Advaxis soars as FDA releases patient death-related clinical hold on its drugs

Shares have flown more than 55% since Tuesday afternoon.

By Nicole Gray • Dec. 17, 2015

Ted Cruz proposes controversial plan to expedite drug approvals through 'reciprocity'

The RESULT plan would essentially allow Congress to overrule FDA decisions. 

By Nicole Gray • Dec. 16, 2015

Mylan to Strides: Help us cover the tab for your noncompliant plants

There were signs of problems at several Bangalore-based facilities before Mylan acquired Strides Arcolabs in late 2014. 

By Nicole Gray • Dec. 16, 2015

Valeant, in the hot seat, beefs up its legal and crisis management muscle

The pharma giant has typically not lobbied Capitol Hill aggressively, making this move a change in strategy. 

By Nicole Gray • Dec. 14, 2015

FDA approves first-of-its-kind chemo overdose antidote, Vistogard

It's a first-in-class oral therapy marketed by Wellstat Therapeutics. 

By Nicole Gray • Dec. 14, 2015

New study: Too many factories, too few inspectors for India's pharma industry

A review by Assocham/RNCOS found that there are roughly 1,500 qualified inspectors for 10,000 Indian manufacturing facilities. 

By Nicole Gray • Dec. 11, 2015

FDA AdComm recommends Teva asthma drug for adults—but not teens

In a rebuke, the committee unanimously voted not to recommend approving the drug for children between the ages of 12 and 17. 

By Nicole Gray • Dec. 11, 2015

A lead researcher and a Boehringer SVP on the drumbeat of innovation in oral anticoagulants

We spoke with the two experts to better understand how innovation can thrive even when things seem to be headed south. 

By Nicole Gray • Dec. 11, 2015

Clinton plan would pump brakes on Pfizer-Allergan deal, other major inversion mergers

The presidential contender's proposal would require inversion deals to set a 50% foreign company ownership threshold before a U.S. firm can shift its tax base, among other measures.

By Ned Pagliarulo • Dec. 10, 2015

Sanofi scores landmark approval for world's 1st Dengue vaccine in Mexico

Dengvaxia will likely be approved in other regulatory markets, too. The big question for Sanofi is, what's an appropriate price point?

By Nicole Gray • Dec. 10, 2015

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