Clinical Trials: Page 20
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Takeda speeds narcolepsy drug to late-stage testing
New results have convinced Takeda to “rapidly” pursue a late-stage program for its drug TAK-861 in one type of narcolepsy, while in another the company opted not to continue.
By Jacob Bell • Feb. 9, 2024 -
Courtesy of Johnson & Johnson
J&J says top drug prospect works across autoimmune disorders
The pharma disclosed positive results from two studies testing its antibody drug nipocalimab in generalized myasthenia gravis or Sjögren's disease.
By Jacob Bell • Feb. 5, 2024 -
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 -
Permission granted by Vertex Pharmaceuticals
Non-opioid drug from Vertex cuts pain in major trial tests
While the overall results were positive, the drug fell short in both studies on a secondary goal comparing it to a widely prescribed opioid.
By Ned Pagliarulo • Jan. 30, 2024 -
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Deep Dive // State of PlayCAR-T for lupus: the ‘tip of the iceberg’ for cell therapy in autoimmune disease
Since a landmark paper in 2022, drugmakers have begun nearly a dozen trials of cell therapies for lupus, with more set to start. Here’s why their efforts are worth watching.
By Ben Fidler • Jan. 30, 2024 -
Permission granted by Bristol-Myers Squibb
Bristol Myers gets positive data in subcutaneous Opdivo trial
An under-the-skin Opdivo shot produced similar results to an intravenous formulation in kidney cancer, giving Bristol Myers a chance at sustaining sales past a key patent expiration in 2028.
By Jonathan Gardner • Jan. 29, 2024 -
Courtesy of Sarepta
Sarepta data show new Duchenne drug’s potency, but highlight side effects
A successor medicine to Sarepta's Exondys 51 appeared better at boosting dystrophin protein production, but was associated with electrolyte imbalances.
By Ned Pagliarulo • Jan. 29, 2024 -
Courtesy of Bristol Myers Squibb
EMA recommends earlier use of Bristol Myers cell therapy for multiple myeloma
The opinion would allow Abecma to be prescribed after two standard therapies and is the latest sign of CAR-T’s growing use in earlier cancer treatment.
By Jonathan Gardner • Jan. 26, 2024 -
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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 -
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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 -
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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
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