Roche looks to wider market for Hemlibra with key approval

The hemophilia A drug is now OK'd for patients without inhibitors, who represent about 70% of the total population with that blood disorder.

By Jacob Bell • Oct. 4, 2018

Intermountain's Liljenquist on price transparency, insulin and having 3 brothers with diabetes

The man behind the push for Civica Rx talks about how he hopes the venture will force transparency across the healthcare sector.

By Samantha Liss • Oct. 3, 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

FDA could set record low for drug marketing warning letters — again

After sending just five letters last year, the FDA office responsible for regulating prescription drug marketing has sent four letters so far in 2018.

By Andrew Dunn • Oct. 3, 2018

Paratek eyes 800 key hospital accounts for new antibiotic's rollout

The pharma shed its clinical-stage title on Tuesday as the FDA approved Nuzyra along with another of its drugs.

By Jacob Bell • Oct. 3, 2018

In reversal, GSK to restart limited payments to doctors

It's a step back from a 2013 pledge that made the British drugmaker an outlier among its industry peers.

By Ned Pagliarulo • Oct. 3, 2018

Lilly's migraine drug wins US approval, pressuring rivals Amgen, Teva

Two rival drugs are already OK'd for sale, setting the migraine market up for fierce competition. Who wins out may depend on how payers react.

By Ned Pagliarulo • Sept. 27, 2018

Pharma advertising in 2018: TV, midterms and specialty drugs

Magna Global expects 2018 to be a banner year for advertising spend, with pharma being one of the largest contributors.

By Jacob Bell • Sept. 26, 2018

ICER finds top asthma biologics overpriced

A draft report from the influential drug pricing group deemed Fasenra, Nucala, Cinqair, Xolair and the still-under-review Dupixent too costly, despite benefits. 

By Andrew Dunn • Sept. 26, 2018

New York regulator warns CVS-Aetna merger could raise prices

The state's top financial watchdog said the pharmacy chain's PBM would have an incentive to give the largest drug discounts to Aetna members.

By Samantha Liss • Sept. 26, 2018

Gilead creates subsidiary to sell generic versions of hep C blockbusters

Asegua Therapeutics will sell authorized generics of Harvoni and Epclusa at an annual list price of $24,000 for the most common course of therapy.

By Jacob Bell • Sept. 24, 2018

Foundation Med advances liquid biopsy ambition with new test

Launch of FoundationOne Liquid will expand the Roche-owned firm's liquid biopsy offerings as demand for blood-based cancer testing grows.

By Ned Pagliarulo • Sept. 24, 2018

UK High Court OKs Avastin off-label use in wet AMD

Doctors in the north of England have won the right to use Avastin to treat wet age-related macular degeneration.

By Suzanne Elvidge • Sept. 24, 2018

Amgen faces a bigger European challenge to Neulasta

Three biosimilar competitors to the blockbuster drug received backing from a key European committee last week.

By Suzanne Elvidge • Sept. 24, 2018

Sarepta strikes out again with European regulators

Despite backing more than a dozen other drugs at its September meeting, the CHMP for a second time refused to support eteplirsen's marketing OK.

By Jacob Bell • Sept. 21, 2018

Acadia shares rise after FDA review of Nuplazid

Following reports of increased risks to Acadia's Parkinson's drug, an analysis by the regulator turned up no new safety findings.

By Suzanne Elvidge • Sept. 21, 2018

5th Humira biosimilar approved in EU as market entry nears

The world's top-selling prescription drug is set to soon face direct competition in Europe, a tantalizing prospect for biosimilar developers.

By Andrew Dunn • Sept. 20, 2018

Hospital group, on defense, pitches 340B 'stewardship'

The initiative amounts to the industry's riposte against calls for increased oversight of the program by watchdogs and lawmakers in both parties.

By Rebecca Pifer Parduhn • Sept. 19, 2018

Does your brand need behavioral science?

Does your brand need a behavioral science solution? Find the right solution to meet your needs.

By Meredith Terry, PHD, Lead Behaviorist, Innovation and Practice MicroMass Communications, Inc. • Sept. 19, 2018

NICE says no to Kymriah for adult lymphoma despite offer on price

NHS recently agreed to cover Kymriah for certain pediatric leukemia cases. However, in its other indication, the Novartis therapy has hit a snag.

By Andrew Dunn • Sept. 19, 2018

Why payers are gobbling up PBMs

On Monday the Justice Department gave its blessing to a $67 billion acquisition of Express Scripts by Cigna.

By Samantha Liss • Sept. 18, 2018

Mylan biosimilar to stress test Amgen Neulasta franchise, analyst predicts

One new Wall Street analysis showed the stakes are high, not just for both companies, but for gauging the disruptiveness of biosimilars in the U.S. overall.

By Andrew Dunn • Sept. 17, 2018

Will Ajovy lead Teva's turnaround?

The Israeli pharma is counting on the migraine drug to help it rebound from recent struggles. A competitive market, however, could mean the expected boost from Ajovy will take time to materialize.

By Ned Pagliarulo • Sept. 17, 2018

Teva wins much-needed US approval of migraine drug

Ajovy will carry an annual list price of $6,900, matching the cost of Amgen and Novartis' rival preventive therapy Aimovig.

By Ned Pagliarulo • Sept. 14, 2018

Patient groups attack CVS use of ICER metrics, urge rethink

In an open letter, more than 90 organizations called on CVS to reconsider its decision to use ICER's drug value assessments for determining coverage.

By Andrew Dunn • Sept. 14, 2018

AstraZeneca wins FDA OK for leukemia drug

The approval gives a lift to AstraZeneca's efforts to expand its modest portfolio in hematological cancers.

By Suzanne Elvidge • Sept. 14, 2018