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

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

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 • 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

Inbrija delay poses question: How far can Acorda fall?

Regulators need more time to assess the biotech's Parkinson's drug. Their final decision, when it comes, will be the difference between Acorda shares trading at $5 or $30 apiece, according to one analyst.

By Jacob Bell • Sept. 13, 2018

Gottlieb rebuffs pharma CEO who claimed price hikes were 'moral requirement'

In a flashback to Martin Shkreli, the head of Missouri drugmaker Nostrum Laboratories unabashedly defended a 400% price increase on an old antibiotic.

By Ned Pagliarulo • Sept. 12, 2018

Portola's C-suite shrinks as chief commercial officer exits

Tao Fu's farewell comes amid a hunt for a CEO, putting more onto the shoulders of interim Co-President Mardi Dier.

By Suzanne Elvidge • Sept. 11, 2018

Roche hits roadblock in UK over Ocrevus price

Final guidance from NICE advised against covering the MS drug for primary progressive patients, despite a lack of other disease-modifying therapies.

By Suzanne Elvidge • Sept. 10, 2018

BlueCross BlueShield Tennessee drops Oxycontin in favor of Collegium's competitor

While still tiny next to the Oxycontin franchise, Xtampza has gained momentum as a challenger to Purdue's market dominance.

By Andrew Dunn • Updated Sept. 7, 2018

Invokana gains heart labeling in Europe

Among diabetes drugs, competition has increasingly been driven by the ability of companies to demonstrate the cardiovascular safety of their medicines.

By Ned Pagliarulo • Sept. 7, 2018

Gilead, Galapagos build case for JAK inhibitor with Phase 2 win

Though filgotinib offers significant benefits to patients with ankylosing​ spondylitis, the drug's real test seems to be whether it can compete in the rheumatoid arthritis market.

By Jacob Bell • Sept. 6, 2018

PhRMA, hospital war over drug prices heats up

A report from the pharma lobby claims hospitals steeply upcharge meds, adding to its efforts to shift criticism on price to other groups.

By Rebecca Pifer • Sept. 6, 2018

Generics group says branded drugmakers blocking $13B in annual savings

An AAM-backed study finds U.S. insurers, consumers and lawmakers could hold onto more money if branded drugmakers weren't taking advantage of federal programs like REMS.

By Jacob Bell • Sept. 5, 2018

Sanofi reaches $25M settlement with SEC on bribery charges

The French pharma neither admits nor denies fault to the claim it bribed government officials in the Middle East in exchange for boosted prescriptions.

By Suzanne Elvidge • Sept. 5, 2018