The experimental Breakthrough Therapy treatment is for acute myeloid leukemia.
Facts tucked among the 9.2 million lines of data: 2% of doctors account for around 25% of Medicare billing.
The regulator has put off the inhaled insulin's PDUFA date by three months.
The ACA has spurred double-digit increases in demand for pharmaceuticals, new data suggest.
The FDA has issued draft guidance that funds FDA inspection of some drug compounders.
At a hearing today, Public Citizen and the generics industry are sounding off on an FDA proposal that would allow generics firms to update labels, regardless of whether the brand has or hasn't.
The Bay State is saying no to the controversial prescription painkiller.
Longtime industry critic, Congressmen Henry Waxman penned a note to Gilead CEO over the "extraordinarily high cost," of its recently approved HCV treatment Sovaldi.
A rival's late-stage trial results suggest the pain med may have a short market life. The key: an FDA division head's documented willingness to overturn the approval should another pain option surface.
Around 25% of 18-34 year-olds have signed up for coverage. Obama's FunnyorDie appearance drives HHS traffic.
The FDA's bad-ad unit took a drugmaker to task for what it calls a misleading Facebook page. History shows the social media surveillance should take no one by surprise.
Draft guidance indicates the regulator is open to using patient experience as criteria for chronic fatigue syndrome treatments.
The agency's move to limit the formulary for certain drug classes is dead.
Sanofi and the firm with which it's co-developing alirocumab disclosed that regulators want some patients to be assessed for neurocognitive side effects.
The FDA's proposed upgrade to its off-label distribution guidelines has some new features, but experts say it is unclear if this means more dollars will flow toward reprints.
After a wave of feedback, the accreditor has deferred a ban on use of corporate logos in disclosures of commercial support.
Innovator companies want the FDA to adopt separate names for biosimilars. Manufacturing changes aren't drastic enough to make it necessary, experts argued at an FTC workshop.
A report indicates pharma companies do not agree on what research needs to be reported.
The draft guidance is mostly procedural, and more guidance is expected, but experts say it does include some long-awaited clarity for advertisers.
The MS pill saw rapid uptake in the US last year, but its overseas launch won't be as quick, CEO George Scangos conceded this week at an analyst conference.
Our year-end list captures the 10 that sparked heaviest interest.
The accreditor wants comments on its new accreditation plan, but a new commendation proposal is yet to come.
The firm has vowed to appeal an FDA rejection that otherwise complicates its bid to expand in multiple sclerosis.
The FDA approved Orenitram (treprostinil), after rejecting it twice before.
Kalydeco failed to hit its primary endpoint of significantly improving lung function in a subset of CF patients, but some did show a benefit.
Teva said a settlement will allow it to sell a copy of the blockbuster ED pill prior to the official LOE.
The regulator tells farmers to limit antibiotic use.
The government division is scrutinizing marketing information for three drugs.
The agency extended the review time for Biogen's Alprolix by three months.
Official numbers are pending, but Reuters notes enrollment appears to be just 3% of the government's goal.
General support for the legislation is up, despite Healthcare.gov woes.
Sebelius took the heat for Healthcare.gov, promising that most people would be able to shop for coverage online by November.
The agency made good on a pledge to expand Bad Ad with a web-based CME course and case studies representing common problems.
The American Medical Association (AMA), together with a slew of co-signers, wants CMS to reverse a decision to include textbooks and journal reprints as reportable items.
It was a 15-0 vote for Gilead's sofosbuvir in hep. C. The expedited PDUFA date: Dec. 8. Janssen's simeprivir was endorsed the day before.
The hep. C drug is safe and effective when used in combination with other therapies, according to information posted by FDA reviewers.
Adding Epzicom to Tivicay in a once-daily cocktail could further boost GSK's HIV franchise, and possibly chip away at Atripla's dominance.
The governor says it is too early to legislate on drugs the FDA is still deliberating over.
The drug maker is giving its inhaled insulin another go.
Approvals and reviews continue—for now—despite government shutdown.
A public information request details closed-door meetings in which industry players paid to sit with government employees and talk pain-medication efforts.
A roundup of some exchange-related news circling the web.
The agency issued final guidance on mobile apps, saying it will focus only on a subset that present the greatest risk to patients if they don't work correctly.
How potential alignment between drug companies and physicians, via the EHR, could extend brand reach.
Researchers says growth will average 5.8% a year between 2012 and 2022. They also anticipate generics will hit a leveling-off point that will drive average Rx prices upwards
Some providers of CME are getting better at complying with accreditation criteria, data show, yet many are still struggling to meet a stricter set of requirements.
The changes, which include tightening prescribing criteria of extended-release and long-acting opioids and a boxed warning for pregnancy, are part of an effort to curb abuse. Some said the FDA's effort is too limited
The FDA and Novartis are investigating reports that a patient has contracted the rare virus.
The drugstore chain says it has cut off over-prescribers of tightly controlled medications.
The drug maker scored its third breakthrough designation label, this time for orphan drug bimagrumab, a possible treatment for a muscle-wasting disease.
FDA's Office of Prescription Drug Promotion issued an Untitled Letter over what it says are misleading copy and overstated efficacy claims online.
HHS is looking into how J&J marketed opioid painkiller Nucynta, adding to the firm's list of investigations and those of the industry as a whole.
GSK sees a regulatory setback on its once-weekly GLP-1 med, and Spectrum Pharma gets hit with an untitled letter from OPDP on a sales aid for Zevalin.
The ad watchdog flagged the drug maker for what it said was yet another misleading Ampyra promotional piece.
With a new era of transparency for doctors and life science manufacturers kicking off today, here's how some organizations are keeping physicians informed.
Companies are moving toward more access to clinical trial data. Despite their new stance, the internal battles haven't quite ended, some say.
A report indicates that the FDA is siding with the European Medicines Agency's finding that GLP-1 diabetes medications are not conclusively linked to pancreatic cancer.
A new survey of doctors reveals how much they know (or don't) about the looming launch of healthcare exchanges.
With a clear buffet exemption in-hand, the agency's position with respect to CME meals seems pretty clear. Industry is pushing for more clarity around the treatment of accrediting bodies.
Elan's strategy: focus on agitation and aggression associated with the disease.
The duo whose nonprofit served as neutral ground for getting FDA and industry talking about digital marketing is starting a for-profit research and advisory firm.
Ranbaxy's ban from US soil has softened the blow for Novartis 2Q sales.
The drug maker can now add five new doses to its generic Opana ER offerings.
FDA's afatinib approval enables the drug maker set up shop in a new therapy space.
Janssen submitted an NDA for its cancer hopeful ibrutinib, well ahead of competitors.