EU turns down Puma breast cancer drug

The CHMP gave a negative opinion on Puma's Nerlynx, indicating efficacy might be an issue.

By Lisa LaMotta • Feb. 26, 2018

KemPharm nabs opioid approval, but no abuse-deterrent label

After several setbacks, the specialty pharma got a green light from the FDA, but not the broad label it wanted.

By Lisa LaMotta • Feb. 26, 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

HIV patients claim CVS steered beneficiaries to its pharmacies

A class-action lawsuit raises questions about how CVS would act if the pharmacy chain successfully merges with Aetna.

By David Lim • Feb. 22, 2018

Spark lays groundwork for US Luxturna launch

The biotech is preparing to commercialize the first stateside gene therapy.

By Lisa LaMotta • Feb. 21, 2018

Gilead wins reprieve in Merck's $2.5B patent lawsuit

A federal judge ruled against Merck's patent for hepatitis C treatment. While the big pharma plans to appeal, it's a noteworthy win for Gilead in the meantime.

By Jacob Bell • Feb. 21, 2018

Mylan touts affordability for developing world HIV combo

Under the shadow of the EpiPen pricing saga, Mylan highlighted its credentials as an affordable provider of anti-retrovirals.

By Suzanne Elvidge • Feb. 21, 2018

Express Scripts joins Walgreens Boots to cut biosimilar costs

The pharmacy benefit manager is expanding its agreement with the drug store giant to simplify the supply chain for specialty pharmaceuticals.

By Lisa LaMotta • Feb. 21, 2018

Amazon selling private-label medications

The e-commerce company is offering an exclusive line of over-the-counter medications, thanks to healthcare supplier Perrigo.

By Daphne Howland • Feb. 21, 2018

Apricus plummets after ED drug rejection

Already approved in Europe, Vitaros didn't gain favor with U.S. regulators, who found CMC and safety issues with the erectile dysfunction drug.

By Jacob Bell • Feb. 16, 2018

J&J gets first-of-its-kind prostate cancer approval

The FDA greenlighted apalutamide for non-metastatic CRPC based on a new endpoint: metastasis-free survival. 

By Lisa LaMotta • Feb. 14, 2018

Fresh data sets up showdown for Lilly's Taltz vs Cosentyx

In the highly competitive IL-inhibitor space, securing new indications has been a key strategy for drugmakers looking to gain an edge.

By Jacob Bell • Feb. 14, 2018

Industry touts savings potential of generics and biosimilars

The trade body for generics and biosimilar manufacturers warns of barriers to entry for its products.

By Suzanne Elvidge • Feb. 14, 2018

BIO: Pain pipeline lacking as opioid crisis continues

The analysis comes as a new Senate report calls into question drugmaker ties to advocacy groups in fighting the epidemic.

By Suzanne Elvidge • Feb. 14, 2018

New approval helps Vertex's 'cleanest growth story in biotech'

Symdeko, a combination treatment for cystic fibrosis, holds a price tag of $292,000 and could provide Vertex up to $200 million in revenue by year's end.

By Jacob Bell • Feb. 13, 2018

Teva's Copaxone sales hit hastened with OK of Novartis copy

U.S. approval of Novartis' version of Copaxone 40 mg came earlier than Teva had assumed, putting further pressure on the Israeli drugmaker's top seller. 

By Ned Pagliarulo • Feb. 13, 2018

What Gilead taught pharma about pricing a cure

With Sovaldi in the rearview mirror and gene therapies progressing quickly, the industry is debating what lessons can be learned about pricing a cure.

By Lisa LaMotta • Feb. 12, 2018

Maker of Oxycontin to halt opioid promotion to doctors

Purdue Pharma faces sharp criticism, as well as lawsuits, for the role its marketing of prescription painkillers may have played in shaping the opioid epidemic.

By Ned Pagliarulo • Feb. 12, 2018

Gilead HIV triplet wins approval, prompts GSK-backed patent lawsuit

Biktarvy's broad label sets it up to steal market share in the HIV space and become another blockbuster drug in Gilead's arsenal.

By Jacob Bell • Feb. 8, 2018

Pharma wades into the world of virtual reality marketing

The technology offers drugmakers and sales reps an original way to tell stories. But whether it will hold up to the test of time remains to be seen.

By Jacob Bell • Feb. 7, 2018

Express Scripts: Plan drug spending rose at slowest rate in 24 years

The PBM says its efforts to rein in rising drug costs have helped the plans it administers secure hundreds of millions in savings last year.

By Ned Pagliarulo • Feb. 7, 2018

New York latest to sue opioid manufacturer Insys

The New York lawsuit is the latest in a spate against the drug company: North Carolina, New Jersey and Illinois have all engaged in legal action against Insys.

By David Lim • Feb. 5, 2018

Allergan picks up pneumonia indication for Avycaz

It's the first time in more than 15 years the FDA approved a gram-negative antibiotic for hospital and ventilator pneumonia.

By Suzanne Elvidge • Feb. 2, 2018

Pfizer's manufacturing fix clears path for Momenta's Copaxone generic

The big pharma remedied issues at its McPherson plant, meaning the launch of 40 mg Glatopa could come "at any time."

By Jacob Bell • Feb. 1, 2018

FDA adds black box warning to Intercept's Ocaliva

Shares in the New York biotech rose on relief the FDA's caution did not broadly limit use of the drug in patients with mild or moderate liver disease. 

By Ned Pagliarulo • Feb. 1, 2018

Vertex looks to own CF market before shifting focus

The biotech revealed the two triple combo regimens it's taking into Phase 3 as it closes in on serving 90% of the cystic fibrosis market.

By Jacob Bell • Jan. 31, 2018