German Merck finally gets yes for MS drug Mavenclad

The FDA approved the drug under a comparatively restrictive label, however, likely meaning the market opportunity for German Merck is small. 

By Suzanne Elvidge • April 2, 2019

Bluebird gene therapy on cusp of European market entry

A nod from an EMA expert panel means Bluebird's LentiGlobin for beta-thalassemia has just one last hurdle before it's cleared.

By Jacob Bell • March 29, 2019

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

Diabetes group nods to Vascepa, sending Amarin stock higher

The ADA updated its medical care standards to include Vascepa as Amarin works toward an expanded heart label for the drug.

By Andrew Dunn • Updated April 3, 2019

Louisiana selects Gilead for subscription-based hep C program

Gilead beat out AbbVie and Merck to be the provider of the first-of-its-kind payment model, which focuses on prisoners and Medicaid patients.

By Andrew Dunn • March 27, 2019

Lilly reveals Humalog pricing details amid larger scrutiny over insulin costs

The average list price on the widely used insulin rose more than 50% from 2014 to 2018, though Lilly noted the drug's average net price declined 8%.

By Jacob Bell • March 25, 2019

Specialty drug costs skyrocketed to $33B in Medicare Part D in 2015

Brand-name specialty drugs accounted for only 1% of all prescriptions in both Medicare Part D and Medicaid, but accounted for 30% of net spending.

By Rebecca Pifer Parduhn • March 21, 2019

Sage's postpartum depression drug is approved. Now comes the hard part

Zulresso's label requires women to undergo a 60-hour infusion and only in certain settings, factors that may hamper the drug commercially.

By Jacob Bell • Updated March 20, 2019

Gilead raises prices on top-selling HIV treatments

The biotech hiked prices on more than a dozen products, including six HIV medicines that each surpassed $1 billion in 2018 sales.

By Andrew Dunn • March 19, 2019

Gearing up for growth

Launch decisions have a lasting impact. Here’s how short-term focus leads to long term success.

March 18, 2019

Aerie's eye drops win FDA approval

Branded as Rocklatan, the drops share an active ingredient with another intraocular pressure drug called Rhopressa that Aerie launched last year.

By Kristin Jensen • March 13, 2019

Dupixent label expansion opens door to thousands more patients

A new approval in younger atopic dermatitis patients could increase the list of people eligible to use the immunology drug by 200,000, according to Sanofi.

By Jacob Bell • March 12, 2019

Pharmas, PBMs and payers all take a slice along drug supply chain, Pew finds

As debate over drug pricing continues, Pew's report seeks to document the share each player pockets as medicines move through the system.

By Les Masterson • March 11, 2019

Mylan's Advair generic pressures GSK with strong launch

Priced at a 70% discount, Mylan's copy of the blockbuster respiratory drug has quickly captured market share.

By Ned Pagliarulo • March 8, 2019

AMAG pregnancy drug's future in doubt after key study miss

A confirmatory trial designed to support Makena's approval failed, likely crimping its commercial prospects. Yet the drug may still remain on market. 

By Jacob Bell • March 8, 2019

Lilly follows Gilead, Mylan lead with authorized generic play

A strategy to "cannibalize your own products before your competition does" — as one consultant put it — serves several purposes for drugmakers under pressure on price.

By Andrew Dunn • March 5, 2019

Lilly to launch generic of its insulin Humalog, cutting list price in half

Introduction of an authorized generic, though, may not dispel criticism of Lilly's pricing, which has come under scrutiny in recent years. 

By Ned Pagliarulo , Andrew Dunn • March 4, 2019

AbbVie, Akcea benefit from latest CHMP recommendations

Risankizumab and volanesorsen​, which would be marketed as Skyrizi and Waylivra, were among eight drugs that got committee support.

By Jacob Bell • March 1, 2019

Roche wins US approval of more convenient Herceptin

Treatment with subcutaneous Herceptin takes just a few minutes, rather than the sometimes hour and a half needed to administer the breast cancer drug intravenously.

By Ned Pagliarulo • March 1, 2019

So far, so good for Alexion's Soliris follow-on

Alexion is working to convert PNH patients to its newer Ultomiris, preparing for a future with biosimilar competition.

By Jacob Bell • Feb. 28, 2019

At Senate hearing, pharma shows split on biosimilars

Merck & Co. and Pfizer are eager to see biosimilar uptake encouraged, a position fellow big pharma J&J doesn't appear to share. 

By Ned Pagliarulo • Feb. 27, 2019

Early Epidiolex sales push up GW Pharma's stock

The cannabis-based epilepsy therapy got off to a strong commercial start in the U.S., analysts said, although the drug's roll-out is still in early days.

By Andrew Dunn • Feb. 27, 2019

How lawmakers could pressure top pharma execs in Senate hearing

Here's a guide to the political pressure points for each of the seven drug companies in front of the Senate Finance Committee today.

By Ned Pagliarulo • Feb. 25, 2019

Intercept stock drop reflects the high bar set for NASH drugs

Though Intercept's drug Ocaliva did score the first Phase 3 victory against the fatty liver disease, investors still appear skeptical of the drug's prospects.

By Jacob Bell • Feb. 22, 2019

Dr. Reddy's relaunches Suboxone generic after court victories

A legal battle had stalled entry of Dr. Reddy's copy, which will now challenge Indivior's opioid dependence treatment in the U.S. 

By Kristin Jensen • Updated Feb. 22, 2019

Sanofi handed payers nearly $12B in drug rebates last year

That's why, despite increasing the U.S. list price on 35 of its 76 prescription drugs, the French pharma reported an average net price decline of 8% in 2018.

By Ned Pagliarulo • Feb. 21, 2019