Clinical Trials: Page 137
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Did Novartis try to sabotage Avastin ophthalmic trials?
Novartis and Roche manufacture Lucentis (ranibizumab) for wet AMD—a considerably more expensive treatment option than Avastin (bevacizumab).
By Nicole Gray • April 6, 2015 -
UK scientists push back against animal testing critics
The British Union for the Abolition of Vivisection wants to end all animal experiments.
By Nicole Gray • April 6, 2015 -
Explore the Trendline➔
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TrendlineNeuroscience drug development
Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.
By BioPharma Dive staff -
PETA hawks animal testing alternatives to CROs in San Diego
Animal rights' issues were part of the conversation at the Society of Toxicology meeting in San Diego last week.
By Nicole Gray • March 31, 2015 -
Guinea becomes focus of Merck Ebola vaccination study
A total of 10,000 at-risk residents will be vaccinated with VSV-EBOV. There will be no placebo arm.
By Nicole Gray • March 25, 2015 -
RA drug that caused 'elephant man' side effect gets another chance
Researchers have changed the dosing protocol for TGN1412.
By Nicole Gray • March 25, 2015 -
U of Minnesota called out for clinical trial practices—again
The university claims that its clinical trial conduct is consistent with the highest ethical standards. But a new report suggests otherwise.
By Nicole Gray • March 24, 2015 -
Here comes the blockbuster: Novartis' Cosentyx bests Stelara in psoriasis trials
Since the drug's approval in January, Novartis has been racking up positive clinical trial data for Cosentyx, showing superiority to both Amgen's Enbrel and now J&J's Stelara.
By Nicole Gray • March 23, 2015 -
Biogen soars as Alzheimer's drug data shows sharp slowdown in cognitive decline
BIIB037 has high expectations as a potential Alzheimer's breakthrough. On Friday, Biogen revealed more data supporting the drug's case.
By Sy Mukherjee • March 20, 2015 -
Deep Dive
9 important things to know about PCSK9 cholesterol drugs
From the democratic nature of their trials to ease of use, PCSK9 drugs are a fascinating advancement for pharma.
By Nicole Gray • March 20, 2015 -
Glaxo's combo respiratory drug deemed safe by FDA staff
Amid concerns about vilanterol-related asthma deaths, Breo Ellipta, which contains a corticosteroid and vilanterol, was extensively tested.
By Nicole Gray • March 18, 2015 -
FDA panel: Pharmacyclics' Imbruvica cancer data strong enough to unblind
Combo treatment with Imbruvica (ibrutinib) and two other drugs showed promise in previously treated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia.
By Nicole Gray • March 17, 2015 -
Could Biogen's Alzheimer's therapy become a breakthrough?
The company's stock has risen about 30% in less than three months, driven in part by early encouraging data.
By Nicole Gray • March 17, 2015 -
Study: AZ's Brilinta shows promise, but comes with risks
Some experts believe the benefits of the drug will outweigh the risk of bleeding.
By Nicole Gray • March 16, 2015 -
Amgen, Sanofi PCSK9 drugs shown to cut CVD risk in half
Some impressive data from a class of drugs expected to rake in billions. But researchers warn that some efficacy questions still linger.
By Sy Mukherjee • March 16, 2015 -
Neuralstem shares tank on discouraging ALS stem cell therapy data
In a phase II clinical trial, only 47% of patients treated with Neuralstem's surgical stem-cell therapy responded to therapy at all.
By Nicole Gray • March 13, 2015 -
Is that clinical trial doc getting pharma money? Patients want to know
87% of MS patients who had never participated in a clinical trial believed that a doctor should disclose any payments from biopharma sponsors.
By Nicole Gray • March 10, 2015 -
Vanda's atopic dermatitis drug fall flat in mid-stage trial
But Vanda plans to add more studies.
By Nicole Gray • March 6, 2015 -
Could Sangamo's gene therapy 'cure' HIV?
Sangamo Biosciences is initiating a clinical study in humans to test a gene therapy technique that has some observers particularly excited.
By Nicole Gray • March 4, 2015 -
Orexigen shoots itself in foot with early disclosure of positive Contrave heart data
Disclosure of interim evidence that Contrave (naltrexone) may prevent heart attacks (instead of causing them) should be a good thing. But Orexigen broke FDA rules and Data Monitoring Committee protocol.
By Nicole Gray • March 4, 2015 -
Positive phase II Provenge data a good early sign for ambitious Valeant
Valeant just cleared its deal with Provenge manufacturer Dendreon and is already touting the phase II data.
By Nicole Gray • Feb. 27, 2015 -
Lilly's long-acting insulin not ready for prime time
Despite positive phase 3 data on peglispro, the company's long-acting insulin-in-development, evidence of liver toxicity will delay FDA review at least two years—and potentially forever.
By Nicole Gray • Feb. 24, 2015 -
Biotech battle: Regeneron's Eylea bests Genenetch's Lucentis in head-to-head
In a head-to-head diabetic macular edema study, Eylea improved vision more than both Lucentis and Avastin.
By Nicole Gray • Feb. 19, 2015 -
EMA defends data black-out policy for AbbVie's Humira
Transparency experts are fuming over the European Medicine Agency's decision to omit certain data from a Humira Clinical Study Report (CSR).
By Nicole Gray • Feb. 12, 2015 -
Former MN gov demands more trial transparency at UMN in wake of '04 suicide
Former Gov. Arne Carlson also called for additional details about the death of a University of Minnesota study subject in 2004.
By Nicole Gray • Feb. 11, 2015 -
New research: Could Novartis CVD game-changer increase dementia risk?
French researchers have raised concerns that an investigational heart failure drug from Novartis could increase the risk of dementia.
By Nicole Gray • Feb. 10, 2015