regulatory affairs Archives - Medical Design Sourcing

In a major shift away from decades of stigma, the FDA has granted Breakthrough Therapy Designation to MindMed‘s MM120, an LSD-based treatment for Generalized Anxiety Disorder (GAD). This milestone not only underscores the growing recognition of the therapeutic potential of psychedelics but also could point to a potential turning point for the struggling psychedelic sector and specifically bolsters the future of MindMed.

[Related: Could LSD change the game in anxiety treatment?]

Psychedelic stocks: A long, strange trip continues

As with many psychedelic companies, MindMed’s stock (NASDAQ: MNMD) has been on a rollercoaster ride in recent years, briefly reaching close to $60 per share in early and mid-2021 amid peaking investor enthusiasm for the potential of psychedelic-based treatments. But the stock, like many others in the sector, has faced significant declines as investor enthusiasm waned later in 2021 and 2022.

The breakthrough therapy des…

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As personalized medicine continues to progress, cell and gene therapy (CGT) development is poised to enable tremendous medical breakthroughs. Unlike traditional treatments which merely manage symptoms, CGT could treat the root biological cause of many diseases: the faulty genes.

“The cell and gene therapy space is truly exciting. What this ultimately means for patients and caregivers, and our ability to play an important part within this paradigm, is exhilarating,” said Dr. Panteli Theocharous, the global vice president and cell and gene therapy strategy lead at PPD.

With more than 20 years of experience in the pharma and biotech industries, Theocharous provides guidance on developing CGTs. He accentuates the importance of partnerships, data-driven approaches and patient-centricity in overcoming challenges.

Yet the path forward is filled with obstacles. In 2021, cell and gene …

regulatory affairs

FDA grants breakthrough status to LSD-based anxiety treatment

CGT demands vision, partnership and patient-centricity to transform healthcare