FDA solicits public comment to study online character space limit; Biogen's Spinraza shows positive results in SMA study; Valeant cuts earnings forecast
Jeanne Martel, president and partner at ClinicalMind, highlights her company's vision and role in communication and technology with MM&M's Jaimy Lee. This video was sponsored by ClinicalMind.
Certain insulins are comparable; Public Citizen criticizes Cures provision on orphan-drug exclusivity; the FDA approves Kanuma
Aggressive treatment of blood pressure reduces deaths; AstraZeneca's experimental lupus drug cut disease activity in trial; Sophiris Bio reports results for enlarged prostate drug
GSK partners with other drugmakers to bolster pipeline; Pfizer makes deal in South Africa for Prevnar 13; the FDA issues guidance on HIV biologic development
Therapy and low-dose drugs found to aid schizophrenia patients more than just antipsychotics; Clinton calls for investigations into drug price increases; Bayer issues RFP for AOR for consumer care brands
Longtime ICC leader Viviano moves to the client side to help the start-up build its marketing team and become a commercial contender.
Sprout's controversial sexual-desire drug receives FDA approval; prescription-drug coverage impacts cash sales at Walmart; Mylan warned about manufacturing violations
Biogen to map ALS genes with Ice Bucket Challenge funds; Merck seeks first-line indication for Keytruda; lawmaker criticizes FDA approval of OxyContin for children
"Me-too" drugs may help lower costs; start-ups send doctors to your home; the FDA is likely to appeal the Amarin ruling
Genetic protein PD-L1 could have potential as a biomarker for a first-line treatment.
Physicians will be notified when patient care is not meeting national guidelines for COPD and asthma.
New data suggest Amgen's PCSK9 may reduce risks of heart attacks, Salix bidding is war too rich for Endo's blood, Actavis bipolar drug use is expanded to 10- to 17-year-olds.
Novartis CEO says cost cutting is looming; Novo Nordisk presents new Saxenda weight-loss data; FDA approves Astellas Pharma's antifungal drug.
The drugmakers will explore combinations of Merck's Keytruda and Eisai's Lenvima and Halaven to treat certain cancers.
The organization plans to publish a scientific and a lay abstract detailing study findings
Genentech Parkinson med encounters preliminary safety issues; Cigna gives Gilead's Harvoni preferred status over AbbVie's Viekira Pak; Valeant proposes $400 million bid to buy bankrupt Dendreon.
One in three adults would rather not take a pill and have a shorter life span; Pfizer's next-gen breast-cancer drug nabs an early approval; Amgen's Humira biosimilar demonstrates clinical equivalence.
Pharma ad budgets are growing, says IPG; Medical device tax debate rages on; Pfizer has PCSK9 pill in the works.
Prime Therapeutics gives Gilead's Harvoni and AbbVie's Viekira Pak preferred formulary status; Novartis and Qualcomm team up for new investment firm; UK cost watchdog axes cancer drug coverage.
BMS halts cancer drug trial over positive Phase-III results; Shire has acquired NPS Pharmaceuticals for $5.2 billion; 23andMe expands Pfizer agreement.
AbbVie announced positive interim Phase-III results Thursday for its endometriosis drug elagolix, but one analyst says its commercial impact is likely linked to its effect on patients' bone mineral density.
The company moves on three leading contenders in the muscular dystrophy segment with the start of a Phase II trial
An investigational JAK inhibitor, baricitinib, bested placebo in moderate to severe plaque psoriasis in a Phase-III trial.
CureClick, TrialReach and WEGO team to leverage health communities and speed trial recruitment.
Amgen's Blincyto was approved for a rare form of leukemia after receiving Breakthrough Therapy designation and a Priority Review.
The drugmaker inked a deal with Zosano worth up to $440 million for the product, which is about to enter Phase-III in clinical trials.
Novartis released Phase-III study results Monday.
The north-of-the-border solution comes amid climbing heroin abuse in the US.
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.
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.
Results of two post-market studies, conducted in part by Boehringer Ingelheim, corroborate the billion-dollar blood thinner's benefit/risk profile.
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.
Merck said in November that a long-running clinical trial finally demonstrated the impact of its Zetia cholesterol-lowering treatment on cardiovascular outcomes.
The Pennsylvania company says it will continue to develop its IO treatment, even without Roche's support.
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.
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.
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.
Canada's National Microbiology Laboratory developed the vaccine, which has been licensed to NewLink Genetics Corp.
Merck unveiled the DPP-IV clinical trial results at the European Association for the Study of Diabetes Annual meeting Thursday.
Analysts do not expect odanacatib to be a major earner.
The company said in a statement that the findings indicated the Spiriva-Striverdi combination treatment could help patients "return to a more independent life."
Lilly's long-acting insulin showed it's more effective in type 1 diabetics than Lantus, but concerns about its overall profile persist.
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.
Phase-III tests indicate Lilly's experimental treatment bests Amgen's for moderate-to-severe plaque psoriasis.
Phase-III tests indicate patients may be able to switch from injectable enzyme-replacement therapies, like Fabrazyme, to the firm's oral drug.
AstraZeneca announced the end of the investigation Tuesday.
Amgen now hopes a separate study will be enough to support the drug's advancement to a second-line therapy, but the lackluster results may impinge on its EU filing schedule.
Blood-cancer drug Kyprolis outperformed standard treatment in a late-stage trial testing the drug in patients with multiple myeloma, said Amgen.
The company is calling the move a withdrawal, as opposed to a recall.
The Wall Street Journal reports that patients are sharing a plethora of information about their clinical trial experiences, from how to get picked, to how to figure out who is in a control group.
A study indicates they may do little to reduce the risk of stroke or heart attack.
The drug did not hit its Phase III primary target of improving progression-free survival.
HPV testing provides an edge over Pap screenings when it comes to detecting cervical cancer risk.
An international AIDS conference this weekend kicked off a new battle in the war against hepatitis C: demonstrating high cure rates in those who are co-infected.
Novartis and the nonprofit Banner Alzheimer's Institutes are testing a theory that treating healthy patients could prevent or delay Alzheimer's disease.
Cyramza patients had more favorable overall survival rates than placebo patients, but the differences were not statistically significant.
The Wall Street Journal notes that a new study on testosterone therapy has some weaknesses, including its sole focus on men who received injections—leaving out pills, patches and gels.
Editorial says risk is small, researchers say it could be clinically relevant.
The American College of Physicians says most women do not need an annual pelvic exam. The American College of Obstetrics and Gynecologists disagrees.
Allergan's latest pipeline news was a mix of the good and the bad. The good: a potential Lucentis competitor is progressing. The bad: migraine medication Semprana has stalled.
The regulator wants men to be part of breast cancer clinical trials.
An FDA advisory panel voted 11-2 against an accelerated approval for AstraZeneca's experimental PARP inihibitor. The panel recommends getting more data before giving the drug the all-clear.
The firm ended the Phase III trial for its ballyhooed immunotherapy, which showed superior survival compared to chemo in advanced melanoma.
An experimental Gelesis weight-loss drug seeks the middle ground between surgery and appetite suppressants.
Phase III results showing improved lung function among cystic fibrosis patients using a combination of Kalydeco and lumacaftor means drugmaker Vertex is filing the two-part drug for FDA approval during the fourth quarter.
BI says there is no unmet need for faldaprevir.
GlaxoSmithKline dismissed a marketer over its approach to clinical trial recruiting.
Gene mutations lead researchers to rethink ways to protect the heart.
Researchers are increasingly using social media to recruit patients, albeit oftentimes in an arms-length manner.
The drugmaker has told global regulators it failed to share 10,000 reported cases of side effects for a variety of its drugs.
Patients taking a high-dose form of Novo Nordisk diabetes drug Victoza saw an average weight loss of 5.9% of their body weight, data from a study show.
Researchers find worries about being misunderstood or mixed in with "junk" news are among the reasons academic researchers are keeping their data points out of the social media swirl. Researchers say this fear is at the expense of a faster way to make an impact on public policy.
The FDA granted the label for Genentech's experimental metastatic urothelial bladder cancer treatment.
The potential of immunotherapy is great, but the news from the 2014 medical meeting shows that great may not be gargantuan in terms of treatment reach.
The CDC said Thursday that most of the 288 recent US measles cases were caused by un-vaccinated travelers who brought the virus home with them.
The regulator is allocating almost $38 million to improve data-guided decision-making.
The drugmaker is set to start patient testing.
The companies announced Tuesday that Arzerra, already indicated for leukemia, failed to outdo Roche's Rituxan in the lymphoma setting.
The Securities and Exchange Commission alleges that two doctors illegally exploited their clinical trial affiliation for financial gain.
Both companies revealed Phase-III data for idiopathic pulmonary fibrosis treatments. The progressive disease generally kills patients within three years of diagnosis.
Gelesis is pouring money into its obesity "smart pill," and Novo reports weighty success among subjects taking liraglutide.
The National Institutes of Health wants female lab animals to be part of the animal testing mix.
The drugmaker announced Wednesday that researchers would be able to access clinical trial data.
GlaxoSmithKline announced Tuesday its Phase-III drug from the Human Genome Sciences acquisition failed to hit its primary endpoint.
Phase-III results for Eli Lilly basal insulin peglispro showed superior blood sugar reduction vs. Sanofi's Lantus in trials, but a number of safety issues could hurt its appeal.
The company announced Monday that researchers will be able to seek out clinical trial data going back to 1998.
FDA warned consumers against using aspirin for primary prevention, following its denial of Bayer's request to allow marketing of aspirin for that use.
According to an analysis of final data from one of the WHI's trials, each dollar received results in a net economic value of $140.
Merrimack Pharma said its candidate for pancreatic cancer increased overall survival, and that it plans to file applications in the US and EU this year.
Two drugmakers, Purdue Pharma and Teva, have abuse-deterrent hydrocodone medications either under FDA review or in late-stage testing.
Panel chair Randall Flick said QRxPharma "had not provided sufficient evidence to support a claim that Moxduo is safer than morphine or oxycodone."
The FDA designation is for an experimental, inhaled form of ciprofloxacin intended to treat a rare lung condition.
The company said it plans to file its rare-disease drug with the FDA later this year, for a 2015 review.
Roche also announced first-quarter sales shrank 1%.