Clinical Trials: Page 2
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BioMarin readies hemophilia gene therapy for FDA submission
But the debate over valrox's durability has not dissipated, as factor expression continued to decline in clinical trial patients.
By Jonathan Gardner • May 28, 2019 -
Novartis gene therapy approved, but will come at cost of more than $2 million
Zolgensma is designed to be a cure for spinal muscular atrophy, but its steep price will pose difficulties for a system designed for chronic therapy rather than one-time treatments.
By Ned Pagliarulo • UPDATED: May 24, 2019 at 2:03 p.m. -
Could Novartis' gene therapy have more than one price?
Indication-based pricing may be possible for less severe patients, who would receive a smaller dose. Lower manufacturing costs would lessen the blow to Novartis too.
By Jonathan Gardner • May 23, 2019 -
No news is bad news for Tocagen
A brain cancer trial of the biotech's combination therapy will continue to final analysis, but investors predict failure as the stock fell to a record low.
By Jonathan Gardner • May 22, 2019 -
Lilly drug scores in Phase 2 Crohn's study
After 12 weeks of treatment, three doses of Lilly's mirikizumab beat placebo on the study's primary endpoint, setting it up for late-stage testing.
By Jacob Bell • May 22, 2019 -
Array gets a win in colorectal cancer
Data for the biotech's triple combination missed expectations, but investors drove shares up to a near record high.
By Jonathan Gardner • May 21, 2019 -
BioCryst meets late-stage study goal, but falls short of competition
The biotech's stock tumbled 50% when markets opened Tuesday, as BioCryst's Phase 3 results failed to stack up to rival therapies.
By Andrew Dunn • May 21, 2019 -
Long-term heart data reassures for Medicines Co.
Inclisiran maintained cholesterol-lowering benefit with fewer side effects than competing Amgen and Sanofi/Regeneron products.
By Jonathan Gardner • May 20, 2019 -
The NASH dash runs into some early hurdles
In a trio of articles, BioPharma Dive explored the key problems the NASH field faces and what's being done to solve them.
By Jacob Bell • May 17, 2019 -
AbbVie brain cancer drug fails late-stage study in another oncology setback
An interim review found the glioblastoma drug didn't improve survival, leading the biotech to end the trial early and halt enrollment for other studies.
By Andrew Dunn • May 17, 2019 -
Breast cancer survival data buoys Macrogenics and Puma
Macrogenics touts signs of an overall survival benefit over Herceptin for margetuximab, while Puma's new Nerlynx study points to a delay in progression, for a price.
By Jonathan Gardner • May 16, 2019 -
Biotech in the spotlight at ASCO as pharma takes back seat
Few major data sets are expected from immunotherapy leaders like Merck, Roche and Bristol-Myers. Instead, studies by Amgen, Macrogenics, Blueprint and Seattle Genetics are drawing attention.
By Ned Pagliarulo • May 16, 2019 -
Pfizer touts late-stage win for JAK drug that could duel with Dupixent
While a thin top-line readout leaves questions on safety, Pfizer says its experimental drug succeeded in a pivotal atopic dermatitis trial.
By Andrew Dunn • May 15, 2019 -
Myovant reports a Phase 3 success, but Wall Street isn't cheered
Results showed Myovant's uterine fibroids drug met its goal, but comparisons to a similar treatment from AbbVie appear to have sapped investor optimism.
By Ned Pagliarulo • May 14, 2019 -
Solid's gene therapy stumble makes Sarepta's lead clearer
Drug-related blood and liver side effects seemed to spook Solid investors.
By Jonathan Gardner • May 14, 2019 -
Fibrogen confuses as it tries to explain blood-boosting drug data
The company claims roxadustat is as safe as Epogen when used to treat anemia in kidney-disease patients, but can't say whether the FDA will agree.
By Jonathan Gardner • May 10, 2019 -
Bristol-Myers' Opdivo fails in Phase 3 glioblastoma test
In the study, Opdivo failed to prolong overall survival in combination with radiation for the hard-to-treat cancer.
By Kristin Jensen • May 09, 2019 -
AstraZeneca's share dilution gamble on Daiichi drug pays off
The U.K.-based pharma sold $3.5 billion worth of shares to pay for a partnership with Daiichi Sankyo on a breast cancer project. Positive trial data suggest the money wasn't wasted.
By Jonathan Gardner • May 08, 2019 -
AstraZeneca blood cancer drug hits study goal early
The results for Calquence help justify AstraZeneca's majority stake in Acerta, but chasing down Imbruvica remains a tall order.
By Ned Pagliarulo • May 07, 2019 -
Roche risdiplam data heats up SMA rivalry with Novartis
The oral agent looks like it could give gene therapy Zolgensma a run for its money.
By Jonathan Gardner • May 07, 2019 -
Epidiolex sales beat Wall Street's bar as GW Pharma reports trial success
The biotech sold more than double what was expected during the cannabis-derived medicine's first full quarter on the market.
By Andrew Dunn • May 07, 2019 -
Novartis makes final Zolgensma pitch before FDA decision
The most severe spinal muscular atrophy patients showed sustained benefit, the company said in a data update at a neurology meeting.
By Jonathan Gardner • May 06, 2019 -
'Pathbreaking' Ionis trial offers way forward in Huntington's disease
Full results from the study were published in NEJM Monday, showcasing what one researcher called the "best piece of news that's emerged from any clinical trial" in the neurodegenerative disease.
By Ned Pagliarulo • May 06, 2019 -
Cytokinetics, Astellas fall short in ALS trial, but spin a success story
While the Phase 2 study failed to achieve its primary goals, the biotech argued it has a clinically meaningful result anyway.
By Andrew Dunn • May 06, 2019 -
Trelegy success gives GSK some respiratory respite
Tumbling sales for Advair have weighed on the British pharma's respiratory business, making positive data for Trelegy in asthma welcome news.
By Ned Pagliarulo • May 03, 2019
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