Pfizer inks marketing deal for Exact's Cologuard

Exact said about 401,000 tests were performed during the first six months of 2018, leading to revenue of $193 million. The CEO now expects $700 million in sales for next year.

By Andrew Dunn • Aug. 22, 2018

FDA extends EpiPen expiration date to ease shortages

Current shortages stemming from ongoing manufacturing delays could put children at risk as the school year approaches.

By Suzanne Elvidge • Aug. 22, 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

Drug combos may prove more costly than generic components, study finds

Research published in JAMA suggests paying for branded drug combos rather than buying the component generics separately may have cost the government program nearly $1 billion in 2016. 

By Suzanne Elvidge • Aug. 22, 2018

HHS touts drug pricing 'wins,' but true tests still to come

The Trump administration has extracted some concessions from a handful of pharma companies, but January will test whether freezes on price hikes last. 

By Ned Pagliarulo • Aug. 21, 2018

EpiPen class action lawsuit against Mylan, Pfizer to continue, judge rules

Multidistrict litigation alleges the companies engaged in "an illegal scheme to monopolize the market" for epinephrine auto-injectors.

By Jacob Bell • Aug. 21, 2018

Walmart, Anthem partner on Medicare program

Tie-ups between healthcare firms and retailers have ticked up, with Walmart now planning to offer discounts on OTC drugs for some Anthem customers.

By Daphne Howland • Aug. 20, 2018

Aimovig launch bolsters hopes for blockbuster sales

Though several recent blockbusters-to-be have disappointed, Leerink analyst Geoffrey Proges believes Aimovig's start augurs well for anti-CGRP drugs.

By Ned Pagliarulo • Aug. 20, 2018

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

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