J&J earnings disappoint, with no word on Actelion deal

In the wake of Donald Trump's recent criticisms of the industry, CEO Alex Gorsky sketched out new efforts to become more transparent on pricing. 

By Ned Pagliarulo • Jan. 24, 2017

7 companies to know in the emerging biosimilars field

Three more biosimilars won FDA approval last year and dozens more are moving through the pipeline. Here's some of the companies at the forefront of the growing drug class.

By Ned Pagliarulo • Jan. 23, 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

5 hurdles facing biosimilar developers

While several biosimilars are poised to enter the U.S. market, there are still plenty of challenges that are affecting this new space of drugs. 

By Lisa LaMotta • Jan. 23, 2017

Biosimilars: What's in a name?

The FDA recently finalized naming conventions for biosimilars, putting in place an important piece of the regulatory framework for the copycat biologics.

By Ned Pagliarulo • Jan. 23, 2017

PhRMA-backed report analyzes 'complex process' of drug pricing

The report details how competition in the industry paired with strong PBM negotiating power can lead to price hikes, but not necessarily beefed-up profits for manufacturers.

By Jacob Bell • Jan. 19, 2017

FDA details thinking on off-label communications

The agency released two other draft guidance documents giving more clarity to the industry on medical product communications. 

By Ned Pagliarulo • Jan. 19, 2017

JPM: AbbVie pledges price increases below 10%

With drug pricing already a contentious topic, companies have been making promises to cap additional hikes.

By Suzanne Elvidge • Jan. 13, 2017

Bird Rock one step closer to acquisition by J&J

The approval of a Phase 1 trial for one of the small biopharma's drugs furthers the possibility of a takeover from Johnson & Johnson, which locked down acquisition rights earlier this year.

By Suzanne Elvidge • Jan. 12, 2017

JPM: Bresch calls out pricing transparency

The Mylan executive had a lot to say about the steps other companies are taking to rein in pricing. 

By Lisa LaMotta • Jan. 11, 2017

JPM: Coherus sticks to 2018 timeline for Humira biosimilar

The California-based biopharma says that it has a strategy that should bring its Humira biosimilar candidate to market next year.

By Judy Packer-Tursman • Jan. 11, 2017

Merck files Keytruda combo for lung cancer

This could be first approval of immuno-oncology chemotherapy combo in non-small cell lung cancer. 

By Suzanne Elvidge • Jan. 11, 2017

JPM: Saunders, Pops, others talk drug pricing

Industry executives and representatives gathered to discuss the complicated issue of drug pricing, failing to find a solution. 

By Lisa LaMotta • Jan. 10, 2017

Report: Oncology, profitable drugs move to market faster, patent exclusivity shrinking

A new report from QuintilesIMS finds certain groups of products are more likely to make it from research to markets and hold on to their patent exclusivity.

By Jacob Bell • Jan. 9, 2017

Judge hands Amgen major patent victory over PCSK9 rivals

A U.S. district court judge barred Sanofi and Regeneron's Praluent from markets, granting Amgen's request for a permanent injunction.

By Ned Pagliarulo • Jan. 6, 2017

Sanofi asked to pull vaccine ads in the Philippines

The country's Food and Drug Administration called on the French pharma to pull radio and television ads for its Dengue fever vaccine, Dengvaxia.

By Jacob Bell • Jan. 4, 2017

Biogen's SMA drug gets high price tag

Spinraza approval could kick off more pricing arguments as Biogen prices on the high end of expectations. 

By Suzanne Elvidge • Jan. 4, 2017

RedHill, Concordia team up to market IBS drug

Under terms of a new agreement, RedHill will gain some U.S. promotional rights to Concordia's Donnatal.

By Jacob Bell • Jan. 3, 2017

Threat grows for biologics makers as biosimilars take root

BioPharma Dive will be publishing several articles in the coming weeks comparing the dependence of some pharmas on revenue from best-selling drugs.

By Ned Pagliarulo • Dec. 29, 2016

FDA warns drugmakers on misleading marketing

Two companies were hit with warning letters last week for failing to disclose risks associated with their respective drugs.

By Ned Pagliarulo • Dec. 21, 2016

Novartis sells US rights to 3 COPD drugs

Sunovion Pharmaceuticals will take over U.S. commercialization, although Novartis will continue to manufacture the medicines. 

By Jacob Bell • Dec. 21, 2016

Bristol continues immuno-oncology push in deal with PsiOxus

The deal could be worth more than $930 million, and gives Bristol-Myers exclusive rights to a pre-clinical oncolytic virus therapy.

By Jacob Bell • Dec. 20, 2016

Pfizer's Chantix loses its black box warning

The big biopharma announced on Friday the FDA had agreed to remove the warning from its smoking cessation drug.

By Jacob Bell • Dec. 19, 2016

BIO President responds to QuintilesIMS pricing report

In a posting on his company's website, Jim Greenwood called the report an "important step in setting the record straight" with regard to increasing drug prices.

By Jacob Bell • Dec. 14, 2016

First charges come in generic price-fixing probe

Accusations levied against former Heritage execs are part of a sweeping investigation by the DOJ into the pricing and marketing of generic drugs in the U.S. 

By Ned Pagliarulo • Dec. 14, 2016

Sanofi, Celgene flagged for misleading DTC ads

Television commercials for Sanofi's Toujeo and Celgene's Otezla both ran afoul of the FDA for creating misleading impressions on safety. 

By Ned Pagliarulo • Dec. 14, 2016