Phase-II results indicate Merck's all-in-one HCV oral could put pressure on Gilead.
The FDA issued an official halt, five days after Halozyme stopped the Phase-II trial because of patient stroke information.
Researchers found a correlation between patients feeling involved and how well they stick—if they stick—to their medication regimens.
Phase-III results prompted the drugmaker to pursue a third-quarter filing.
Researchers find public service announcements and physician information don't change minds, but a California practice found one way it could.
Analysts say the Indianapolis, IN, drugmaker's Phase-I results show CDK 4/6 inhibitors will have a role in breast cancer treatment and that Pfizer's palbociclib will not clear the field.
Sunday's data readout has divided the Street between the enthusiastic and the disappointed. The key reason: progression-free survival gains were not as high as anticipated.
The drugmaker is ceasing a trial called MAGRIT after it was unable to identify patients who could benefit from MAGE-A3.
The drugmaker saw positive results in demonstrating LDL reductions in Japanese patient populations.
Detailed Phase-III results from several PCSK9 candidates confirm the clinical ability of the newest class of cholesterol-lowering treatments.
The drugmaker said successful results prompted an independent Data Monitoring Committee to recommend stopping the trial. The news follows an uneven week of pipeline drug news.
The FDA has approved a 24-hour version of Pfizer's heartburn medication.
A rival's late-stage trial results suggest the pain med may have a short market life. The key: an FDA division head's documented willingness to overturn the approval should another pain option surface.
Pfizer hit its endpoints for preventing pneumonia among the elderly, but the data may not be robust enough to spur vaccination.
Bayer and Amgen's Onyx subsidiary announce an oncology drug failed a Phase-III trial goal among liver cancer patients.
Sanofi and the firm with which it's co-developing alirocumab disclosed that regulators want some patients to be assessed for neurocognitive side effects.
Data presented at a conference yesterday suggest AbbVie's all-oral regimen may be more effective than Gilead's at curing the virus in certain patients, but will it confer an edge?
A study says that more opioid abusers get their medications via prescription than they do second-hand.
Sanofi top-lined positive clinical data today from its investigational basal insulin, as it seeks to defend its position in this fast-growing segment.
The drugmaker says interim trial data meets FDA review requirements and is hoping for June 2014 approval.
New results from its Phase II safety trial show the LDL-cholesterol lowerer was not associated with a major increase in adverse events vs. standard of care.
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.
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.
The drugmaker blasted the price-control agency for being shortsighted and underestimating the industry's role in health and savings.
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.
The FDA told the drugmaker in a letter before the December PDUFA date that evidence does not support an expanded indication.
The AAP says greater access and education are critical in curbing STIs.
The hep. C drug is safe and effective when used in combination with other therapies, according to information posted by FDA reviewers.
Word came of Breakthrough Designation for an HCV hopeful, a day after a hiccup in a heart drug trial.
A report says oncologists may be using GSK's Tafinlar and Mekinist together in a non-FDA approved combination therapy.
Adding Epzicom to Tivicay in a once-daily cocktail could further boost GSK's HIV franchise, and possibly chip away at Atripla's dominance.
On Monday Regeneron reported more positive Ph. III data for its wet AMD/macular edema drug Eylea (aflibercept).
Lantus-like rivals can expect a wary reception from endocrinologists, even if these biosimilars reach market, researchers predict.
The agency says the copycat antidepressant failed to meet bioequivalency requirements.
In schizophrenia, non-compliance can be disastrous. Do depot drugs really make a difference for patients?
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.
The drug maker says a patient's physician did not link the MS drug to her death.
The drug maker says it is accelerating development of new drugs and focusing on expanding indications of current ones.
Recent studies underscore a need for greater engagement in multicultural communities.
Monday's announcement builds on a stream of recent R&D relationships.
A public information request details closed-door meetings in which industry players paid to sit with government employees and talk pain-medication efforts.
Researches say cognitive enhancers, a group which includes drugs like Aricept and Exelon, fail to slow decline in patients with Alzheimer's over the long term.
Eli Lilly is the first Big Pharma to team up with the agency in its rare-disease pre-clinical development program.
GlaxoSmithKline heats up the CLL category with its second breakthrough designation therapy of the year, topped off by priority review for a melanoma combo treatment.
Bristol-Myers Squibb said Thursday that the drug failed to hit its primary goal in a prostate cancer trial, but some analysts say the data is not the last word on its potential in this tumor type.
The advisory panel endorsed the treatment with an 11-2 vote.
The changes, which include tightening prescribing criteria of extended-release and long-acting opioids and a boxed warning for pregnancy, are part of an effort to curb abuse. Some said the FDA's effort is too limited
The experimental LAMA/LABA combination could shake up the category.
Price, market potential and emotional pull make this subcategory of orphan diseases one to watch, an analyst writes. Hint: it's not oncology.
For women suffering from breast cancer, online tools appeared to be helpful in battling depression, a randomized trial showed.
Researchers say a two-year study shows the DPP-IV drug is not linked to a higher cardiovascular risk.
Squeezed in the wet AMD space, Roche could get some eye-care breathing room if it can snag first-to-market status in the dry AMD category. Early results bode well.
Two of the most difficult-to-treat hepatitis C patient groups saw high cure rates in an NIH-led study, results released Tuesday show.
Sales may be rising, but a new study finds current psoriasis therapies leave room for improvement. Over half of patients said they want better options.
Phase II studies found recreational abusers were not significantly bothered by the mechanism meant to make a "deterrent" version unpleasant to snort.
Amgen's newest oncology asset could reach great heights, if the firm can capitalize on its existing commercial and R&D capabilities.
Phase III results of its Crohn's and ulcerative colitis medication show positive patient response in a category among patients who have exhausted other options.
The drug maker scored its third breakthrough designation label, this time for orphan drug bimagrumab, a possible treatment for a muscle-wasting disease.
The FDA approved GlaxoSmithKline's second quadrivalent flu vaccine, but a CVS study indicates that consumers are big fans of the vaccination, as long as they aren't the ones rolling up their sleeves.
The data suggest Boehringer's hep. C combo could find a treatment niche.
Phase III data for MannKind's Afrezza is positive, but past experience shows inhaled insulin may not be an immediate win.
Data show doctors are increasingly leaning on Regeneron's Eylea over Roche's Lucentis, as the two battle for share of the wet-AMD market.
The GSK-Pfizer-Shionogi daily HIV medication gets the regulatory all-clear. The approval could put BMS/Gilead's best-selling daily med Atripla on the defensive.
Phase III results of Eli Lilly lung cancer drug necitumumab took analysts by surprise on two levels: by helping it avoid the dustbin and in succeeding where Erbitux had failed.
Proteus Digital Health's ingestible sensor shows utility as an adherence tool for those on psych meds, a study suggests.
Regeneron says it will seek a diabetes macular edema indication for Eylea this year, potentially encroaching on yet another Lucentis market.
Companies are moving toward more access to clinical trial data. Despite their new stance, the internal battles haven't quite ended, some say.
A report indicates that the FDA is siding with the European Medicines Agency's finding that GLP-1 diabetes medications are not conclusively linked to pancreatic cancer.
While a strong launch of CF drug Kalydeco helped to hike the biotech's forecast, hep. C contender VTX-135 was hit with a partial clinical hold.
The CDC says HPV vaccination rates are not improving. The latest data comes just as a recent report shows the vaccine cannot only help fend off cervical cancer, but throat cancers as well.
The interim results of a Phase III study augur well for use of Roche's Rituxan successor in more than one type of leukemia, one analyst said.
Analysts gave the infusion therapy a warm reception in RA, despite stiff competition in this category.
Elan's strategy: focus on agitation and aggression associated with the disease.
Ranbaxy's ban from US soil has softened the blow for Novartis 2Q sales.
The drug maker can now add five new doses to its generic Opana ER offerings.
FDA's afatinib approval enables the drug maker set up shop in a new therapy space.
The drug maker's third round of testing will focus on mild Alzheimer's patients. Candidates must test positive for beta amyloid.
Janssen submitted an NDA for its cancer hopeful ibrutinib, well ahead of competitors.