Boehringer drug lands US, EU orphan tag

Boehringer drug lands US, EU orphan tag

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

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The FDA has issued draft guidance that funds FDA inspection of some drug compounders.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

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

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

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

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Draft guidance indicates the regulator is open to using patient experience as criteria for chronic fatigue syndrome treatments.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

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

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

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

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

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

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

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.

Healthcare reform fanbase rises

General support for the legislation is up, despite Healthcare.gov woes.

House hearings: Sebelius's mea culpa, Oz and Chicken Little

Sebelius took the heat for Healthcare.gov, promising that most people would be able to shop for coverage online by November.

OPDP expands "Bad Ad" with CME

OPDP expands "Bad Ad" with CME

The agency made good on a pledge to expand Bad Ad with a web-based CME course and case studies representing common problems.

AMA slams CMS stance on reprints

AMA slams CMS stance on reprints

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.

FDA panel endorses Gilead, Janssen hep. C drugs

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.

FDA briefing documents: Sofosbuvir safe, effective

The hep. C drug is safe and effective when used in combination with other therapies, according to information posted by FDA reviewers.

Suddenly hot ViiV sends HIV cocktail to FDA

Suddenly hot ViiV sends HIV cocktail to FDA

Adding Epzicom to Tivicay in a once-daily cocktail could further boost GSK's HIV franchise, and possibly chip away at Atripla's dominance.

Calif. governor vetoes biosimilars bill

The governor says it is too early to legislate on drugs the FDA is still deliberating over.

MannKind sends insulin to FDA

The drug maker is giving its inhaled insulin another go.

FDA reviews continue for now

Approvals and reviews continue—for now—despite government shutdown.

Pharma paid for opioid influence, access to FDA officials

A public information request details closed-door meetings in which industry players paid to sit with government employees and talk pain-medication efforts.

Healthcare reform roundup

Healthcare reform roundup

A roundup of some exchange-related news circling the web.

FDA exempts most mobile apps from scrutiny

FDA exempts most mobile apps from scrutiny

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.

Could EHR incentives draw pharma into exam room?

Could EHR incentives draw pharma into exam room?

How potential alignment between drug companies and physicians, via the EHR, could extend brand reach.

CMS projects healthcare spending to rise

CMS projects healthcare spending to rise

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

CME compliance trends up among some outfits

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.

FDA tightens indication and label for opioid sub-category

FDA tightens indication and label for opioid sub-category

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

FDA investigating report of PML in a Gilenya patient

The FDA and Novartis are investigating reports that a patient has contracted the rare virus.

CVS joins prescription crackdown

The drugstore chain says it has cut off over-prescribers of tightly controlled medications.

Novartis breakthough designation hat trick

The drug maker scored its third breakthrough designation label, this time for orphan drug bimagrumab, a possible treatment for a muscle-wasting disease.

Merz web-copy shortcuts don't sit well with OPDP

FDA's Office of Prescription Drug Promotion issued an Untitled Letter over what it says are misleading copy and overstated efficacy claims online.

J&J painkiller probe expands scrutiny of industry marketing

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.

Business briefs: GlaxoSmithKline and Spectrum

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.

OPDP sends Warning Letter to Acorda

The ad watchdog flagged the drug maker for what it said was yet another misleading Ampyra promotional piece.

Good day, Sunshine: Tools help docs track payments

Good day, Sunshine: Tools help docs track payments

With a new era of transparency for doctors and life science manufacturers kicking off today, here's how some organizations are keeping physicians informed.

The complexity of cracking open the data door

The complexity of cracking open the data door

Companies are moving toward more access to clinical trial data. Despite their new stance, the internal battles haven't quite ended, some say.

Report: FDA comfortable with EMA's diabetes conclusions

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.

Doctors could use more info on health exchanges: study

A new survey of doctors reveals how much they know (or don't) about the looming launch of healthcare exchanges.

Industry pushing for further clarity on Sunshine Act

Industry pushing for further clarity on Sunshine Act

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 beyond-the-plaque Alzheimer's med gets fast-tracked

Elan's strategy: focus on agitation and aggression associated with the disease.

Pharma digerati launch advisory firm

Pharma digerati launch advisory firm

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.

Novartis hikes '13 forecast, thanks to generic Diovan delay

Ranbaxy's ban from US soil has softened the blow for Novartis 2Q sales.

Actavis gets go-ahead to expand generic painkiller portfolio

The drug maker can now add five new doses to its generic Opana ER offerings.

Approval clears Boehringer to enter oncology space

FDA's afatinib approval enables the drug maker set up shop in a new therapy space.

Janssen whizzes promising CLL agent over to regulators

Janssen submitted an NDA for its cancer hopeful ibrutinib, well ahead of competitors.

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