Clinical Trials: Page 120
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Sanofi's sarilumab bests blockbuster Humira in Phase 3 study
The IL-6 antibody is slated for a regulatory decision from the FDA by Q4 2016.
By Ned Pagliarulo • March 11, 2016 -
Death from French drug trial likely due to high doses of compound
The drug trial left one man dead and five others in the hospital in January. Portuguese drugmaker Bial had been testing an FAAH-enzyme inhibitor for the treatment of pain and mood disorders.
By Ned Pagliarulo • March 10, 2016 -
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 -
French regulator halts manufacturing at HIV-focused biotech
A November inspection by ANSM turned up 45 manufacturing deficiencies, including five critical flaws.
By Nicole Gray • March 10, 2016 -
Novartis' Cosentyx proves superior to Janssen's Stelara in head-to-head comparison
The efficacy data further bolsters the profile of Cosentyx, which recently had its label expanded to include indications for ankylosing spondylitis and psoriatic arthritis.
By Nicole Gray • March 7, 2016 -
In high-profile failure, Celldex's cancer vaccine crashes in phase 3
The biotech ended its study early after an interim analysis showed patients treated with the gliobastoma drug fared slightly worse than the control group.
By Ned Pagliarulo • March 7, 2016 -
AbbVie paying Boehringer $595M upfront to gain access to psoriasis drug
The compound, an anti-IL23 antibody, is currently in phase 3 development for the treatment of psoriasis. Two other phase 2 studies are evaluating the drug against Crohn's disease, asthma, and psoriatic arthritis.
By Ned Pagliarulo • March 7, 2016 -
New study strengthens link between Zika and serious birth defects
Published in NEJM, the small study found 29% of pregnant women infected by Zika had fetuses showing serious abnormalities in ultrasound readings.
By Nicole Gray • March 7, 2016 -
Montgomery County Planning Commission
GSK's asthma drug Nucala boosted by long-term safety study
The company also published post-marketing safety results for its Advair Diskus product, showing comparable safety results to a common corticosteroid.
By Nicole Gray • March 7, 2016 -
Much-anticipated trial shows Novo's Victoza reduces CV risk
The results could help keep Victoza competitive with Eli Lilly/Boehringer Ingelheim's Jardiance, which became the first diabetes drug to demonstrate a cardiovascular benefit.
By Ned Pagliarulo • March 4, 2016 -
Merck forges ahead with phase 3 trial of Humira biosimilar
A number of other companies, including Amgen, Novartis, and Boehringer Ingelheim, are developing other biosim versions, hoping to wrest away some of Humira's $14 billion in 2015 sales.
By Nicole Gray • March 3, 2016 -
San Diego-based Conatus takes aim at unmet medical need in cirrhosis
While new meds from Gilead, AbbVie, and Merck have been game-changers for hepatitis C treatment, few options exist for liver cirrhosis.
By Nicole Gray • March 2, 2016 -
AstraZeneca's mesothelioma drug fails monotherapy testing
Tremelimumab did not improve overall survival in patients with advanced mesothelioma.
By Nicole Gray • March 2, 2016 -
Roche's asthma drug stumbles on mixed phase 3 results
The Swiss drugmaker did, however, receive some good news when its lymphoma drug won second-line approval from the FDA.
By Nicole Gray • March 1, 2016 -
FDA offering $2 million in new grants for rare disease research
The grants will fund natural history studies into the progression of rare diseases in patients over time.
By Shalina Chatlani • Feb. 29, 2016 -
Novo Nordisk notches another phase 3 success for GLP-1 drug
The weekly diabetes candidate semaglutide successfully completed four prior phase 3 trials which compared Novo's next-gen hopeful to existing treatments.
By Nicole Gray • Feb. 25, 2016 -
Amgen's bone-building osteo drug dazzles in phase 3, but could face hefty competition
The candidate's significantly more convenient dosing option could still give it a leg up over a potentially more effective competitor from Radius Health.
By Nicole Gray • Feb. 24, 2016 -
Why uptake of new PCSK9 cholesterol meds has been so slow
More accelerated uptake of Sanofi/Regeneron's Praluent and Amgen's Repatha by both payers and doctors is not expected until there is convincing outcomes data available.
By Nicole Gray • Feb. 24, 2016 -
Do big name journals have a 'marketing trial' problem?
A team of medical journal editors found that a fifth of 194 trials published in six well-regarded medical journals could be classified as oriented toward marketing.
By Nicole Gray • Feb. 24, 2016 -
Startup AvroBio touts gene therapy candidates for blood cancer, Fabry disease
The Toronto-based company hopes to begin phase 1 programs for both candidates in early to mid-2016.
By Nicole Gray • Feb. 22, 2016 -
The flip side of the T-cell hype: Experts urge caution on huge costs, safety concerns
From the estimated half-million dollar cost of production to potentially devastating adverse events, at least one analyst is pointing out potential problems with the much-hyped therapy.
By Nicole Gray • Feb. 21, 2016 -
Celgene hitches wagon to Bluebird, doles out $10M as biotech launches 1st CAR-T trial
Celgene has decided to opt in as Bluebird Bio moves its CAR-T therapy into human multiple myeloma studies.
By Nicole Gray • Feb. 19, 2016 -
New Zafgen data shows obesity med's promise in diabetics—but will FDA lift its clinical hold?
The FDA placed a complete clinical hold on beloranib in December after two patients participating in trials died from blood clotting.
By Nicole Gray • Feb. 19, 2016 -
Armed with strong new data, Regulus aims to defy skeptics of its hep C injectable
But given that currently available oral therapies from Gilead, AbbVie, and Merck cure almost all forms of chronic hepatitis C (HCV), the biotech still has a hard case to make.
By Nicole Gray • Feb. 18, 2016 -
AstraZeneca scores a clutch 'breakthrough' for major bladder cancer med
The breakthrough therapy designation gives durvalumab's prospects a boost, and should help AstraZeneca catch up in the immunotherapy space.
By Nicole Gray • Feb. 18, 2016 -
Struggling Clovis to once again chase FDA favor for would-be Tagrisso competitor
Clovis' stock is down 80% since last fall, when the FDA requested more clinical data on its lead lung cancer candidate rociletinib.
By Nicole Gray • Feb. 16, 2016
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