An industry update: the latest developments in therapeutic delivery

Area of Science:

• Pharmaceuticals and Biotechnology
• Drug Development
• Medical Devices

Background:

• The pharmaceutical industry continuously evolves with new drug approvals, clinical trial outcomes, and market dynamics.
• Regulatory bodies like the US FDA play a crucial role in approving novel therapeutics and monitoring market access.

Purpose of the Study:

• To provide a comprehensive overview of key developments in the pharmaceutical and biotechnology sectors during September 2017.
• To highlight significant drug approvals, rejections, clinical trial results, and strategic partnerships within the industry.

Main Methods:

• Information was gathered from company press releases, scientific literature, patent filings, and various news outlets.
• Key events including regulatory approvals, clinical trial outcomes, and business developments were identified and summarized.

Main Results:

• Three new molecular entities were approved by the US FDA: Aliqopa (copanlisib dihydrochloride), Solosec (secnidazole), and Verzenio (abemaciclib).
• Intarcia Therapeutics' diabetes drug-device combination was rejected by the FDA. Biosimilar approvals continued to increase, with Sandoz advancing its Rituxan biosimilar application.
• Positive results were reported for Duaklir (COPD) and a Duchenne muscular dystrophy treatment, while Intepirdine (Alzheimer's) failed in trials. Oncology saw continued collaboration and approvals.

Conclusions:

• September 2017 was marked by significant regulatory actions, including new drug approvals and a notable rejection, alongside mixed clinical trial outcomes across various therapeutic areas.
• The growing impact of biosimilars and strategic licensing deals underscore the dynamic nature of the pharmaceutical market. Emerging research also suggests potential links between olfactory dysfunction and Parkinson's disease risk.