The Supreme Court’s review of the health care reform law threatens to undermine some of the foundations of pharma planning for the next several decades: a larger insured population with drug coverage, low out-of-pocket costs for drug patients, and substantial IP hurdles for biosimilar challengers. But at the same that the Court is making the Affordable Care Act provisions of the strategic picture more blurry, the court may be clarifying pharma’s continued dominance in the key new field of personalized medicine.
Prometheus Rebound: Where Weak Patents Can Benefit Pharma
Biotech and pharma companies were disappointed when the Supreme Court limited patent rights surrounding personalized medicine. But the ruling may end up simplifying the path to adoption of targeted therapies by reaffirming a much more critical point: the therapeutic—not the diagnostic—is the dominant partner.
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The departure data emerged along with a Health and Human Services Department memo describing conceptual plans to consolidate and restructure offices at the FDA and other agencies.
Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.
Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.
Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.
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The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.
Pharma executives and investors are waiting with bated breath to find out if President Trump will include drugs in a new round of tariffs to be announced on 2 April.
One CDRH employee said the cuts already are having a major effect on morale.