Sanofi's sarilumab bests blockbuster Humira in Phase 3 study

The IL-6 antibody is slated for a regulatory decision from the FDA by Q4 2016. 

By Ned Pagliarulo • March 11, 2016

First generic version of Viagra in the U.S. approved by FDA

The generic pill is made by the US division of Teva, which just won approval from the European Commission for its acquisition of Allergan's generics portfolio.

By Ned Pagliarulo • March 10, 2016

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

VA broadens Hep C coverage to all veterans, not just the sickest

The Department of Veterans Affairs cited lower costs for hep C drugs as well as increased funding from Congress as factors in its decision. 

By Ned Pagliarulo • March 10, 2016

Black box warning order clouds future for Bayer's Essure

The permanent birth control device has had a troubled history, including lawsuits and patient complaints to the FDA.

By Nicole Gray • March 9, 2016

Colombia health ministry recommends compulsory license for Novartis' Gleevec

Compulsory licensing has been a point of controversy between pharmaceutical companies and governments, most recently in India. 

By Nicole Gray • March 9, 2016

US prescription drug spending increases to an estimated $457 billion in 2015

After a slowdown between 2008 and 2012, growth in drug spending accelerated sharply in 2014 and is projected to have remained high in 2015. 

By Ned Pagliarulo • March 9, 2016

Kentucky Senate overwhelmingly passes biosimilar prescription bill

The legislation would allow pharmacists to dispense an interchangeable biosimilar in place of a branded biologic. However, somewhat controversially, the bill also requires pharmacists to notify doctors of the switch. 

By Nicole Gray • March 9, 2016

India will reportedly refrain from issuing compulsory drug licenses

The licenses enable local companies to override the patents of large pharmaceutical companies and manufacture cheap copies to boost patient access.

By Ned Pagliarulo • March 8, 2016

Senate HELP Committee to mark up 21st Century Cures legislation

The committee will consider seven bills in a morning session Wednesday as members seek to bridge a growing divide between Democrats and Republicans on a way forward. 

By Nicole Gray • March 8, 2016

Industry groups, doctors ask CMS to withdraw proposed Part B experiment

Accidentally posted online earlier this year, the proposal would test changes to Part B drug reimbursement rates to doctors. 

By Nicole Gray • March 8, 2016

EMA debuts new program to speed up review of innovative drugs

Called "PRIME," the program reinforces the existing accelerated assessment pathway and will increase regulatory support early in the development process of priority drugs. 

By Ned Pagliarulo • March 7, 2016

Moody's downgrades pharma industry outlook, cites lower pricing

The credit-rating agency highlighted the slow uptake for some new products as another factor reducing growth expectations. 

By Ned Pagliarulo • March 4, 2016

Alaska Permanent Fund betting big on biotech startups

The Fund has invested over $280 million into Juno Therapeutics, Codiak BioSciences, and Denali Therapeutics. 

By Nicole Gray • March 4, 2016

Much-anticipated trial shows Novo's Victoza reduces CV risk

The results could help keep Victoza competitive with Eli Lilly/Boehringer Ingelheim's Jardiance, which became the first diabetes drug to demonstrate a cardiovascular benefit. 

By Ned Pagliarulo • March 4, 2016

Endo to pay $200K penalty, overhaul marketing of opioid painkiller

An investigation by the New York Attorney General found Endo had improperly marketed Opana ER, creating a "false sense of security" for health care providers. 

By Nicole Gray • March 4, 2016

BMJ study: Single dose vials cost nearly $2B a year in wasted cancer drugs

Although packaged in single-dose vials, the drugs are typically administered based on patient body weight, leading to leftover medicine which is often discarded. 

By Nicole Gray • March 3, 2016

Express Scripts unimpressed by insulin data on Novo's Tresiba

Results from a switching study comparing Novo Nordisk's Tresiba to Sanofi's Lantus showed patients treated with Tresiba had a lower rate of hypoglycemic events. 

By Ned Pagliarulo • March 3, 2016

Amgen going after Novartis for Enbrel patent infringement

Amgen seeks an injunction against Novartis' Sandoz unit to block sales of its biosimilar version of Enbrel if it gains approval from the FDA. 

By Nicole Gray • March 3, 2016

Bayer's Essure permanent birth control gets black-box warning

Numerous problems associated with the device have prompted calls for the FDA to take it off the market. 

By Nicole Gray • March 2, 2016

Animated drug ads prompt FDA study into effect on consumer behavior

A number of high profile drugs, such as Novartis' Lamisil and Pfizer's Zoloft, rely on animated characters to represent the disease and the patient, respectively. 

By Ned Pagliarulo • March 2, 2016

Teva planning global rebrand as it works to close Allergan generics deal

The rebranding will be adopted internally over the next 12 months before being introduced externally. 

By Nicole Gray • March 2, 2016

Clinton ad lambastes Valeant for 'predatory' pricing

Valeant's fortunes had already taken a hit earlier in the week when a new SEC investigation into the company surfaced. 

By Nicole Gray • March 2, 2016

AARP report: Average prescription drug cost rose by 10% in 2013

Although the price of generic drugs fell by 4%, sharper increases in brand-name and specialty drug categories drove overall costs up. 

By Nicole Gray • March 1, 2016

Doctors Without Borders blasts $1700 price tag of Otsuka TB drug

The humanitarian medical organization recommended a price of $500 per treatment, 70% less than the price set by the Japanese drugmaker. 

By Nicole Gray • Feb. 26, 2016

Merck's Zepatier holds its own in safety comparison to Gilead meds

A recent report from Advera Health Analytics found Zepatier as safe as market-leading Harvoni, a potential boost in its fight for market share. 

By Nicole Gray • Feb. 25, 2016