Regulation

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....

Gottlieb’s exit interview

FDA Commissioner Scott Gottlieb sat down with BioCentury after announcing his resignation to discuss his approach to promoting medical product innovation, the importance of strategic communications, and how a reorganization will bring FDA drug reviews...

Gottlieb’s durable reforms

While most of the changes Scott Gottlieb has set in motion in just under two years as FDA commissioner are works in progress, and some may falter in his absence, an important number are well...

Products on shutdown standby

Products on shutdown standby On Jan. 14, FDA said it has reserves to continue drug reviews for five more weeks if the government shutdown continues. There are at least six PDUFA dates for new products...

FDA to facilitate access to unapproved drugs

FDA plans to launch a new program in 2019 that will help patients gain access to unapproved therapies. The agency will field telephone requests from physicians and patients, streamline the application process, and act as...

Path to opioid-free pain relief

To jump-start development of analgesics that can help stem the opioid crisis, companies want FDA’s upcoming guidelines to reduce uncertainty around outcomes that constitute clinically meaningful opioid sparing. But while an advisory panel put some...

FDA to apply light touch to biopharma apps

Concerned that regulatory uncertainty is preventing biopharma companies from developing digital tools that could help patients manage their health, FDA plans to exempt a broad range of apps and other software from premarket review. In...