Clinical Trials: Page
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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 -
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 -
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 -
AbbVie's JAK-1 inhibitor hits the mark in Crohn's disease
A Phase 2 study showed upadacitinib significantly reduced patients' intestinal inflammation, results that should push the drug into late-stage testing.
By Jacob Bell • May 10, 2017 -
New partnership will advance novel platform for I/O
Takeda and GammaDelta Therapeutics will collaborate to develop a T-cell platform for use in cancer and auto-inflammatory disease treatments.
By Barbara Boughton • May 10, 2017 -
Kite discloses patient death in CAR-T trial, sparking safety worries
The death was the first in Kite's testing of axi-cel related to cerebral edema, a potentially fatal condition which had derailed a competing treatment from Juno Therapeutics.
By Ned Pagliarulo • May 8, 2017 -
Teva crashes out of laquinimod MS program
The Israeli pharma's Copaxone follow-on laquinimod fails in the CONCERTO trial, forcing the company to abandon the drug in multiple sclerosis.
By Suzanne Elvidge • May 8, 2017 -
Prescribed Reading: Deals to come, but when?
Pfizer and Gilead could be in a deal-making mood, while the FDA continues to approved drugs at a rapid clip and clinical failures keep coming.
By Lisa LaMotta • May 5, 2017 -
Abivax shares soar on mid-stage HIV results
Treatment with ABX464, in addition to current anti-retroviral drugs, reduced viral reservoirs in the blood — positive results that have pushed shares of the biotech up.
By Suzanne Elvidge • May 3, 2017 -
Neurotrope nosedives on iffy Alzheimer's trial
The biotech tries to spin poor results in a trial of its Alzheimer's disease drug, but investors aren't buying it.
By Suzanne Elvidge • May 2, 2017 -
Late-stage failure puts an end to Aeterna Zentaris' lead therapy
Zoptrex's miss caused the Canadian pharma's stock to plummet 60% on Monday.
By Jacob Bell • May 2, 2017 -
Sponsored by Covance
Stepping up the game: Measles, mumps, rubella, and varicella (MMRV) concomitant testing support for vaccine evaluation
New CRO testing spaces fill the need for high quality data generated using quantitative immune assays and PRNt testing calibrated to the WHO international standard.
By Rolando Pajon, PhD, Vaccine Validation Scientist, Vaccine and Novel Immunotherapeutic Laboratory Solutions • May 2, 2017 -
Medeor gets FDA go-ahead for Phase 3
The biotech is developing an immunotherapy that could replace immunosuppressants for transplant patients should it be successful.
By Suzanne Elvidge • May 1, 2017 -
Prescribed Reading: Rough start for pharma, but optimism abounds
First quarter earnings were not particularly strong, but there were several bright spots; Gottlieb confirmation rolls forward; and The Medicines Co. lays down cash for its CV outcomes trial.
By Lisa LaMotta • April 28, 2017
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