Camino Minerals Corp

The three largest US pharmaceutical wholesalers—Cardinal Health, Cencora, and McKesson—are leveraging vertical integration to expand their influence beyond traditional drug distribution into the buy-and-bill market.

Outlook Therapeutics has commercially launched LYTENAVA™ (bevacizumab gamma) in Germany and the UK, marking the first and only approved ophthalmic formulation of bevacizumab for wet AMD treatment in Europe.

• Harrow has executed a five-year strategic supply and development agreement with the current contract manufacturing organization for TRIESENCE®, ensuring stable supply of the ocular corticosteroid. • The company has begun developing an enhanced version of TRIESENCE®, with plans to submit a new drug application (NDA) to the FDA by the end of 2027. • TRIESENCE® is FDA-approved for visualization during vitrectomy and treatment of ocular inflammatory conditions unresponsive to topical corticosteroids, addressing a product previously on the FDA's Drug Shortage List.

The cell and gene therapy (CGT) sector is rapidly evolving, with allogeneic cell therapies representing 50% of Phase I cell therapy trials, indicating a significant shift in therapeutic modalities.

Experts highlight the growing acceptance of non-interventional and observational studies in rare disease research, with regulators showing increased flexibility for orphan drug development pathways.

Outlook Therapeutics received a positive opinion from the European Medicines Agency's CHMP for ONS-5010/LYTENAVA™ (bevacizumab gamma) for wet AMD treatment, with European Commission decision expected in Q2 2024.

The US biosimilar market has shown significant growth with 20 approved products, projected to reduce drug costs by $100 billion over the next five years through increased competition and adoption.

The US biosimilar market has evolved significantly since Sandoz's Zarxio launch five years ago, with six major biosimilar launches occurring in recent months and potential cost savings of $54 billion through 2026.