Clinical Trials: Page 126
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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 -
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 -
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 -
Disappointment for Incyte as phase 3 failure prompts halt on Jakafi solid tumor trials
The company had hoped to expand the blood cancer med's indication to spur future growth.
By Ned Pagliarulo • Feb. 12, 2016 -
Obama budget's $825 million NIH boost could hit big snags over funding structure
The president's FY2017 budget increases NIH funding to $33.1 billion, a 2.6% increase over 2016, and more or less keeps the FDA budget flat. But some advocacy groups and lawmakers are wary of its reliance on mandatory funding.
By Sy Mukherjee • Feb. 10, 2016 -
Deep Dive
BIO CEO 2016: What it will take to achieve Cancer MoonShot 2020
Experts from Bristol-Myers Squibb, Friends of Cancer Research, and others discussed the promise and the perils surrounding the ambitious effort and the development of next-gen cancer meds during a panel at the BIO CEO & Investor Conference in New York.
By Nicole Gray • Feb. 10, 2016 -
Update: After patient deaths, FDA puts CTI BioPharma's myelofibrosis on full clinical hold
The phase 3 myelofibrosis therapy pacritinib has been issued a full clinical hold after regulators found that patients in the study's drug arm were starting to die at higher rates compared to the placebo group.
By Sy Mukherjee • Feb. 8, 2016 -
An Indian biotech is already developing two Zika vaccine candidates
Bharat Biotech claims it likely is the first company to file for a global patent for a Zika vaccine candidate.
By Ned Pagliarulo • Feb. 8, 2016
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