21st Century Cures orphan drug exclusivity measures could divide consumer and patients advocates

Consumer advocate Public Citizen has released a report arguing the 21st Century Cures Act would drive biopharma profits at the expense of patients' access to medication. 

By Nicole Gray • Dec. 10, 2015

EMA chief: Faster drug approvals can quell Rx sticker shock

In response to rising prescription costs, the head of the European Medicines Agency proposed asking companies for lower drug prices in exchange for expedited approvals. That could prove to be a controversial gambit.

By Nicole Gray • Dec. 10, 2015

Senators mull speedier generics pathway amid outrage over Turing, Valeant price hikes

In a hearing Wednesday, senators expressed anger over recent hikes in drug prices and explored ways to incentivize competition in older off-patent drug markets. 

By Ned Pagliarulo • Dec. 9, 2015

Alexion scores FDA nod for orphan drug derived from genetically engineered chickens

The biotech acquired the treatment, Kanuma, during late-stage development when it bought Synageva Biopharma for $8.4 billion in May. 

By Nicole Gray • Dec. 9, 2015

FDA approves Baxalta's Vonvendi for von Willebrand bleeding disorder

The condition affects about 1% of the American population. 

By Nicole Gray • Dec. 9, 2015

Obama FDA nominee under the microscope as regulators review pivotal Xarelto trial he ran

It could potentially prove to be a hurdle to Dr. Robert Califf's confirmation as FDA commissioner. 

By Nicole Gray • Dec. 8, 2015

Merck & Samsung Bioepis nab 2nd major biosim approval in Korea

The biosimilar of Remicade is indicated in Korea for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, and plaque psoriasis in adult patients. 

By Nicole Gray • Dec. 8, 2015

ASH15: Bluebird tanks 35% on gene therapy data; Novartis preps 2017 filing for blood cancer CAR-T

Biopharma firms chasing next-generation blood disorder therapies presented some major data at the American Society of Hematology meeting over the weekend.

By Nicole Gray • Dec. 7, 2015

Game on: Amgen files biosimilar Humira, pulls ahead of the pack

The biotech giant filed for FDA approval of ABP501 for both rheumatoid arthritis and plaque psoriasis, challenging the best-selling drug in the world.

By Nicole Gray • Dec. 2, 2015

Pentagon official's emails demonstrate that Theranos concerns date back to 2012

Three years ago, a military official investigating the firm's blood-testing technology became wary about a lack of regulatory compliance, according to the Washington Post. 

By Nicole Gray • Dec. 2, 2015

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