Novo Nordisk goes for broke on semaglutide heart data

The diabetes giant is asking the FDA for permission to market cardiovascular claims before a long-term outcomes study is complete.

By Jonathan Gardner • June 11, 2019

Judge, CVS witness clash on merger settlement, July hearing set

Federal Judge Richard Leon told lawyers they might want to cancel their summer vacation plans as he voiced concern about the leverage the merged health giant will wield in the marketplace.

By Dana Elfin • June 6, 2019

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

Mitsubishi pulls EU application for ALS drug, citing 'unwarranted' data request

Regulators had concerns that data from a key study that has helped Radicava in other markets isn't strong enough to warrant approval in the bloc.

By Jacob Bell • May 31, 2019

Seniors' out-of-pocket spending on cancer drugs climbs higher

Despite efforts to limit Medicare Part D beneficiaries' financial exposure to high-cost drugs, price increases have wiped out some of the expected savings.

By Samantha Liss • May 29, 2019

Gilead C-suite shifts again with chief commercial officer appointment

Bristol-Myers Squibb veteran Johanna Mercier will fill the position in July, while Laura Hamill, who joined Gilead's top ranks last year, will be leaving.

By Jacob Bell • May 29, 2019

Teva settles for $85M in Oklahoma opioid lawsuit

Yet a looming question for the Israeli pharmaceutical giant, as well as other drugmakers, is whether more states will follow in suing over the opioid crisis.

By Jacob Bell • May 28, 2019

Novartis gene therapy approved, but will come at cost of more than $2M

Zolgensma is designed to be a cure for spinal muscular atrophy, but its steep price will pose difficulties for a system designed for chronic therapy rather than one-time treatments. 

By Ned Pagliarulo • Updated May 24, 2019

ICER sees current DMD therapies as too pricey, but notes data limitations

Though evidence supporting Sarepta's eteplirsen and golodirsen and PTC's deflazacort "remains sparse," ICER expects all three drugs wouldn't hit certain cost-effectiveness thresholds.

By Jacob Bell • May 23, 2019

Private payers cover more than 40% of drug costs

Patients pay 14% of overall retail drug spend in the U.S. in the form of out-of-pocket costs, according to a new analysis from the Kaiser Family Foundation.

By Rebecca Pifer Parduhn • May 21, 2019

ICER seeks to make drug price research more accessible

Pharmas and payers use ICER's work to inform their approach on pricing and coverage, making the group a key voice in the debate over drug value.

By Ned Pagliarulo • May 20, 2019

The NASH dash runs into some early hurdles

In a trio of articles, BioPharma Dive explored the key problems the NASH field faces and what's being done to solve them.

By Jacob Bell • May 17, 2019

No one knows the size of the NASH market

Industry is still using a broad estimate for the NASH population, which has led to very different views on the size of the potential market opportunity.

By Jacob Bell • May 16, 2019

On the path to patients, NASH drugs may hit a payer roadblock

Wall Street estimates and clinical data suggest the earliest NASH drugs could come with limited efficacy but high price tags. Healthcare providers fear that won't sit well with payers.

By Jacob Bell • May 15, 2019

Will a big needle burst the NASH bubble?

With less invasive tests still a few years off, doctors worry liver biopsies will limit access to the initial wave of NASH drugs — if any make it to market. 

By Jacob Bell • May 14, 2019

Gilead donates Truvada for PrEP to CDC, with mixed reactions

While the donation will make the preventive treatment available to uninsured Americans, it doesn't lower the cost for others.

By Andrew Dunn • May 10, 2019

Nearing gene therapy launch, Bluebird cautions a slower start

Zynteglo, Bluebird's experimental therapy for beta-thalassemia, could soon be cleared in Europe. Reworking payment models to adjust will take time.

By Ned Pagliarulo • May 9, 2019

Drugmakers will soon be required to disclose prices in TV ads

Forcing pharma's hand, the Trump administration finalized a proposal requiring list prices in DTC advertising, inviting a possible legal challenge from industry.

By Ned Pagliarulo • May 8, 2019

Catalyst dives as FDA approves rival's rare disease drug

Jacobus Pharmaceutical's Ruzurgi is cleared for a different age range than Catalyst's Firdapse, yet investors appear concerned about off-label use eroding the latter's business. 

By Jacob Bell • May 7, 2019

J&J touts YouTube successes after growing spend on the platform 250%

While drugmaker marketing for pharmaceuticals still relies heavily on TV, J&J has found success with digital advertising for its consumer brands. 

By Peter Adams • May 3, 2019

Alnylam posts strong Onpattro sales as competition heats up

Onpattro's performance in the first quarter beat expectations. But can Alnylam sustain that momentum if Pfizer wins approval for its would-be rival tafamidis?

By Ned Pagliarulo • May 2, 2019

Pfizer prospects for tafamidis market

The rare disease tafamidis treats is underdiagnosed, Pfizer says, so increasing awareness will be essential. Payers, meanwhile, may seek outcomes-based contracts.

By Jonathan Gardner • April 30, 2019

At gene therapy meeting, insurance execs grapple with expected cost

As more gene therapies move closer to market, questions around pricing and reimbursement have taken on greater urgency for regulators, payers and drugmakers.

By Ned Pagliarulo • April 30, 2019

Praluent scores heart label, matching Amgen's rival Repatha

The cholesterol drug from Sanofi and Regeneron is now approved for prevention of cardiovascular events like heart attack or stroke.

By Ned Pagliarulo • April 29, 2019

AbbVie wins hep C contract with Washington state in latest 'Netflix' deal

Louisiana inked a similar agreement last month with a Gilead subsidiary, pioneering a model that aims to boost access while containing drug costs.

By Andrew Dunn • Updated April 26, 2019

Praluent's lower list price isn't yielding better sales yet

Though the Sanofi-Regeneron cholesterol drug took a 60% list price cut in March, stateside sales were down 27% due to "significantly increased rebates."

By Jacob Bell • April 26, 2019