It's the second for this cancer drug in two weeks.
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.
The Food and Drug Administration has been intent on elevating and reorganizing its office of Generic Drugs since 2012.
HPV testing provides an edge over Pap screenings when it comes to detecting cervical cancer risk.
Hires and promotions for Manufacturers, Agencies and Media
NPR reports that the move has made Sierra Sandison a type 1 diabetes hero and that users have given the Facebook photo over 4,000 "likes."
CEO Severin Schwan tells Reuters that the Swiss firm will be looking for small acquisitions and partnerships.
AbbVie, in the latest example of a US drugmaker seeking to lower its tax rate, said today that it's buying Dublin-based Shire for $54 billion.
Dr. Joep Lange was en route to the International AIDS Conference in Melbourne, Australia.
He started the Dose of Digital blog in 2008, then left healthcare. Now, after more than two years away, Jonathan Richman says he's back in the business.
Haymarket Media launched the site PsychiatryAdvisor.com today.
Treasury Secretary Jacob Lew is urging lawmakers to prevent companies from "effectively renouncing their citizenship to get out of paying taxes," while also benefitting from the US-funded infrastructure.
Researchers found that patients were more accurate when doling out medication measured in milliliters as opposed to teaspoons or tablespoons.
Regulatory Focus reports that the regulator has issued a Warning Letter to AB Science for marketing its canine tumor drug Kinavet for unapproved, off-label uses.
Industry reined in commercial support for CME in 2013—the sixth consecutive annual decrease—data released today by the ACCME show.
An advocacy group alleges that Shire's decision to ignore the US Fabry disease market was the result of a backroom deal with Sanofi.
Novartis and the nonprofit Banner Alzheimer's Institutes are testing a theory that treating healthy patients could prevent or delay Alzheimer's disease.
Abbott and Mylan are setting up a generics business. The all-stock deal will give some branded generics a new home and offer Abbott a tax benefit that will increase over time.
Cyramza patients had more favorable overall survival rates than placebo patients, but the differences were not statistically significant.
German healthcare data from 2004 through 2010 across a data set that included 146,000 patients shows dementia surfaced later among Actos patients.
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.
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.
Allergan will implement company-wide cost-cutting maneuvers, Bloomberg reports, to keep Valeant at bay.
Prices for some generics are rising, thanks to limited competition.
UnitedHealthcare finds drug costs more than doubled.
Servier and Teva have been fined for keeping a generic heart medication off the market.
The companies will develop Lilly's glucokinase activator LY2608204.
The drugstore chain will no longer sell Sudafed in West Virginia.
It's the generics maker's second recall of 2014.
The Wall Street Journal notes that a new study on testosterone therapy has some weaknesses, including its sole focus on men who received injections—leaving out pills, patches and gels.
Credit card and loyalty program purchases will help Carolinas HealthCare System flag potential patient behavior issues.
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.
Editorial says risk is small, researchers say it could be clinically relevant.
Zogenix is working on a less easily abused formulation of its controversial prescription painkiller.
The European Commission is rolling out a verified-account tag it hopes will connect Internet users with trustworthy drug sources.
French lawmakers have the chance to vote for off-label use of Avastin, potentially eating into the turf of higher-priced Lucentis.
Health insurers and pharmacies signed a letter asking the FDA to require biosimilars and branded biologics to share the same name.
Boehringer Ingelheim's experimental idiopathic pulmonary fibrosis treatment nintedanib is also an orphan drug.
The Indian Pharmaceutical Alliance makes a bid for legislators' attention.
The American College of Physicians says most women do not need an annual pelvic exam. The American College of Obstetrics and Gynecologists disagrees.
The website is a joint effort between Merck and The Lancet.
The regulator wants men to be part of breast cancer clinical trials.
The networking site's emotion experiment rankles some in the science and political communities.
Novartis no longer has a lock on the Diovan market: the FDA approved Ranbaxy's generic, which will be made in the US.
An internal probe for a controversial ad for hypertension drug Blopress was released by Takeda, but the report is in Japanese.
Pennsylvania drugmaker Auxilium will merge with Vancouver-based biotech QLT to lower its corporate tax rate.
FDA says it will fast track the blood-thinner antidote, designed to thwart runaway bleeding.
Certain claims of the patents protecting the ADHD drug were both infringed and valid, a court ruled, giving Shire a boost as it contends with a takeover bid by AbbVie.
The firm said it expects to more than double its revenue within the decade, as the surging incidence of diabetes expands demand for its products.
The regulator is issuing draft guidance to address gene therapies.
An experimental Gelesis weight-loss drug seeks the middle ground between surgery and appetite suppressants.
Dublin-based Shire is urging shareholders to back independence and ignore AbbVie's $46.4 billion bid.
BI says there is no unmet need for faldaprevir.
GlaxoSmithKline dismissed a marketer over its approach to clinical trial recruiting.
Gene mutations lead researchers to rethink ways to protect the heart.
Farzad Mostashari is leading a startup to help primary care physicians create Accountable Care Organizations
Lawmakers criticized Columbia University chairman and professor of surgery Dr. Mehmet Oz for calling weight-loss supplements miracles on his TV program, despite lacking scientific proof to support those claims.
Colorado's version of the FDA's compassionate use rule does not sit well with lobbying group Pharmaceutical Research and Manufacturers of America.
The companies resubmitted SGLT2 inihibitor empagliflozen for FDA review. The EC approved the drug in May.
FDA issued two guidance documents today for industry and its representatives to communicate online about prescription drugs and devices.
The Centers for Medicare and Medicaid Services launched a new site Monday to help patients understand how to use their health coverage.
The drugmaker is pulling its US marketing application for the anemia drug.
Recent FDA guidelines for health-tracking apps mean Apple's HealthKit, and similar apps, won't have to jump regulatory hurdles before going live.
The deal makes Medtronic the most recent company to seek out lower tax rates.
The all-oral genotype 1 medication got the Breakthrough Therapy designation Friday.
The drugmaker has told global regulators it failed to share 10,000 reported cases of side effects for a variety of its drugs.
The Italian Medicines Agency is guiding patients away from Roche's costlier AMD-indicated Lucentis.
A USA today analysis shows Medicare painkiller prescriptions rose 30% between 2007 and 2012.
The Oregon Health Plan wants to keep hep. C medications Sovaldi and Olysio off its list of covered treatments.
Eli Lilly's gastric cancer drug Cryamza failed to hit its primary Phase III liver cancer target.
CFO Frank D'Amelio told an investors conference AstraZeneca wanted more money.
CEO David Pyott told Modern Healthcare that acquisition fallout would have probably included a pinched R&D budget and higher product prices.
August 15 is John Johnson's last day as president and CEO.
Two studies found two different facets of statin therapy—one found patients moved less a year after starting their regimens, and another that the drugs upped the diabetes risk for some.
Express Scripts said that family and internal medicine doctors were the top opioid prescribers between 2011 and 2012.
Steven Stack will be the association's youngest president when he takes office in 2015.
A study shows that total knee replacement is rising—and occurring in more youthful people. The uptick tracks with the rise in obesity.
The Windy City seeks $9.5 million in damages in a lawsuit that accuses manufacturers of misleading consumers.
The WSJ reports that Merck, Sanofi and GSK are looking to put older medications at arm's length.
A study shows doctors have been giving more political donations—and leaning heavily Democrat—since 1991.
The company says the re-lo is for personal reasons. The move will put him in close proximity to Genzyme, as well as other members of the French firm's executive committee.
Patients have to be high-risk or Baby Boomers for coverage.
Shwen Gwee, the social media guru, has joined Digitas Health Lifebrands as VP of social strategy.
The company has created three new departments.
The company is buying Genia Technologies for $125 million.
The FDA granted the label for Genentech's experimental metastatic urothelial bladder cancer treatment.
In addition to raising its bid for Allergan, Valeant is lobbying for a shareholder meeting to oust six board members.
Promotions and hires for manufacturers, agencies and technology companies
Michael A. Griffith, Executive vice president, inVentiv Health
The CDC said Thursday that most of the 288 recent US measles cases were caused by un-vaccinated travelers who brought the virus home with them.
The government's anti-trust agency said the drug companies colluded to push doctors toward pricier Lucentis over Avastin.
Companies including WellPoint and Highmark are deploying financial incentives for doctors to stick with recommended cancer treatments.
The new offer is $49.4 billion.
The company is settling around 4,000 cases for around $162,500 apiece.
The company announced Tuesday that the UK fraud agency is giving the company a closer look.
The drugmaker has paired up with Incyte and CytomyX in two separate deals.
The regulator is allocating almost $38 million to improve data-guided decision-making.
The maker of an FDA-approved app says its algorithm can use images to assess surgery-related blood loss.
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.
Saeed Motahari, formerly AbbVie's VP of US sales and marketing, specialty brands, is Purdue Pharma's new SVP, chief commercial officer—a new position.