Influential GOP lawmaker calls for tax overhaul in wake of Pfizer-Allergan inversion deal

Rep. Charles Boustany (R-LA) said the U.S. tax code and high corporate tax rates have driven the recent inversion frenzy. 

By Nicole Gray • Dec. 2, 2015

FDA approves 3rd multiple myeloma med in a month, this time from Bristol-Myers & AbbVie

This is the second FDA-approved monoclonal antibody for the treatment of multiple myeloma in November and the fourth multiple myeloma med approved this year.

By Nicole Gray • Dec. 1, 2015

REPORT: Key lawmakers own major stakes in biopharma, healthcare firms they oversee

A searing analysis by Stat News finds that approximately 30% of U.S. Senators and 20% of Representatives—including important figures like House Energy and Commerce Committee Chairman Rep. Fred Upton (R-MI)—have major investments in biotechs, medical device firms, and major pharma companies like Merck, Pfizer, and J&J.

By Sy Mukherjee • Dec. 1, 2015

In rare setback, Bristol-Myers' Opdivo denied expanded melanoma label

The FDA issued a complete response letter asking for more data on the effect of Opdivo (nivolumab) in patients with BRAF V600 mutation-positive metastatic melanoma.

By Nicole Gray • Nov. 30, 2015

UPDATE: BioMarin Duchenne drug appears destined for failure after brutal FDA meeting

FDA advisers didn't appear swayed by emotional testimony from patients and advocates during Tuesday's meeting.

By Nicole Gray • Nov. 25, 2015

So your biopharma got fined millions by the feds—Where does that money go?

Major players in the industry regularly settle federal suits with hefty payouts. But could that cash be put to better use by the government—and are fines even an effective way of ensuring ethical behavior?

By Sy Mukherjee • Nov. 25, 2015

Bristol-Myers' unstoppable Opdivo now approved for advanced kidney cancer

This is yet another major indication for Opdivo (nivolumab), which is already FDA-approved for the treatment of melanoma and non-small cell lung cancer (NSCLC). 

By Nicole Gray • Nov. 24, 2015

Horizon Pharma ditches $1 billion hostile bid for Depomed

Horizon has been chasing Depomed for 6 months—but Depomed wants no part of it.

By Nicole Gray • Nov. 23, 2015

Samsung Bioepis close to major EU approval for Enbrel biosimilar

The European Medicines Agency recommended approval of Benepali, heating up the biosimilar market for Enbrel. 

By Nicole Gray • Nov. 23, 2015

FDA approves 3rd multiple myeloma med of 2015, Takeda's Ninlaro

Ninlaro (ixazomib) is the first FDA-approved oral proteasome inhibitor. 

By Nicole Gray • Nov. 23, 2015

FDA approves first-ever nasal spray to fight opioid overdose

Adapt Pharma's Narcan is a nalaxone-based treatment and will be launched in January 2016.

By Nicole Gray • Nov. 20, 2015

Sandoz chases 2-for-2 record as US biosim pioneer as FDA agrees to review copycat Neulasta

The FDA has agreed to review Sandoz's (part of Novartis) biosimilar version of Amgen's Neulasta (pegfilgrastim). 

By Nicole Gray • Nov. 19, 2015

In unexpected setback, UK cost regulators reject Amgen's PCSK9 drug

The National Institute for Health and Care Excellence (NICE) decided against including Repatha (evolocumab) on the UK's list of reimbursable drugs due to concerns about cost-effectiveness and clinical outcomes. 

By Nicole Gray • Nov. 19, 2015

Innovation update: Advancing the standard of care in rheumatoid arthritis

This year’s ACR meeting highlighted new developments in rheumatoid arthritis (RA). We spoke to Dr. Terence Rooney, Medical Director of Lilly Bio-Medicines and Dr. Rory O’Connor, Senior Vice President and Head of Global Medical Affairs at Pfizer about JAK inhibition, innovation, and new treatment options for RA. 

By Nicole Gray • Nov. 19, 2015

Senators grilled Obama's nominee for FDA chief. Here's how he responded

The powerful Senate Health, Education, Labor, and Pensions Committee questioned Dr. Robert Califf on everything from his past ties to the pharmaceutical industry to how he'd tackle the major issues facing the Food and Drug Administration. 

By Sy Mukherjee , Ned Pagliarulo • Nov. 18, 2015

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