Clinical Trials: Page 98
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Hopes are high for cannabinoid data in epilepsy
GW Pharmaceuticals' stock price spiked after it published epilepsy data, and submission for Epidiolex in the U.S. is now imminent.
By Suzanne Elvidge • May 26, 2017 -
Aerie shares rise on trial success for eye drug
The positive results could help Aerie make the jump from a clinical-stage company to a commercial one over the next two years.
By Ned Pagliarulo • May 25, 2017 -
Explore the Trendline➔
National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
TrendlineCell therapy
The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.
By BioPharma Dive staff -
Neurocrine's Tourette's trial gets a red light
Ingrezza failed to beat placebo in a Phase 2 trial, pushing its stock price down.
By Suzanne Elvidge • May 24, 2017 -
Trial success buoys AstraZeneca's hopes for asthma biologic
Benralizumab is the most advanced example of AstraZeneca's push to expand its respiratory portfolio into biologics.
By Ned Pagliarulo • May 23, 2017 -
Celgene MS drug succeeds in second Phase 3 study
But the drug failed to beat out Biogen's Avonex in slowing disability progression, a missed opportunity to stand out in a crowded therapeutic class.
By Ned Pagliarulo • May 22, 2017 -
La Jolla falls on mixed results for shock treatment
The drug met its primary endpoint, boding well for its chances with the FDA. But results were less promising on secondary measures of organ failure and mortality.
By Suzanne Elvidge • May 22, 2017 -
Safety signal derails expected approval of Amgen bone drug
Amgen no longer expects to win U.S. approval this year for romosuzumab after reporting an imbalance of cardiovascular adverse events in a comparator study.
By Ned Pagliarulo • May 22, 2017 -
Prescribed Reading: ASCO dominates, Icahn BMS interest just a rumor
The abstracts have arrived! Carl Icahn's first quarter holdings are released and J&J gets a black box warning.
By Lisa LaMotta • May 19, 2017 -
Albireo rises on Phase 3 plans for liver drug
Following discussions with the FDA and EMA, the Boston-based biotech plans to kick off its Phase 3 trial in the second half of this year.
By Suzanne Elvidge • May 19, 2017 -
7 Areas to watch from the ASCO abstracts
With oncology's biggest meeting less than two weeks away, here are seven highlights from the recently released abstracts that are worth keeping an eye on.
By Ned Pagliarulo • May 18, 2017 -
Shire's angioedema drug scores in Phase 3
Patients receiving a 300 mg dose of lanadelumab every other week had an 87% reduction in average number of hereditary angiodema attacks versus those on placebo.
By Jacob Bell • May 18, 2017 -
J&J claims higher R&D productivity than peers
The pharma giant laid out a future filled with billion-dollar products for investors, promising 10 new blockbusters by 2021.
By Suzanne Elvidge • May 17, 2017 -
Concert trial on hold while FDA reviews tox studies
The biotech's baldness drug was put on clinical hold by the regulatory agency in order to assess non-clinical toxicology studies.
By Lisa LaMotta • May 17, 2017 -
Editas delays CRISPR move to human trials
The biotech announced a delay for its planned IND filing, giving competitors an opening to start trials in the closely watched field first.
By Lisa LaMotta • May 16, 2017 -
Minerva's schizophrenia drug heads to late stages
The central nervous system drug developer has completed an end-of-Phase 2 meeting with the FDA, and plans to kick off late-stage testing later this year.
By Jacob Bell • May 16, 2017 -
FDA
Drug adherence: What you need to know
One of the biggest problems in the medical field is patients not taking their drugs or using them improperly. When patients are non-adherent, drugs don't work.
By Lisa LaMotta • May 15, 2017 -
FDA
5 trends changing drug adherence for the better
Many things can affect whether a patient takes a drug as prescribed, but stakeholders are intervening in order to make patients more compliant with their meds.
By Lisa LaMotta • May 15, 2017 -
Ionis safety issues are a win for Alnylam
A Phase 3 study of Ionis' drug inotersen met both its primary endpoints. But new safety concerns pushed shares in the biotech down nearly 10% Monday.
By Lisa LaMotta • May 15, 2017 -
Deep Dive
Solutions to clinical trial adherence remain elusive
Making sure patients take their medications is crucial to clinical trial success, but exactly how to do that remains a daunting task for investigators.
By Jacob Bell • May 15, 2017 -
Medication adherence: The secret sauce for better outcomes?
Rates of non-adherence vary widely and depend on condition, price and other issues. But unfilled prescriptions and missed doses cost the healthcare system billions annually.
By Malorye Allison Branca • May 15, 2017 -
Prescribed Reading: Checkpoint inhibitors change cancer
Approvals and failures of checkpoint inhibitors have dramatically changed the cancer landscape, and could even have an impact on how the FDA approaches approvals. Elsewhere, Pfizer's getting into genes and Advair avoids competition.
By Lisa LaMotta • May 12, 2017 -
Interim results from Capricor's ALLSTAR trial were anything but
The clinical-stage biotech's stock tanked roughly 60% Friday morning after interim analysis gave a grim outlook for the success of its lead candidate.
By Jacob Bell • May 12, 2017 -
AstraZeneca rises after positive lung cancer results for key drug
Imfinzi improved progression-free survival in the Phase 3 PACIFIC study, building confidence in the drug's chances in a crowded field.
By Ned Pagliarulo • May 12, 2017 -
Roche's Tecentriq fails trial, raising questions about approval
The late-stage failure in bladder cancer now calls into question the FDA's initial decision to OK the drug.
By Lisa LaMotta • May 10, 2017 -
AstraZeneca relies on biomarkers for Phase 3 asthma studies
A failure in the STRATOS 1 study has prompted the company to look at a sub-population in a second ongoing Phase 3 study.
By Lisa LaMotta • May 10, 2017
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