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

AstraZeneca settles Texas suits claiming it mismarketed Crestor, Seroquel

The British drugmaker will pay $110 million to resolve the charges — far less than the $5 billion Texas originally sought in its 2013 claim.

By Ned Pagliarulo • Aug. 8, 2018

CMS to allow step therapy in Medicare Advantage plans

A CMS senior adviser said the move could save 15-20% of the $12 billion spent annually by MA plans on pricey Part B drugs. Not all analysts buy that estimate.

By David Lim • Aug. 8, 2018

Gemphire stock drops to all-time low as lead drug delayed

Phase 3 studies of gemcabene can't begin until a partial clinical hold on the drug's class is lifted — something Gemphire now needs more data to do. 

By Andrew Dunn • Aug. 7, 2018

Pain Therapeutics reorganizing as abuse-deterrent opioid rejected again

CEO Remi Barbier called the FDA's decision "bizarre ... especially during a time of staggering human and economic toll created by opioid abuse and addiction."

By Jacob Bell • Aug. 6, 2018

Latest PRV sale further evidence of sliding value

Ultragenyx and Kyowa Kirin sold a PRV for just $81 million, reinforcing the downward trend in prices commanded by the regulatory "fast passes."

By Ned Pagliarulo • Aug. 2, 2018

FDA makes new moves to cut veterinary drug use in AMR fight

A new blueprint builds on existing guidance, including establishing appropriate durations of use of medically-important antimicrobials.

By Suzanne Elvidge • Aug. 2, 2018

EMA faces higher staff losses ahead of move to Amsterdam

The regulator is putting business continuity plans in place, as it expects to lose up to a third of its staff.

By Suzanne Elvidge • Aug. 2, 2018

FDA approves Shionogi's thrombocytopenia drug

Mulpeta was cleared for patients with chronic liver disease-associated thrombocytopenia undergoing medical or dental procedures.

By Barbara Boughton • Aug. 1, 2018

Gencaro back from the brink as FDA gives Phase 3 go-ahead

Regulators have told Arca a single Phase 3 study could be sufficient to support an NDA for the heart medicine.

By Suzanne Elvidge • Aug. 1, 2018

Gottlieb teases guidance on continuous trials, touts surrogate endpoints

In a self-described "tweetorial," the FDA chief said modernizing clinical trials could help cut costs.

By Lisa LaMotta • July 30, 2018

FDA rejects Insys opioid pain spray

Regulators cited concerns about the safety and efficacy of Buvaya, a form of the opioid buprenorphine.

By Barbara Boughton • July 30, 2018

With CHMP thumbs up, Alynlam's RNAi moves a step closer to EU market

The drugs committee of the EU regulator this month recommended a slate of new drugs for approval, including the newly named Onpattro from Alnylam.

By Suzanne Elvidge • July 30, 2018