Clinical Trials: Page 4
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Allogene to shift strategy in bid to reposition CAR-T
The company plans to restructure and will start a new late-stage study testing whether its “off-the-shelf” therapy can boost cure rates when used early on.
By Ben Fidler • Jan. 4, 2024 -
Deep Dive
10 clinical trials to watch in the first half of 2024
A non-addictive pain pill faces its definitive test, while study results in ALS and for a Duchenne gene therapy could have far-reaching implications.
By Ben Fidler , Jacob Bell , Ned Pagliarulo , Jonathan Gardner , Delilah Alvarado • Jan. 2, 2024 -
Trendline
Immunology
Promising new mechanisms of action are driving significant pharmaceutical company investment into drugs for immune diseases like psoriasis and Crohn’s.
By BioPharma Dive staff -
Sarepta tests FDA flexibility with bid to expand Duchenne gene therapy’s approval
The biotech is asking the agency to clear its treatment Elevidys in more patients with the disease, despite a confirmatory trial that missed its main goal.
By Ned Pagliarulo • Dec. 22, 2023 -
Sanofi scraps a top ADC prospect after study setback
The drug, acquired via a deal with ImmunoGen, was the most advanced experimental medicine in the French pharma’s pipeline.
By Ben Fidler • Dec. 21, 2023 -
Argenx autoimmune drug study fails in blow to expansion hopes
The Dutch biotech’s star product has lost some luster after a second failed Phase 3 trial in two months, this time for a skin condition called pemphigus.
By Kristin Jensen • Dec. 20, 2023 -
Deep Dive // ALS drug development
As ALS research booms, one treatment center finds itself in the spotlight
The Healey center is at the front of ALS research and care, earning acclaim from patients, doctors and scientists. Still, the complexities of the disease and of drug development have brought hard-felt losses.
By Jacob Bell • Dec. 20, 2023 -
Investors still aren’t sold on UniQure’s gene therapy for Huntington’s
The biotechnology company’s share price fell more than 10% Tuesday after the disclosure of more data from a small study.
By Jacob Bell • Dec. 19, 2023 -
Obesity drugs
Structure shares sink as obesity pill misses expectations in small study
Results from a Phase 2 trial fell short of what’s been seen with a similar Eli Lilly medicine, causing the closely watched biotech’s shares to plummet.
By Ben Fidler • Dec. 18, 2023 -
New Moderna cancer vaccine data spurs share rally
Shares climbed by double digits after new evidence led to speculation among analysts that Moderna and partner Merck could seek an approval before completing Phase 3 testing.
By Jonathan Gardner • Dec. 14, 2023 -
Vertex builds case for non-opioid pain drug ahead of key study readouts
The closely watched medicine showed promise treating a form of chronic nerve pain, with the results suggesting comparable effects to an available therapy.
By Kristin Jensen • Dec. 13, 2023 -
ASH23: Pharma branding, Editas’ high bar and clinical trial diversity
Editas had the tall task Monday of convincing ASH attendees its gene therapy for sickle cell disease could improve on Casgevy and Lyfgenia.
By Gwendolyn Wu , Ned Pagliarulo • Dec. 11, 2023 -
Sponsored by Celonis
Life sciences leaders invest in process mining to accelerate digital transformation
Research from Everest Group shows how life sciences leaders are investing in process mining to speed time-to-market, improve regulatory compliance and drive innovation.
By Rachel Stolba • Dec. 11, 2023 -
ASH23: CAR-T for autoimmune disease, real-world questions and sickle cell’s social media mentions
Results disclosed at the American Society of Hematology meeting suggested potential for cell therapy in lupus and pointed out drug trial limitations.
By Ned Pagliarulo • Dec. 9, 2023 -
Merck suffers bad week as 3 Keytruda combination trials fail
The setbacks for Merck demonstrate the challenge drug developers face in improving on Keytruda, which has brought in at least $18 billion so far this year for its maker.
By Jonathan Gardner • Dec. 8, 2023 -
Pharvaris shares spike as drug appears to prevent symptoms of rare disorder
The company moved quickly to capitalize on the stock surge, announcing plans to raise $300 million through a secondary stock offering.
By Jacob Bell • Dec. 6, 2023 -
German Merck’s MS drug falls short in pair of Phase 3 tests
The results dim the outlook of BTK inhibitors as potential autoimmune disease treatments and could have ramifications for Roche, Sanofi and Novartis.
By Kristin Jensen • Dec. 6, 2023 -
EyePoint sees stock surge on AMD drug trial data
The biotech said Phase 2 study results showed its experimental medicine for age-related macular degeneration was "non-inferior" to Regeneron's Eylea.
By Ned Pagliarulo • Dec. 4, 2023 -
Sponsored by Worldwide Clinical Trials
Revolutionizing clinical trials: Unlocking peak efficiency with total laboratory automation in bioanalysis
With clinical trials becoming more complex, finding ways to streamline and automate laboratory processes is vital when analyzing bioanalytical samples.
Dec. 4, 2023 -
Sponsored by Target RWE
Overcoming scalability challenges in real-world data processing for transformative patient care
Accurate and timely processing of data is imperative to create robust analytical datasets that can be used in the RWE setting.
By Rob Sullivan, Chief Data & Analytics Officer • Dec. 4, 2023 -
Pfizer plans for oral obesity drug hit new setback
The company won’t continue development of a twice-daily dose of its experimental weight loss medicine danuglipron after study data showed high rates of side effects.
By Ned Pagliarulo • Dec. 1, 2023 -
CRO disputes Acelyrin’s implication of trial misconduct
Trial contractor Fortrea is fighting back as Acelyrin unveils a CRO audit in the wake of a major late-stage study failure.
By Kristin Jensen • Nov. 30, 2023 -
GSK cancer drug Blenrep gets surprise trial win
One year after the U.K. drugmaker withdrew the multiple myeloma drug from the U.S. market because of negative data, new study results might crack open the door to a relaunch.
By Jonathan Gardner • Nov. 27, 2023 -
Regeneron, Sanofi to seek new Dupixent approval in US after COPD success
Results from the second of two Phase 3 trials testing the blockbuster drug in the respiratory condition showed treatment could reduce attacks and improve lung function.
By Ned Pagliarulo • Nov. 27, 2023 -
Xenon drug misses main goal of depression study
Yet, the company believes there were enough positive findings in the mid-stage trial to warrant further study of its drug, called XEN1101, in depression.
By Jacob Bell • Nov. 27, 2023 -
Bayer ends large blood thinner trial for ‘inferior efficacy’
Company shares fell after study monitors called for halting a planned 18,000-person trial because Bayer’s drug wasn’t working as well as Eliquis.
By Jonathan Gardner • Updated Nov. 20, 2023