Boehringer wins EU approval for Humira biosimilar

Cyltezo won't launch in Europe until October 2018 at the earliest, but that still could be years before it enters the U.S. market due to litigation with AbbVie.

By Suzanne Elvidge • Nov. 15, 2017

AstraZeneca wins US approval for asthma biologic

The British drugmaker, long a leader in respiratory disease, has turned to biologics like Fasenra to fuel growth over the next decade.

By Ned Pagliarulo • Nov. 15, 2017

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

Amazon tells regulators it will not sell drugs

The e-commerce giant reportedly told Indiana and Tennessee regulators it would sell medical supplies from its new healthcare distribution centers.

By Edwin Lopez • Nov. 15, 2017

Digital Abilify pill secures first-of-its-kind FDA approval

Abilify MyCite embeds a sensor within a pill, and pairs the combo with a wearable patch, in order to help patients stay on regimen.

By Jacob Bell • Nov. 14, 2017

Hospitals file lawsuit to block 340B drug payment cut

Plaintiffs including the AHA argue the reimbursement change exceeds the authority of the HHS secretary and is "arbitrary and capricious."

By Shannon Muchmore • Nov. 14, 2017

Novo cuts more jobs in commercial restructuring

Increased competition and higher pricing pressures have hurt the Danish drugmaker in its core diabetes business.

By Lisa LaMotta • Nov. 13, 2017

Anthem reverses course, agrees to cover Sarepta's Duchenne drug

The insurer had originally decided last October against covering Exondys 51, citing the drug's mixed clinical evidence. 

By Suzanne Elvidge • Nov. 13, 2017

Ocrevus, Mvasi and 8 other drugs get CHMP go-ahead

The EMA advisory committee's latest approval recommendations included copycat and generic offerings that could sap money from blockbuster franchises.

By Jacob Bell • Nov. 10, 2017

Analysts fret over MannKind's disappearing cash

The inhalable insulin maker continues to struggle to commercialize its only product, putting a squeeze on the company's cash holdings. 

By Lisa LaMotta • Nov. 8, 2017

Spark gene therapy for blindness could come at steep cost

While no price has been set, Spark's CEO suggested the one-time treatment would be worth more than $1 million per patient. 

By Ned Pagliarulo • Nov. 8, 2017

Alkermes defends promotion of its opioid dependence drug

In a recent letter, California Senator Kamala Harris demanded the company provide more details on how it promoted the drug to law enforcement agents.

By Jacob Bell • Nov. 8, 2017

Alecensa vs. Xalkori: New approval pits Roche against Pfizer

An expanded label for Roche's Alecensa should help the Swiss pharma wrest control of the first-line market for ALK+ lung cancer away from Pfizer's Xalkori.

By Suzanne Elvidge • Nov. 8, 2017

Regeneron boosted by Eylea strength

The biotech's future growth, however, will increasingly depend on the performance of the newer biologics Dupixent, Praluent and Kevzara.

By Ned Pagliarulo • Nov. 8, 2017

Ohio voters knock down drug pricing initiative

About 80% of voters cast ballots against Issue 2, which would have prevented the state from buying prescription drugs at prices higher than what the Department of Veterans Affairs pays.

By Jacob Bell • Nov. 8, 2017

Diabetes drags on Sanofi, even as Dupixent shines

Although strong growth from Sanofi's new immunology drug Dupixent was a bright spot, the French drugmaker's diabetes business continued to struggle.   

By Ned Pagliarulo • Nov. 2, 2017

ICER looks to expand watchdog role with new funding

A nearly $14 million grant will enable the research group to analyze the clinical and cost effectiveness of all new medicines approved in the U.S.

By Ned Pagliarulo • Nov. 1, 2017

MSF inks deals for lower-cost hep C treatments

The organization says it can now buy generic versions of Gilead's Sovaldi and Bristol-Myers' Daklinza for $120 per 12-week treatment course. 

By Jacob Bell • Nov. 1, 2017

Verastem moves closer to US filing for blood cancer drug

Verastem's bet on duvelisib could pay off if the FDA looks favorably on the company's planned application for approval. 

By Suzanne Elvidge • Nov. 1, 2017

The globalization of the pharma industry

From China to Brazil, maturing economies and improving regulatory environments will open up opportunities for an industry on the hunt for new growth.

By Lisa LaMotta • Nov. 1, 2017

Allergan draws up battle plans as Restasis, other drugs face patent expiries

Company CEO Brent Saunders plans to hold back on business development until Restasis' situation becomes clearer. 

By Jacob Bell • Nov. 1, 2017

Barriers remain for a drug industry ready to blossom in Brazil

A poor patient population, a tricky tax code and turmoil within the government have created obstacles for pharma companies entering the Brazilian market. 

By Jacob Bell • Oct. 30, 2017

3 Trends in pharma globalization

As healthcare becomes a global economy, pharma companies face a slew of challenges as they try to commercialize in multiple markets across the globe. 

By Lisa LaMotta • Oct. 30, 2017

Merck sales slip, even as Keytruda gains ground

A cyberattack in June resulted in $135 million in lost sales, compounding the financial hit Merck felt from several products losing market exclusivity. 

By Ned Pagliarulo • Oct. 27, 2017

Amazon reportedly snaps up wholesale pharmacy licenses

The e-commerce giant has received regulatory approval from 12 states, and analysts have said it's only a matter of time before it dives into the market.

By Daphne Howland • Oct. 27, 2017

Gilead warns hep C sales could fall further

Investors were spooked by comments from Gilead execs that the company's hepatitis C drugs were likely to come under more pressure in the fourth quarter. 

By Ned Pagliarulo • Oct. 26, 2017