Clinical Trials: Page
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Prescribed Reading: No such thing as unicorns
Both closely watched Axovant and Intarcia had major setbacks this week, despite high hopes that their therapies would be game-changers.
By Lisa LaMotta • Sept. 29, 2017 -
Deep Dive
A drug 15 years in the making: Alnylam's quest to prove RNAi
This month's success from the APOLLO study puts the biotech on the brink of making the technology a medical reality for patients.
By Ned Pagliarulo • Sept. 29, 2017 -
Explore the Trendline➔
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TrendlineRadiopharmaceuticals
A series of technological advances have led to an explosion of scientific progress — and dealmaking — involving medicines that can precisely deliver radioactive materials into tumors.
By BioPharma Dive staff -
Zynerba shares up on rare disease trial success
Cannabis-based company's Phase 2 trial met its primary endpoint in Fragile X, shooting its shares up over 50%.
By Suzanne Elvidge • Sept. 29, 2017 -
Pharma tackles the ever-present problem of unmet need
Industry executives are focused on targeting what they see as the largest untapped markets.
By Lisa LaMotta • Sept. 27, 2017 -
Mateon shuts down lead trial due to bad data
The small biotech will lay off 60% of its staff after halting its most advanced clinical study due to lack of efficacy.
By Lisa LaMotta • Sept. 27, 2017 -
PureTech's Gelesis touts obesity drug's success in study
But a miss on one of the study's co-primary endpoints could complicate the company's pitch to the FDA.
By Suzanne Elvidge • Sept. 26, 2017 -
Arbutus' hepatitis B drug shows Phase 2 promise
Fresh data in hand, Arbutus plans to advance its lead RNAi therapeutic into a new study later this year.
By Suzanne Elvidge • Sept. 26, 2017 -
Axovant's closely watched Alzheimer's drug fails late-stage trial
Intepirdine failed to meet either of the study's endpoints, sending shares in the unorthodox biotech down more than 70%.
By Ned Pagliarulo • Sept. 26, 2017 -
Acer jumps on 7-year-old data
The rare disease drugmaker's stock rose nearly 10% after announcing it had confirmed results from a 2010 study of celiprolol.
By Jacob Bell • Sept. 25, 2017 -
Allergan touts new data from failed NASH study
Cenicriviroc didn't meet the CENTAUR study's primary endpoint, but did show benefit in liver fibrosis.
By Jacob Bell • Sept. 22, 2017 -
Versartis crashes after Phase 3 miss
Friday's setback throws the biotech's plans to bring a long-acting human growth hormone to market into doubt.
By Ned Pagliarulo • Sept. 22, 2017 -
Prescribed Reading: Consolidation, clinical holds and landmark results
The FDA continues its clinical hold spree for PD-1/L1s, consolidation is rampant in the CDMO space and RNAi may become a reality very soon.
By Lisa LaMotta • Sept. 22, 2017 -
Intercept shares plummet on FDA warning
A FDA safety alert for Ocaliva, following a 'Dear Dr.' letter last week, knocked 25% off Intercept's stock.
By Suzanne Elvidge • Sept. 22, 2017 -
Alzheimer's drug development just as challenging as ever
While biotech holds its breath for results from Axovant, a report from PhRMA showcases how hard it is to bring a new treatment to market.
By Lisa LaMotta • Sept. 21, 2017 -
Provention builds pipeline with Janssen licensing deal
Launched earlier this year, Provention now boasts a lineup of three in-licensed drug candidates.
By Ned Pagliarulo • Sept. 21, 2017 -
Alnylam soars on trial win for RNAi drug
Patisiran's success marks a major milestone for the Cambridge biotech, which has spent 15 years developing the science behind its RNA interference approach.
By Ned Pagliarulo • Sept. 20, 2017 -
Supernus tweaks ADHD studies to boost chances of success
A planned interim analysis prompted the Maryland specialty pharma to drop a low dose of its drug for impulsive aggression in two Phase 3 trials.
By Suzanne Elvidge • Sept. 19, 2017 -
AbbVie, Roche to seek broader market for leukemia drug after trial success
The drugmakers hope Venclexta could replace chemotherapy in combination treatment of relapsed, refractory CLL patients.
By Ned Pagliarulo • Sept. 18, 2017 -
Nabriva shares leap higher on antibiotic trial success
Positive results from Nabriva's LEAP 1 study augur well for the potential of the company's novel anti-infective in a common type of bacterial pneumonia.
By Ned Pagliarulo • Sept. 18, 2017 -
EMA backs approval for J&J's Tremfya
A positive opinion from the EU drugs regulator sets up J&J to expand Tremfya's market to Europe.
By Suzanne Elvidge • Sept. 18, 2017 -
FDA places two combo studies of Roche's Tecentriq on partial hold
The decision follows recruitment halts for a number of other trials involving PD-(L)1 inhibitors in certain blood cancers due to safety concerns.
By Suzanne Elvidge • Sept. 18, 2017 -
AstraZeneca's Bydureon falls short in heart study
Lack of a heart benefit means a comeback for Bydureon probably isn't in the cards.
By Lisa LaMotta • Sept. 14, 2017 -
Lilly's baricitinib fails to outshine Sanofi's Dupixent
A mid-stage study in atopic dermatitis hit its goal, but results appeared to fall short of the mark set by Sanofi and Regeneron's already approved treatment.
By Lisa LaMotta • Sept. 14, 2017 -
Pfizer, Astellas eye wider market for prostate cancer drug
Xtandi's broader commercial prospects were a key factor in Pfizer's decision to pick up the drug in a $14 billion acquisition of Medivation last fall.
By Ned Pagliarulo • Sept. 14, 2017 -
Lexicon, Sanofi drug could be first oral for type 1 diabetes
Positive results in three Phase 3 trials could set the SGTL1/SGLT2 inhibitor up to be the first oral treatment for the less common form of the chronic condition.
By Lisa LaMotta • Sept. 13, 2017