AHF: Gilead's new HIV med an attempt to evergreen, avoid patent expiration

Does tenofovir's new, improved side-effect profile make Genvoya a new drug, or just a tweaked version of Stribild?

By Nicole Gray • Nov. 11, 2015

Allergan asks SCOTUS to take a hard look at pharma's controversial 'hard switch' tactic

The company lost in federal court when attempting to pull its Alzheimer's med Namenda in order to force patients over to a new formulation. If the Supremes take the case, it would have industry-wide implications for antitrust laws. 

By Nicole Gray • Nov. 10, 2015

23andMe redux? Startup DNA4Life gets FDA warning letter on DTC genetic testing kit

Despite claims to the contrary from the company's CEO, the firm is facing the same regulatory hurdles as 23andMe.

By Nicole Gray • Nov. 9, 2015

Armed with FDA panel nod, Merck hopes long-languishing sugammadex will finally win approval

Sugammadex is already approved in 70 countries as an anesthesia reversal agent. 

By Nicole Gray • Nov. 9, 2015

Hello, Genvoya: Gilead does it again with approval of single-dose, once-daily HIV pill

Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) is approved for the treatment of HIV-1 infection in adults and pediatric patients aged 12 and older. 

By Nicole Gray • Nov. 6, 2015

OxyContin gets political as Jeb Bush slams label expansion for kids, excess prescriptions

The presidential contender criticized what he sees as a culture of over-prescribing medicines, going so far as to say that marijuana is no longer the "gateway drug."

By Sy Mukherjee • Nov. 5, 2015

As generic drug savings reach all-time high, experts ponder biosims' long-term impact

U.S. generic drug savings reached a peak of $254 billion in 2014, but biosimilars were not part of the analysis. How will those figures look once biosims enter the equation?

By Nicole Gray • Nov. 5, 2015

FDA alleges major violations, use of old ingredients at Chinese Pfizer plant

During an inspection in April, FDA inspectors turned up quality failures and use of expired materials at a plant in Dalian. The agency also says the plant tried to obfuscate its shortcomings.

By Nicole Gray • Nov. 2, 2015

Activist investor Ackman holds marathon call defending embattled Valeant

Among his most blunt points: At the end of the day, Valeant will likely have to do little more than pay a fine if allegations against the company prove actionable.

By Nicole Gray • Nov. 2, 2015

Can Novartis take on Boehringer and Glaxo with its new COPD combo?

The drug maker plans to launch Utibron Neohaler (indacaterol/glycopyrrolate) for chronic obstructive pulmonary disorder (COPD) by Q1 2016. It'll have to elbow its way into the field.

By Nicole Gray • Nov. 2, 2015

Merck lowers cost of Remicade in UK as biosimilars enter market

Earlier this year, the National Insitute of Health and Clinical Excellence (NICE) lowered approved biosimilar versions of Remicade (infliximab). 

By Nicole Gray • Oct. 29, 2015

Senate efforts to advance 21st Century Cures aims appear stymied

Since the 21st Century Cures Act was introduced in April 2014, the political climate has become much less pro-pharma.

By Nicole Gray • Oct. 29, 2015

FDA approves Amgen's first-in-class oncolytic viral therapy

Imlygic (talimogene laherparepvec) is an oncolytic immunotherapy that uses a genetically modified strain of the herpes virus. 

By Nicole Gray • Oct. 29, 2015

Despite concerns, Express Scripts sticks with AbbVie's hep C therapy

Last week, the FDA warned about increased risk of serious liver injury associated with the VieKira Pak therapy. 

By Nicole Gray • Oct. 29, 2015

FDA inspection calls Theranos 'nanotainers' uncleared devices, cites quality assurance problems

The agency conducted inspections at two CA-based Theranos facilities from August 25 to September 16. 

By Nicole Gray • Oct. 27, 2015

Alexion shocks with lower-than-expected price for just-approved orphan drug

Alexion's Strensiq is the first approved treatment for hypophosphatasia (HPP).

By Nicole Gray • Oct. 26, 2015

FDA cautiously recommends approval of AZ's gout drug

A panel of independent FDA advisers voted 10-4 in favor of approving lesinurad, but the vote on approving the drug's safety profile was less positive. 

By Nicole Gray • Oct. 25, 2015

San Diego-based compounder to offer $1 alternative to Turing's Daraprim

The market responds to Martin Shkreli and Turing Pharma's 5,000% price hike on the drug.

By Nicole Gray • Oct. 22, 2015

FDA approves a new pancreatic cancer drug, Merrimack's Onivyde

But it comes with a black box warning for "severe neutropenia and diarrhea."

By Nicole Gray • Oct. 22, 2015

FDA questions AstraZeneca about safety of phase 3 gout drug

The company has submittted a dossier for the candidate, lesinurad, to the FDA and is awaiting a panel recommendation. 

By Nicole Gray • Oct. 22, 2015

REPORT: American man in India illegally exported execution drugs to Nebraska, other states

Chris Harris set up an office in India from which he offered sodium thiopental to states, which wanted to stock execution drugs, according to an investigative report by BuzzFeed. The sales date back to 2010.

By Nicole Gray • Oct. 21, 2015

The Amarin effect? FDA removes warning letter aimed at Pacira from web site

This is the latest action resulting from pharma companies pushing back against what they see as FDA over-regulation and attempting to protect their First Amendment rights. 

By Nicole Gray • Oct. 21, 2015

23andMe relaunches expanded genetic tests after 2-year, FDA-mandated hiatus

The firm will begin presenting users with health data once again—and this time, with regulators' approval and at a far higher price.

By Sy Mukherjee • Oct. 21, 2015

A Boehringer SVP and BioSig's CEO dish on the 'heart' of innovation

BioPharma Dive spoke with Dr. Sabine Luik, Senior Vice President of Medicine & Regulatory Affairs at Boehringer Ingelheim and Greg Cash, CEO of BioSig Technologies, about different strategies for reducing the risk of stroke in patients with atrial fibrillation—and what makes their products innovative.

By Nicole Gray • Oct. 20, 2015

A bipartisan bashing: Rubio slams drug prices, pharma's 'pure profiteering'

The GOP presidential hopeful from Florida joins Democrats Hillary Clinton and Bernie Sanders in criticizing what he sees as the industry's excesses and calls for pay-for-performance. 

By Sy Mukherjee • Oct. 20, 2015