Lilly's JAK woes set the stage for AbbVie, Gilead to jump ahead

An adcomm's iffy stance on baricitinib could mean one less thing to worry about for rivals looking to break into the fairly open JAK inhibitor market.

By Jacob Bell • April 24, 2018

Lilly's baricitinib wins FDA panel nod, but still dogged by safety issues

Lilly entered the Food and Drug Administration committee meeting on Monday with a fuzzy outlook for its potentially billion-dollar arthritis drug. It left in much the same fashion.

By Jacob Bell • April 23, 2018

Brain Talk: Tackling a crisis while treating the patient

While the opioid crisis has brought to light the overuse and abuse of these drugs, there are still patients who suffer from pain and are responsibly using opioids as treatment.

April 23, 2018

As India, China drug industries mature, FDA scrutiny an overhang

Rising numbers of warning letters have put production quality in focus, just as both countries turn further toward novel drug R&D. 

By Ned Pagliarulo • April 23, 2018

Pfizer's Herceptin copy hits FDA roadblock

Regulators handed Pfizer a Complete Response Letter four months after approving Mylan's copycat version of the breast cancer drug. 

By Ned Pagliarulo • April 23, 2018

GW wins panel backing for Epidiolex, looks to FDA decision

Following an advisory committee's unanimous recommendation for Epidiolex, GW Pharma awaits a June decision on approval by the regulator. 

By Randi Hernandez • April 20, 2018

Prescribed Reading: Shire on the block; FDA flip-flops

There are potentially multiple suitors looking to take out Shire. Elsewhere, the FDA is making surprise reversals.

By Lisa LaMotta • April 20, 2018

Lilly's baricitinib to face tough questions at AdComm

FDA staff reviewers raised doubts about the safety of the once-rejected rheumatoid arthritis drug ahead of an advisory committee meeting Monday.

By Lisa LaMotta • April 19, 2018

Rigel secures FDA approval for rare disease drug

News of the OK helped shares in the biotech recover from the effect of a clinical setback earlier this month. 

By Randi Hernandez • April 18, 2018

FDA staff positive on GW Pharma drug for seizures

Agency documents on the first whole-plant-based cannabis drug Epidiolex appear favorable for GW ahead of the Thursday advisory meeting. 

By Randi Hernandez • April 18, 2018

DEA seeks to more strictly manage opioid manufacturing

A proposed rule would allow the agency to consider drug misuse when setting the annual quotas that govern production of the painkillers. 

By Ned Pagliarulo • April 18, 2018

Amazon reportedly drops plan to distribute drugs to hospitals

The report is not entirely unexpected. Amazon previously canceled a wholesaler application in Maine and has told other state regulators it does not intend to sell drugs.

By David Lim • April 17, 2018

Alkermes up after FDA reversal on depression drug

The agency's about-face comes just two weeks after it issued a Refusal to File letter to the company.

By Lisa LaMotta • April 16, 2018

Prescribed Reading: Novartis ups the ante in gene therapy, while GSK folds on the space

Big pharmas are placing their bets on the future of gene therapy, with one European company going all-in and another pulling out.

By Lisa LaMotta • April 13, 2018

ICER releases draft report on CGRP migraine drugs

The watchdog group's review says that Aimovig could only treat 16% of the population without affecting the healthcare budget.

By Suzanne Elvidge • April 13, 2018

Maker of Pfizer med warned for continued testing issues

Tris Pharma has for years ruffled feathers at the FDA for not adequately investigating drug product failures.

By Jacob Bell • April 12, 2018

FDA to take closer look at liver data, delaying AbbVie's elagolix

The agency pushed back its decision date for the endometriosis-associated pain drug by three months in order to review liver function tests. 

By Lisa LaMotta • April 10, 2018

Celltrion acknowledges CRLs in potential hurdle for Teva

Rejection by the FDA of the two biosimilar candidates Celltrion develops with Teva could also prove a headache for the Israeli drugmaker's migraine therapy.

By Randi Hernandez • April 9, 2018

Clovis closes in on rival PARP drugs with latest approval

Rubraca is behind AstraZeneca's Lynparza and Tesaro's Zejula in terms of sales, but a new label expansion could strengthen the drug's competitive standing.

By Jacob Bell • April 6, 2018

Ohio bans pharmacy gag clauses, clawbacks

The effort highlights an ongoing debate about the opaque world of drug pricing.

By Randi Hernandez • April 6, 2018

Medicare to pay hundreds of thousands for CAR-T therapies

CMS will give hospitals outpatient reimbursements of about $400,000 for Gilead's Yescarta and $500,000 for Novartis' Kymriah.

By Jacob Bell • April 6, 2018

Surgeon General: More people should carry naloxone

The advisory comes a week before Congress is set to consider two competing packages aimed at curbing the opioid crisis.

By David Lim • April 5, 2018

Pharma turns to new pain options amid opioid crisis

In its latest spotlight, BioPharma Dive explores the drug industry's efforts to develop novel approaches to treat pain and deter abuse.

By Lisa LaMotta • April 4, 2018

Proposed China tariffs target dozens of medical products

Insulin products, vaccines and certain active pharmaceutical ingredients imported from China could face a new 25% tariff under the Trump administration's proposed plan. 

By Ned Pagliarulo • April 4, 2018

Alkermes hit with Refusal to File for depression drug

The FDA did not accept the company's application for its depression drug, sending shares sliding.

By Lisa LaMotta • April 2, 2018