Regs

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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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.

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