Goldman Sachs's Jami Rubin says AbbVie's pipeline assets make it a stealth competitor.
The commericalization/development deal covers up to six anti-cancer assets, and gives OncoMed a 50/50 US partnership over the experimental monoclonal antibody demcizumab.
Sanofi top-lined positive clinical data today from its investigational basal insulin, as it seeks to defend its position in this fast-growing segment.
Chronic disease patients seek online support and information, and show little love for branded websites.
Contrary to a claim by a Kentucky Republican congressman that he was assured by FDA that it would not approve new opioids unless they had abuse-deterrent formulations, the agency says it never made such a commitment.
Research suggests ADHD is becoming a regular fixture in adolescence. At the same time, publishers and startups have developed increasingly complex tools to separate patients from abusers.
The marketing watchdog's untitled letter says a direct mailer failed to disclose "material facts" from the warnings and precautions section of the PI.
A poll indicates new cholesterol guidelines won't shake up the statin market in 2014.
The drugmaker says interim trial data meets FDA review requirements and is hoping for June 2014 approval.
Janssen's hepatitis C drug Olysio (simeprevir) offers modest benefit over standard of care, but resistance in a subgroup of patients could hinder broader uptake.
Regulators say the company has not received approval for the device's touted functions.
A study points out barriers to e-prescribing pharma products and shows how doctors rate various EHRs.
Bernstein analyst Tim Anderson says Novartis has become a stealth player in the CDK-4/6 inhibitor competition.
The agency's bad-ad warning letter calls the new violations "particularly troubling."
The PBM encourages step-therapy to control costs.
Phase III clinical trial results underwhelm investors who feel on-market drugs offer better patient value.
The patient population is small, at around 3,000, but the expected price tag is $330,000 a year.
The avatar, part of an app designed to assist caregivers, was chosen as the winner of the two-day competition.
The catch is the difference between sales and revenues. Generics will continue to be a force, and small-audience drugs will become increasingly important.
Known as Breo Ellipta in the US, GlaxoSmithKline's Relvar Ellipta was approved by the EMA for asthma and COPD. The overall market is expected to continue to grow, but an NIH study indicates more patient conversations need to happen.
The drugmaker says it will not pursue regulatory review of its Phase III JAK2 inhibitor fedratinib.
Reviewers supported the drug's approval, but concerns about REMS and clinical trial integrity indicate the vote was not a roaring endorsement.
Aggressive new recommendations for treating patients at high risk of cardiovascular disease could significantly alter the treatment landscape.
The company also has breakthrough therapy designations for CLL and Waldenstrom's macroglobulinemia.
A report says this year's approvals could be worth more than last year's, even though the number of approvals will be fewer.
Most patients would advise today's FDA Lemtrada panel to allow doctors to gauge the drug's risk-benefit profile, although there was strong sentiment on either side of the issue.
The company says it will cut staff and costs, focus on big accounts and try to keep sales reps from leaving.
Mike Myers, president, and two other senior execs have left the agency Palio+Ignite, and a trio of long-time Palio leaders has assumed leadership of the inVentiv Health Communications shop.
The drugmaker's latest financial plans could power it through mid-2015.
An investigational cardiovascular heart drug failed to reduce the risk of heart attack or stroke, a miss which some on Wall Street say raises questions about the drugmaker's ability to deliver in late-stage trials.
The FDA's Bad Ad group says the drugmaker misbranded its cholesterol drug during interviews on CNBC.
The company's pursuit of a tighter research focus follows a path very much like that of its peers.
Safety reviewers' reservations about the MS drug's risk profile, unveiled in briefing documents ahead of an ad-com meeting, suggest it won't be smooth sailing for the drug in the US.
AbelsonTaylor delivered a perfect pitch of a different kind last night when the agency's in-house ensemble, Hard to Swallow, won Pharmapalooza 6, the industry's annual battle of the bands contest.
A poll by consulting firm QPharma indicates doctors are in the dark about what needs to be reported and what will be revealed.
Bayer filed for a new indication in the EU, following Regeneron's sBLA submission with the FDA.
The Kaiser Family Foundation's just-launched website, funded by Gilead, addresses healthcare reform from a distinct perspective.
The drugmaker says 20 jobs, or 17% of its workforce, will be gone by the end of the year.
The publisher says the latest release enriches the CE experience through direct links to Nursing Advisor content.
Data released at the Boston meeting of the American Association for the Study of Liver Diseases hints at an upcoming Gilead-Merck brawl.
The company will shell out $2.2 billion over allegations of marketing misconduct for Risperdal, Invega and Natrecor.
The regulator approved the CLL medication Friday, giving the drugmaker time to create a marketing transition before Rituxan goes generic. The approval marks another milestone: the first drug approved with a Breakthrough Designation label, a tag that is now coming under scrutiny.
The drug maker's vision for 2014: fighting to keep Victoza top-of-mind with a US field force of around 3,000.
Saatchi & Saatchi Health Communications and Wellness merge, Heartbeat brought into the fold.
The company's latest numbers show generics continue to pummel sales. Former GSK-er Marc Dunoyer replaces departing CFO Simon Lowth.
The drug company is ceasing US distribution and marketing the leukemia drug after the FDA said it was worried about blood clots among clinical trial patients.
A 15% increase in sales came on the back of HIV franchise meds Stribild and Complera/Eviplera.
Pharmapalooza, the industry's annual "battle of the bands" charity contest, returns to New York's B.B. King Blues Club & Grill on Wednesday, November 6th.
Researchers found that most healthcare apps have limited functionality, don't serve patients with multiple needs, and taper off when support is needed most. No wonder adoption is low.
The company says it recaptured some former advertisers and that third-quarter traffic is up compared with last year.
Third-quarter earnings did not stir up analysts, who were more focused on the pipeline and Pfizer's future organizational plans.
The agency made good on a pledge to expand Bad Ad with a web-based CME course and case studies representing common problems.
The American Medical Association (AMA), together with a slew of co-signers, wants CMS to reverse a decision to include textbooks and journal reprints as reportable items.
Based on its first three months on market, Tecfidera is one launch that's living up to its hype.
The company says it is moving its Januvia sales pitch from defending market share to expanding it.
Vyvanse was one of six drugs with double-digit revenue increases, propelling sales of the specialty drugmaker Shire up 13% for the quarter.
Smartphone users, while in the exam room, are more apt to be in "switch mentality," a study finds.
Amid talk of cost containment, Lilly said it's also enjoying nice returns from some of its older diabetes drugs.
BMS is showing signs of emerging from the cliff, but doubt lingers on Eliquis's slow launch in a post-Plavix marketplace.
Adding Epzicom to Tivicay in a once-daily cocktail could further boost GSK's HIV franchise, and possibly chip away at Atripla's dominance.
The marketing push follows the September launch of a patient support program and the announcement it was doubling its sales force.
Researchers say it's not just payers supporting the switch, and all ages appear to be brand agnostic.
Sales of its breast cancer treatments boosted totals for the first nine months of 2013, along with diagnostics, which saw a 3% increase over last year.
Lantus-like rivals can expect a wary reception from endocrinologists, even if these biosimilars reach market, researchers predict.
Eisai, the marketing half of the Arena-Eisai collaboration, plans to double the sales force by December.
The company beat consensus estimates, with particular sales strengths from its pharmaceuticals division.
EHRs could be a vehicle for pharma to find its way into the physician's workflow. First, industry needs to learn how to leverage them appropriately.
The generics giant said it will lay off about 5,000 employees as it braces for the expiry of one of its specialty brands.
An analyst notes that early Phase III results in a psoriasis clinical trial could change the drug's efficacy profile. It could also fill out the financial potential of a standalone innovative unit, should Pfizer divide.
A roundup of news related to hepatitis C.
The short answer: we're not financially prepared for a slowly aging, healthy population, according to a recently published analysis.
Recent studies underscore a need for greater engagement in multicultural communities.
Attendance by physicians crept up in 2012, said the trade group HCEA, but overall turnout was flat, likely because exhibitors brought less personnel along to meetings.
A Credit Suisse analyst notes that the company will need to make a significant impact to meet even lowered expectations. A possible fix: more sales reps behind Belviq.
Echoing a strategy similar to that posed by Merck, the drug maker told investors that its strategy for hitting revenue targets includes efficiencies. It also depends on a regulatory-friendly pipeline.
The winners of the MM&M Awards were announced last night.
A study shows consumers are increasingly pleased with retail pharmacies, compared to mail order pharmacies, which are often considered a key means of driving adherence and lowering healthcare coverage costs.
A roundup of some exchange-related news circling the web.
Growing client demand encouraged the agency to make its HCP content capabilities official.
The FDA approved the drug maker's depression drug Brintellix, one day after the Danish company announced a reorg that includes shifting 180 to 200 jobs.
The midnight shutdown put 800,000 government employees on leave, including those at the FDA, NIH and CDC.
The company will "fill the bag" of its sales reps, as part of a reorganization that also includes 8,500 job cuts and a more refined R&D focus.
The first on-demand way to tap the influencer community in healthcare went live today, and results of a real-world test show it has the potential to accelerate the research process.
Congress continues to war over healthcare reform. Exchanges will be able to take on members even if the government closes up shop.
The diabetes-cholesterol combo is no more.
The $25 million-plus deal is for worldwide rights to an experimental treatment being developed by private firm Gliknik.
The company has off-loaded two medications and a manufacturing site, part of an ongoing effort.
The scandal over Diovan draws regulatory attention.
The company has partnered with Univision on a dance competition that supports health and weight loss. The segment, called Ritmo Dieta, will run for 13 weeks on the variety program Sábado Gigante.
The second-line drug sped from Priority Review status for the first-line indication to approval in just over two months.
More than 40 industry thought leaders collaborated yesterday to design five patient influencer-powered companies that should be funded. Here are their ideas.
The new tools aim to help patients and providers better track blood glucose levels and administer insulin.
Phase III ramucirumab hit gastric cancer goals, but failed among breast cancer patients.
The regulator says serial filers and time restraints are draining resources and staff.
The Kimberly-Clark-backed cold and flu predictor mixes Big Data, and big branding, with an individualized focus.
The partnership seeks to improve medication adherence through predictive analytics.
The agency issued final guidance on mobile apps, saying it will focus only on a subset that present the greatest risk to patients if they don't work correctly.
An upcoming leadership summit is devoted to exploring whether health social media is driving meaningful change, as well as new ways to engage with health activists.
How potential alignment between drug companies and physicians, via the EHR, could extend brand reach.
Doctors shared their information preferences with CMI/Compas, revealing ways marketers can better pace their communications to max out channels.