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Politics, Policy & Law

Sharpless' homecoming: the NCI chief's lessons from his time at FDA

NCI Director Ned Sharpless has returned from his seven month stint as acting FDA Commissioner aiming to take on the regulatory hurdles that lie ahead for promising technologies, and seeking ways for NCI's grants to...

With Treasury’s CFIUS rules in effect, eyes on Commerce definitions

Although the finalized rules governing Treasury Department’s review of foreign investments in U.S. companies went into effect Thursday, ambiguity from the Commerce Department on what biotechnologies could merit mandatory filings means lingering uncertainty for biopharma....

HHS forms foundry to combat biologic threats

HHS launched a biotech foundry this week that is intended to protect against and respond to health security threats and enhance daily medical care. In a statement, HHS Secretary Alex Azar cited the coronavirus outbreak...

Catalyzing controversy: FDA emails challenge its claims that price plays no role in approvals

Over 200 pages of emails released as a result of litigation against FDA and HHS challenge FDA’s claims that it does not consider price when making approval decisions. The emails pull back the curtain on...

When single-payer systems adopt innovation better than U.S. commercial payers

It is a truth universally acknowledged, to borrow from Jane Austen, that a single-payer system will say “no” to new technology. If they accept it at all, they do so only when the prices are...

Senate bill introduced to close Orphan drug ‘loophole’

Legislation introduced Tuesday in the Senate seeks to tighten the little-used cost recovery pathway to obtaining Orphan Drug designation in the U.S. The Fairness in Orphan Drug Exclusivity Act is identical to a bill, H.R....

Trump budget request claims $135B in drug savings, calls for NIH cut that won’t happen, flatlines FDA

President Donald Trump’s FY21 budget includes provisions the administration says will save $135 billion in drug costs over 10 years. The White House recycled ideas it has proposed over the last two years but did...

GAO finds little evidence Priority Review program spurring drug development

There is little evidence that the U.S. rare pediatric disease Priority Review voucher program has incentivized development of medicines, according to a Government Accountability Office report . The report could influence Congress, which is facing a...

CMS says proposed Medicare Part D specialty tier won’t hurt, may help a little

CMS damned with faint praise its proposal to create a new specialty tier in Medicare Part D. The proposal , announced Wednesday, would allow Part D sponsors to establish a second, “preferred” specialty tier with lower...

Trump boosts Grassley-Wyden drug pricing bill

President Donald Trump and Vice President Mike Pence have publicly endorsed pending Senate legislation that seeks to restructure the Medicare Part D drug benefit and impose inflation caps on prescription drug prices. “I’ve been speaking...

FDA’s Pazdur supports expanded access for approved drugs

Richard Pazdur, director of FDA’s Oncology Center of Excellence, Wednesday said he supports authorizing expanded access requests for unapproved uses of approved medicines. Although physicians can prescribe drugs for off-label indications, it can be difficult...

FDA, FTC vow to crack down on advertising and commercial practices that impede biosimilar uptake

FDA and FTC Monday said they will crack down on false and misleading advertising that denigrate biosimilars and will act to prevent commercial practices that delay or block biosimilar competition. FTC said it will “review...

U.S. declares 2019-nCoV a public health emergency

HHS Secretary Alex Azar Friday declared that 2019 Novel Coronavirus (2019-nCoV) poses a public health emergency. The declaration of a public health emergency, which came a day after WHO declared the coronavirus outbreak a Public...

As U.K. departs EU, industry to push for close EMA ties, access to talent

With Brexit now official, the British life sciences industry plans to prioritize cooperation with EMA on regulation of medicines and access to global talent in the upcoming trade negotiations between the U.K. and EU. The...

Biotech diversity is still lacking, BIO finds

In a report released Thursday, BIO detailed the results of its inaugural diversity survey that found biotech boards and C-suites are still overwhelmingly white and male, which in turn can make it harder for companies...