As the FDA notes, many IND delays can be tied to CMC challenges. Quite often, warning signs are visible - analytical methods that are good enough but hard to scale- process steps that rely on the skills of an operator or one site- issues on stability or delivery that are shelved into future work.Such considerations … Continue reading Insidious CMC Risks in Regulatory Filings
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Lilly Scoops up Adverum for $261M, with CVR and Loan
Adverum Biotechnologies (ADVM:NASDAQ) is being acquired by Eli Lilly and Company for $261M. While the acquisition proposes a transfer of $261M from Lilly to Adverum's stockholders, it is structured through a milestone payment and a bridge-loan. Payment Snapshot Upfront - $3.56/shareCVR - max $8.91/share contingent upon FDA approval and target sales of Ixo-vec.Bridge Loan - … Continue reading Lilly Scoops up Adverum for $261M, with CVR and Loan
Pfizer’s Big Beautiful Deal: Cheaper Drugs, US jobs, Tariff Relief
Pfizer has signed a momentous agreement with the US Federal government. Here's a snippet of what Pfizer gets and what we get (to be instituted in 2026): Quick Outline Pfizer will adhere to the most favored nation (MFN) pricing for all sales to Medicaid. So, Medicaid, usually the biggest customer to big pharma, will pay … Continue reading Pfizer’s Big Beautiful Deal: Cheaper Drugs, US jobs, Tariff Relief
BK talks Biopharm 