Clinical Trials: Page 14
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Lilly gene therapy finding puts focus on hearing loss treatment pipeline
An 11-year-old boy born deaf can hear after receiving Lilly's genetic medicine. Others, including biotechs in China and Regeneron in the U.S., are taking aim at the same drug target.
By Ned Pagliarulo • Updated Jan. 25, 2024 -
Mohammed Haneefa Nizamudeen via Getty Images
Gilead ADC medicine misses goal in closely watched lung cancer study
Trodelvy didn’t outperform chemotherapy in a large study of people with a common lung tumor, a setback that sent company shares down by double digits.
By Jonathan Gardner • Jan. 22, 2024 -
Explore the Trendline➔
Meletios Verras via Getty Images
TrendlineOncology's research boom
More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.
By BioPharma Dive staff -
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Ionis says rare disease drug succeeds in late-stage HAE study
The medicine, called donidalorsen, reduced hereditary angioedema-related attacks in the Phase 3 trial. Several competing options to it are already available or in advanced testing, however.
By Ben Fidler • Jan. 22, 2024 -
Novartis details first-line data for radiopharma drug Lutathera
Phase 3 trial results showed Lutathera cut the risk of disease progression or death by 72% as initial treatment for gastroenteropancreatic neuroendocrine tumors, or GEP-NETs.
By Ned Pagliarulo • Jan. 19, 2024 -
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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 -
Kendall Davis/BioPharma Dive
Deep Dive10 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 -
Courtesy of Sarepta
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 -
Courtesy of Sanofi
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 -
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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 -
Massachusetts General Hospital
Deep Dive // Brain drug revivalAs 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 -
Courtesy of UniQure
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 -
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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 -
Bill Sikes/AP
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 -
Courtesy of Nick Agro/American Society of Hematology
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 -
Permission granted by Celonis
Sponsored by CelonisLife 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 -
ASH/Nick Agro 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 -
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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 -
Elizabeth Regan/BioPharma Dive
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 -
Courtesy of Merck KGaA
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 -
Zorica Nastasic via Getty Images
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 -
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Sponsored by Worldwide Clinical TrialsRevolutionizing 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 -
shutterstock.com/DadBusiness
Sponsored by Target RWEOvercoming 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 -
Michael M. Santiago via Getty Images
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 -
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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
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