Eisai-Merck partnership picks up first-line Lenvima approval

While Keytruda combo trials remain in progress, the companies secured an important OK for the kinase inhibitor in hepatocellular carcinoma.

By Suzanne Elvidge • Aug. 20, 2018

Opdivo gets speedy approval in 3rd-line small cell lung cancer

Though Bristol-Myers' drug is breaking into a less competitive market, it may soon run into trouble there from the likes of Tecentriq and Keytruda.

By Jacob Bell • Aug. 17, 2018

Explore the Trendline➔

Commercialization

New drugs for obesity and Alzheimer’s look set to become blockbusters, reshaping pharma marketing strategies just as many current top-sellers near looming patent cliffs.

By BioPharma Dive staff

Teva granted FDA approval for first EpiPen generic

It's the latest blow to Mylan, which came under fire for hiking EpiPen's price over the last decade and is now facing manufacturing challenges for the flagship product.

By David Lim • Aug. 16, 2018

Sun Pharma receives FDA approval for dry eye drug

Cequa's thumbs up continues a relatively positive year for the Indian pharma as it now dives deeper into the complex yet profitable ophthalmology market.

By Andrew Dunn • Aug. 16, 2018

Vertex's Kalydeco first CF drug cleared for infants

The biotech's hold on the cystic fibrosis market has grown tighter with more drug approvals and label expansions.

By Suzanne Elvidge • Aug. 16, 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

CVS adopts ICER metrics in shift to value-based drug pricing

The move also helps CVS counter the narrative that PBMs are to blame for exorbitant drug pricing.

By Andrew Dunn • Aug. 15, 2018

J&J, ViiV tout positive data for two-drug HIV therapy

The ATLAS study provides even more evidence to back up the two-drug approach to HIV.

By Jacob Bell • Aug. 15, 2018

New York sues Purdue over opioid marketing

Purdue kept up deceptive marketing tactics even after executive guilty pleas in 2007 and an agreement with the state to stop in 2015, the lawsuit claims.

By Andrew Dunn • Aug. 15, 2018

With Mylan reeling, Kaléo touts its EpiPen rival for back-to-school season

Manufacturing delays at a Pfizer-owned EpiPen plant have created an opportunity for Kaléo.

By Nick Paul Taylor • 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

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

Perrigo to split off generic drugs unit

It's the latest indication of the pain felt by generic drugmakers as competition and pricing pressures hurt bottom lines.

By Barbara Boughton • Aug. 10, 2018

CVS rejects pharma claim that rebates push up drug prices

Responding to charges that PBMs pocket much of drug rebates, the pharmacy giant said it retains only 2% of the price concessions from drugmakers. 

By Ned Pagliarulo • Aug. 9, 2018

Novo expects more pricing pressure for diabetes drugs

The Danish drugmaker warned investors that net prices for its drugs, particularly basal insulin, are expected to be lower in 2019 than this year. 

By Suzanne Elvidge • Aug. 8, 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

Regeneron eyes DTC for its top-seller

While Eylea continues to dominate eye disease markets, its manufacturer is looking to reach more diabetic macular edema patients.

By Jacob Bell • Aug. 8, 2018

5 takeaways from payer Q2 earnings reports

Health insurers found success in Medicare, Medicaid and even the ACA exchanges.

By Les Masterson • Aug. 8, 2018

Vertex's Orkambi approved for kids with CF

A label expansion should strengthen Vertex's grip on the cystic fibrosis market.

By Suzanne Elvidge • 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

Express Scripts drops Mavyret from 2019 formulary in blow to AbbVie

The PBM will exclude 48 drugs, including AbbVie's fast-selling hepatitis C medicine, from its list of preferred drugs next year.

By Ned Pagliarulo • Aug. 7, 2018

Teva confident migraine drug will launch this year despite new manufacturing woes

On Tuesday, contract manufacturer Celltrion disclosed it received a Form 483 for its plant in Incheon, South Korea, which makes Teva's fremanezumab.

By Jacob Bell • Aug. 7, 2018