Mylan, Theravance win FDA approval for COPD drug

The companies now face the daunting task of launching Yupelri into a market dominated by several heavyweight brands.

By Suzanne Elvidge • Nov. 12, 2018

UK's NICE gives early no to expanded use of AstraZeneca's Lynparza

In a draft decision, a committee for the U.K.'s cost watchdog recommended not providing coverage for expanded use of the PARP inhibitor in ovarian cancer.

By Andrew Dunn • Nov. 9, 2018

Explore the Trendline➔

Commercialization

New drugs for obesity are becoming blockbusters, while Trump administration pressure is reshaping pharma marketing strategies ahead of looming patent cliffs.

By BioPharma Dive staff

PARP makers search for a way to break through

Though Lynparza, Zejula and Rubraca saw growth in the third quarter, they've each had trouble breaking further into the ovarian cancer maintenance market.

By Jacob Bell • Nov. 8, 2018

Earnings reveal pharma's mixed feelings on Trump drug pricing proposal

A plan that would shake up how CMS pays for Medicare Part B drugs could leave the bottom lines of major players like Roche, Amgen and Bristol-Myers exposed, according to analysts.​

By Jacob Bell • Nov. 7, 2018

Novartis gives up on biosimilar Rituxan in US

An additional ask from the FDA, which had rejected Novartis' copycat version earlier this year, seems to have changed the big pharma's thinking. 

By Kristin Jensen • Nov. 5, 2018

Lilly strengthens Trulicity's leading position with REWIND results

Wall Street analysts note data from the cardiovascular outcomes study could help differentiate the diabetes drug in the crowded GLP-1 market.

By Jacob Bell • Nov. 5, 2018

Humira biosimilar discounting 'aggressive' as competition enters in Europe

AbbVie, though, is confident it can deliver double-digit earnings growth in 2019 despite the biosimilar headwinds in Europe to Humira.

By Ned Pagliarulo • Nov. 2, 2018

Insulin drugmakers under scrutiny for pricing, patent practices

Reports from a Congressional caucus and a consumer group could fuel further criticism of the top diabetes pharma companies, in particular Sanofi.

By Andrew Dunn • Nov. 2, 2018

Gilead's stock wobbles on HIV pricing concerns

In a cost-saving effort, United Healthcare will offer patients who opt for cheaper HIV drugs prepaid debit cards, spurring concerns Gilead could be exposed to pricing pressures in HIV.

By Ned Pagliarulo • Nov. 1, 2018

Shingrix gives GSK a near-term boost

Questions on future growth still loom large, however, amid a pipeline revamp and competitive pressures in the pharma's core therapeutic areas.

By Ned Pagliarulo • Nov. 1, 2018

Novartis wins US nod for Humira biosimilar, but focus now on Europe

A settlement deal blocks market launch in the U.S. until 2023. In Europe, however, the battle for market share is just beginning. 

By Ned Pagliarulo • Oct. 31, 2018

Come January, will pharma pricing pledges hold?

Pfizer CEO Ian Read indicated this week that the pharma, which rolled back some price hikes in July, would return to "business as normal" next year. 

By Ned Pagliarulo • Oct. 31, 2018

Red pill or blue? It could be a billion-dollar decision

Viagra and Nexium ​underscore how marketers and manufacturers can use color to make a drug franchise more successful.

By Jacob Bell • Oct. 29, 2018

Amgen, Regeneron appear most at risk from Trump's latest pricing plan

Pharma hates the proposal to link Medicare Part B payments to international prices. But some drugmakers would stand to lose more than others.

By Ned Pagliarulo • Oct. 26, 2018

Trump pitches new plan to bring US drug prices down

The administration's latest effort will take aim at Medicare Part B, aiming to link drug payments in the U.S. to the prices pharmaceutical companies set abroad. 

By Ned Pagliarulo , David Lim • Updated Oct. 25, 2018

FDA approves flu drug with new mechanism of action

Just in time for the flu season, the newly OK'd antiviral treatment could be the viral boost that Roche needs.

By Suzanne Elvidge • Oct. 25, 2018

Amgen cuts US Repatha price 60% amid market pressure

While effective, the cholesterol drug's $14,520 list price has been a tough pill to swallow for payers. Now, Amgen will cut the price to $5,850.

By Ned Pagliarulo , Jacob Bell • Updated Oct. 24, 2018

DTC's big issues: Trump, cancer drugs and the First Amendment

Direct-to-consumer drug advertising, while always controversial, looks set to become a battleground yet again.

By Ned Pagliarulo , Jacob Bell , Andrew Dunn • Oct. 24, 2018

Reimbursement lags cancer drug approvals, but some European countries wait longer

While approvals of new drugs are centralized in the EU, decisions on reimbursement falls to individual countries — with varying results.

By Ned Pagliarulo • Oct. 24, 2018

Advair copy approval 'imminent,' Mylan says, but investors jittery

An FDA decision was expected in mid-October after the company was hit with a CRL in June. Hundreds of millions of dollars could be on the line.

By Ned Pagliarulo • Oct. 23, 2018

Biogen talks threats to Spinraza, but mum on BAN2401

The spinal muscular atrophy drug was the big biotech's main growth driver in the quarter. Yet attention remains on Alzheimer's data due Thursday.

By Jacob Bell • Oct. 23, 2018

First Amendment takes center stage in DTC price fight

A string of court decisions have bolstered commercial speech rights for industry. The Trump administration's push to require prices in TV ads could become the next legal battleground.

By Andrew Dunn • Oct. 22, 2018

Viagra no more: The changing face of drug ads on TV

Gone are twin bathtubs and little blue pills. Instead, pharma promotions on TV are more likely to feature complex biologics and cancer drugs. 

By Ned Pagliarulo • Oct. 22, 2018

FDA unconvinced by Novartis pitch for canakinumab

The agency knocked back an application for approval of the drug, already on the market as Ilaris, as a treatment for cardiovascular risk reduction. 

By Jacob Bell • Oct. 19, 2018

AbbVie reaches 5th deal to secure Humira through 2023

Through a settlement with AbbVie, Fresenius Kabi's copycat biologic won't launch in the U.S. until late 2023, pending it securing FDA approval by then. 

By Suzanne Elvidge • Oct. 19, 2018