FDA feedback will influence a new clinical trial design, but the regulator's recent reaction was a bit of a surprise.
CureDuchenne is giving biotech Prosena $7 million to help its Duchenne Muscular Dystrophy treatment move along.
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 drugmaker says the therapeutic approach has a narrow treatment potential.
The drugmaker was scant on details, but Phase-III ramucirumab results among non-small cell lung cancer patients showed increased overall and progression-free survival vs. placebo.
Ten pharma companies will share money and biomarker research under an NIH collaboration.
168 employees will be pink-slipped this quarter.
The company known for Eylea has launched a genetics discovery unit and teamed up with a partner to sequence 100,000 patient genomes.
Mid-stage data show the drug, romosozumab, was associated with significant increases in bone mineral density compared to Lilly's Forteo and off-patent Fosamax.
The move is designed to help the drugmaker pursue more external transactions to bulk up its product line.
A recent poll shows a strong desire among web-savvy patients to play a more active role in medical research.
The company's pursuit of a tighter research focus follows a path very much like that of its peers.
AstraZeneca and Roche strike antibiotic deals.
Monday's announcement builds on a stream of recent R&D relationships.
The midnight shutdown put 800,000 government employees on leave, including those at the FDA, NIH and CDC.
GSK sees a regulatory setback on its once-weekly GLP-1 med, and Spectrum Pharma gets hit with an untitled letter from OPDP on a sales aid for Zevalin.
Companies are moving toward more access to clinical trial data. Despite their new stance, the internal battles haven't quite ended, some say.
Quarterly sales fell 11% compared to the same period last year. The company plans on weathering a continued flow of patent losses with a narrower R&D focus.
The drug maker's third round of testing will focus on mild Alzheimer's patients. Candidates must test positive for beta amyloid.
China alleges GSK foul play; a report links Incyte's Jakafi with PML; Pfizer gets a double-dose of good Prevnar news; Europe puts almost $29B toward research.
A two-year study shows Gilead's Quad pill outpaces an older combination drug over two years, and GSK is seeking to expand its oncology presence.
Astellas teams up with Cytokinetics for muscle weakness research; ADA says lifestyle changes don't protect diabetics' hearts; AJMC talks pharmacists as diabetes counselors; and AARP helps with healthcare reform education.
Studies undercut Medtronic spine treatment benefit, AMA wars over obesity classification, Komen gets a new CEO, GSK offloads thrombosis meds, Lilly gains diabetes treatment, AZN chooses new site
Roger Perlmutter has begun to trim the fat off Merck's lackluster pipeline.
Novartis is advancing its "breakthrough" lung cancer drug into Phase III based on promising Phase I data.
GSK's newest cancer approvals highlight a problem that stalks progress with personalized medicines.
Merck's proposed insomnia drug scores a thumbs-up from an FDA advisory panel, and long-time Forest Labs CEO Howard Solomon announces his coming retirement.
GSK and the US Department of Health and Human Services inked a deal to fund development of new antibiotics, an area where clinicians face a dearth of new options.
It was a particularly grim Monday for 200 Astellas employees in the US, who were informed that they were being let go and it was their last day with the company.
The regulatory coup means BMS gets to work with FDA to develop its home-grown hep. C cocktail, which is on a competitive track to another hep. C alliance with Merck.