J&J nabs early approval for first-of-its-kind multiple myeloma med Darzalex

Darzalex (daratumumab) is the first approved monoclonal antibody for the treatment of multiple myeloma and is expected to be a major blockbuster (with a blockbuster price).

By Nicole Gray • Nov. 17, 2015

Senators to grill Obama's FDA commish nominee on pharma ties

Dr. Robert Califf comes well prepared as a trained cardiologist and investigator—but is he too connected to the biopharma industry? 

By Nicole Gray • Nov. 17, 2015

FDA approves Baxalta's longer-lasting hemophilia A drug

Adynovate is modified to last longer in the blood and to potentially require less frequent injections than unmodified Antihemophilic Factor.

By Nicole Gray • Nov. 15, 2015

In major victory, AstraZeneca wins FDA approval for potential $3B lung cancer med

Tagrisso (osimerinib) is now approved for second-line treatment of EGFR-mutated non-small cell lung cancer (NSCLC). 

By Nicole Gray • Nov. 15, 2015

China FDA cracks down on pharmas in quality control effort

The China Food and Drug Administration (CFDA) has rejected 11 drug applications from eight companies in the midst of a major health reform initiative. 

By Nicole Gray • Nov. 13, 2015

FDA approves Genentech's Cotellic as part of melanoma combo

Cotellic (cobimetinib) is intended to be used in combination with Zelboraf (vemurafenib), also from Genentech. 

By Nicole Gray • Nov. 11, 2015

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