FDA delays key Tecentriq decision by 3 months

Roche had hoped to secure a first-line approval for the immunotherapy in lung cancer by this week. Now, it will have to wait until December after an FDA review extension.

By Ned Pagliarulo • Sept. 6, 2018

Novartis CAR-T therapy snags UK coverage, cutting list price 23% from US

One of the fastest funding deals in U.K. history leaves Novartis ahead of rival Gilead in the battle to secure commercial returns for CAR-T across the pond.

By Andrew Dunn • Sept. 5, 2018

Chi-Med wins landmark cancer drug approval in China

Fruquintinib is the first cancer medicine discovered and developed by a Chinese company to secure an unconditional OK in the country. Partner Eli Lilly will sell the drug there.

By Ned Pagliarulo • Sept. 5, 2018

Lupin's Tarapur facility gets clean bill of health from FDA

Amid widespread problems with valsartan production, a cGMP inspection has alleviated concerns at one of Lupin's Indian plants.

By Suzanne Elvidge • Sept. 5, 2018

FDA knocks back Sunovion's ADHD drug

It's two steps forward and one step back for the Massachusetts drugmaker, which received a Complete Response Letter for dasotraline.

By Suzanne Elvidge • Sept. 4, 2018

What you need to know about the evolving regulatory landscape

BioPharma Dive takes an in-depth look at how the FDA has changed in recent years — and where it might be headed.

By Jacob Bell • Aug. 31, 2018

FDA warns of link between some diabetes drugs and serious infection

SGLT2 inhibitors, a kind of Type 2 diabetes medication, have been connected with a rare and sometimes life-threatening genital infection.

By Suzanne Elvidge • Aug. 30, 2018

Pfizer calls out pharma peers for 'scare tactics' on biosimilars

Frustrated by slow uptake of its biosimilars, Pfizer is petitioning the FDA to set ground rules for what biologic makers can say about copycat rivals.

By Ned Pagliarulo • Updated Aug. 29, 2018

FDA warns 21 websites selling unapproved opioids

Scott Gottlieb has upped the agency's oversight of illegal online pharmacies that put the U.S. public at risk through counterfeit or contaminated opioids.

By Suzanne Elvidge • Aug. 29, 2018

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