UK's NICE judges Yescarta too pricey, dealing blow to Gilead

Cost and reimbursement issues will be a key test for Gilead as it seeks to sell its CAR-T treatment in Europe.

By Ned Pagliarulo • Updated Aug. 29, 2018

Waylivra rejection raises questions about Ionis, Akcea ability to close

A CRL for Waylivra and a delay for Tegsedi hurt shares in the two biotechs and call into question what's going wrong with their approval applications.

By Jacob Bell • Aug. 28, 2018

FDA ups the ante for copycats, antibiotics, orphan drugs. But is it working?

Regulators are using incentives to spur development of much-needed drugs. The results so far have been mixed.

By Jacob Bell • Aug. 27, 2018

FDA confronts its limits in push on drug pricing

Legally, regulating prices is outside of the FDA's purview. But that hasn't stopped Scott Gottlieb from taking a more vocal approach to the hot-button issue than past FDA chiefs.

By Ned Pagliarulo • Aug. 27, 2018

Novartis, Gilead CAR-T therapies approved in Europe, putting spotlight on global manufacturing

Kymriah and Yescarta are churned out in a matter of weeks — a production task that gets more difficult as approvals expand their geographic reach.

By Jacob Bell • Aug. 27, 2018

FDA cautions drugmakers on using placebos in cancer drug studies

Draft guidance from the agency reinforces the practice of measuring experimental cancer drugs against active controls.

By Barbara Boughton • Aug. 24, 2018

Insurers, PBMs nudge FDA to finalize interchangeability guidance

A lack of final guidance from the FDA could be reducing patient access to biologics, according to a letter from payers, trade bodies and patient groups.

By Suzanne Elvidge • Aug. 24, 2018

SEC charges former Sangamo exec, others with insider trading

Biotech remains fertile ground for illegal trading ahead of market-moving events, as seen most notably in the recent charges against Rep. Chris Collins.

By Suzanne Elvidge • Aug. 24, 2018

Mallinckrodt gets CRL for newborn jaundice drug

The rejection of stannsoporfin, which Mallinckrodt acquired with its purchase of InfaCare, represents the latest setback for the troubled company.

By Suzanne Elvidge • Aug. 23, 2018

Allergan may not lose much from latest FDA rejection

Wall Street didn't put much stock in the company's uterine fibroids drug Esmya. Now that the drug received a CRL, analysts expect investors to shift focus to more promising assets.

By Jacob Bell • Aug. 22, 2018

HHS touts drug pricing 'wins,' but true tests still to come

The Trump administration has extracted some concessions from a handful of pharma companies, but January will test whether freezes on price hikes last. 

By Ned Pagliarulo • Aug. 21, 2018

EMA bars valsartan API made by second Chinese drugmaker

The EMA has revoked Zhejiang Tianyu's authorization to make the heart drug ingredient for EU medicines after finding traces of a carcinogen in batches produced by the manufacturer. 

By Suzanne Elvidge • Aug. 21, 2018

Trump seeks federal opioid lawsuit, DOJ aims to slash manufacturing quotas

The president said he'd like Attorney General Jeff Sessions to launch a federal suit in addition to ongoing state legal actions. Meanwhile, the DOJ and DEA proposed further cuts to quotas on opioids for 2019.

By Andrew Dunn • Aug. 17, 2018

US agencies pitch efforts to spur gene therapy development

The chiefs of the FDA and NIH laid out proposals in a New England Journal of Medicine editorial aimed at pushing forward advances in the expanding field.

By Suzanne Elvidge • Aug. 17, 2018

FDA seeks go-ahead to study risk info in DTC print ads

The proposed studies would use eye-tracking technology to better understand where and for how long consumers look at risk claims.

By Jacob Bell • Aug. 15, 2018

Biogen's Spinraza gets an early no-go from NICE

While noting Spinraza's efficacy in the clinic, the U.K. agency concluded it wasn't a cost-effective use of National Health Service resources. 

By Jacob Bell • Aug. 14, 2018

FDA sets out vision to use real-world data in product evaluations

The agency wants insights into safety and efficacy outside of controlled research environments.

By Nick Paul Taylor • Aug. 14, 2018

Telling doctors about their patients' opioid deaths curbed prescriptions

A letter from the San Diego County medical examiner resulted in lower high-intensity prescribing, fewer opioid prescriptions and overall lower opioid intake, according to an analysis.

By Les Masterson • Aug. 13, 2018

FDA OKs marketing of contraceptive app

The Natural Cycles app has generated controversy in Europe, where women have reported unplanned pregnancies while using it.

By Susan Kelly • Aug. 13, 2018

Regeneron quickly clears up 12-week Eylea CRL

Regulators rejected Eylea amid "ongoing labeling discussions" with Regeneron, yet an approval four days later suggests the problems were easily solved.

By Jacob Bell • Updated Aug. 17, 2018

Amicus secures US approval for Fabry disease drug

It's an outcome that looked to be in question when the FDA asked for more data two years ago. But an agency reversal cleared the way for Amicus to move forward. 

By Ned Pagliarulo • Updated Aug. 13, 2018

In first, FDA approves RNA interference drug from Alnylam

Alnylam's drug, called Onpattro, will carry an average annual list price of $450,000, although the biotech expects rebates to bring the net price down by a fifth.

By Ned Pagliarulo • Updated Aug. 10, 2018

NICE suspends review of Vertex's Symkevi

U.K. regulators and Vertex have been sparring over the price of the company's cystic fibrosis drugs. In the latest twist, the biotech did not provide the data needed for NICE's review.

By Suzanne Elvidge • Aug. 10, 2018

FDA adcom support puts Paratek's antibiotic closer to approval

The committee voted 17-1 and 14-4 in favor of approving omadacycline for two kinds of infection.

By Jacob Bell • Aug. 9, 2018

FDA OKs first generic under new approval pathway

The "Competitive Generic Therapy" designation was created to speed review for copies of single-source drugs — part of the FDA's broader plan to boost competition.

By Suzanne Elvidge • Aug. 8, 2018