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Regulation

Congo, three other countries license Merck’s Ebola vaccine

As biopharmas gear up to develop vaccines and therapies for COVID-19, four African countries at risk from the Ebola outbreak approved and licensed a vaccine from Merck & Co. Friday. The Democratic Republic of the...

Controversy over stretching expanded access to off-label uses

Compassionate use is no exception to the axiom that sooner or later, someone will find an unexpected and controversial way to bend any law or regulation for unanticipated purposes. FDA’s expanded access, or compassionate use,...

EMA’s plan to integrate real-world data across Europe

One of EMA’s top priorities for incorporating real-world data earlier in the regulatory process is establishing DARWIN, a centralized system that would enable it to obtain harmonized data from healthcare systems across Europe. RWD is...

Regulatory response: FDA authorizes emergency 2019-nCoV diagnostic, EMA activates emergency plan

FDA and EMA each unveiled measures Tuesday to combat the 2019-nCoV outbreak, with the U.S. agency issuing emergency use authorization for a diagnostic and its European counterpart activating its emerging health threats management plan. Both...

Disparities in FDA decisions on Sarepta DMD therapy raise questions about integrity of review process

Documents released Wednesday by FDA reveal unexplained discrepancies between an August complete response letter for Vyondys 53 golodirsen and December’s surprising accelerated approval of the therapy. The differences between FDA’s skepticism about the development program...

Fewer FDA approvals in 2019, but a basket of firsts

While the year held fewer approvals of new molecular entities than 2018, it was not short of major achievements. FDA greenlit several drugs with innovative modalities, against novel targets and for diseases that have long...

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...