Clinical Trials: Page 106
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OncoMed hit with another mid-stage failure
The company's shares plummeted further after another Phase 2 trial flopped.
By Jacob Bell • April 17, 2017 -
FDA digests Ritter's mid-stage microbiome data
The drug developer plans to milk the lactose intolerance market as it pushes its lead microbiome drug towards Phase 3.
By Suzanne Elvidge • April 13, 2017 -
Explore the Trendline➔
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TrendlineNeuroscience drug development
Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.
By BioPharma Dive staff -
Novan spikes on positive antifungal results
The topical drugmaker scored a win for its platform and is exploring options to move its therapy forward.
By Lisa LaMotta • April 12, 2017 -
Neurocrine's Ingrezza secures FDA approval
The company's stock jumped more than 20% after the FDA approved the tardive dyskinesia drug — Neurocrine's first product cleared for market.
By Jacob Bell • April 12, 2017 -
Rebiotix gut bug knocks out C. diff. in PUNCH study
The microbiome treatment showed positive results in the Phase 2 trial testing the drug against the difficult-to-treat bacterial infection.
By Suzanne Elvidge • April 12, 2017 -
Roche takes on Pfizer with new lung cancer data
The trial results from the Swiss pharma will allow it to take on Pfizer's Xalkori in first-line lung cancer.
By Lisa LaMotta • April 10, 2017 -
OncoMed slammed by fizzled Bayer deal, Phase 2 failure
The cancer-focused company saw shares slide nearly 43% in premarket trading on Monday.
By Jacob Bell • April 10, 2017 -
Deep Dive
5 trends shaping rare disease drug development
Sales of orphan drugs have grown rapidly, prompting drugmakers to invest in rare diseases. But with that growth has come new scrutiny.
By Ned Pagliarulo • April 10, 2017 -
Deep Dive
Clinical trial enrollment gets harder as patient populations shrink
It can be a long shot to find patients for some rare disease clinical trials. Recruiting challenges, however, often make those odds even smaller.
By Jacob Bell • April 10, 2017 -
How the Orphan Drug Act changed the development landscape
The 1983 law opened the doors to a flood of treatments for rare diseases, but rising costs and hundreds of still-untreated conditions have raised questions about whether changes are needed.
By Malorye A. Branca • April 10, 2017 -
Prescribed Reading: AACR, Gottlieb and recalls
Scott Gottlieb faced a Senate committee for the top slot at the FDA, while data pours in from AACR and Mylan and GSK issue U.S. recalls.
By Lisa LaMotta • April 7, 2017 -
Allergan moves Botox into Phase 3, despite mid-stage failure
Even after a failed Phase 2 , the specialty pharma will move the drug forward in major depressive disorder.
By Lisa LaMotta • April 6, 2017 -
GAIN Act gives Zavante a shot at new antibiotic development
After getting extended exclusivity through the GAIN Act, Zolyd shows solid results in a late-stage study of patients with complicated urinary tract infections.
By Suzanne Elvidge • April 6, 2017 -
Deep Dive
AACR recap: IDOs under the microscope
Combination immunotherapy continued to draw attention at AACR. Elsewhere, survival data on several checkpoint inhibitors hinted at some long-term benefit.
By Ned Pagliarulo • April 5, 2017 -
Corbus pushes toward Phase 3 after positive meeting with FDA
A "successful" end of Phase 2 meeting with the FDA clears Corbus for rare disease Phase 3 and filing.
By Suzanne Elvidge • April 5, 2017 -
Sponsored by inVentiv Health
How real-world evidence is changing the game
A metaphor for our times: how the demand for real-world evidence is changing the offensive playbook for commercial success.
By David Thompson, Ph.D Senior Vice President, Real World Evidence & Insights at inVentiv Health • April 4, 2017 -
AACR: NewLink's IDO data shows promise, but is it enough?
Combining NewLink's indoximod with Keytruda improved response rates in advanced melanoma patients. Yet, it may not be enough to catch Incyte's rapidly advancing IDO1 inhibitor.
By Ned Pagliarulo • April 4, 2017 -
AACR: Incyte hedges bet on combo strategy
The Delaware-based biotech plans to test its IDO1 inhibitor epacadostat in similarly targeted Phase 3 studies with Merck's Keytruda as well as Bristol-Myers' Opdivo.
By Ned Pagliarulo • April 3, 2017 -
AACR: Busy start for Bristol-Myers Squibb's Opdivo
New data from two abstracts presented at the research conference gave a clearer picture of Opdivo's long-term survival benefit.
By Ned Pagliarulo • April 3, 2017 -
CAR-T race heats up as Kite, Novartis complete filings to FDA
Which company reaches market first may not matter much at first, but the coming quarters should see a flurry of activity in the emerging CAR-T field.
By Ned Pagliarulo • April 2, 2017 -
Prescribed Reading: All the approvals
FDA goes on an approval spree, drug manufacturers toe the line on pricing, and Vertex has both good and bad news.
By Lisa LaMotta • March 31, 2017 -
J&J, Genmab abandon NHL indication for Darzalex
The companies chose not to move forward with a mid-stage study of Darzalex in non-Hodgkin's lymphoma after patients failed to reach the desired level of overall response rates.
By Suzanne Elvidge • March 31, 2017 -
Karyopharm shakes off clinical hold for lead cancer med
The quick reversal of the FDA's partial clinical holds reaffirmed that administrative problems were the main culprit holding up the trials.
By Jacob Bell • March 30, 2017 -
Vertex boosted by strong trial data for next-gen CF drug
Success for the experimental treatment would bolster Vertex's cystic fibrosis portfolio and provide a foundation for future triple-combos.
By Ned Pagliarulo • March 29, 2017 -
AACR preview: IDO1, CDK 4/6 and cancer combos
Biopharma dollars have been pouring into cancer research as new technologies make the leap to market. Next week's AACR conference will highlight some of what could come next.
By Ned Pagliarulo • March 29, 2017
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