FDA invites pharma input in off-label debate

A two-day industry meeting continues Thursday, aiming to gather input on the FDA's regulatory approach to off-label drug promotion. 

By Ned Pagliarulo • Nov. 9, 2016

FDA asks how best to tweet Rx risks (in exactly twice this much space)

If a drug's benefits are promoted on social media, is posting a link to its risks enough to strike a balance?

By Judy Packer-Tursman • Nov. 9, 2016

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

Endo talks pricing, generics market turmoil

Generics are Endo's bread and butter, but the company acknowledged that the copycat drugs may face continued headwinds next year.

By Jacob Bell • Nov. 8, 2016

Armed with positive data, Biogen accelerates launch prep for SMA drug

Infrastructure and logistics must be adjusted to prepare for greater patient demand, the firm said at a conference

By Judy Packer-Tursman • Nov. 8, 2016

Doctors willing to prescribe biosimilars, survey shows

Yet a lack of knowledge about the FDA approval process for the copycat biologics, along with uncertainty about the drugs' safety, suggests some concerns. 

By Ned Pagliarulo • Nov. 2, 2016

Mitsubishi strengthens arthritis portfolio with TissueGene deal

The licensing partnership comes as a growing share of Japan's population is dealing with joint problems.

By Jacob Bell • Nov. 2, 2016

Lupus Foundation launches "Cut it Out" campaign

Is 14 days too long for people to abstain from coffee or movies out? Lupus advocates hope it will help others relate. 

By Judy Packer-Tursman • Nov. 2, 2016

Merck KGaA and ACS spotlight cancer in women

Better diagnosis and preventive measures could reduce cancer deaths in women.

By Suzanne Elvidge • Nov. 2, 2016

Lilly feels the Bern over insulin pricing

Vermont Sen. Bernie Sanders took another swipe at the drug industry and its pricing strategies, this time targeting Eli Lilly and Novo Nordisk. 

By Lisa LaMotta • Nov. 2, 2016

Pfizer touts Ibrance's safety as competition intensifies

It's showdown time as Pfizer, Novartis and others try to corner a lucrative market.

By Judy Packer-Tursman • Nov. 2, 2016

Shire confident in hemophilia despite looming pricing challenge

As part of the Baxalta deal, Shire picked up a portfolio of hemophilia drugs, which it hopes to grow as a complement to its ADHD and genetic disease drugs.

By Ned Pagliarulo • Nov. 1, 2016

Amid pricing scrutiny, Amgen CEO predicts more value-based contracts

CEO Robert Bradway defended Amgen's pricing strategy last week, but said the biotech should not be rewarded if its drugs don't deliver a strong benefit.

By Ned Pagliarulo • Oct. 31, 2016

Celgene's Otezla grows, but still lags anti-TNF market

While the arthritis drug is picking up new patients, it has failed to steal patients from entrenched TNF inhibitors. 

By Lisa LaMotta • Oct. 27, 2016

FDA taking a closer look at DTC animation

But major players like Eli Lilly, AstraZeneca and Regeneron have some issues with the agency's proposal.

By Jacob Bell • Oct. 26, 2016

Amgen invests in Israeli digital health incubator

The incubator, which is backed by a multinational consortium, aims to invest in 40 new companies over eight years. 

By Joe Cantlupe • Oct. 26, 2016

Allergan puts Profiles in Focus with DTC campaign

Kybella's DTC campaign taps into people's worries about looking good in social media pics. 

By Suzanne Elvidge • Oct. 26, 2016

NCPA: FDA to blame for EpiPen price hikes

A report from the National Center for Policy Analysis pins the blame for price increases of the epinephrine auto-injector on federal regulators. 

By Joe Cantlupe • Oct. 26, 2016

Opportunistic Kaleo promises lower-cost EpiPen alternative

Amidst ongoing backlash over Mylan's pricing of EpiPen, Kaleo hopes to relaunch its beleaguered epinephrine autoinjector.

By Lisa LaMotta • Oct. 26, 2016

Humana to cover Sarepta's DMD drug with caveats

Coverage for the controversial treatment will require prior authorization.

By Ned Pagliarulo • Oct. 26, 2016

How pharma is using Twitter to connect with patients

Big pharma has a lot of constraints when it comes to social media, but their Twitter feeds can be very useful ... sometimes. 

By Lisa LaMotta • Oct. 26, 2016

Lilly says complete Sola failure unlikely

A looming readout from Lilly's Phase 3 trial of its Alzheimer's drug solanezumab will likely prove pivotal in shaping the near-term outlook for the drugmaker.

By Ned Pagliarulo • Oct. 25, 2016

BI tapping real-world data for Pradaxa

Boehringer Ingelheim’s reversal agent showed effectiveness in hospital and physician offices caring for AF patients, compared to the standard of care. 

By Joe Cantlupe • Oct. 24, 2016

Pfizer anchors inflammation hopes in Xeljanz

After a slow launch, the RA drug is picking up speed, leading the big pharma to invest in growing it further. 

By Lisa LaMotta • Oct. 19, 2016

Merck lays groundwork for biosimilar push

The New Jersey pharma launched a new educational website on biosimilars, hoping to boost awareness as it readies several candidates for the U.S. market. 

By Ned Pagliarulo • Oct. 19, 2016

Lilly expands global health efforts

With Lilly 30x30, the drugmaker plans to earmark $90 million over the next five years to improve access to diabetes, cancer and TB care. 

By Suzanne Elvidge • Oct. 19, 2016