BioPharm Executive

Intra-Cellular submitted its application to the FDA for Caplyta’s approval in major depressive disorder, potentially opening up an additional $1 billion in sales. Still, the stock remains “cheap,” according to Jefferies analysts.

Eli Lilly topped the list of the 20 biggest pharmas by market cap with a more than 39% improvement year-to-date in its share price. Other companies have not been so lucky.

Currently, Eli Lilly’s GLP-1 drugs Mounjaro and Zepbound (tirzepatide) are not on the FDA’s shortage list but compounded pharmacies are still making them. That’s unprecedented.

A judge in the U.K. last month sided with Pfizer over GSK in a respiratory syncytial virus vaccine patent lawsuit, positioning both companies to compete for that market and laying down a marker for ongoing legal clashes in other parts of the world.

While the full impact of the Supreme Court decision remains unknown, the new regulatory landscape could be a net positive for drug developers.

A handful of billion-dollar deals in the rare disease space highlights the uptick in Big Pharma’s investment, but it’s still extremely low compared to the money flowing to more common indications.

A slow launch for Alzheimer’s medicine Leqembi, a lackluster pipeline and a challenging drug launch environment are just a few of the factors that have sent Biogen’s shares down this year.

Novo Holdings’ acquisition of Catalent has ignited concerns from industry stakeholders, who fear that the consolidation could limit competition, but there is also the possibility that the deal could represent an opportunity for smaller-scale CDMOs to find new partners.

Suggestions that the U.S. should emulate other countries on drug price controls or patents obscure how our present policies have allowed drug development to flourish.

CEO Roberto Iacone admitted in an interview that the market remains tough, even for a biotech in the red-hot ADC world. But Alentis is targeting an IPO as early as 2025.