Research & Development

FDA wants more info on Acura pain drug

FDA wants more info on Acura pain drug

By

FDA feedback will influence a new clinical trial design, but the regulator's recent reaction was a bit of a surprise.

Prosena gets nonprofit boost

CureDuchenne is giving biotech Prosena $7 million to help its Duchenne Muscular Dystrophy treatment move along.

Study finds researchers are social-media shy

Study finds researchers are social-media shy

By

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.

Novartis dials down RNA research

The drugmaker says the therapeutic approach has a narrow treatment potential.

Lilly's ramu' has squamous, non-squamous potential

Lilly's ramu' has squamous, non-squamous potential

By

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.

Big Pharma puts $250M towards disease collaboration

Ten pharma companies will share money and biomarker research under an NIH collaboration.

AstraZeneca closes India R&D shop

168 employees will be pink-slipped this quarter.

Regeneron doubles up on genetics

Regeneron doubles up on genetics

By

The company known for Eylea has launched a genetics discovery unit and teamed up with a partner to sequence 100,000 patient genomes.

Amgen bone-builder bests older meds: trial

Amgen bone-builder bests older meds: trial

By

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.

Merck moving to regional R&D hubs: WSJ

The move is designed to help the drugmaker pursue more external transactions to bulk up its product line.

Patients sound off on helping pharma find new molecules

Patients sound off on helping pharma find new molecules

By

A recent poll shows a strong desire among web-savvy patients to play a more active role in medical research.

BMS narrows its R&D focus

BMS narrows its R&D focus

By

The company's pursuit of a tighter research focus follows a path very much like that of its peers.

Flavor of the week: antibiotics

AstraZeneca and Roche strike antibiotic deals.

Astellas inks neurodegenerative collaboration deal

Monday's announcement builds on a stream of recent R&D relationships.

Shutdown dims lights at FDA, NIH and CDC

Shutdown dims lights at FDA, NIH and CDC

By

The midnight shutdown put 800,000 government employees on leave, including those at the FDA, NIH and CDC.

Business briefs: GlaxoSmithKline and Spectrum

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.

The complexity of cracking open the data door

The complexity of cracking open the data door

By

Companies are moving toward more access to clinical trial data. Despite their new stance, the internal battles haven't quite ended, some say.

Merck braces for revenue shortfall amid patent losses

By

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.

Amyvid tracer figures in Lilly's latest solanezumab trial

By

The drug maker's third round of testing will focus on mild Alzheimer's patients. Candidates must test positive for beta amyloid.

Business briefs: GSK, Incyte, Pfizer, plus EU's R&D hike

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.

Business briefs: Gilead, Bristol-Myers Squibb and GlaxoSmithKline

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.

Business briefs: Astellas, ADA, AJMC, AARP

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.

Business briefs: Medtronic, AMA, Komen, GSK, Lilly, AZN

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

R&D chief's spring-cleaning sweeps through Merck labs

By

Roger Perlmutter has begun to trim the fat off Merck's lackluster pipeline.

Novartis readying 2014 filing for lung cancer drug

Novartis readying 2014 filing for lung cancer drug

By

Novartis is advancing its "breakthrough" lung cancer drug into Phase III based on promising Phase I data.

GSK gets 2 cancer pills approved, but a deeper question is left unanswered

GSK gets 2 cancer pills approved, but a deeper question is left unanswered

By

GSK's newest cancer approvals highlight a problem that stalks progress with personalized medicines.

Business Briefs: Merck and Forest Labs

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.

US awards GSK $200M to fight "superbugs"

By

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.

Astellas shutters OSI and Perseid, lets 200 US staff go in R&D reorg

Astellas shutters OSI and Perseid, lets 200 US staff go in R&D reorg

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.

BMS scores "breakthrough" label for hep. C candidate

By

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.

Email Newsletters