Transparency Archives - Medical Design Sourcing

[PIRO4D/Pixabay]

Pharmaceutical companies are running into pushback for their “patent thicket” tactics, designed to maintain exclusive rights and delay cheaper generics. The Financial Times reported that an ethical investor coalition is pushing for greater transparency and urging major drug makers to disclose their patent strategies.

Unraveling the patent thicket mystery

Patent thickets are a common intellectual property tactic in pharma. Companies file numerous patents beyond the primary one for a specific compound. Critics say this cunning approach stalls the introduction of generics even after the 20-year exclusivity of primary patents expires. Consequently, drug prices remain high, and affordable medications remain out of reach for many.

Drugs like Humira (adalimumab) and Keytruda (pembrolizumab), for example, have experienced extended periods without biosimilar or generic competition, lea…

[Image courtesy of FDA]

Diversity in clinical trials is crucial for ensuring that new medical treatments are safe and effective for all populations. Last year, the FDA released draft guidance that aims to improve the enrollment of historically underrepresented populations in clinical trials.

Demand is growing for more transparency and diversity in clinical trials, according to Erin Leckrone, senior director of clinical trials at Be The Match BioTherapies. Additionally, a growing number of stakeholders are stepping forward to promote diversity. “The COVID pandemic really amplified a lot of people’s voices in this space,” she said.

A growing number of stakeholders have stepped forward to demand better diversity in clinical trials and to understand “what data is actually collected as part of the clinical trials,” Leckron said. Those players range from regulatory agencies like the FDA to clinical trial …

Transparency

Big Pharma, it’s time to talk: Investors demand transparency on patent thickets

Breaking down barriers: Prioritizing diversity in clinical trials