Clinical Trials: Page 27
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Viking joins obesity drug development race with early study data
The biotech is working on a dual-acting weight loss treatment that could compete with medicines from Novo Nordisk, Eli Lilly and others.
By Jonathan Gardner • March 28, 2023 -
Intra-Cellular shares rise on depression study’s success
The biotech’s drug lumateperone scored in a late-stage study of patients with either bipolar or major depressive disorder — results which some analysts called a “clear win.”
By Jacob Bell • March 28, 2023 -
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 -
Novartis
Novartis, following Lilly, claims success in early breast cancer study
The Swiss drugmaker believes the findings could support an approval of Kisqali in adjuvant breast cancer and, potentially, broader use than Lilly’s rival drug Verzenio.
By Jonathan Gardner • March 27, 2023 -
Jacob Bell/BioPharma Dive
ALS drug developmentALS drugmakers, encouraged by recent FDA feedback, set their sights on a key protein
A closely watched meeting showed the FDA’s own external advisers think that effects on this protein, known as neurofilament, could be enough to warrant conditional approval of certain drugs.
By Jacob Bell • Updated March 31, 2023 -
Courtesy of Sanofi
Sanofi, Regeneron surge as Dupixent scores in COPD trial
The two companies gained billions of dollars in market value after their antibody drug succeeded against a disease that’s been difficult to treat with biologic medicines.
By Ben Fidler • March 23, 2023 -
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Karuna’s schizophrenia drug succeeds in a second late-stage trial
The results add to a growing body of evidence that Karuna’s drug, known as KarXT, could be a valuable new option for patients living with the brain disorder.
By Jacob Bell • Updated March 20, 2023 -
Permission granted by West Pharmaceutical Services
Sponsored by West Pharmaceutical ServicesEarly decisions to de-risk the transition to combination products
Speeding up the drug development process through a less optimized containment and delivery system may have been an option in the past, but both expectations and the competitive environment are changing.
March 20, 2023 -
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Takeda, chasing Bristol Myers, unveils awaited TYK2 drug data
"This is why we did the deal," said Takeda R&D chief Andy Plump, referring to his company's $4 billion acquisition of the medicine from startup Nimbus Therapeutics.
By Ben Fidler • March 18, 2023 -
Courtesy of Merck & Co.
Merck TIGIT drug misses goal in lung cancer trial, adding to doubts over approach
The combination drug didn’t help patients any more than chemotherapy, but Merck will continue the trial to test it together with chemo.
By Jonathan Gardner • March 17, 2023 -
Permission granted by Open Clinica
Sponsored by OpenClinicaClinical trial researchers are burned out too. Automated data capture is helping.
Manual data transcription increases clinical research coordinator burnout. There is a better way.
By Ben Baumann, OpenClinica Co-Founder and COO • March 13, 2023 -
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FDA advisers back earlier use of Roche lymphoma drug
The positive vote comes despite doubts from FDA scientists and increases the chance that Polivy could soon be approved as a first-line treatment alongside a drug regimen called R-CHOP.
By Jonathan Gardner • March 10, 2023 -
National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.
Lilly reaches end of the road with long-studied Alzheimer’s drug
Prior trial failures hadn’t halted testing of solanezumab, once Lilly’s top Alzheimer’s drug candidate. But its final study defeat may help scientists better understand how to target the brain disease.
By Jonathan Gardner • March 9, 2023 -
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AstraZeneca builds on study successes in early lung cancer
The pharma’s drug Tagrisso extended survival in a trial that stirred debate at ASCO three years ago, while its immunotherapy Imfinzi reduced the risk of relapse in a different study.
By Ben Fidler • March 9, 2023 -
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With PCSK9 pill, Merck aims to succeed where others failed
The company is planning an ambitious Phase 3 program testing its oral cholesterol-lowering drug, which in a mid-stage trial appeared to match the effects of approved injectable competitors.
By Christopher Newman • March 7, 2023 -
Courtesy of Merck & Co.
Merck drug data suggest ‘new direction’ for rare blood vessel disease
Treatment with Merck’s sotatercept helped improve the exercise capacity of patients with pulmonary arterial hypertension, anticipated results from a Phase 3 study showed.
By Christopher Newman • March 6, 2023 -
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Esperion shares sink on highly anticipated heart drug results
The company says the findings could spur wider adoption of its pill Nexletol, though shares fell 20% as the data was short of Wall Street expectations.
By Christopher Newman • March 6, 2023 -
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BridgeBio shares jump on dwarfism drug data
The results impressed analysts and suggest the biotech's drug could become a threat to BioMarin's Voxzogo, sending shares up about 60%.
By Kristin Jensen • March 6, 2023 -
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Sponsored by Kroger HealthKroger Health works to expand access to clinical trials
Kroger Health seeks to increase awareness among more eligible clinical trial participants.
March 6, 2023 -
Exelixis reports trial failure for cancer drug combination
The setback is the second for the pairing of Cabometyx and Roche’s immunotherapy Tecentriq, dimming Exelixis’ hopes of further expanding its drug’s use before a key patent expires.
By Jonathan Gardner • March 3, 2023 -
Permission granted by Veeva Systems
Despite study setback, a biotech plans to push tremor drug into late-stage testing
An experimental medicine from Praxis Precision Medicines missed the main goal of a Phase 2b trial. But there were also some positive findings, which have encouraged the company to press forward.
By Jacob Bell • March 3, 2023 -
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FDA asks advisers to review Lynparza amid growing scrutiny of PARP drugs
The meeting to discuss Lynparza's use as a frontline treatment for prostate cancer follows a string of withdrawals for drugs in its class, and evidence it didn’t meaningfully extend survival in late-stage testing.
By Jonathan Gardner • March 2, 2023 -
Permission granted by Bristol-Myers Squibb
Bristol Myers, J&J plan tests of new blood thinner in nearly 50,000 patients
The Phase 3 program for their medicine, milvexian, will be among the largest in drug development and almost twice the size of what Bayer has planned for a competing treatment.
By Kristin Jensen • March 2, 2023 -
Courtesy of Merck & Co.
Merck reports two Phase 3 study misses for Keytruda
The negative results in prostate and lung cancer are rare trial failures for the immunotherapy, and could limit expanded use of the drug in treating those tumor types.
By Jonathan Gardner • Feb. 28, 2023 -
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Following another trial failure, a brain biotech considers ‘strategic alternatives’
Aptinyx has joined a lengthy list of drugmakers looking to cut costs and explore strategic options after hitting setbacks in key clinical studies.
By Jacob Bell • Feb. 28, 2023 -
Courtesy of Intellia Therapeutics
Sickle cell pipeline narrows as gene therapy developers rethink research plans
Graphite Bio and Sangamo are stopping work on their respective sickle cell gene therapies, while Intellia revealed partner Novartis ended development of its genetic treatment for the blood disease.
By Ned Pagliarulo • Feb. 23, 2023
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