Policy

Policy

The Schedule Wars: What Trump's Vaccine Executive Order Really Means for Public Health and the Pharma Industry

Trump's executive order to reduce childhood vaccines from 17 to 11 raises critical questions about public health policy, pharmaceutical industry impacts, and the politicization of vaccine recommendations.

Policy

Washington Draws a Line Around the Lab: The BINSA Bill and the Future of US-China Biotech Deals

Senators Pete Ricketts and Elissa Slotkin have introduced the Biotech Investment National Security Act (BINSA), which would subject US-China pharmaceutical deals to federal scrutiny. The bipartisan bill signals a major shift in how Washington views biotech collaboration with China.

Pharmaceuticals

When Off-Label Becomes Official: The Lytenava Approval and What It Means for the Retina Market

The FDA's approval of Lytenava formalizes what retina specialists have done off-label for over 20 years. The regulatory hurdle is cleared. The commercial one may prove harder.

Policy

The Rules of the Trip: What the FDA's Finalized Psychedelic Guidance Really Means for Drug Development

The FDA's finalized guidance on psychedelic drug development provides the clearest regulatory roadmap yet for companies developing psilocybin, MDMA, and related compounds as treatments for psychiatric disorders.

Biotechnology

The Heart of the Matter: Capricor's Deramiocel Faces Its Defining FDA Moment

On July 29, an FDA advisory committee will evaluate deramiocel, Capricor's allogeneic cell therapy for Duchenne muscular dystrophy cardiomyopathy. If approved, it would be the first cell-based therapy targeting DMD cardiac dysfunction.

Biotechnology

When the AI Builds the Drug: What Anthropic's Claude Science Means for Pharma

Anthropic's announcement of Claude Science and its internal drug discovery program signals a major shift in how AI companies are approaching the life sciences—and what it means for pharmaceutical companies.

Pharmaceuticals

The mRNA Flu Shot That Almost Wasn't: What Moderna's Unanimous FDA Panel Vote Really Means

On June 18, 2026, an FDA panel voted unanimously to advance Moderna's mRNA flu vaccine, mFlusiva. But the real story isn't the vote—it's the extraordinary regulatory turmoil that preceded it, and what it reveals about vaccine policy in America.

Policy

Europe's Pharma Exodus: What Germany's Drug Pricing Reform Means for the Future of Global Biotech Investment

When Eli Lilly announced it was cutting its planned German investment in half, the news landed with the weight of a verdict. Together with Boehringer Ingelheim's cancellation of 900 million euros in spending, more than $2 billion in future investment was pulled from Germany in a single day.

Policy

After Makary: What the FDA's Leadership Vacuum Means for Drug Development

Marty Makary's sudden resignation as FDA commissioner leaves the pharmaceutical industry facing regulatory uncertainty at a critical moment for biotech recovery.

Policy

The Trial That Never Stops: How the FDA's Real-Time Clinical Trial Push Could Reshape Drug Development

The FDA has launched proof-of-concept real-time clinical trials with AstraZeneca and Amgen, signaling a fundamental shift in how drug development data is monitored and regulatory decisions are made.

Policy

When the Oval Office Becomes a Drug Policy Lab: What Trump's Psychedelics Order Means for Biotech

Trump's executive order fast-tracking FDA review of psychedelic drugs like psilocybin and ibogaine signals a major shift for mental health treatment and the biotech sector.

Policy

The Lobbyist Who Ran Out of Road: What Steve Ubl's Departure Reveals About Pharma's Washington Problem

Steve Ubl's announcement that he will step down as president and CEO of PhRMA signals that the political architecture the pharmaceutical industry built over the past decade is under unprecedented stress.