In sunny world of LASIK marketers, a dark underbelly

In sunny world of LASIK marketers, a dark underbelly

Last week, the former FDA branch chief who originally approved LASIK machines asked FDA to reconsider its denial last month of his petition to ban these devices.

Payment database confounds doctors

ProPublica reports that doctors are struggling with a time-intensive registration process and are getting an error message that CMS says is not an error message.

Gilead's idelalisib hat trick

The FDA greenlighted the drug for three cancers.

Avastin pockets another Priority Review label

It's the second for this cancer drug in two weeks.

Court invalidates some healthcare subsidies

The lawsuit has been wending its way through the courts for a while, and, although it is being deliberated in several other venues, the decision is part of a legal dispute that puts patients in the 36 states offering federal exchanges in limbo.

FDA generic division overhaul kicks in

The Food and Drug Administration has been intent on elevating and reorganizing its office of Generic Drugs since 2012.

FDA gets treatment guidance from patient advocates

FDA gets treatment guidance from patient advocates

Parent Project Muscular Dystrophy (PPMD) and allied stakeholders recently gave FDA the first patient advocacy-initiated guidance for a rare disease to help accelerate development and review of potential therapies for Duchenne muscular dystrophy.

Roche seeks Avastin cervical-cancer indication

Roche seeks Avastin cervical-cancer indication

The FDA granted Priority Review for consideration of Avastin for some cervical-cancer patients.

Advocacy group alleges Sanofi-Shire conspiracy

An advocacy group alleges that Shire's decision to ignore the US Fabry disease market was the result of a backroom deal with Sanofi.

Committee votes on two health bills today

The House Energy and Commerce Committee is putting two health-related bills to vote Monday. One covers new sunscreen ingredients, the other muscular dystrophy research.

Senators press Gilead over Sovaldi price

Senators press Gilead over Sovaldi price

In the latest chapter in the Sovaldi pricing saga, Senators Ron Wyden and Charles Grassley urge Gilead to clarify Sovaldi sticker shock.

BMS readies nivolumab for melanoma filing

BMS readies nivolumab for melanoma filing

Bristol-Myers Squibb is moving forward with its FDA filing of PD-1 Opdivo (formerly known as nivolumab) for patients with advanced melanoma who have been previously treated with the BMS drug Yervoy.

FDA quicker on approval trigger than EU: study

The FDA began its drug review at a median time of 103 days sooner than the EMA. Being first, researchers found, often resulted in quicker approval.

EU fines six for pay-for-delay

Servier and Teva have been fined for keeping a generic heart medication off the market.

"Likes" put Zarbee's in FDA crosshairs

"Likes" put Zarbee's in FDA crosshairs

The FDA says the OTC remedy maker's online behavior—including Liking customer Facebook posts—has put the company's drugs in unapproved drug territory.

OPDP slaps Gilead with Untitled Letter

OPDP slaps Gilead with Untitled Letter

The drugmaker received a notice from the advertising watchdog over promotion of hep. B treatment Viread in a sponsored link on Google AdWords.

Purdue pain drug gets priority status

Purdue pain drug gets priority status

Purdue Pharma expects the FDA to vote yea or nay on the drug by October.

CVS joins West Virginia pseudoephedrine fight

The drugstore chain will no longer sell Sudafed in West Virginia.

Sun recalls cancer drug

It's the generics maker's second recall of 2014.

Merck stifles ezetimibe criticism

The head of evidence-based medicine at Milan's health authority Alberto Donzelli has pulled down criticism of Merck's cholesterol drug ezetimibe from his website, after the drugmaker sent two cease-and-desist letters.

CMS plans to end CME Sunshine exemption

CMS plans to end CME Sunshine exemption

In what amounts to a sudden about face, CMS wants to delete the Sunshine rule's exclusion for continuing medical education.

EC cracks down on fraudulent drugs

The European Commission is rolling out a verified-account tag it hopes will connect Internet users with trustworthy drug sources.

Insurers put in bid for biosimilar naming

Health insurers and pharmacies signed a letter asking the FDA to require biosimilars and branded biologics to share the same name.

BI drug gets priority review

Boehringer Ingelheim's experimental idiopathic pulmonary fibrosis treatment nintedanib is also an orphan drug.

India's generics makers hire Beltway help

The Indian Pharmaceutical Alliance makes a bid for legislators' attention.

BI's Pradaxa antidote gets Breakthrough label

FDA says it will fast track the blood-thinner antidote, designed to thwart runaway bleeding.

Panel votes against AZ's olaparib

Panel votes against AZ's olaparib

An FDA advisory panel voted 11-2 against an accelerated approval for AstraZeneca's experimental PARP inihibitor. The panel recommends getting more data before giving the drug the all-clear.

FDA Guidance expands environmental perspective

The regulator is issuing draft guidance to address gene therapies.

FDA adds to "low-T" drugs' warning label

FDA adds to "low-T" drugs' warning label

Four months after announcing a review of low-testosterone treatments for risk of heart attack and stroke, the regulator expanded the classes' warning label to include a general risk of blood clots.

FDA Twitter guidance greeted with caution

FDA Twitter guidance greeted with caution

Guidance on promoting products in 140 characters and correcting misinformation serves as a guarded green light, says one observer.

PhRMA uneasy about "right-to-try" laws

Colorado's version of the FDA's compassionate use rule does not sit well with lobbying group Pharmaceutical Research and Manufacturers of America.

Lilly, BI resubmit diabetes medication

The companies resubmitted SGLT2 inihibitor empagliflozen for FDA review. The EC approved the drug in May.

FDA releases new draft social media guidance

FDA issued two guidance documents today for industry and its representatives to communicate online about prescription drugs and devices.

HealthKit won't tangle with the FDA

Recent FDA guidelines for health-tracking apps mean Apple's HealthKit, and similar apps, won't have to jump regulatory hurdles before going live.

FDA labels AbbVie hep C drug Breakthrough

The all-oral genotype 1 medication got the Breakthrough Therapy designation Friday.

OPDP says phentermine site thin on details

OPDP says phentermine site thin on details

The bad-ad watchdog says the promotional website for the weight-loss medication Suprenza leaves out too much information.

FDA pauses Orexigen drug approval

FDA pauses Orexigen drug approval

The regulator wants more time to discuss post-marketing requirements.

Medicare to cover some hep. C screening

Patients have to be high-risk or Baby Boomers for coverage.

Genentech cancer med nabs Breakthrough status

The FDA granted the label for Genentech's experimental metastatic urothelial bladder cancer treatment.

CMS: docs can sign up for Sunshine peek

CMS: docs can sign up for Sunshine peek

Will docs line up to glimpse their payment data—and get a chance to correct mistakes—or will low awareness overshadow the latest milestone in the law's roll-out?

Italy fines Roche and Novartis

The government's anti-trust agency said the drug companies colluded to push doctors toward pricier Lucentis over Avastin.

Boehringer settles Pradaxa suits

The company is settling around 4,000 cases for around $162,500 apiece.

Fraud office looks at GSK

The company announced Tuesday that the UK fraud agency is giving the company a closer look.

FDA examines DTC close up

FDA examines DTC close up

The regulator's latest study will use eye-tracking tools.

FDA invests in clinical trial data

The regulator is allocating almost $38 million to improve data-guided decision-making.

CA counties sue makers of painkillers

Orange and Santa Clara counties are suing painkiller makers like Purdue and Endo, a suit akin to deceptive ad cases launched against the tobacco industry.

China continues industry probe

Roche says reps from China's antitrust agency visited one of its sites.

Sun's FDA Warning Letter

Sun's FDA Warning Letter

The FDA's seven-page letter outlines some of the problems the regulator has with one specific Sun site.

OPDP takes on sales aid for alcohol drug

OPDP takes on sales aid for alcohol drug

The advertising watchdog gave drugmaker Alvogen 15 days to make amends.

Clinical trial nabs SEC attention

The Securities and Exchange Commission alleges that two doctors illegally exploited their clinical trial affiliation for financial gain.

FDA seeks math of similarity

A three-year, $1 million project seeks an equation for generics and biosimilars.

FDA says no to Novartis heart drug

FDA says no to Novartis heart drug

Novartis says the FDA wants more serelaxin efficacy data.

BMS, AbbVie land Breakthrough label

The FDA granted Breakthrough Therapy status to the duo's multiple myeloma treatment.

FDA standing by its Zohydro approval

FDA standing by its Zohydro approval

The regulator defends its approval decision in a web post.

FDA OKs Merck clot drug

Zontivity (vorapaxar) was approved for patients who have already suffered a heart attack or have arterial blockages in the legs.

Xtandi seeks first-line status

The FDA has granted priority review status for the expanded-indication review.

FDA to review generic blood-pressure med

Prompted by thousands of adverse events, the agency is said to be undertaking an extensive review of generic copies of Toprol XL.

Janssen submits HCV combo to FDA

The drugmaker sent Olysio + Sovaldi to regulators for an additional indication in HCV patients with liver scarring.

FDA nixes use of aspirin for primary prevention

FDA warned consumers against using aspirin for primary prevention, following its denial of Bayer's request to allow marketing of aspirin for that use.

Heart pill approval a much-needed win for AZ

Epanova—a drug meant for patients with a high triglyceride count—won approval from FDA today, a small but symbolic win for AZ as it seeks to fend off a takeover attempt by Pfizer.

Olympus pill camera approved

The trackable device offers a 160-degree view of a patient's insides.

FDA panel shoots down OTC Singulair

FDA panel shoots down OTC Singulair

Merck's ex-blockbuster allergy drug, Singulair, received a thumbs-down from an FDA advisory panel asked to consider an OTC switch.

Industry resists FDA power grab on social media

Industry resists FDA power grab on social media

The response period may have ended in mid-April, but some of the harshest criticisms of FDA's social media draft guidance weren't posted until the end of the month.

New painkillers stalk Zohydro

New painkillers stalk Zohydro

Two drugmakers, Purdue Pharma and Teva, have abuse-deterrent hydrocodone medications either under FDA review or in late-stage testing.

Latest Breakthrough nod goes to Novartis

The FDA announced Tuesday its approval of lung cancer drug Zykadia for patients with metastatic ALK-positive non-small cell lung cancer.

Pharma pumps up lobbying spend

Roll Call finds some significant increases in lobbying spend between Q4 and Q1.

Panel votes against painkiller

Panel chair Randall Flick said QRxPharma "had not provided sufficient evidence to support a claim that Moxduo is safer than morphine or oxycodone."

Bayer drug gets orphan label

Bayer drug gets orphan label

The FDA designation is for an experimental, inhaled form of ciprofloxacin intended to treat a rare lung condition.

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.

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