Prior authorization limits would be 'reasonable' for CGRP drugs, ICER says

While Amgen won some credit for pricing its new migraine drug lower than expected, payers could still act as a gatekeeper for access to CGRP inhibitors. 

By Ned Pagliarulo • July 5, 2018

Digital health funding sets new H1 record with $3.4B raised

The sustained growth reflects the sector's maturation and a healthy venture ecosystem, a new Rock Health report says. Despite bullish investment levels, however, exits have been slow. 

By Meg Bryant • July 3, 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

FDA calls Pfizer Estring marketing misleading

The agency's Office of Prescription Drug Promotion took the pharma to task for not mentioning the product's risks.

By Suzanne Elvidge • July 3, 2018

CMS to states: Medicaid must cover accelerated approval drugs

The agency explained that any treatment cleared through the accelerated approval pathway and defined as a "covered outpatient drug" must be covered.

By David Lim • June 28, 2018

Gottlieb calls out Perrigo for missed postmarket study deadline

The FDA chief took to Twitter to remind drugmakers of their responsibilities to conduct required follow-up studies. 

By Ned Pagliarulo • June 27, 2018

Achaogen gets a yes and a no for antibiotic Zemdri

The FDA granted approval for urinary tract infections but not for blood infections, spurring a 20% stock slump.

By Suzanne Elvidge • June 27, 2018

DIA18: How much are PRVs even worth?

Evidence has shown the value of these regulatory fast passes has diminished in recent years, and may trend further downward as the market matures.

By Jacob Bell • June 27, 2018

DIA18: Value-based contracts pose more questions than answers

Drugmakers and payers are still figuring out what data are needed to support a new wave of pricing agreements and how to collect that information earlier.

By Jacob Bell • June 26, 2018

Connecting in context: Leveraging geo-location campaigns to drive ROI

Mobile campaigns continue to dominate the advertising space, but with good reason. Geo-location technology is providing new and effective ways of reaching target audiences.  

By Catherine Dold • June 25, 2018

CVS, facing Amazon threat, offers at-home prescription delivery

The pharmacy giant said it will become the first national drugstore to deliver prescriptions directly to consumers.

By Rebecca Pifer • June 20, 2018

Purdue Pharma lays off 350, cutting remainder of sales force

The layoffs mark an end to the Oxycontin maker's direct marketing of its prescription medicines to doctors.

By Ned Pagliarulo • June 20, 2018

Gottlieb lays out FDA plans to speed generic reviews, spur label updates

The agency is set to launch a new review tool aimed at reducing the number of cycles of application review.

By David Lim • June 19, 2018

How badly does Alexion want its Soliris follow-on? Enough to use a rare fast pass

In submitting ALXN1210, the rare disease biotech used one of its priority review vouchers to hasten an approval decision from regulators.

By Jacob Bell • June 19, 2018

Nonprofit pharma picks up coveted PRV

Securing approval for its river blindness drug also hands Medicines Development for Global Health a coveted regulatory fast pass.

By Suzanne Elvidge • June 15, 2018

GSK touts two-drug HIV therapy, intends to file this year

Success of the doublet should help GSK better compete with Gilead, its main competitor in the HIV market. 

By Jacob Bell • June 14, 2018

Biosimilars could still pack revenue-busting punch, analyst suggests

Uptake of the few copycat biologics launched in the U.S. has been slow. Yet a Leerink analyst expects a typical biosimilar will erode 20% of branded drug sales in the first year post-launch. 

By Ned Pagliarulo • June 13, 2018

Big pharma shows no signs of 'massive' drug price cuts

The nation's largest drugmakers have yet to voluntarily bring down prices on their drugs as President Trump claimed they would — and recent exchanges with lawmakers signal such reductions may not be coming.

By Jacob Bell • June 13, 2018

FDA permits more expansive communication between drugmakers, payers

New guidance sets out the agency's thinking on what information companies can share with insurers about their products, including for unapproved uses.

By Ned Pagliarulo • June 13, 2018

FDA mulls new incentives to stem antimicrobial resistance

The agency is working to smooth approval pathways for new products, while proposing changes to reimbursement to account for limited use.

By Suzanne Elvidge • June 13, 2018

First Neulasta biosimilar headed to US market

The FDA has approved Mylan and Biocon's copycat pegfilgrastim, putting even more pressure on the already weakening Amgen franchise.

By Jacob Bell • June 6, 2018

FDA puts illegal opioid websites on notice, issues warning letters

Commissioner Scott Gottlieb said the effort is one piece of a broader effort to crack down on opioids sold online and shipped by mail.

By David Lim • June 6, 2018

Dova reveals $9K to $13.5K Doptelet price, stock sags

After keeping quiet at approval, the company disclosed a steeper-than-expected price for the thrombocytopenia treatment. At least one analyst is worried it could hurt uptake.

By Suzanne Elvidge • June 1, 2018

PhRMA criticizes ICER in latest skirmish over valuing drugs

The drug lobby sponsored an analysis that found ICER's cost-effectiveness methods would force seniors to switch treatments if ever adopted in Medicare Part B.

By Ned Pagliarulo • May 31, 2018

Allergan to sell off women's health, anti-infective businesses

CEO Brent Saunders, who has been under pressure over Allergan's sliding share price, emphasized the move does not signal a "fire sale" at the pharma.

By Ned Pagliarulo • May 30, 2018

TherapeuticsMD garners FDA OK for Imvexxy

After a prior rejection, the women's health company gets the go-ahead for its estrogen capsule for pain during sex.

By Lisa LaMotta • May 30, 2018