The fine is for Pradaxa documents that have gone missing. The company is accused of hiding risk information about its blood thinner.
The FDA granted priority review for the experimental, all-oral Gaucher's disease treatment.
The $120.4-million deal is part of Savient's bankruptcy auction.
Vaccine LU AF20513 is the their third Alzheimer's collaboration.
A Penn State researcher thinks it can help women with menstrual cramps.
The HHS Secretary has some positive enrollment stats to share, but sentiment shows she and Obama need some reputation rehab.
Genentech has gone out of its way to keep doctors choosing Lucentis over cheaper Avastin, the paper reports, and they have little incentive to do otherwise.
The company released two financial scenarios. The key is generic Copaxone.
People asked, experts answered.
Danish police are investigating the drugmaker over its decision to wait two days before announcing the FDA's February rejection.
Covidien is buying ingestible-camera company Given Imaging.
The retraction comes six months after researchers were fired over misrepresented data.
The government division is scrutinizing marketing information for three drugs.
Reports of a Dec. 5 deal between the US and China could deepen inspectors' reach.
Their letter to CMS voices disagreement with the decision to make textbooks and journals reportable under the Sunshine Act.
The drug failed to hit its Phase III targets.
Phase-IIIb study results indicate Lyxumia—which is approved abroad but not in the US—was "non-inferior" in terms of controlling blood sugar levels regardless of whether the shot was given before breakfast or later.
Novo's global diabetes study finds that only 29% of polled patients were asked what they thought about prescribed regimens.
The company's new president and possible CEO is expected to have significant latitude to change things.
The trio will focus on using immune systems to attack cancer.
AstraZeneca has been awarded $76 million in damages in a ruling over Apotex's sales of a generic version of Prilosec.
Impax Laboratories announced that it has reached an agreement with Purdue Pharma to settle patent litigation surrounding Impax's generic version of OxyContin.
Following a Warning Letter from the FDA, 23andMe has stopped marketing its DNA test.
The agency extended the review time for Biogen's Alprolix by three months.
Forest's cost-savings initiative is aimed at reducing operating expenses by $500 million, while Eisai said it's cutting 130 positions in the US and Europe.
Spectrum DNA says its genetic services are at the ready, even if 23andMe's are not.
The FDA said it's reviewing the available and related scientific information on the issue of reduced efficacy in heavier women.
The leukemia drug is staying on the market, but for a more restricted patient population.
Critics worry the talked-about approval plan could mean adverse events surface far too late.
The FDA said it is requiring the removal of certain restrictions on prescribing and use of the diabetes drug Avandia.
EU's CHMP offered a recommendation this week for Gilead's sofosbuvir while also agreeing in principle to give Biogen Idec's Tecfidera "new active substance" gives it 10 years of exclusivity.
An organ-donation campaign with a Brazilian football tie-in, and a UK managed-access company's series of documentary films, took top honors.
Fetterolf, joining as SVP of innovation, is reuniting with another Palio+Ignite veteran.
Summaries max out at 160 characters and most queries are clinical.
Actavis shrinks its staff by 30%, and Bayer reduces its California footprint.
The National Health Service is expected to have a $49-billion deficit by 2020.
The drugmaker revealed the data a year after stopping a Phase III trial.
The drugmaker's green light was paired with the EMA's decision that several thousand unreported AEs were no big deal.
ProPublica's deep-dive into Medicare brand-prescribing habits show brands make a dent in Medicare's budget.
New results from its Phase II safety trial show the LDL-cholesterol lowerer was not associated with a major increase in adverse events vs. standard of care.
AbbVie released top-line results from its Phase III SAPPHIRE-1 study of its hepatitis C cocktail.
The company is rolling out two new clinical trials, and Phase I data suggests an antidote could be on its way.
The company is paying $2.5 billion over its DePuy hip replacements and $11 million in a lawsuit over its seizure drug Topamax.
Early clinical trial results indicate 81% of advanced melanoma patients survived for one year.
The agency says mobile traffic has more than doubled over the past 12 months.
The calculator meant to help doctors use the new cholesterol guidelines appears to be flawed.
New software is helping drugmakers troubleshoot clinical trials before recruitment.
EyeonFDA finds that, when it comes to black-boxed drugs' marketing materials, the FDA is more likely to issue Warning Letters than untitled letters.
The president says current subscribers will be able to keep their plans.
Domestic manufacturers are being pressured to offer domestic discounts to international clients.
The EMA is wading through thousands of comments and may push back its clinical trial transparency initiative.
The company's changes are no longer limited to R&D.
The US-only recall amounts to less than 1% of the company's inventory.
Site fixes are reported to lag, but CMS plans on inviting consumers to give Healthcare.gov another go.
The tool lets researchers tap into health data from work, meaning the year-long waits for data are over.
The cutbacks will leave a staff of eight.
The drugmaker now owns the @Pfizer handle in addition to @Pfizer_news
The current number is reported to hover around $4 billion.
The regulator says the drugmaker needs to do more testing.
Official numbers are pending, but Reuters notes enrollment appears to be just 3% of the government's goal.
PNAS fixed a citation issue by adding quotes, but readers are not completely sold.
The companies are plunking down substantial sums to increase their reach.
The company announced the layoffs Friday.
The proposed change would allow generics makers to update labels even if branded drugmakers do not, possibly opening up generics to new liability issues.
Novartis is cutting jobs in California and adding some in Massachusetts, while Shire is trimming its UK R&D staff.
The Centers for Medicare and Medicaid Services won't say if the change is connected to Healthcare.gov's bumpy launch.
The uptick is being linked to looser DSM guidelines.
General support for the legislation is up, despite Healthcare.gov woes.
Researchers find an increased link between testosterone therapy, heart attack and stroke.
The drugmaker blasted the price-control agency for being shortsighted and underestimating the industry's role in health and savings.
AstraZeneca and Roche strike antibiotic deals.
The NIH says the insight could inspire new ways to tackle the brain-destroying disease.
The "New Endo" will be one company on the outside, two on the inside.
The news is part of an ongoing reorg by the Swiss firm that is rumored to include selling off its animal health business.
The regulator has rescheduled two advisory committees cancelled during the government shutdown.
They're not hiding their love or disdain for reform, including one who says the law brings bias into the exam room.
The voice-activated app costs 99 cents.
Researchers think a two-hormone approach could help control diabetes and obesity.
Subscribers will be able to use co-pay cards on Obamacare exchanges.
A day after calling a reported dispute with the board "baseless," Jeremy Levin left the firm he had joined just 18 months ago.
Sebelius took the heat for Healthcare.gov, promising that most people would be able to shop for coverage online by November.
The regulator will study how teens perceive ads and if targeted media needs unique standards.
Researchers say the drug class could be linked to a lower autoimmune risk among diabetics.
The FDA told the drugmaker in a letter before the December PDUFA date that evidence does not support an expanded indication.
Lawrence Foster's crisis management strategy has become the touchstone for reputation management. His advice is credited with saving Tylenol from being wiped from the marketplace, despite a deadly tampering crisis.
Generic giant Teva refuted allegations that the CEO, Jeremy Levin, and the board of directors were at odds over the company's cost-saving maneuvers.
The company's hep. C drug Incivek peaked in 2011. Competition and pipeline drugs have forced the company to regroup.
John Whyte of the Discovery Channel is the organization's new director of professional affairs and engagement.
The prostate cancer drug company is reportedly seeking a buyer to turn things around.
Just a day after tightening rules around hydrocodone-based combo drugs, the regulator approved a pure-play hydrocodone-based standalone drug, Zohydro.
A court refuses to compel a government agency to schedule the firm's epilepsy drug, as the med's patent clock ticks.
Updates include responsive design and information in Spanish.
The AAP says greater access and education are critical in curbing STIs.
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 said Thursday that it will recommend that hydrocodone (Vicodin) and hydrocodone combination products be reclassified to Schedule II.
A roundup of firms' quarterly performance culled from sources around the web.
A wide-ranging piece recounts the pushback from oncologists that led to a decrease in the price of Zaltrap.
The hep. C drug is safe and effective when used in combination with other therapies, according to information posted by FDA reviewers.
Word came of Breakthrough Designation for an HCV hopeful, a day after a hiccup in a heart drug trial.
A report says oncologists may be using GSK's Tafinlar and Mekinist together in a non-FDA approved combination therapy.