Clinical Trials: Page 107
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Opinion
Building a lab when constrained by space
Kendall Square has become a thriving hotspot for biotech and pharma, but real estate is both expensive and limited. Accelerated Commercialization Spaces offer companies a cost-friendly alternative.
By Seth Taylor • April 20, 2017 -
Biopharma opening up to new ways of partnering on R&D
A report from Deloitte found the number of early-stage, science-focused collaborations to have increased rapidly over the past 10 years.
By Ned Pagliarulo • April 20, 2017 -
Explore the Trendline➔
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TrendlineOncology's research boom
More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.
By BioPharma Dive staff -
Courtesy of AbbVie
AbbVie's PARP inhibitor fails two late-stage cancer trials
Veliparib did not meet primary endpoints in studies testing it as a treatment for lung and breast cancer.
By Jacob Bell • April 20, 2017 -
Novartis CAR-T candidate clinches breakthrough designation
It's the second such designation for the immunotherapy, which is in a dead heat with Kite Pharma's drug to be first to market.
By Jacob Bell • April 19, 2017 -
Positive results help Ultragenyx recover after prior failure
The ultra rare disease biotech announced positive topline results for its mid-stage drug partnered with Japan's Kyowa Hakko Kirin Co.
By Lisa LaMotta • April 19, 2017 -
Mateon announces positive topline data in ovarian cancer
Results from a combination study in recurrent ovarian cancer provided an early glimmer of hope in hard-to-treat patients.
By Suzanne Elvidge • April 19, 2017 -
Deja vu for Circassia with second allergy failure
The British biotech once again blames a high placebo effect for the failure of one of its allergy immunotherapies.
By Lisa LaMotta • April 18, 2017 -
Allergan, Novartis ink NASH partnership
The deal will pair Allergan's drug cenicriviroc and Novartis' candidate LJN452 in a Phase 2b study of patients with the liver disease.
By Jacob Bell • April 18, 2017 -
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 -
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
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