The drugmaker is debuting a DTC campaign for the older constipation drug, despite a crowded therapeutic category and potential generics on the horizon.
A survey shows fewer payers expect more restrictive policies in the near-term.
The reveal comes days before hydrocodone products jump to a more restrictive access tier.
New Pfizer Viagra ads bring women into limelight; Open Payments database debuts to criticism; AbbVie/Shire deal set to be completed.
Late-stage immunotherapy results presented at a European medical conference over the weekend were heralded by clinicians, as AstraZeneca's lung-cancer darkhorse showcased strong early-stage results.
The FDA's Office of Prescription Drug Promotion says Pacira's promotional materials for Exparel are "extremely concerning," but the drugmaker tells investors the fuss is probably because opioids have been getting a lot of attention lately.
Promotions and hires for agencies and manufacturers
Mobile health devices may be more than they appear to be—consumers are taking an open-source approach to getting the monitors they want.
Inversion rules have Medtronic asking for a Covidien do-over, Roche's Perjeta has "unprecedented success," while AstraZeneca's Iressa does not.
US government looks for alternative, nondrug, pain relief options for veterans; Gilead's HCV combo scores positive opinion in EU; FDA reopens commentary for social media draft guidance.
There are similarities between the 2014 formularies and their commercial counterparts. However, differences in the drug benefit designs show the predominance of four to five tiers, higher deductibles and higher copays or coinsurance levels compared to commercial benefits.
Shire pays $56-million fine to resolve improper ADHD marketing claims; FDA updates Chantix labeling to reflect new safety studies; GSK names new chairman.
Two FDA guidance documents on how health product manufacturers may participate in social media have each drawn criticism from affected industry and consumer groups.
MyStar Connect—available in Europe—translates glucose readings into actionable graphics.
The all-cash deal gives Acorda access to an experimental inhaled Parkinson's treatment that is meant to help patients when medication levels dip and symptoms surface.
Final guidance will float in around January, but the news puts Janssen and AbbVie on notice.
The reason: opioids.
Lightbulb company Royal Philips is swapping its heritage for the consumer healthcare business.
Pfizer tries to acquire Actavis; PhRMA says FDA social media rules are bad for consumers; US diabetes rates begin to slow.
The Treasury announced Monday it would eliminate certain techniques companies use to facilitate so-called tax inversions, which a number of drug companies have undertaken in the past six months.
The drugmaker says the Phase-I monoclonal antibody has three distinct mechanisms of action.
The Office of the Inspector General says more needs to be done to keep Medicare patients from using the discount cards.
Treasury Department takes action against corporate tax inversions; CDC pegs Ebola worst case scenario at 1.4 million infected by new year; NIH allocates $10 million in grants to increase female clinical trials.
The Office of Prescription Drug Promotion took aim at Cipher Pharmaceuticals and its marketer Kowa, in an Untitled Letter over an e-mail alert making what it said were unsubstantiated assertions.
The bill proposes fining branded drugmakers for not complying.
The Chesterbrook, PA, drug manufacturer announced Monday Endo's unsolicited $2.2-billion bid undervalued the company.
GSK releases polio-infected water into Lasne River in Belgium; House reps Burgess and Schwartz introduce CME exemption bill for Sunshine Act; NIH and FDA announce plan to create facebook-esque catalogue of oral-drugs.
Lilly's weekly GLP-1 shot is approved, BI expands its lung-cancer portfolio, GSK's China investigation closes, NY proposed Sovaldi triage and India imposed price limits on 36 new medicines.
An FDA advisory panel voted overwhelmingly against the use of testosterone-replacement drugs for "low-T" Wednesday, saying the label should narrow and that more safety information is needed.
The drugstore chain has lowered its forecast, and generics are just one reason.
Plans to unwind the Suffern, NY, site move forward this winter.
Merck unveiled the DPP-IV clinical trial results at the European Association for the Study of Diabetes Annual meeting Thursday.
FDA panel votes overwhelmingly against Low-T drugs; Stenda approved for fast-acting ED treatment; and Bayer hones life-sci focus, spins off material sciences business.
A mélange of new treatments awaiting approval and a lack of patient support are driving down drug utilization for Gilead's HCV blockbuster, according to a new study.
Endo's timing also comes as Auxilium has committed to reorganizing and merging with Canada's QLT.
The Department of Justice is looking into Medicaid pricing.
Switzerland is pushing Roche to lower its prices on Perjeta
HealthKit off to a bumpy start; Endo offers $2.2 billion for Auxilium; Gilead advanced pancreatic cancer drug fails in trial.
Keytruda was the first of the new PD-1 class of immuno-oncology drugs to reach the US, but Bristol-Myers Squibb and Ono could run away with the competition, according to one analyst.
Analysts do not expect odanacatib to be a major earner.
The designation is for diabetic retinopathy for patients with diabetic macular edema.
NY's attorney general alleges that a formulation switch is an attempt to create monopoly.
Allergan inches closer to Valeant takeover; Mylan trials underway for Lantus biosimilar and generic Advair; FDA advisers to make decision tomorrow on whether testosterone products are being prescribed correctly and if the drugs' label merits change.
Phase-III results of the AbbVie-Biogen Idec experimental multiple sclerosis shot Zinbryta (daclizumab) indicate the drug bests Avonex (interferon beta-1a) on some measures among relapse-remitting MS patients.
Takeda's Director of Obesity Marketing Katie Andino told MM&M in a phone interview that the drugmaker will be taking a unique approach to woo patients, physicians and payers.
The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.
Hires and promotions for manufacturers, regulatory and agencies
Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.
To find stability, children's hospitals must offer value to today's more empowered healthcare consumers. This requires building strong relationships with moms—specifically millennial moms.
Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.
An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are expected to ship in 2015.
Stream Health, WPP's "unconference" which took place in Florida earlier this week, provided a diverse and large amount of content in a short amount of time.
With its label extended to the pre-chemo setting, the prostate cancer drug is poised to reach a new group of urologists, and could upend J&J's Zytiga.
Researchers using an experimental test have discovered that the 50% of surveyed diabetics may also have undetected heart muscle damage.
The plan is to bring in-house products to the market as well as through acquisitions.
Healthcare workers seek out health-related information on their own time, and through internet connections other than ones offered by their employers.
The first-in-class PD-1 was approved only last week.
EU grants Lilly/BI Lantus biosimilar approval; FDA approves Contrave weight-loss pill; Republicans take increased NIH funding off the table in Medical Innovation Act.
A series of CME initiatives, funded by Mallinckrodt, is designed to change opioid prescribing behavior.
A Centers for Disease Control and Prevention report indicates that following basic childhood care and prevention guidelines could catch health concerns before they become health problems that require costly medical services later in life.
The $225-million deal will give Mylan one of two generics for the deep vein thrombosis drug.
The Milbank Quarterly has published a study that may put Sunshine skeptics on edge.
The impact health monitors have on consumer habits and on patient-physician relationships has yet to be quantified.
A US investigation into GlaxoSmithKline has stirred up internal paperwork that the UK drugmaker was looking into compliance violations in its consumer division in 2012.
Auxilium slashes headcount by 30%; poll finds majority of voters support action against tax inversions; FDA panel votes 6-4 against Actavis-backed blood-pressure pill.
The FTC is suing AbbVie and two other firms in a pay-for-delay case that could have wider implications for pharma
The London healthcare brand and research agency will be part of Omnicom's DAS Group.
The new site, which includes professional resources on diabetes, debuted online and in app form today.
An FDA advisory panel will consider evidence supporting a weight-loss indication Thursday.
The media company has added managed-markets expertise to its roster, bringing on the former head of IMS Health's global payer/provider division.
Mayo Clinic is reported to partner with Apple's iWatch for remote patient outreach; FTC sues AbbVie and Teva over pay for delay; JAMA study concludes that drugs given to patients with advanced dementia are not worth the price.
Manufacturer, agency and consulting hires and promotions
The company said in a statement that the findings indicated the Spiriva-Striverdi combination treatment could help patients "return to a more independent life."
Thomson Reuters finds the pharmaceutical industry is getting better at abandoning failures earlier.
BMS files patent suit over Merck's Keytruda; Purdue says reformulated Oxycontin curtails abuse; Lilly sues CMS over Alzheimer's disease diagnostic agent.
What's happening in the pharmacy business is a study in leadership, with important lessons for pharma
Gilead in talks to license Sovaldi in several countries, CMS gets over 800 comments requesting CME exemption, pharmacist tied to meningitis scare is arrested, Keytruda wins approval, RTC rebrands to Wunderman
@Point of Care has integrated IBM's much-touted Watson cognitive technology into its real-time clinical-decision platform
Lilly's long-acting insulin showed it's more effective in type 1 diabetics than Lantus, but concerns about its overall profile persist.
The FDA approved the drug previously known as pembrolizumab, now known as Keytruda, for patients with unresectable or metastatic melanoma who have taken Bristol-Myers Squibb's Yervoy (ipilimumab).
The numbers folks at the Centers for Medicare and Medicaid Services anticipate sluggish growth in US healthcare spend, but prescriptions look ready to take off.
The latest data shows an overall widening of the US.
Bloomberg reports that India's Wockhardt has become an M&A target.
Pfizer will sell two Novartis drugs in the UK.
PD-1 inhibitor launches in Japan with a lofty price tag; more Zohydro pushback; J&J developing Ebola vaccine.
Brown has stepped down as general manager of the IPG network to lead the GuideMark Health agencies as CEO.
Google's independent biotech announced today it will enlist AbbVie in its mission to cure death.
The $310,000 price for the Gaucher disease medication is typical of the rare-disease category.
Parent company CVS Caremark is changing its name to better reflect "its broader health care commitment."
Sales reps are among the pinked-slipped in Spain.
AbbVie inks agreement for oncology asset; largest single day med device recall on record; US appeals court revives Botox improper labeling/marketing case.
The new PCSK9 class of cholesterol-lowering antibodies continues to look promising, but many doctors—particularly PCPs—have never even heard of the experimental drugs.
The FDA froze the clinical trial of anti-Fzd7 vantictumab in July over concern about "bone-related adverse events."
Baylor College of Medicine researchers have found that an estrogen replacement suppressed binge-eating behavior among lab mice.
Key opinion leaders indicate they are ready to embrace Novartis's experimental heart failure medication LCZ696. Such a move could upend heart failure treatment protocols.
Sanofi and Regeneron unveil Phase-III results of their PCSK9; Merck will present data on its anti-PD-1 at the end of this month; WSJ op/ed suggests US should lead fight against Ebola; Novo Nordisk kills inflammatory business unit to shift resources to diabetes and obesity; generics firm Cipla could stand to gain from Advair patent expiry.
Takeda closes out a good-news, bad-news kind of week, AstraZeneca adds a new clinical trial for its experimental PD-1, and researchers link a funeral to the Ebola outbreak.
With wearable technology, digital health has moved past content we can search, share and engage with to something far more personal—defining ourselves as the data that we track, analyze and share.
Click the above link to access the complete Digital Edition of the September 2014 issue of MM&M, with all text, charts and pictures.
Agencies must generate emotional resonance with the target audience, not unlike Apple, Pepsi or Nike
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