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 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.
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.
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.
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.
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.
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.
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 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.
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.
The Centers for Disease Control and Prevention says 11.4% of women are still not screened for cervical cancer.
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.
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.
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.
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
Sanofi courts AstraZeneca CEO Soriot; Teva CEO optimistic on Copaxone patent ruling; AstraZeneca scores approval of diabetes combo drug.
Herper writes that Sanofi—without Viehbacher—is at risk of moving too slowly in an increasingly competitive industry.
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 drug is now expected to be filed by mid-2015, rather than by year's end.
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.
Ebola comes to NY; AstraZeneca drops antibiotics; FDA approves hemophilia A drug.
Cymbalta and Evista patent losses drove down sales, but Lilly said it does not plan to replenish the sales force it thinned in anticipation of the decline.
The antipsychotic's hold on the market has been steady, despite generics of drugs such as AstraZeneca's Seroquel.
Researchers say the iPad app could help assess vision loss.
FDA panel endorses Novartis psoriasis drug; court rules with Pfizer on cancer drug patent; drugmakers may look for indemnity against losses from Ebola vaccines.
Despite strong performance by its MS therapies, the drugmaker's robust third-quarter sales were overshadowed by the death of a patient taking Tecfidera.The patient had a rare brain infection.
GlaxoSmithKline's third-quarter sales fell 10% for the quarter, compared to last year, and new Ellipta products failed to cushion the 24% drop in US Advair sales.
Canada's National Microbiology Laboratory developed the vaccine, which has been licensed to NewLink Genetics Corp.
Bloomberg reports that the race to merge with Omega also includes privately-held Boehringer Ingelheim and Perrigo.
Sen. Bernard Sanders (I-VT) could hold a hearing after midterm elections to discuss the impact of costly new HCV treatments on the US Department of Veterans' Affairs.
The Post X-er, Post-Boomer generation considers traditional healthcare "sick care."
Shire bows out of AbbVie acquisition; CVS's PBM will charge premium for consumers who fill scripts at tobacco-selling pharmacies; Reckitt Beckinser will rebrand following demerger.
Preliminary Phase-II data suggest remission rates among patients taking the drug were significantly better than those for subjects on current treatments.
Takeda and Orexigen's prescription weight-loss drug Contrave has hit the market with a wraparound patient support system.
Valeant indicated in its third-quarter earnings call that it expects to increase its bid for Allergan.
Amgen sues Sanofi and Regeneron over PCSK9 patents; FDA panel wants Chantix black box to stay; Valeant-Allergan uproar rises in pitch; Pharmacyclics and Roche team up against CLL; and GSK's Ebola vax may "miss" the current crisis.
AbbVie's board is encouraging shareholders to kill the Shire acquisition, and analysts say a breakup would still leave Shire in a strong position.
Pre-review documents indicate a favorable opinion of the IL-17 inhibitor secukinumab.
Resignations stymied the Office of Pharmaceutical Quality's beginning.
AbbVie board recommends against Shire deal; consultancy says Netherland's generic bias hampers branded drug sales; Genentech and BI score FDA approval for fatal lung disease.
AbbVie is thinking about modifying or walking away from its offer to buy Dublin's Shire. A breakup would cost the Illinois company over $1.6 billion.
The drugmaker is offering Scotland's NHS a money-back guarantee for Olysio patients.
A draft guidance publication date determines whether drugmakers get three or five years of market exclusivity.
Jilted Salix acquisition target Cosmo Pharmaceutical is headed for the Emerald Isle.
AbbVie's board to reconsider Shire move; docs warm up to ACA; Eisai orphan thyroid cancer drug receives Priority Review.
Hepatitis C medication Olysio contributed to the the 18% bump in Johnson & Johnson's third-quarter sales, but Gilead's new drug may diminish J&J's potential.
The FDA will vote for or against the breast cancer drug by April 13, 2015.
The regimen's anticipated average price of $80,000 is expected to determine how competitors stay competitive.
Ireland plans on closing off a tax advantage but pharma does not appear to flinch.
BMS, Janssen and Pharmacyclics to test Opdivo/Imbruvica pairing; Google's latest health experiment will connect docs and patients over video-conferencing Hangouts tool; Five Ranbaxy execs resign after generics firm was acquired by Sun.
The sofosbuvir-ledipasvir combo is expected to run the average genotype 1 patient $80,000.
Solutions for how to handle specialty medication costs are lacking, but the data around them shows a need for serious problem-solving.
The company is working with the FDA on new clinical trial requirements.
Endo to acquire Auxilium for an estimated $2.6bn; Novartis says good-bye to three execs; NIH opens wallet for rare disease research; CMS's Open Payments show financial disparity between men and women; Clarient and GSK collaborate in cancer testing.
The company says ABP 510 hit its primary endpoint in an adalimumab comparison.
In short: more antibotic prescriptions are written in the afternoon than in the morning.
The US Preventive Services Task Force wants adults at risk for type 2 diabetes to get tested.
Two cardiology associations advise prescribing Brilinta over Plavix for management of acute chest pain without electrocardiogram changes.
The drugmaker is poised to cut 14 pipeline projects loose.
Cigna said found paying for medications and hospitalizations were top healthcare concerns.
Genentech's decision to pare access to three breast cancer drugs has spurred hospitals to take action.
Two regulatory agencies have rejected the drug, but analysts indicate the pipeline acute heart failure treatment could have limited market success.
An analyst says the $12.2B deal creates a one-stop shopping experience for hospitals.
Novartis BMS collaboration to evaluate Opdivo paired with three lung cancer treatments; Forbes weighs in on 60 Minutes segment; Sanofi management disagreements delay established drug portfolio sale; FDA sets price for Rare Pediatric Disease Priority Review vouchers; the GPhA challenges lawmakers' misconceptions of generic drug prices.
Salix-Cosmo tax-inversion deal quashed, chronic heart failure market set to expand, rising generic drug prices get lawmakers' attention, NICE gives leukemia drug a thumbs-down, FDA has a good rep
Eli Lilly said it discontinued tabalumab, a drug being tested in Phase-III trials for lupus, after it failed to outperform the standard of care.