Regulation

Stephen Hahn’s road to White Oak

The path to Stephen Hahn’s confirmation as FDA commissioner is enveloped in clouds of flavored vapor, littered with piles of Impossible Burgers, and passes tanks filled with precocious fish. The Trump administration’s policies on regulating...

China and the U.S. are enacting policies that could stymie biomedical innovation

Amidst rising tensions between the U.S. and China, both governments have enacted policies in recent years that could hinder innovation and hurt public health over the long term. Protectionist mindsets, coupled with concerns about industrial...

Mapping China and U.S. wall-building around genetic data

Against a backdrop of trade tensions, Chinese and U.S. regulators have been erecting regulatory frameworks to control foreign access to their populations’ genetic data. With China’s policies finalized and U.S. reforms taking shape piece by...

Biopharma, patients should demand changes to CFIUS regulation

In a misguided effort to protect U.S. national security, the Treasury Department has proposed barriers to Chinese investments in U.S. biopharma companies that would slow the development of new medicines, constrain funding for emerging companies...

FDA guidance seeks to better integrate patient priorities into drug development

Patient-centered drug development must start with an understanding of what patients feel is important about their condition and the attributes they’d like to see in medicines. A draft guidance FDA released Monday on Methods to...

FDA’s international drug review pilot could simplify cancer trials, get drugs to patients faster

FDA believes its new framework for the submission and review of cancer drugs concurrently in multiple countries will speed up patient access to new therapies and streamline drug development. The agency unveiled the framework, dubbed...

Lackluster U.S. biosimilars market sparks radical recommendations

The lackluster U.S. biosimilars market has led to calls for a new regulatory paradigm that could slash the cost of development. Biosimilars developers and critics of the sector agree on one thing: as it has...

Timeline of a debacle: Novartis missteps hold lessons for diligence, new modalities

Aside from all the questions about who knew what when, and how they should have acted, the Zolgensma data fiasco reveals that Novartis’ due diligence team missed some warning signs. The case has the hallmarks...

Digital platforms that could make real-world data usable

As real-world data grows in importance so does the need to stitch together disparate data sources in a way that makes the information usable. A recent meeting co-hosted by FDA and the Duke Margolis Center...

FDA revamps NDA process to get top problems to sponsors faster

FDA has two primary goals in its overhaul of the NDA process. The first is to find the show-stopping issues sooner and put that information in sponsor’s hands. The second is to create more time...

A half step forward for heart failure as FDA guidance leaves key question unanswered

A draft FDA guidance for heart failure endpoints could spark investment and accelerate development of cardiovascular therapies. But companies still don’t have a clear sense of when and whether they’ll need to gather mortality data...

Why China’s 4 + 7 policy is good news for innovative drug developers

China’s new policy on generic drugs is likely to have knock-on benefits for drug developers aiming to bring innovative compounds to the China market. For multinationals, it will come after some pain, as they’ll see...

Manufacturing new modalities

Cell and gene therapies won’t enter the mainstream of medicine until manufacturing processes become far more efficient, according to FDA Commissioner Scott Gottlieb and FDA Center for Biologics Evaluation and Research Director Peter Marks. The...

Talk less, do more: Germline gene editing needs real plans, not just moratoria

We’ve moved on from sound and fury. We’re now just signifying nothing. The latest public proclamation on germline gene editing, couched in a call for a moratorium, is as much preaching to the choir as...

Sharpless has the edge on FDA job

Norman (Ned) Sharpless, director of the National Cancer Institute, is the leading candidate to take over FDA leadership, Trump administration officials told BioCentury. HHS Secretary Alex Azar hasn’t made a final decision, the officials said....