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

Gottlieb: FDA working on new biosimilar policies

The agency chief aims to boost biosimilar competition, teasing at a CNBC conference efforts to spur development of the copycat biologics.

By Lisa LaMotta • March 28, 2018

Legislation looks to limit length of opioid prescriptions

The American Medical Association has called for more research, noting prescription length depends on situation and type of care.    

By Les Masterson • March 27, 2018

Aetna to offer point of sale pharmacy rebates to 3M customers

The insurer has opposed an idea from CMS to mandate Part D sponsors pass on a percentage of rebates to customers at the point of sale.

By David Lim • March 27, 2018

Payers use data to flag those at greatest risk of opioid abuse

The idea is to pinpoint patients most likely to become addicted and help prevent opioid abuse before it starts.

By Les Masterson • March 26, 2018

FDA issues draft guidance on compounding at outsourcing facilities

In an attempt to protect patients from compounded drugs with questionable quality, the agency outlined how to characterize bulk drug substances and certify their use for compounding by outsourcing facilities.

By Randi Hernandez • March 26, 2018

Prescribed Reading: AbbVie disappoints; Regeneron deals in genes

Investors questioned AbbVie's strategy in oncology after a clinical miss. Elsewhere, Regeneron partnered with Alnylam to probe the potential of a genetic discovery.

By Lisa LaMotta • March 23, 2018

FDA warns Indian drugmaker over open-air API production

Inspectors from the agency weren't thrilled to find birds and insects nearby equipment used for drug manufacturing.

By Ned Pagliarulo • March 22, 2018

FDA to study how drug promotion affects doctors' decisions

Drugmakers spend billions of dollars trying to get their products in front of prescribers, and the FDA wants to know how influential that practice has become.

By Jacob Bell • March 21, 2018

Seattle Genetics secures key label expansion for Adcetris

The antibody-drug conjugate is now approved together with chemo for frontline Hodgkin lymphoma, giving newly diagnosed patients another treatment option.

By Ned Pagliarulo • March 21, 2018

HHS makes case against hospitals' 340B suit in new filing

Big cuts by HHS to payments made from pharmas to hospitals have become the center of a major legal fight.

By David Lim • March 21, 2018

New FDA transparency push begins with J&J's Erleada

The prostate cancer drug is the first in a new program which will involve publishing the key clinical trial data supporting approval decisions.

By Jacob Bell • March 20, 2018

CSL Behring's Hizentra wins FDA nod for CIDP

The company is hoping the plasma derivative's subcutaneous administration will differentiate it enough to capture market share.

By Randi Hernandez • March 19, 2018

CMS finalizes coverage of DNA sequencing for cancer patients

The agency will also cover similar tests approved by the FDA.

By Jeff Byers • March 19, 2018