Clinical Trials: Page
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Novartis creeps in on Pfizer's Ibrance
The Swiss giant's oncology strategy is coming together as a Breakthrough Therapy designation moves it closer to filing on one of its key growth drivers.
By Lisa LaMotta • Aug. 4, 2016 -
FDA hits Adaptimmune with partial hold on T-cell therapy
The company said the trial halt was unrelated to any safety issues.
By Nicole Gray • Aug. 4, 2016 -
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 -
Expansion on the horizon for Pfizer's Xeljanz
Pfizer bounced back from an earlier regulatory setback with strong Q2 results and new clinical data supporting two new indications for its rheumatoid arthritis drug.
By Edwin Lopez • Aug. 3, 2016 -
Lymphoma drug from Takeda, Seattle Genetics beats out existing meds in late-stage trial
The companies are jointly developing Adcetris for treatment of cutaneous T-cell lymphoma, a type of non-Hodgkin lymphoma.
By Nicole Gray • Aug. 2, 2016 -
Biogen snaps up rights to neuromuscular disease drug after trial success
Shares in Ionis Pharmaceuticals, which had developed the drug until now, rose sharply on the positive results. Biogen stock climbed modestly.
By Ned Pagliarulo • Aug. 1, 2016 -
Tokai cuts workforce by 60% after phase 3 failure with prostate cancer drug
Once the layoffs take effect, Tokai will have only 10 full-time employees.
By Nicole Gray • Aug. 1, 2016 -
Microbiome biotech on edge after critical phase 2 failure
Seres Therapeutics' lead candidate failed to meet its trial endpoint, driving the company's stock down 75% this morning.
By Edwin Lopez • July 29, 2016 -
Phase 1 trial reveals high efficacy for hemophilia A gene therapy
BioMarin's pipeline candidate increased plasma factor VIII levels to 50% in two thirds of hemophilia patients.
By Nicole Gray • July 28, 2016 -
TauRx Alzheimer's drug flunks late-stage study
But the privately held company tried to salvage hopes for the experimental drug, pointing to a benefit seen in a small subgroup of patients.
By Ned Pagliarulo • July 27, 2016 -
Tokai Pharma tumbles after Phase 3 failure
After Tokai said it would terminate a late-stage study of its prostate cancer drug, company stock plummeted nearly 80%.
By Nicole Gray • July 27, 2016 -
FDA
Celgene abandons plans for new Revlimid indication after trial disappointment
The cancer drug failed to improve overall survival for patients with large B-cell lymphona in a phase 3 trial.
By Nicole Gray • July 26, 2016 -
Regulators to expedite review of Merck's Ebola vaccine
Merck plans to submit its Ebola vaccine to regulatory authorities on both sides of the Atlantic next year, aiming to win approval and launch V920 by the end of 2017.
By Nicole Gray • July 26, 2016 -
Alzheon readies Phase 3 study of Alzheimer's drug
Two Phase 1b studies showed a favorable pharmacokinetic profile, clearing the way for the planned pivotal trial to begin early next year.
By Ned Pagliarulo • July 25, 2016 -
AbbVie partners with Bristol-Myers in combo study of cancer drugs
The early-stage trial will test AbbVie's experimental Rova-T with Bristol-Myers' two approved immunotherapies.
By Ned Pagliarulo • July 25, 2016 -
Amgen, Allergan get biosimilar lift with positive data on Herceptin copy
Trial results showed "no clinically meaningful differences" between the biosim and Herceptin, company executives said.
By Nicole Gray • July 22, 2016 -
Chinese team to test CRISPR in humans, jumping ahead of planned US study
Led by a scientist from Sichuan University, the Chinese study will seek to genetically engineer the T-cells of patients with lung cancer.
By Ned Pagliarulo • July 22, 2016 -
FDA
Valeant wins backing of FDA panel for psoriasis drug
While the recommendation is welcome news for a company still struggling to remake its image, Valeant could face significant competition for brodalumab.
By Ned Pagliarulo • July 20, 2016 -
Ziopharm says patient death unrelated to gene therapy
The patient had died two weeks after receiving treatment with the company's experimental drug, sparking safety concerns.
By Ned Pagliarulo • July 19, 2016 -
Sponsored by Covance
The art and science of forecasting with clinical informatics
New informatics technology is improving forecasting and site selection efforts to advance studies and reduce overall costs.
July 19, 2016 -
After phase 2 success, Brainstorm sees promise for ALS drug
Brainstorm's drug, called NurOwn, met its primary endpoint for safety and tolerability.
By Nicole Gray • July 19, 2016 -
Roche blood cancer drug falls short in late-stage study
Gazyva, an heir apparent to Roche's aging Rituxan, failed to meet its primary endpoint in patients with diffuse large B-cell lymphoma.
By Ned Pagliarulo • July 18, 2016 -
Late-stage study confirms efficacy of AstraZeneca's Tagrisso
The positive results help cement Tagrisso's status as a second-line treatment for a type of lung cancer.
By Edwin Lopez • July 18, 2016 -
Patient dies in clinical testing of Ziopharm gene therapy
The brain cancer patient died from intracranial hemorrhage 15 days after Ziopharm's gene therapy injection.
By Edwin Lopez • July 15, 2016 -
FDA
FDA staff raises safety concerns for Valeant psoriasis drug
Six suicides occurred during clinical testing of the drug, which Valeant had licensed from AstraZeneca last year.
By Ned Pagliarulo • July 15, 2016 -
Deep Dive
Why Allergan thinks an 'open science' approach can help it develop new antibiotics
BioPharma Dive spoke with David Nicholson, head of R&D at Allergan, about his company’s continued efforts to develop novel antibiotics, even as other companies have dropped out of R&D.
By Ned Pagliarulo • July 14, 2016
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