Regulatory and financial incentives have sparked major investment in orphan drug development, but now some stakeholders are questioning whether the focus on orphans is orphaning another market: primary care conditions that are still not adequately treated. Are incentives needed?
In late February, the Food amd Drug Administration approved its fifth novel prescription drug or biologic for 2014: AstraZeneca PLC’s Myalept (metreleptin for injection) for the treatment of a very rare fat disorder called generalized lipodystrophy.
Patients with congenital or acquired general lipodystrophy (also known as Lawrence-Seip syndrome) have a near-absence of body fat in the...
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Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.
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The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.
Devika Wood, CEO of Brain+, explains the importance of developing health tech solutions for dementia and the growing need to both raise awareness and improve overall access to nondrug interventions like CST.
In a challenging funding environment for biopharma, strategic dealmaking has become a critical growth engine. In Vivo explores what it truly takes to navigate high-stakes acquisitions and partnerships, drawing on insights from seasoned industry leaders.
While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.
