Recently, the FDA has requested Sarepta Therapeutics, Inc., a Massachusetts-based biopharmaceutical company, to suspend all distribution of its DMD gene therapy Elevidys (delandistrogene moxeparvovec), following the deaths of three patients—two non‑ambulatory teenagers and one …

Introduction If you asked us (and many other industrial consultants) what one of the most common commercial strategy mistakes we see in otherwise well-positioned early-stage companies is, without a doubt, it would be the …

We spoke in detail about our activities at BeyondBiotech podcast, you can listen to the episode here: https://podcast.labiotech.eu/1995493/episodes/16219760-cracking-the-code-of-biotech-valuations

Earlier this year the FDA has introduced significant regulatory changes for Laboratory Developed Tests (LDTs) to enhance their oversight and ensure higher standards of safety and effectiveness. These changes align LDTs with the regulatory …

With a focus on addressing a wide spectrum of diseases and conditions, the US witnessed the most novel drug approvals in 6 years. Here we provide an overview of the key highlights in treatments …