Clinical Trials
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SponsoredDisruptive innovation – the impact on clinical trials
Senior pharma executives weigh in on how the industry is experiencing a digital disruption, impacting the entire spectrum of drug development.
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Novo's case for oral semaglutide bolstered by Phase 3 trial wins
The key diabetes drug for Novo beat out the Danish drugmaker's own Victoza as well as Merck & Co.'s Januvia in two late-stage studies.
By Ned Pagliarulo • June 21, 2018
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Incyte preps Jakafi expansion into graft-versus-host disease
With positive topline results from the pivotal REACH1 study in hand, Incyte plans to file an application next quarter.
By Jacob Bell • June 21, 2018
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Heron shares jump on pain drug's Phase 2b successes
The biotech plans to submit the non-opioid analgesic to the FDA later this year, aiming to secure an approval in postoperative pain management.
By Suzanne Elvidge • June 21, 2018
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Anika shares slump on Phase 3 miss
The regenerative medicine company's osteoarthritis treatment failed to meet its goal, spurring investor worries about approval in the U.S.
By Ned Pagliarulo • June 20, 2018
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3 patients add $2.5B to Sarepta's value
Preliminary results from a few DMD patients given the biotech's gene therapy widely beat expectations, stoking hopes of a truly disease-modifying treatment.
By Jacob Bell • June 19, 2018
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SponsoredElectronic platforms drive improvements in vaccine study efficiency and data quality
Electronic diary (eDiary) cards are helping sponsors overcome the unique data collection challenges associated with vaccine trials.
By Tim Davis, VP Digital Patient, ERT
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Vertex opens doors to new research site in San Diego
Research at the new complex, which is one of three hubs for the biotech, will focus on cystic fibrosis as well as other therapeutic areas, including pain.
By Suzanne Elvidge • June 19, 2018
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Ziopharm shares tumble as clinical hold delays CAR-T
The FDA put a halt to the company's Phase 1 trial before it even began, seeking more information on the company's manufacturing plans.
By Suzanne Elvidge • June 19, 2018
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Solid finds its footing as FDA lifts trial hold
Shares rose on news the biotech will resume enrollment into a Phase 1/2 study of its experimental gene therapy for DMD.
By Ned Pagliarulo • June 18, 2018
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Valeant hit with CRL for key dermatology drug
While the pharma seems hopeful of a quick resolution, the red light from the FDA is a blow to Valeant's plans to turn around its dermatology business.
By Ned Pagliarulo • June 18, 2018
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ObsEva's endometriosis win puts it back in investors' good graces
The biotech is now looking to take two doses of linzagolix into Phase 3 for pain associated with the condition.
By Jacob Bell • June 18, 2018
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Cytokinetics says early SMA treatment shows promise
Investors, however, were not so convinced, sending shares in the biotech sliding Monday morning.
By Suzanne Elvidge • June 18, 2018
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ColumnPrescribed Reading: J&J sells off units; another Alzheimer's defeat
Big pharma extended its string of divestitures and portfolio streamlining this week. Meanwhile, manufacturers can't seem to beat Alzheimer's disease.
By Lisa LaMotta • June 15, 2018
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Bluebird's changes to LentiGlobin begin to pay off
The gene therapy continued to show promise in two genetic blood disorders, but questions of durability remain.
By Ned Pagliarulo • June 15, 2018
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Lilly's Olumiant delivers positive Phase 2 lupus data
The trial win is likely welcome news for Lilly and partner Incyte in light of the drug's narrow and disappointing approval in rheumatoid arthritis.
By Suzanne Elvidge • June 15, 2018
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GSK touts two-drug HIV therapy, intends to file this year
Success of the doublet should help GSK better compete with Gilead, its main competitor in the HIV market.
By Jacob Bell • June 14, 2018
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Flex calling it quits after trial stop
Safety concerns for its lead candidate are forcing the company to abandon development and pursue strategic options.
By Lisa LaMotta • June 13, 2018
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Galmed stock jumps sky-high on mixed results for NASH drug
While the company touted the drug's impact on liver fat, a closer look at the study results raises questions about how effective the treatment really is.
By Suzanne Elvidge • June 13, 2018
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Lilly, AstraZeneca pull the plug on Alzheimer's trials
Two late-stage trials for the debilitating neurological condition were stopped for futility, further weakening the amyloid hypothesis.
By Lisa LaMotta • June 12, 2018
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Allergan notches another CGRP success, but faces changing migraine market
The pharma's atogepant succeeded in a late-stage study, advancing its plans in the space. Rivals, however, look set to jump ahead.
By Ned Pagliarulo • June 11, 2018
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Vical abandons herpes vaccine after mid-stage miss
It's the latest in a series of trial failures that have pummeled the San Diego biotech's stock over the last several years.
By Jacob Bell • June 11, 2018
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FDA lays out biosimilar guidance for agency meetings
One aim of the draft guidance is to speed biosimilars' path to market by improving communication with the regulator.
By Suzanne Elvidge • June 06, 2018
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ASCO18: 3 unanswered questions from oncology's largest conference
This year's ASCO meeting showcased dozens of major advances in cancer care, but several major questions remain in the red-hot field of immunotherapy.
By Ned Pagliarulo • June 06, 2018
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BIO18: Pfizer (sort of) inches back to neuro; Building ties with FDA
Day Three of the BIO International convention shined a light on the neuroscience space and its evolution.
By Lisa LaMotta • June 06, 2018