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.
Taken to new heights on the launch of MS blockbuster Tecfidera, the drug maker has raised its 2014 forecast.
Generics took a $2.2-billion bite out of sales, but growth products like Gilenya helped to minimize the impact.
A clinical trial shows that using Xtandi before chemotherapy—Zytiga's indication—improves progression-free survival.
The company said it may use Phase II data of a breast cancer drug for FDA review, part of an earnings presentation that also included its perspective on what a pre-2017 breakup would take.
A young company is hoping its analytics platform can help doctors and pharma figure out who's going to stop taking their medication, and get them back on track.
Friday's no-nivolumab news event disappointed some, but analysts generally rooted for BMS, which saw year-end sales fall 7%, because of anticipated immuno-oncology success.
If the HCV drug's trajectory continues, it could exceed Q1 and 2014 sales forecasts, despite payers' reported unease over price.
The third lifestyle survey shows that doctors are battling the bulge just like everyone else.
Researchers say it's too early to declare the 2012 program a success but that the label will benefit drugs beyond those with orphan status.
Positive results from a Phase-III trial edge Amgen's evolocumab closer to approval, though it's still behind rivals in the PCSK9 race.
Analyst Thomas Wei reviews the prescription slimming category and sees two different realities for Vivus and Arena.
Two JAMA articles and an editorial give a rundown of what the FDA leaves unsaid in its approvals process and how general housekeeping items can get drugs rejected.
The latest IMS report shows that 50% of the top 50 pharma companies are not on social media. Executive Director Murray Aitken tells MM&M it is to pharma's detriment.
The 20-year McCann veteran, who most recently headed McCann Health North America, has left the network for a dual role at inVentiv Health.
Endo signed Ogilvy PR to a one-year deal for comms support, following a selection process that reportedly lasted but a few weeks.
Merck and Celgene are exploring a combination that could solidify their immuno-oncology footholds.
The new network, PD One, will allow reps to connect with HCPs through PDI's Medical Bag.
Gregg Geider, who headed up high-profile accounts at Omnicom's Harrison & Star, has joined IPG's ICC Lowe Pace as managing director.
A month after UBM Canon closed the B2B magazine, marketing firm Outcomes LLC announced its return to twice-a-year publication.
Analyst Seamus Fernandez, of Leerink Partners, says the drugmaker is set to be a considerable immuno-oncology and respiratory presence.
The draft guidance is mostly procedural, and more guidance is expected, but experts say it does include some long-awaited clarity for advertisers.
The company known for Eylea has launched a genetics discovery unit and teamed up with a partner to sequence 100,000 patient genomes.
The drugmaker announced Friday that the DOJ wants documents regarding sales and marketing of Juxtapid, its drug for an ultra-rare lipid disorder.
The MS pill saw rapid uptake in the US last year, but its overseas launch won't be as quick, CEO George Scangos conceded this week at an analyst conference.
The FDA said it's OK to use Mekinist and Tafinlar for unresectable metastatic melanoma or metastatic melanoma with the BRAF V600 or V600K mutation.
AZ's delayed diabetes pill was given the FDA nod today, the second treatment of its kind available in the US behind J&J's Invokana.
The new deals seek out new strategies to address an expansive category.
CMS could provide more guidance for how to crack down on healthcare fraud, the OIG asserts in a report.
Generics accounted for almost 75% of dispensed drugs in 2012, according to CMS researchers.
The data and analytics giant is looking to launch an IPO. The company, which is the subject of an antitrust suit, said in its prospectus that it anticipates future acquisitions.
The company's guidance aligns with expectations that 2014 will be a nail-biter.
The warfarin replacement will be evaluated in a post-trial safety study, regulators said last Friday.
The company releases 2014 guidance Tuesday, but signals from the previous 12 months indicate the Indiana drugmaker is determined to hit its $20-billion earnings target, patent losses be damned.
Mid-stage data show the drug, romosozumab, was associated with significant increases in bone mineral density compared to Lilly's Forteo and off-patent Fosamax.
An untitled letter from the FDA's bad-ad unit shows Amarin's triglyceride-lowering medication faced multiple challenges in 2013.
Our year-end list captures the 10 that sparked heaviest interest.
The firm has vowed to appeal an FDA rejection that otherwise complicates its bid to expand in multiple sclerosis.
The move to digitize a series of books it co-created with Disney for kids with type 1 diabetes was spurred by a meeting with the online diabetes community.
Lobbying groups say the ad tax draft proposal could wreak havoc throughout the ad industry and its partners, such as publishers and broadcasters, if it were to go through.
Kalydeco failed to hit its primary endpoint of significantly improving lung function in a subset of CF patients, but some did show a benefit.
BMS is giving up its stake of the AstraZeneca diabetes joint venture for $2.7 billion up front, and future milestone payments.
Sovaldi is already approved for most patients with HCV, but its marketer may have earned itself some breathing room against rivals in the next stage of the all-oral hep. C arms race.
Biogen Idec and JV partner Samsung are going into the biosimilars business.
A recent poll shows a strong desire among web-savvy patients to play a more active role in medical research.
Famous from his reality show, "The Osbournes," Jack narrates his life with MS in a web documentary series.
The physician networking service rolled out a job-hunting service that brings the medical job search into the modern age and provides a revenue stream.
The FDA's Center for Drug Evaluation and Research released a preliminary year-in-review report that says the agency has cleared 26 new molecular entities this year.
The company expects to join the prescription weight-loss market by 2014's third quarter.
Pew Charitable Trust's proposed conflict of interest guidelines could mean even less face time for sales reps and less industry money for CME programs.
The Boston-based agency hopes the new department will allow teams a broader perspective.
The bad-ad watchdog issued an untitled letter to drugmaker Duchesnay in November.
FDA panel briefing documents indicate concern remains over bladder cancer, as the drug dapagliflozin undergoes a second review Thursday.
The company says Docnet is more than a social site—it's a hub that merges networking, research and financial (as in Sunshine) resources.
The drug is priced at $28,000 a month, before add-ons like ribavirin and (possibly) interferon.
A survey of US hepatologists signals pent-up demand exists for the paradigm-changing HCV treatment, but that not all patients will get the drug right away.