Here are the latest stories being discussed in biopharma today:
1. Lilly’s $8 Billion Gamble on Alzheimer’s Drug
Eli Lilly hopes for FDA approval of its Alzheimer’s drug, donanemab, after several decades of trials and errors, and a whopping $8 billion investment. This faith in the controversial amyloid hypothesis has not only showcased perseverance but also puts the company standing at the edge of potentially transforming the Alzheimer’s drug landscape.
2. Novo Nordisk’s $1.46B Molecular Glue Agreement
Novo Nordisk is signing a $1.46 billion deal with biotech firm Neomorph to develop ‘molecular glues’. This novel approach links proteins together without the need for binding pockets, making previously ‘undruggable’ targets accessible. Novo Nordisk hopes to apply this technology in managing chronic metabolic and rare diseases.
3. Vote-Based Advisory Committees Remain Essential, FDA Insists
Despite talks for reforms, the FDA insists that votes from advisory committees will still be significant. The reform aims to make the advisory process efficient, more predictable, and ensures consistency in committee discussions across the different agency centers.
4. Colorado Eyeing Payment Limit on Amgen’s Enbrel
Colorado’s Prescription Drug Affordability Board has initiated a potentially six-month discussion to set an upper payment limit for Amgen’s arthritis drug, Enbrel, citing the drug as unaffordable for many patients within the state. Patients and caregivers say the cost makes the drug difficult to access.
5. FDA Facilitates Safety Monitoring for Biologics Meeting
The FDA officials and drug developers gathered to streamline safety monitoring for biologics at a meeting arranged by the American Association of Pharmaceutical Scientists. The session focused on tackling therapeutic drug monitoring, an essential practice to optimize dosages.
6. Rocket Pharma’s Rare Disease Day Extravaganza As FDA Ruling Looms
Rocket Pharma is planning to globally light up several landmarks to raise rare disease awareness as it awaits the FDA’s decision on its first drug candidate, Krezladi, meant for treating severe leukocyte adhesion deficiency-I (LAD-I).
7. Stringent Singulair Safety Warnings Needed, NY AG Says
New York’s Attorney General is calling for stricter safety warnings for Singulair. The AG’s office has noted several severe side effects, including nightmares and depression, linked to the asthma drug marketed by Merck.
