Regs

Boehringer drug lands US, EU orphan tag

Boehringer drug lands US, EU orphan tag

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The experimental Breakthrough Therapy treatment is for acute myeloid leukemia.

Sunshine data highlights major billers

Facts tucked among the 9.2 million lines of data: 2% of doctors account for around 25% of Medicare billing.

FDA won't review Afrezza until July

The regulator has put off the inhaled insulin's PDUFA date by three months.

Health reform spurs Rx growth, data show

Health reform spurs Rx growth, data show

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The ACA has spurred double-digit increases in demand for pharmaceuticals, new data suggest.

Compounders get version of PDUFA

The FDA has issued draft guidance that funds FDA inspection of some drug compounders.

In DC, parties argue generic label freedom

In DC, parties argue generic label freedom

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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.

Massachusetts bans Zohydro

The Bay State is saying no to the controversial prescription painkiller.

Waxman takes aim at Gilead over Sovaldi pricing

Waxman takes aim at Gilead over Sovaldi pricing

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Longtime industry critic, Congressmen Henry Waxman penned a note to Gilead CEO over the "extraordinarily high cost," of its recently approved HCV treatment Sovaldi.

Possible Zohydro competitor surfaces

Possible Zohydro competitor surfaces

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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.

Young adult ACA enrollment holds steady

Around 25% of 18-34 year-olds have signed up for coverage. Obama's FunnyorDie appearance drives HHS traffic.

OPDP slams Facebook page

OPDP slams Facebook page

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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.

FDA drafts patient-centric CFS guidance

Draft guidance indicates the regulator is open to using patient experience as criteria for chronic fatigue syndrome treatments.

CMS backs off Part D revision

The agency's move to limit the formulary for certain drug classes is dead.

Lipid agents come under FDA scrutiny

Lipid agents come under FDA scrutiny

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Sanofi and the firm with which it's co-developing alirocumab disclosed that regulators want some patients to be assessed for neurocognitive side effects.

Off-label guidance may not be publishing boon

Off-label guidance may not be publishing boon

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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.

ACCME tables logo ban again

ACCME tables logo ban again

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After a wave of feedback, the accreditor has deferred a ban on use of corporate logos in disclosures of commercial support.

Must biosimilar names be distinct? No, experts argue

Must biosimilar names be distinct? No, experts argue

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.

Companies view Sunshine differently

Companies view Sunshine differently

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A report indicates pharma companies do not agree on what research needs to be reported.

FDA eases rules on ads in social media

FDA eases rules on ads in social media

The draft guidance is mostly procedural, and more guidance is expected, but experts say it does include some long-awaited clarity for advertisers.

Biogen CEO cautions on Tecfidera EU launch

Biogen CEO cautions on Tecfidera EU launch

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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.

The year's most popular stories

The year's most popular stories

Our year-end list captures the 10 that sparked heaviest interest.

ACCME closer to revising criteria

The accreditor wants comments on its new accreditation plan, but a new commendation proposal is yet to come.

Lemtrada US rejection snarls Sanofi

Lemtrada US rejection snarls Sanofi

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The firm has vowed to appeal an FDA rejection that otherwise complicates its bid to expand in multiple sclerosis.

Oral form of Remodulin approved

The FDA approved Orenitram (treprostinil), after rejecting it twice before.

Kalydeco misses trial endpoint, though some benefit

Kalydeco misses trial endpoint, though some benefit

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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, Pfizer settle on Viagra generic date

Teva said a settlement will allow it to sell a copy of the blockbuster ED pill prior to the official LOE.

FDA limits antibiotic use

The regulator tells farmers to limit antibiotic use.

OIG subpoenas United Therapeutics paperwork

The government division is scrutinizing marketing information for three drugs.

FDA pushes review date for Biogen blood drug

The agency extended the review time for Biogen's Alprolix by three months.

ACA enrollment misses target

Official numbers are pending, but Reuters notes enrollment appears to be just 3% of the government's goal.

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