Lilly’s diabetes and weight loss drug, tirzepatide. A Florida federal judge discarded the case, stating that Eli Lilly can’t leverage state law to privately enforce the Federal Food, Drug, and Cosmetic Act.
CMS To Increase Reimbursement For New Sickle Cell Gene Therapies
The Centers for Medicare and Medicaid Services (CMS) plan to raise reimbursement rates to 75% (from the typical 65%) for Vertex Pharmaceuticals/CRISPR Therapeutics’ Castgevy and bluebird bio’s Lyfgenia. These are newly approved sickle cell gene therapies potentially reversing the effects of the disease. The changes will be implemented during the US government’s 2025 fiscal year.
FD Commissioner Calls on House Committee to Combat Drug Shortages
FDA Commissioner Robert Califf addressed the House Oversight Committee, requesting more authority to monitor supply chains and prevent drug shortages. He stressed the importance of coordination between the FDA, manufacturers, and federal agencies to enhance production and incentivize domestic pharmaceutical manufacturing.
Fujifilm Invests $1.2B to Expand North Carolina Biomanufacturing Facility
Fujifilm Diosynth Biotechnologies is investing $1.2 billion to extend its large-scale biomanufacturing facility located in Holly Springs, North Carolina. They will add eight new 20,000-liter mammalian cell culture bioreactors to the existing eight by 2028, creating 680 jobs by 2031.
AstraZeneca’s Fasenra Expands Approval in Children with Severe Asthma
The FDA extended approval for AstraZeneca’s asthma treatment, Fasenra, to include maintenance treatment of severe eosinophilic asthma in children aged 6 to 11 years. The drug first received approval for use in patients aged 12 years and older in 2017.
Moderna Halts African Facility Build Due to Dropping Covid-19 Vaccine Demand
Moderna has paused its plans to build an mRNA vaccine production site in Kenya due to the lack of vaccine orders for Africa since 2022 and cancellation of previous orders. As a result, the company faces over $1 billion in losses and write-downs. Moderna plans to reevaluate the future demand for mRNA vaccines in Africa before proceeding.
