Clinical Trials
-
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 -
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 -
Explore the Trendline➔
digicomphoto via Getty ImagesTrendlineNeuroscience 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 -
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 -
Sponsored by Worldwide Clinical Trials
Revolutionizing 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 -
Sponsored by Target RWE
Overcoming 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 -
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 -
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 -
GSK cancer drug Blenrep gets surprise trial win
One year after the U.K. drugmaker withdrew the multiple myeloma drug from the U.S. market because of negative data, new study results might crack open the door to a relaunch.
By Jonathan Gardner • Nov. 27, 2023 -
Regeneron, Sanofi to seek new Dupixent approval in US after COPD success
Results from the second of two Phase 3 trials testing the blockbuster drug in the respiratory condition showed treatment could reduce attacks and improve lung function.
By Ned Pagliarulo • Nov. 27, 2023 -
Xenon drug misses main goal of depression study
Yet, the company believes there were enough positive findings in the mid-stage trial to warrant further study of its drug, called XEN1101, in depression.
By Jacob Bell • Nov. 27, 2023 -
Bayer ends large blood thinner trial for ‘inferior efficacy’
Company shares fell after study monitors called for halting a planned 18,000-person trial because Bayer’s drug wasn’t working as well as Eliquis.
By Jonathan Gardner • Updated Nov. 20, 2023 -
Biohaven hopes to muscle in on Ozempic with a different type of weight loss drug
Several biotech companies, Biohaven among them, are trying to develop medicines that could trim the waistline while building lean tissue.
By Kelly Bilodeau • Nov. 20, 2023 -
Gene therapy safety
Paper details Astellas gene therapy study that led to patient deaths
The company, which is working with regulators to lift a clinical hold, said the treatment could still help people with X-linked myotubular myopathy.
By Kristin Jensen • Nov. 16, 2023 -
Anthos blood thinner bests Xarelto on safety in mid-stage study
Trial results add to evidence that so-called Factor XIa inhibitors could have less bleeding risk than currently available oral anticoagulants like Xarelto.
By Ned Pagliarulo • Updated Nov. 14, 2023 -
Sponsored by Target RWE
Real-world evidence in pharmaceutical drug development – faster, safer and more relevant?
Regulatory agencies have set the framework and use cases for RWE. How can these increase the probability of success or efficiency in a pre-clinical and clinical drug development program?
By Lutz Schlicht, PhD, Target RWE • Nov. 13, 2023 -
Sponsored by Pearson
3 ways decentralized clinical trials could help advance research on rare diseases
Explore how decentralized clinical trials (DCTs) can enhance rare disease research in three key ways.
Nov. 13, 2023 -
Gene editing
First look at Verve study data offers base editing ‘proof of principle’
Early clinical trial results showed Verve’s therapy can substantially lower bad cholesterol. Still, investors sent the biotech’s shares down by 40% Monday.
By Ned Pagliarulo • Nov. 12, 2023 -
Obesity drugs
Detailed trial data confirm Wegovy heart benefit
As GLP-1 drugs for weight loss take off, the results for Novo Nordisk’s treatment could help convince insurers to expand coverage.
By Jonathan Gardner • Nov. 11, 2023 -
Atara’s cell therapy approach to MS falls short in study
Shares in the biotech tumbled by 75% as results from a Phase 2 trial showed more improvement in participants given a placebo.
By Kristin Jensen • Nov. 9, 2023 -
Celldex’s reinvention advances with inflammatory disease drug data
Shares in the biotech jumped higher Monday on positive results for the company's drug barzolvolimab in two chronic itching conditions.
By Ned Pagliarulo • Nov. 6, 2023 -
Sarepta gene therapy for Duchenne misses main goal of key study
Results from the EMBARK study, which were meant to confirm the approval of Sarepta's Elevidys, sent the company's shares down more than 40% Tuesday.
By Ned Pagliarulo • Updated Oct. 31, 2023 -
Novartis bet on kidney disease drug yields positive study data
The pharma paid more than $3 billion this summer to acquire Chinook Therapeutics and a therapy that just met its goal in a Phase 3 trial.
By Ned Pagliarulo • Oct. 30, 2023 -
Pfizer, BioNTech say combo flu, COVID shot met goal in study
The partners announced the trial had succeeded weeks after Moderna disclosed positive results from a study of its similar combination vaccine.
By Kristin Jensen • Oct. 26, 2023 -
New Alzheimer's drugs
Eisai says new data could support more convenient form of Alzheimer’s drug Leqembi
An under-the-skin injection of Leqembi performed about the same as the already marketed intravenous form, according to trial results presented Wednesday. A new approval application is expected by the end of March.
By Jacob Bell • Updated Oct. 26, 2023 -
"HIV virus". Retrieved from NIAID / NIH.Gene editing
Excision gives first look at gene editing therapy for HIV
The study results, while only from three participants, offer a glimpse at how one of the few in vivo CRISPR therapies in U.S. human testing is working.
By Ned Pagliarulo • Oct. 25, 2023