Government

Business briefs: AbbVie, FDA, and health spending projections

AbbVie and Galapagos go after cystic fibrosis; FDA's NME approval pace slows; government shutdown could slow ad-com votes; and a report shows privately insured patients had emptier pockets in 2012 than 2011

US awards GSK $200M to fight "superbugs"

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GSK and the US Department of Health and Human Services inked a deal to fund development of new antibiotics, an area where clinicians face a dearth of new options.

It's Consumer's Choices as Guidelines Change

It's Consumer's Choices as Guidelines Change

Welcome to the ambivalent world of healthcare, where confusion reigns as shifts in science and guidelines seemingly raise more questions than they answer.

Obama budget would bleed pharmas

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The White House released its proposed budget for the 2014 fiscal year this morning, and while it gives a modest boost to Health and Human Services, it also seeks to extract more cost savings from pharmas.

For Obama's head-less CMS, third time's the charm

For Obama's head-less CMS, third time's the charm

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Acting administrator Marilyn Tavenner seems on track for confirmation, with the blessings of all industry stakeholders

Success in emerging markets hinges on broad network

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Execs told Booz & Co researchers that the relationships web in emerging markets needs to be deeper than one-on-one sales pitches.

Court could punt "Pay for Delay" back to Congress

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Eight members of the Supreme Court heard testimony in the case of FTC v. Actavis this morning, and the fate of so-called "pay for delay" settlements hangs in the balance.

Senate vote puts ACA's device tax in doubt

Senate vote puts ACA's device tax in doubt

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In a big win for the device industry, Senators voted overwhelmingly on a symbolic— but politically potent—motion to scrap the 2.3% device excise tax.

Sequester cuts could snarl approvals for years

Sequester cuts could snarl approvals for years

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With sequester cuts taking effect and no sign of a deal to end them in sight, FDA stands to lose 5% of its 2013 budget—though coming five months into the Federal fiscal year, it will feel more like 9%—and while the agency has said it has no plans at present for layoffs, it's certain the approvals process will slow as the agency absorbs the loss.

CMS warms to some stakeholders, burns others with Sunshine rule

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Clinical Research Organizations, marketing research firms, accredited CME providers and lawyers look to be the big winners in CMS's Sunshine Act rule.

CMS releases "Sunshine" final rule: federal preemption, August start date

CMS releases "Sunshine" final rule: federal preemption, August start date

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CMS issued its long-delayed final rule for collecting data on industry payments to physicians, ordering data collection to begin in August and asserting that the federal law preempts state laws.

Congress spares pharmas from going over another cliff—for now

Congress spares pharmas from going over another cliff—for now

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For the drug industry, the big news in the "fiscal cliff" deal is that the next big congressional showdown—one that could have big implications for the healthcare industries—has been kicked down the road a couple months.

Congress loses a healthcare mover, and pharma an unlikely ally on IPAB

Congress loses a healthcare mover, and pharma an unlikely ally on IPAB

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The November elections were arguably the most important for healthcare policy in 40 years, cementing, as they did, the Affordable Care Act by awarding President Obama a second term. But with all eyes glued to the drama at the top of the ticket, many missed a major Congressional upset that could have big implications for healthcare policy.

Amgen pleads guilty, takes CIA in $762 million False Claims Act case

Amgen pleads guilty, takes CIA in $762 million False Claims Act case

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Amgen "marketed the spread" between the price practices pay for Aranesp and that patients pay as a means of driving sales—to the point of having speakers tell docs that they could make a million more each year by prescribing the Amgen anemia drug over its competitor, Procrit.

FDA regulatory policy chief to take on compounding question

FDA regulatory policy chief to take on compounding question

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FDA's Jane Axelrad is leaving the Office of Regulatory Policy to head the agency's compounding policy rethink.

CBO: more scripts filled, less healthcare spending

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The nonpartisan Congressional Budget Office is tallying medical savings differently, adding a new perspective to chatter about the financial implications of nonadherence and rising drug prices.

Congressmen spar over meningitis blame

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Members of the House Energy and Commerce committee alternatively blamed and excused the FDA over the meningitis outbreak that has killed 32 patients.

Full steam ahead for Obamacare, but gridlock isn't going anywhere

Full steam ahead for Obamacare, but gridlock isn't going anywhere

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President Obama has cemented his greatest legislative achievement, the Affordable Care Act, but the status quo should prove anything but boring, with implementation of the law sure to mean more political fireworks

Voting with their wallets, pharmas say no thanks to change

Voting with their wallets, pharmas say no thanks to change

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Barack Obama edged Mitt Romney in fundraising from pharmas in the 2012 election, even as the industry favored Republicans in other contests. Were change-weary drug companies voting for the status quo?

Sunshine Act could scare docs away from commercially-supported CME

Sunshine Act could scare docs away from commercially-supported CME

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Physicians are reconsidering their participation in industry-sponsored CME, fearful that their inclusion in Sunshine Act databases as having received payments from companies will tarnish their reputations and fuel perceptions of conflicts of interest, a survey has found.

HHS expands 9/11 health program to cover cancers

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The Department of Health and Human Services observed the anniversary of the September 11, 2001 attacks by extending coverage of a program for first responders sickened by their work at Ground Zero, the Pentagon and the Flight 93 crash site in Shanksville, PA to cover some 50 cancers.

Amid misspent billions, the promise of personalized medicine

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The Institute of Medicine has released a report putting the cost of unnecessary medical care at $750 billion a year and counting. What does it mean for pharmas? Depends on how you read it.

Healthcare takes center stage at political conventions

Healthcare takes center stage at political conventions

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Healthcare policy is having its day in the spotlight of presidential politics as Republicans and Democrats rekindle their sparring over the Affordable Care Act, Medicare and Medicaid.

GSK in biggest-ever $3b marketing fraud settlement

GSK in biggest-ever $3b marketing fraud settlement

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GlaxoSmithKline will pay $3 billion to settle state and federal charges that it promoted antidepressants Paxil and Wellbutrin for unindicated uses and withheld safety data on diabetes drug Avandia.

In PhRMA-White House emails, little sizzle, less scandal

In PhRMA-White House emails, little sizzle, less scandal

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Congressional Republicans are trumpeting a cache of emails that give a glimpse into how the White House's deal with the pharma industry on healthcare reform came together. There's not much 'there' there, but there are some titillating glimpses into the legislative sausage factory.

PhRMA's Washington wish list

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PhRMA presented Washington with its legislative wish list - and a warning that plenty of other countries are trying to woo the industry away from the US.

Obamacare Court fail could hit pharmas with "double whammy"

Obamacare Court fail could hit pharmas with "double whammy"

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If the Supreme Court finds the "individual mandate" provision of the Affordable Care Act unconstitutional, as now seems surprisingly possible, the biopharma industry could be looking at a worst possible outcome situation.

Obamacare reconsidered: a pretty good deal for the drug industry

Obamacare reconsidered: a pretty good deal for the drug industry

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As the Supreme Court weighs the constitutionality of the Patient Protection and Affordable Care Act's "Individual Mandate"—and maybe the law itself—a pretty sweet deal for the drug industry hangs in the balance.

President's budget would deal a wallop to biopharma wallets

President's budget would deal a wallop to biopharma wallets

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President Obama's proposed 2013 budget would mandate an estimated $156 billion in new rebates to low-income seniors through Medicare over the next decade - discounts that would come out of the pockets of drug companies and could cost tens of thousands of jobs, according to PhRMA.

DOJ hit pharmas for $2.2 billion in 2011 False Claims Act cases

DOJ hit pharmas for $2.2 billion in 2011 False Claims Act cases

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Pharmas shelled out $2.2 billion in False Claims Act fines and settlements with the Justice Department this year as the feds' healthcare fraud haul hit an all-time high.

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