Astellas has settled a False Claims case with the Department of Justice over the 2010-2013 marketing of an antifungal medication. Astellas denies the allegations.
The experimental Breakthrough Therapy treatment is for acute myeloid leukemia.
Physicians Interactive is introducing the third wave of its Omnio app, making the tablet-only tool available for iPhones and Android phones.
The newly formed group will be known as Calcium with Steve Michaelson, formerly of Rosetta Wishbone, at the helm.
Medscape's survey of over 24,000 physicians found that a paycheck is not necessarily linked to a physician's professional satisfaction.
Centers for Disease Control data shows that diabetes complications including heart attack and amputation fell in the twenty years between 1990 and 2010. The bad news: the number of diagnosed diabetes patients tripled during that same time period.
Boehringer Ingelheim says it is no longer pursuing an interferon-free combination of faldaprevir and deleobuvir.
Roche also announced first-quarter sales shrank 1%.
The latest IMS Institute for Healthcare Informatics assessment of 2013's prescription drug use shows that 2.3% of prescriptions account for 30% of a patient's out-of-pocket prescription costs.
New data from the International Liver Congress in London this past weekend showed strong efficacy for Gilead's Sovaldi and AbbVie's combo regimen when paired with ribavirin.
Physicians Desk Reference is on a mission to expand its image beyond just being that heavy book doctors consult for information
Phase-II results indicate Merck's all-in-one HCV oral could put pressure on Gilead.
CDM, the Omnicom network of healthcare agencies, named Josh Prince, previously the group's chief creative officer, to president. He replaces Carol DiSanto.
Express Scripts said treatments for diabetes are the most expensive of the traditional medications, while specialty drugs are eating up a significant portion of total drug spend.
The FDA issued an official halt, five days after Halozyme stopped the Phase-II trial because of patient stroke information.
Researchers found a correlation between patients feeling involved and how well they stick—if they stick—to their medication regimens.
Analysts say the Indianapolis, IN, drugmaker's Phase-I results show CDK 4/6 inhibitors will have a role in breast cancer treatment and that Pfizer's palbociclib will not clear the field.
The drugmaker said today that FDA has granted the company a Breakthrough Therapy designation and a priority review for its sofosbuvir/ledipasvir combo.
Sunday's data readout has divided the Street between the enthusiastic and the disappointed. The key reason: progression-free survival gains were not as high as anticipated.
GlaxoSmithKline got some unwelcome attention from the FDA inspectors: a March 27 warning letter about unacceptable manufacturing and communications at a Cork, Ireland, manufacturing site where it found contamination issues.
A recent study shows that generic fill data, often used to promote the cost-savings associated with generic drugs, may hide the impact some health insurance plans have on patient medication use.
The ACA has spurred double-digit increases in demand for pharmaceuticals, new data suggest.
Praised for helping navigate the shift by advertisers into digital, media vet Kim Kadlec is leaving pharma for a new role at AOL.
MannKind's inhalable insulin, a pipeline contender for 14 years, scored a near unanimous vote from an FDA advisory committee yesterday.
A court granted Lilly six more years of patent protection for the almost $3-billion-dollar-a-year cancer drug.
At a hearing today, Public Citizen and the generics industry are sounding off on an FDA proposal that would allow generics firms to update labels, regardless of whether the brand has or hasn't.
Detailed Phase-III results from several PCSK9 candidates confirm the clinical ability of the newest class of cholesterol-lowering treatments.
The drugmaker said successful results prompted an independent Data Monitoring Committee to recommend stopping the trial. The news follows an uneven week of pipeline drug news.
Phase-I tests show Novartis's ceritinib works on Xalkori-resistant patients.
The company, which expects a 9% to 10% sales jump in 2014, says it will split into two independent companies by the middle of next year.
The company said it wants to wait for more data to come in.
A study by consulting firm Accenture shows that patients not only expect digital outreach, but that their desire to be engaged is consistently being ignored.
Merck has broadened its analytics approach to include team-ups with a slate of organizations at the intersection of Big Data and health IT.
The UK's National Institute for Health and Care Excellence says it bounced Bayer's drug for failing to compare itself to current treatments, and Sanofi's over cost.
Analyses by Jefferies indicate that although doctors are interested in the experimental anti-cholesterol drugs, CV data will be a critical differentiator.
AbbVie's "Perspectives—Art, Inflammation and Me," an exhibit centered around inflammatory diseases, looks to offer patient perspective through an artistic medium.
Longtime industry critic, Congressmen Henry Waxman penned a note to Gilead CEO over the "extraordinarily high cost," of its recently approved HCV treatment Sovaldi.
Celgene is looking to market the $22,500-a-year-drug as a pre-biologic, which means jumping ahead of rivals like Enbrel and Humira.
The Committee for Medicinal Products for Human Use endorses the SGLT2 inhibitor. The FDA refused to approve the drug earlier this month because of manufacturing issues.
The drugmaker halted Phase III trials of a three-month medication based on good efficacy feedback.
The 2013 guidelines add 12.8 potential statin users to the pool, but this growth does not necessarily mean still-experimental PCSK9s will be able to capitalize on the greater patient population.
Biogen Idec announced yesterday that FDA will extend Plegridy's review data for three months; regulators did not request additional studies be done, the drugmaker said.
Researchers find that Canada has been a significant contributor to Zetia sales.
A recent Medscape survey found that under-40s were more likely to work for a healthcare organization than were their older colleagues, trading autonomy for work-life balance and income predictability.
The company unveiled the mix-and-match marketing management tool at the Eye for Pharma conference in Barcelona.
The FDA approved the blood drug to prevent deep vein thrombosis and pulmonary embolism among hip- and knee-replacement patients. The approval means BMS and Pfizer may encroach upon the territory of J&J's Xarelto.
The Thousand Oaks, Calif. company says its cholesterol-lowering antibody hit its clinical trial endpoint among rare disease patients.
A rival's late-stage trial results suggest the pain med may have a short market life. The key: an FDA division head's documented willingness to overturn the approval should another pain option surface.
Analysts indicate the earlier-than-expected patent loss will not be a significant upset to Pfizer's present. The drugmaker plans to appeal the decision.
A report of over 270,000 US medical sites signals that EHR adoption is no longer a luxury reserved for hospitals and health systems.
The FDA's bad-ad unit took a drugmaker to task for what it calls a misleading Facebook page. History shows the social media surveillance should take no one by surprise.
Pfizer hit its endpoints for preventing pneumonia among the elderly, but the data may not be robust enough to spur vaccination.
Express Scripts notes that these prescriptions may not, in fact, be for ADHD.
Bayer and Amgen's Onyx subsidiary announce an oncology drug failed a Phase-III trial goal among liver cancer patients.
A survey of patients found greater prescription drug adherence among patients who received a free 30-day sample in addition to a prescription.
Sanofi and the firm with which it's co-developing alirocumab disclosed that regulators want some patients to be assessed for neurocognitive side effects.
Draftfcb Healthcare has rebranded to FCB Health, and has also acquired UK healthcare agency Halesway, effective immediately, the agency announced today
Biopharma lobbying groups attacked the president's FY 2015 budget as soon as the ink had dried on the $3.9-trillion document
Phase-II data show reduced hepatitis-C RNA levels among HIV-positive patients, the drugmaker shared at a medical meeting. Boehringer also released co-infection data.
The newly titled Nurse Practitioner Perspective rolls out this month, keeping pace with an educational shift in the nursing field.
The issue: Boehringer's manufacturing site. The FDA is not asking for new clinical studies.
The drugmaker announced Tuesday that it will pursue a Phase-III Yervoy-nivolumab study.
Data presented at a conference yesterday suggest AbbVie's all-oral regimen may be more effective than Gilead's at curing the virus in certain patients, but will it confer an edge?
The FDA's proposed upgrade to its off-label distribution guidelines has some new features, but experts say it is unclear if this means more dollars will flow toward reprints.
After a wave of feedback, the accreditor has deferred a ban on use of corporate logos in disclosures of commercial support.
Kynamro's slow start, coupled with competition, has prompted Sanofi to add sales reps.
Spurred by a 2013 report of a possible link between drugs like Merck's Januvia and pancreatitis or pancreatic cancer, the FDA and EMA said they have not found a definitive link but will continue to collect data.
The publisher aims to bring patient stories to life through long-form multimedia narratives.
A national survey indicates that obesity rates for children ages 2 to 5 has fallen since the early 2000s, yet overall numbers remain largely unchanged and high.
Phase-III results, top-lined today, show Lilly's investigational GLP-1 drug is well-positioned to eat into the multi-billion-dollar diabetes market now dominated by Novo Nordisk.
Endo settled off-label charges for $192 million, resolving civil "whistleblower" suits filed by two sales reps and a physician.
The drugmaker revealed efficacy data that analysts say could prompt the health agencies to emphasize adult vaccination.
The FDA commissioner said the agency is doing its job, not picking a fight, when it inspects drug-making facilities, and that India must take an active role for a harmonious supply chain.
Suppliers are touting a deeper level of analysis, in some cases bypassing the market-research function and reaching the highest levels of their pharma clients.
Pfizer's consumer website for Advil in South Korea offers a strange appeal to women who experience menstrual pain.
The drugmaker's new vaccine has more brawn, but vaccination rates among boys and girls remain low.
The drugmaker was scant on details, but Phase-III ramucirumab results among non-small cell lung cancer patients showed increased overall and progression-free survival vs. placebo.
A report published by JAMA indicated that online reviews sway a percentage of patients, but that personal recommendations hold more weight.
The drugmaker, hitherto known for its generic expertise, says the purchase could mean that half its future revenue will come from branded, specialty drugs.
The drugmaker's purchase of private biotech CoStim Pharmaceuticals comes with a host of experimental immuno-oncology agents.
Merck announced this week that its insulin glargine biosimilar, being developed with Samsung and Biogen Idec, would soon enter Phase-III trials.
The fast-tracked drug netted another indication today, this one for a form of leukemia. Lower dosage of the drug for that indication shrinks the price compared to lymphoma.
FDA's request for additional Phase-I research has some consumer groups claiming regulatory bias toward male sex drugs during the approval process.
The CEO told Leerink analysts the pharma business needs better margins, not unfettered R&D budgets.
The third Pharmacy Benefit Management Institute specialty medication survey expects specialty medications, which average around $3,000 per month per patient, will account for 50% of the drug spend within four or five years.
The regulator says a 2013 study that indicated a higher rate of heart failure compared to placebo—but not death—has prompted a second look at the diabetes medication.
Driven by a number of high-profile buys in 2013, pharma saw a return to investment through acquisition after a 2012 dip.
A six-month pilot program at the University of Chicago improved glycemic control and engaged patients and HCPs through one key device: a mobile phone.
The drugmaker expects to return emerge from 2016 with over 5,000 fewer employees and return to growth mode in 2017.
Constant exchange rates provide a positive framework for quarterly and year-end totals, whereas straight percentages indicate lower sales.
Chicago-based shop GA Communication Group says it's striving for the middle ground in an increasingly polarized agency landscape.
The company expects to return to growth in 2015 as it focuses on immunotherapy collaborations.
Innovator companies want the FDA to adopt separate names for biosimilars. Manufacturing changes aren't drastic enough to make it necessary, experts argued at an FTC workshop.
The proposed solutions include education, access and low-cost interventions.
J&J's campaign picks up where the FDA left off when it alerted physicians to concerns about prescribing acetaminophen-containing drugs but deferred action relative to OTC products.
The company said in a statement that it is talking with the FDA about next steps. Data on overall survival—a key metric for how oncologists view new cancer meds—remains under wraps.
Studies associating the therapies with higher heart risks triggered the review.
The regimen continues to show strong efficacy in a certain subtype, but it won't be easy to overcome the competitive advantages in Gilead's favor, analysts say.
Last year's merger of two big ad networks prompted indie shops to step up recruiting, and get creative. Blanketed media buys, organ-themed T-shirts and ice cream giveaways are among tactics.
Higher prices helped insulate Q4 and annual sales, which fell and rose 2%, respectively. Lilly said its insulin glargine biosimilar will go nowhere if it is not substantially different from the competition.