FDA issued a complete response letter on daclatasvir.
United Healthcare's Baby Blocks app seeks to become all-in-one hub for expectant moms and their babies.
An advisory panel voted against adding warnings to steroid injection labels.
The agency sent a Warning Letter to three marketers over their use of metatags in search engine marketing tactics.
Tecfidera gets label change; Amgen and AstraZeneca report psoriasis Phase-III antibody results; JAMA study reinforces statin guidelines.
Encouraging competitors to take an artistic approach to "Breathless Moments," the competition is a first for Bayer, which is already working on next year's effort.
The scientist is also banned from receiving federal funding.
The German firm positions to focus on pharma pipeline and animal health.
Onexton is a first-and-only drug combination for treating acne.
AstraZeneca and Ranbaxy pay-for-delay case marches on; FDA extends Novartis multiple myeloma Priority Review timeline; Endo pays $25 for testosterone nasal gel.
Complementary solutions to drive growth with health plans as well as pharma clients, companies say.
The Center for Drug Evaluation and Research's director says there is a need for new opioids and cuts off dosing comparisons between extended-release and immediate-release opioids.
The north-of-the-border solution comes amid climbing heroin abuse in the US.
The reason: coordination and effectiveness.
BioMarin to acquire Dutch biotech Prosensa; Woodcock says significant efficacy key to Breakthrough Therapy designation; Stryker considers $16 billion bid for UK devicemaker Smith and Nephew.
EMA revises its conflict of interest policy; AbbVie all-oral HCV combo drug receives positive EU recommendation; Merck may help NewLink Genetics scale production of its Ebola vaccine.
In a company-hosted seminar today, the Paris-based drugmaker gave investors a preview of the future of its diabetes franchise.
The first approved hydrocodone formulated to discourage misuse raises a challenge to controversial Zohydro.
The IMS Institute for Healthcare Informatics notes that developed markets remain a key driver.
CRS asks if high prices are a tool to offset CMS rebates, the FDA adds another DTC study to its lineup, and the NIH proposes making more clinical trial data public.
With the purchase of Olson Communications, the agency aims to serve clients eager for expertise from outside the healthcare industry.
Drug makers favor big spending on speakers' events and doctor outreach.
The scoop means the maker of HCV drugs Harvoni and Sovaldi can give any drug an accelerated review time.
Sanofi vets Takeda, devicemaker CEO candidates; Shaq returns for IcyHot; Royalty Pharma buys royalties on Vertex's Kalydeco.
Results of two post-market studies, conducted in part by Boehringer Ingelheim, corroborate the billion-dollar blood thinner's benefit/risk profile.
Researchers say the average cost of bringing a drug from concept to approval, and through post-approval assessments for reasons such as new doses or formulations, hovers at around $2.8 billion per drug in 2013 dollars.
A head-to-head comparison between Sanofi and Regeneron's experimental PCSK9 shows alirocumab lowers LDL levels more effectively than Merck's Zetia, which is part of the just-acquitted Vytorin.
As generic drug use soars, the agency intends to "create parity" in label-change rules for brands and generics.
A pipeline drug from Novartis has the potential to alter the progression of heart disease and keep patients out of the hospital.
Ackman walks away with $2.5 billion, despite no Allergan deal; Ranbaxy sues FDA over generic Nexium rights; Indian government's Health Ministry recommends breaking BMS cancer drug patent.
Patients taking Vytorin experienced a 6.4% reduced relative risk for cardiovascular events, the company said.
A trio of doctors make a case for putting limits on digital promotions, including those in EHRs and through social networks.
A US Senate bill would also make treatments for the disease eligible for priority review vouchers.
The Pennsylvania company says it will continue to develop its IO treatment, even without Roche's support.
Actavis and Allergan have a $66-billion-dollar deal, Merck's Vytorin hits its endpoint, and Pfizer puts up $850 million for an experimental cancer drug.
Pfizer reportedly not interested in acquiring AZ; high deductible plans set to envelop healthcare insurance exchanges; GSK's mature drug portfolio finds a wholesale suitor.
Despite hurdles of practitioner buy-in and legacy IT, value-based care is on pace to overtake fee-for-service.
The Healthcare Women's Business Association's new look comes with a side of new programming in an effort to reach more women in more places.
Valeant's war for Allergan also includes a soft touch when it comes to doctors: the WSJ reports that the company is winning over professionals with trips and consulting offers.
A 4-1BB agonist highlights a discussion with analysts on the drug giant's immunoncology pipeline, with a number of combination options to be tested next year.
Actavis and Allergan are close to a deal in the $60-billionish range; AstraZeneca is working on a Brilinta antidote; scientists find what amounts to a naturally occurring version of Merck's Zetia.
Researchers studying the distribution of brick-and-mortar pharmacies in Chicago link adherence issues with geographic barriers to care.
The industry-supported group WomenHeart launched a heart failure awareness campaign Wednesday, as well as a push for gender-specific research.
In a $1 billion deal, Servier will develop and market Intarcia Therapeutics' implantable device in markets outside the US and Japan.
An arduous reimbursement process has put a damper on how quickly patients can receive the drug, say analysts, citing KOLs.
Life expectancy for patients cured of advanced HCV similar to healthy peers: study; Ackman takes a $2 billion stake in animal drugmaker Zoetis; Amgen and AstraZeneca report that brodalumab bested Stelara in psoriasis head-to-head.
Category news shows that marketing to the obese may mean marketing to related conditions.
An SEC filing by Merck suggests results of long awaited trial are favorable but come too late to have a commercial impact on sales of Vytorin and Zetia.
Transitional pass-through reimbursement status clears way for commercialization.
The CBO projected 13 million enrolled in 2015, but its projections were based before final 2014 numbers were in.
FDA will evaluate effect of pharma commercial barrage; Pfizer settles Neurontin marketing lawsuit for $321 million; AbbVie and Gilead release top-line results on HCV combo therapies.
A Merck hep. C regimen that included two of its own agents paired with Gilead's Sovaldi faltered in four- and six-week regimens, according to analysts, leading to questions about the drugmaker's HCV prospects
Testing has already started abroad, and Boehringer says this is the first clinical trial that tests an antidote among patients taking a new oral anticoagulant.
The deal will cap the monthly price some patients may pay for medications such as Atripla.
Patients will now be able to compare plans and identify ones that have disease-specific programs.
Dendreon goes Chapter 11; Mylan and Disney agree to EpiPen promotions; FDA pulls Ranbaxy generic claims for Nexium and Valcyte.
Woodcock says opioids without abuse-deterrent features are here to stay; UCB sells generic drug business to Advent and Avista; new antibiotic-free drug eradicates MRSA.
The Office of Prescription Drug Promotion took aim at a professional sales aid for Sciecure's insomnia drug Doral, saying the brochure omits risk info, material facts and makes unsubstantiated superiority claims.
The company raised guidance for the end of the year and said Ranbaxy's being bounced from the Nexium competition probably means it has esomeprazole market to itself through 2014.
A medical device from Aethlon, used on an Ebola patient with multiple organ failure, was associated with promising results.
An app that times chest compressions and prompts paramedics to administer medications won top prize at the Emergency Medicine Hackathon.
Eli Lilly's Cyramza approved for stomach and esophageal cancer; hedge fund may sue AbbVie for failed Shire acquisition; J&J's Olysio approved for use with Sovaldi.
Developing exclusive features from proven generics is a growing opportunity for patients as much as it is a ploy for life-cycle extension.
The Centers for Disease Control and Prevention says 11.4% of women are still not screened for cervical cancer.
Forrester Research says broadcast and TV will lose out to interactive marketing by 2019.
Researchers find that jet lag has an impact on the microscopic level.
The Hill outlines its healthcare expectations with a GOP Congress, Sanofi's executive shakeup may have an impact on MannKind's Afrezza launch, AstraZeneca's olaparib may have prostate cancer prospects, the FDA granted orphan status to an experimental Merrimack pancreatic cancer drug, and researchers are struggling to get Ebola virus samples.
CMS redefined the Sunshine CME exemption, still allowing most payments to go unreported.
Craig Sullivan is tapped to take over as president upon Abbate's retirement at the end of the year.
The two drugmakers have failed to reach an agreement.
The Austin agency says it beat out FCB, Ogilvy CommonHealth, GSW Worldwide and H4B Chelsea for the work.
The new language is in response to a 2011 citizen's petition.
For example: Tufts Center for the Study of Drug Development reseachers say it takes 18% longer to develop CNS drugs than it does non-CNS drugs.
AstraZeneca, Pharmacyclics and Janssen collab on Imbruvica; BMS to test HCV prices; WHO director general takes aim at pharma over lack of Ebola treatments.
An FDA study of Medicare patients found that patients who took Pradaxa showed a reduced risk of stroke and brain hemorrhage.
According to a survey, general practitioners are against new NHS guidelines on prescribing statins.
The new PDR significantly increases access to the EHR/EMR channel for reaching prescribers with the right message at right time.
Although sales have not skyrocketed, Arena and PBM Express Scripts have seen demand for prescription weight-loss medications rise, and researchers at The Obesity Society find the majority of weight-loss intervention candidates are eligible for prescription weight-loss medications.
Bayer Consumer consolidates agency business; Publicis offers $3.7 billion for Sapient; Boehringer Ingelheim signs option deal for fatal lung disease drug.
Bristol-Myers Squibb's Opdivo improves survival rate in lung cancer patients; Businessweek says new Viagra spot targets a younger audience; NIH launches database to keep track of different countries' clinical trial regulations
Cleveland Clinic releases their annual list of highly promising innovations.
Public Citizen tells FDA it should withdraw draft guidance that it believes will allow drugmakers to tell physicians marketed drugs are less risky than their labels indicate.
Orphan drug growth will easily outpace non-orphans through 2020.
Sanofi courts AstraZeneca CEO Soriot; Teva CEO optimistic on Copaxone patent ruling; AstraZeneca scores approval of diabetes combo drug.
The country's drug ministry has identified drugs as an area for savings.
The company unveils a plan for deploying controllable nanoparticles into peoples' bodies for monitoring health conditions.
Herper writes that Sanofi—without Viehbacher—is at risk of moving too slowly in an increasingly competitive industry.
Widely used plastics such as PET will have to be replaced with more costly glass containers.
The former FDA director of medical device compliance has petitioned the agency to make oral contraceptives over-the-counter.
Sanofi CEO fired; Sovaldi sales slow; Ranbaxy CEO affirms generic Nexium rights.
Despite the Treasury's crackdown on inversions, CEO Ian Read says they would still invert for the right deal.
The drugmaker plans to cut 600-1,100 jobs next year.
Sanofi is expected to slash prices of its diabetes products to retain US market access.
With Ranbaxy's failure to launch a low-cost version of the acid reflux drug, pressure is mounting on FDA to speed a generic to market.
Sanofi CEO says diabetes sales will slow in 2015; Takeda/Lilly Actos settlement slashed by 99%; study says Sovaldi is cost-effective for prisoners.
The editorial team of MM&M announces a call for nominations for its first-ever compilation of the Top 40 Healthcare Transformers.
The drug is now expected to be filed by mid-2015, rather than by year's end.
The new initiative will look to recruit a teenager with epilepsy to appear in the next iteration of its educational comic book series.
The drugmaker's pharma sales fell by 4%, even as Merck's Keytruda cancer darling received another Breakthrough Therapy designation.
Study shows Xarelto.com is top branded website among PCPs; Janssen launches IBD educational campaign; Merck's Keytruda scores Breakthrough Therapy designation in lung cancer.
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