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
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.
Welcome to the ambivalent world of healthcare, where confusion reigns as shifts in science and guidelines seemingly raise more questions than they answer.
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.
Acting administrator Marilyn Tavenner seems on track for confirmation, with the blessings of all industry stakeholders
Execs told Booz & Co researchers that the relationships web in emerging markets needs to be deeper than one-on-one sales pitches.
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.
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.
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.
Clinical Research Organizations, marketing research firms, accredited CME providers and lawyers look to be the big winners in CMS's Sunshine Act rule.
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.
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.
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 "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's Jane Axelrad is leaving the Office of Regulatory Policy to head the agency's compounding policy rethink.
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.
Members of the House Energy and Commerce committee alternatively blamed and excused the FDA over the meningitis outbreak that has killed 32 patients.
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
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?
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.
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.
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 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.
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.
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 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.
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.
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 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.
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.
Does a health psychology approach hold the key to Rx adherence? In MM&M's latest Leadership Exchange Uncut eBook, industry stakeholders from the payer, provider, academic and pharma realms explore the "why" behind medicine taking. Access here.