Here are the latest stories being discussed in biopharma today:
Novo Nordisk Plans Boston Expansion with Focus on Future Innovations
Novo Nordisk, the world’s second most valuable pharmaceutical company, seeks new innovative breakthroughs following the release of Ozempic or Wegovy. The company plans to set up roots in Boston, an epicenter of innovation, to augment its R&D activities. Novo Nordisk is pouring its drug profits into exploring genetic medicine treatments aimed at achieving greater weight loss and counteracting the muscle loss caused by its existing drugs.
Moderna Shares Rare Disease Ambitions
Moderna has shared that its commitment to rare diseases includes around nine Investigational New Drugs (INDs) in the planning phase, with potentially many more to follow. The company hopes to enhance its portfolio of rare disease programs over the next few years. Moderna’s efforts have been supported by early data from its lead programs for propionic acidemia and methylmalonic acidemia.
Califf Discusses Drug Shortage Scope and Post-Market Data Compilation
FDA Commissioner Robert Califf highlighted the challenges posed by drug supply issues, cautioning that efforts to inspect generic drug facilities could exacerbate US drug shortages. Califf said that improvement in post-market data collection was necessary for medicines that received accelerated approvals.
Small Fraction of Rare Pediatric Designations have led to FDA Vouchers
Only 7% of drugs with rare pediatric disease designations have obtained priority review vouchers from the FDA, reveals an agency review covering a decade’s worth of data. The report indicates a high proportion of gene therapies among designation recipients, predominantly targeting liver-related diseases.
Argenx Launches New Awareness Campaign for Rare Autoimmune Condition
Argenx has initiated the “Shining through CIDP” campaign to spread awareness for the rare autoimmune disease known as chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The campaign includes social media outreach, a real-stories miniseries, and a TV commercial.
Jordanian OTC Drug Manufacturer Issued FDA Warning over Unacceptable Hazards
Amman Pharmaceutical Industries, a generic drug manufacturer, was issued a warning from the FDA due to unacceptable conditions leading to drug contamination. Inspectors found “fundamental design flaws” and “serious data breaches” at the manufacturer’s Jordanian facility.