Clinical Trials: Page
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A biomarker could tackle one of worst diseases in sports
Exosome Sciences is investigating a potential biomarker for a rare neurodegenerative disease that has plagued veterans and professional athletes.
By Jacob Bell • Feb. 13, 2017 -
Prescribed Reading: When will Gilead tap its cash hoard?
2017 looks bleak for Gilead's hepatitis C business, Lundbeck reports yet another Alzheimer's trial failure and a new pricing controversy bubbles up.
By Lisa LaMotta • Feb. 10, 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 -
Deep Dive
Microbiome work reignites after Seres' initial flame-out
Despite a trial failure from the first public microbiome-focused company's lead product, market analysts say investment is still flowing and the field could show dramatic growth over time.
By Judy Packer-Tursman • Feb. 10, 2017 -
FDA
Acorda speeds toward filing of Parkinson's drug
An inhalable version of levodopa showed positive results in Phase 3, setting up the biotech for a potential approval.
By Lisa LaMotta • Feb. 9, 2017 -
Janssen touts Xarelto's broader uses, halts CV trial early
The blockbuster blood thinner has proven so effective at preventing heart attack and stroke in certain patients that a global Phase 3 study is being stopped more than a year early.
By Judy Packer-Tursman • Feb. 9, 2017 -
Amgen secures FDA approval for hormone drug
The approval should help ease the threat Amgen faces as generics move in on the company's older drug for a similar indication.
By Jacob Bell • Feb. 8, 2017 -
Lundbeck brings latest Alzheimer's failure
The Danish drugmaker reported two late-stage failures that put an end to its 5-HT6 antagonist in yet another setback for the space.
By Lisa LaMotta • Feb. 8, 2017 -
Express Scripts says branded drug prices rose nearly 11% last year
The large PBM contrasted those rising costs with the slower cost growth experienced by its members, touting its efforts to secure rebates from drugmakers.
By Jacob Bell • Feb. 6, 2017 -
Innate's cancer immunotherapy falls short in Phase 2
The French drugmaker has licensed rights to lirilumab to Bristol-Myers Squibb, which is testing the anti-KIR drug in combination with other cancer agents, including Opdivo.
By Ned Pagliarulo • Feb. 6, 2017 -
Amgen buoyed by Repatha success, earnings beat
Repatha met its goal in a closely watched cardiovascular outcomes trial, potentially giving the slow-growing drug a competitive edge over rival Praluent.
By Judy Packer-Tursman • Feb. 3, 2017 -
Prescribed Reading: A week dominated by politics and earnings
Pharma's sit down with President Trump was a hot topic in earnings calls this week as markets tried to gauge the new administration's approach to the industry.
By Lisa LaMotta • Feb. 3, 2017 -
Catabasis' DMD drug fails in Phase 2
The rare disease drugmaker revealed top-line data showing its treatment for Duchenne muscular dystrophy did not significantly outperform placebo.
By Jacob Bell • Feb. 1, 2017 -
Pfizer counts on Ibrance as Prevnar sales slip
Sales of the breast cancer drug continued to grow strongly in the fourth quarter, bolstering the company's confidence it can stave off potential inbound competition.
By Ned Pagliarulo • Jan. 31, 2017 -
Ocera tumbles 70% after phase 2 failure
Top-line results floor share value as Phase 2b study doesn't show statistical significance.
By Suzanne Elvidge • Jan. 31, 2017 -
Regulus hits further setbacks as clinical hold upheld
Stock dropped by 20% after hours on Friday following an FDA request for more data on the microRNA-targeting drug RG-101.
By Suzanne Elvidge • Jan. 30, 2017 -
Prescribed Reading: J&J closes $30B deal, FDA talks regen med
J&J finally closes the deal with Actelion, despite poor data for Opsumit, while the FDA creates a new designation and Biogen looks to woo payers with data.
By Lisa LaMotta • Jan. 27, 2017 -
Pfizer set to move C. diff vaccine into Phase 3
An interim analysis of data from a Phase 2 study showed positive immunogenic effects from treatment with the experimental vaccine.
By Judy Packer-Tursman • Jan. 27, 2017 -
Vertex touts CF drugs, but sees promise in pain
The Boston-based company anticipates sales growth for its cystic fibrosis drug Orkambi in Europe this year, but some analysts see movement there as slow-going.
By Judy Packer-Tursman • Jan. 26, 2017 -
Novartis aims to gain ground on I/O leaders
Merck, Roche and Bristol-Myers have seized the lead in immuno-oncology, but Novartis hopes to build a broad portfolio of second-generation immunotherapies that can close the gap.
By Ned Pagliarulo • Jan. 25, 2017 -
FDA
FDA report stresses importance of Phase 3 testing
Several rumored candidates for FDA chief under President Trump have previously criticized the FDA approval process as being too slow.
By Judy Packer-Tursman • Jan. 25, 2017 -
Deep Dive
Lilly turns to pain after solanezumab failure
With a new focus on pain and migraine medications, Eli Lilly hopes to reinvigorate its neuroscience pipeline and portfolio.
By Jacob Bell • Jan. 25, 2017 -
Why biosimilars could be market disruptors
The biologic copies are just now entering the U.S. market and could mean a shift in several major therapeutic indications.
By Suzanne Elvidge • Jan. 23, 2017 -
Marinus up on small ganaxolone hope
The Pennsylvania biotech reported positive data in a small number of patients, giving hope to investors.
By Lisa LaMotta • Jan. 23, 2017 -
Actelion misses goal in study, but takeover talks likely unaffected
Pharma giant J&J is in exclusive discussions with Actelion about a potential acquisition of the Swiss biotech and its portfolio of drugs for pulmonary hypertension.
By Ned Pagliarulo • Jan. 23, 2017 -
FDA gives go-ahead to Synergy's constipation drug
Facing a crowded market, the company’s CEO asserts that Synergy has “the right strategic vision and the right launch plan” for Trulance.
By Judy Packer-Tursman • Jan. 22, 2017
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