Marketing
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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 at 11:16 a.m.
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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 at 10:23 a.m.
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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 at 4:13 p.m.
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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
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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
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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. 09, 2018
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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. 08, 2018
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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. 08, 2018
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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. 08, 2018
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Deep Dive5 takeaways from payer Q2 earnings reports
Health insurers found success in Medicare, Medicaid and even the ACA exchanges.
By Les Masterson • Aug. 08, 2018
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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. 08, 2018