Clinical Trials
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European study finds popular ALS drug ineffective
The failure of a medicine known as TUDCA is yet another disappointment for ALS patients, as it comes just after Amylyx’s therapy Relyvrio proved unsuccessful in confirmatory testing.
By Jacob Bell • March 27, 2024 -
Obesity drugs
Viking stays in obesity drug race with early data for weight loss pill
The results are from a small Phase 1 study, but suggest Viking’s oral GLP-1 drug may not come with high rates of gastrointestinal side effects.
By Jonathan Gardner • March 26, 2024 -
Trendline
Cell therapy
Six CAR-T cell therapies are now approved in the U.S., and their continued emergence has helped fueled further research into next-generation approaches.
By BioPharma Dive staff -
Stoke shares surge on updated results for Dravet drug
The biotech is trying to develop a Spinraza-like drug for the condition, a form of genetic epilepsy. Fresh data appear supportive of a high dose’s effectiveness.
By Ned Pagliarulo • March 26, 2024 -
Axsome drug succeeds in narcolepsy symptoms trial
Despite the late-stage victory, shares of the New York-based biotech dipped more than 3%. One analyst argued that Axsome’s drug has “largely been falling under investor radars.”
By Jacob Bell • March 25, 2024 -
FDA rejects Regeneron lymphoma drug, setting back company’s oncology push
The agency wants Regeneron to make more progress with a confirmatory trial before clearing odronextamab, a “bispecific” antibody being developed for multiple blood cancers.
By Jonathan Gardner • March 25, 2024 -
Sponsored by TriNetX
Improving clinical trial design with real-world data
Leveraging real-world data (RWD) transforms global clinical trials, enhancing patient engagement and improving regulatory decision-making.
March 25, 2024 -
Roche autoimmune disease drug disappoints in closely watched trial
Though the medicine hit its goal in a Phase 3 study in myasthenia gravis, the results fell short of expectations in a boost to rival drug developers like Argenx and AstraZeneca.
By Jonathan Gardner • March 21, 2024 -
Acelyrin eye drug heads to late-stage testing after trial win
The biotech, which raised $540 million in an initial public offering last year, is pitching the medicine as a potential challenger to Amgen’s blockbuster eye drug Tepezza.
By Jacob Bell • March 20, 2024 -
With new data, Bayer readies rival to Astellas menopause drug
Following a third successful Phase 3 trial, the company is planning approval filings for the medicine, which it acquired in a $425 million deal four years ago.
By Delilah Alvarado • March 19, 2024 -
Merck reveals plans to develop newer HPV shots
The pharma intends to test a single-dose regimen as well as a shot that may provide broader protection than the current versions of Gardasil that regularly generate billions in annual sales.
By Delilah Alvarado • March 13, 2024 -
Acadia drug fails schizophrenia trial, setting back company’s expansion plans
The setback shuts out Acadia’s top medicine from a large sales opportunity and heightens the biotech’s dependence on a pipeline filled with risky drug prospects.
By Kristin Jensen • March 12, 2024 -
Roche, following setbacks, turns to its next Alzheimer’s drug
Roche said its experimental Alzheimer’s disease drug trontinemab showed it might be able to clear brain plaques faster than other medicines.
By Jonathan Gardner • March 11, 2024 -
Q&A
Amylyx CEOs look for a path forward following major setback
Justin Klee and Joshua Cohen spoke to BioPharma Dive about the next steps for their company, which is considering pulling its only product from market after the drug failed a confirmatory study in ALS.
By Jacob Bell • March 11, 2024 -
Amylyx ALS drug fails crucial study, putting company’s future in doubt
The results have led Amylyx to pause promotion of Relyvrio and potentially pull it from the market in the coming weeks, a major blow to the company and ALS patients.
By Jacob Bell • Updated March 8, 2024 -
NodThera says inflammation drug has positive effect in Parkinson’s
The results from the privately held biotech add to early evidence supporting the potential of an increasingly popular drug target known as NLRP3 inflammasomes.
By Jacob Bell • March 7, 2024 -
Novo’s latest obesity pill spurs major weight loss in small trial
Early results from a Phase 1 study suggest the drug, amycretin, could be as potent as injectable medicines already sold by Novo and rival Eli Lilly.
By Jonathan Gardner • March 7, 2024 -
Alnylam, Roche blood pressure drug scores in second mid-stage trial
The study results further validate Roche’s recent decision to acquire rights to the drug, which is being developed for people with a stubborn form of hypertension.
By Jonathan Gardner • March 5, 2024 -
Apogee data hint at potential for long-lasting eczema drug
The biotech, which raised $300 million in an IPO last year, disclosed early results suggesting its therapy could be dosed less frequently than medicines from Eli Lilly and Regeneron.
By Kristin Jensen • March 5, 2024 -
Akero strengthens MASH drug’s case with new study data
The updated results show that responses to the drug, which is currently in late-stage testing, deepened with time, helping the company rebound from an earlier setback.
By Ben Fidler • March 4, 2024 -
Sponsored by QIAGEN
Using knowledge graphs to drive drug discovery
How are knowledge graphs changing the path of drug discovery?
March 4, 2024 -
Incannex says psilocybin therapy lowered anxiety in small study
Shares of the Australian biotech rocketed up about 55% after the company announced results from a mid-stage study in generalized anxiety disorder.
By Jacob Bell • Feb. 28, 2024 -
Viking data suggest obesity drug could rival Zepbound, Wegovy
The biotech’s drug led to significant weight loss in a Phase 2 trial, causing shares to double as analysts compared results to the marks set by drugs from Eli Lilly and Novo Nordisk.
By Jonathan Gardner • Feb. 27, 2024 -
Janux shares triple on early cancer immunotherapy data
Analysts viewed results for one of Janux’s drug, a T cell engager aimed at metastatic prostate cancer, as potentially best-in-class in a field that’s crowded with competitors.
By Ned Pagliarulo • Feb. 27, 2024 -
Minerva schizophrenia drug rejected by FDA
The agency’s complete response letter knocks back Minerva’s attempt to secure approval of the drug over agency reviewers’ objections.
By Ned Pagliarulo • Feb. 27, 2024 -
GSK drug meets goal in late-stage gonorrhea study
The drug, one of several GSK is developing for drug-resistant bacteria, has now succeeded in testing against two different infections.
By Delilah Alvarado • Feb. 26, 2024