Clinical Trials: Page 18
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After ‘sobering’ FDA panel, psychedelics supporters wonder what’s next
A vote against MDMA-assisted therapy set back a high-profile treatment. Proponents argue the panel offered few solutions to longstanding problems, making the path forward unclear.
By Jacob Bell • June 7, 2024 -
Alyssa Eckel-Martin/BioPharma Dive
Sponsored by BioLineRx[Podcast] The Power of Persistence: From Biotech Incubator to Product Launch
How can small and mid-sized biotech companies better manage pharmacovigilance during clinical trials? Listen to the podcast to learn how strategic alliances are helping.
By BioPharma Dive's studioID • Updated June 18, 2024 -
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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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FDA panel votes against MDMA therapy for PTSD, citing muddy data and safety concerns
“I just feel very convinced that I had to vote no,” said one member of the committee, which was unconvinced by Lykos Therapeutics’ data on MDMA-assisted treatment for post-traumatic stress disorder.
By Jacob Bell • Updated June 4, 2024 -
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BridgeBio data show sustained benefit for achondroplasia drug
Longer follow-up results from a mid-stage trial indicate the company’s treatment for a genetic cause of dwarfism may be competitive to an approved therapy from BioMarin Pharmaceutical.
By Ned Pagliarulo • June 4, 2024 -
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Viking says biopsy data confirm MASH drug’s benefit
The company may look to license the experimental liver disease drug as it focuses on an obesity treatment that's shown early promise.
By Jonathan Gardner • June 4, 2024 -
ASCO / Nick Agro
ASCO24: Tagrisso in the spotlight, Caribou’s adjustment and Lilly’s KRAS competitor
AstraZeneca’s therapy could see wider use after ASCO data. Elsewhere, Caribou sought to explain an alternative cell therapy strategy that will delay its study plans.
By BioPharma Dive staff • June 3, 2024 -
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Structure pill leads to competitive weight loss in obesity study
Shares in the company soared by more than 50% as study data showed the pill led to similar levels of weight loss as a rival drug being developed by Eli Lilly.
By Delilah Alvarado • June 3, 2024 -
Menarini Silicon Biosystems
Sponsored by Menarini Silicon BiosystemsA true liquid biopsy hub – Menarini Silicon Biosystem
Liquid biopsy has emerged as a revolutionary tool for clinical trials, offering cellular and cell-free methods that provide valuable insights into disease progression and treatment response.
June 3, 2024 -
Jonathan Gardner/BioPharma Dive
AstraZeneca immunotherapy extends survival by two years in rarer type of lung cancer
The findings, from a trial testing Imfinzi in limited-stage small cell lung cancer, could help AstraZeneca expand the drug's use.
By Jonathan Gardner • Updated June 2, 2024 -
ASCO / Nick Agro
GSK builds case for return of multiple myeloma drug Blenrep
Study results showed the antibody-drug conjugate helped stave off disease progression better than a standard treatment. But eye-related side effects remained common.
By Jonathan Gardner • June 2, 2024 -
Permission granted by Daiichi Sankyo
With new Enhertu data, an ADC could overtake chemo in breast cancer
The results are a step forward for antibody-drug conjugates, which Enhertu makers AstraZeneca and Daiichi Sankyo see replacing chemo in many tumors.
By Ben Fidler • June 2, 2024 -
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Gilead’s Trodelvy misses goal in bladder cancer study
Treatment didn’t significantly improve overall survival in the trial, a finding that one analyst described as a “meaningful setback” to Gilead’s oncology pipeline.
By Ned Pagliarulo • May 31, 2024 -
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Novartis study points to larger role for targeted leukemia drug
Results from a trial called ASC4FIRST show Scemblix outperformed Gleevec and other drugs in treating newly diagnosed chronic myeloid leukemia.
By Ned Pagliarulo • Updated June 3, 2024 -
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J&J antidepressant eases symptoms, improves sleep in key trial
The company has put high expectations on the drug, an orexin-2 antagonist called seltorexant, as a cornerstone of its neuropsychiatry pipeline.
By Ned Pagliarulo • May 29, 2024 -
Elizabeth Regan/BioPharma Dive
Insmed shares double as lung drug data convince Wall Street
After reporting positive clinical trial results for its drug brensocatib, Insmed plans to later this year file for U.S. approval in bronchiectasis that’s not associated with cystic fibrosis.
By Ned Pagliarulo • May 28, 2024 -
ASCO / Nick Agro
Certain menopausal hormone therapy could raise ovarian cancer risk, study finds
The findings, from two trials involving thousands of women, could influence guidelines around use of hormonal treatment for menopause symptoms.
By Delilah Alvarado • May 23, 2024 -
ASCO / Nick Agro
ASCO24: An early look at cancer drug study results
Clinical trial abstracts posted Thursday ahead of this year’s ASCO meeting give a peek at anticipated datasets from Immunocore, Merus, J&J and Merck & Co.
By BioPharma Dive staff • Updated May 24, 2024 -
Elizabeth Regan/BioPharma Dive
Dyne shares jump on trial data for muscle disease drugs
Updated study results for the biotech’s medicines for myotonic dystrophy Type 1 and Duchenne muscular dystrophy appeared to impress analysts and investors on Wall Street.
By Ned Pagliarulo • May 20, 2024 -
iStock / Worawut Prasuwan
Sponsored by PanalgoThe ABCs of SDOH: Meaningful strategies to improve patient outcomes
As biopharmaceutical and medical device companies increasingly recognize the impact of SDOH, a question emerges: how can these sponsors effectively integrate SDOH data into clinical trial recruitment and real-world evidence strategies?
By Meg Richards, PhD, MPH, Executive Director, Scientific Strategy at Panalgo, with Andrew Goldstein, VP of Client Partnerships at Panalgo • May 20, 2024 -
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Detailed trial data show Bayer drug alleviates menopause symptoms
Full study results disclosed ahead of a medical meeting showed elinzanetant consistently reduced the frequency and severity of hot flashes.
By Delilah Alvarado • May 16, 2024 -
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Lilly’s once-weekly insulin matches daily shots in late-stage tests
The results, which showed Lilly’s drug was as effective at controlling blood sugar as standard injections, come as Novo Nordisk seeks approval for a competing once-weekly insulin.
By Ned Pagliarulo • May 16, 2024 -
Courtesy of Roche
Roche keeps pace in obesity drug field with early study data
A drug Roche acquired in a buyout of Carmot Therapeutics and that works similarly to Zepbound helped people lose nearly 19% of their body weight in a Phase 1 trial.
By Jonathan Gardner • May 16, 2024 -
Permission granted by Biogen
ALS drug developmentBiogen, Ionis shelve ALS drug following study failure
While results indicated the drug works as intended, it didn’t have enough of an effect on a protein that’s become integral to many ALS research programs.
By Jacob Bell • May 16, 2024 -
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Novo Holdings buys stake in life sciences tools company; BioMarin lays off 170
The parent of Novo Nordisk is acquiring 60% ownership of Single Use Support, which specializes in handling of advanced therapies. Elsewhere, BioMarin and gene therapy developer Tenaya are cutting jobs.
By Ned Pagliarulo • May 15, 2024 -
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Sponsored by PearsonAcknowledging comorbidities in trial design is essential for successful outcomes
Examine why adaptive trials that consider comorbidities are critical for a successful trial outcome.
May 13, 2024
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