Clinical Trials: Page 44
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Jeenah Moon via Getty Images
A worrisome side effect stalls a closely watched multiple myeloma drug
Pfizer halted a key trial of one of the most advanced bispecific antibody drugs in development for the blood cancer after several cases of peripheral neuropathy.
By Ben Fidler • Updated May 4, 2021 -
Courtesy of Sarepta
Sarepta's second-gen Duchenne drug shows signs of topping its first
An experimental Duchenne drug developed with a newer technology may be more potent than Sarepta's marketed treatment Exondys 51. But early data also brought new safety concerns.
By Jonathan Gardner • May 3, 2021 -
Explore the Trendline➔
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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 -
Permission granted by Clinical Ink
Sponsored by Clinical InkHow BYOD leads to patient-centric clinical trials
Learn why clinical trial sponsors are moving to BYOD for a better patient experience, greater compliance, and higher-quality data – all at a lower cost.
By Jonathan Andrus, Chief Business Officer, Clinical Ink • May 3, 2021 -
Sean Gallup via Getty Images
Denying problems, AstraZeneca says US coronavirus vaccine filing due within weeks
Five weeks after AstraZeneca reported positive trial results, the company has still not applied to the FDA for authorization, saying the size of the dataset has slowed its submission.
By Jonathan Gardner • April 30, 2021 -
Jacob Bell/BioPharma Dive
FDA gives first citation to biotech for failure to report clinical trial details
The agency threatened to fine Acceleron for not posting study results to clinicaltrials.gov. Whether the action is a sign of a larger crackdown is unclear.
By Kristin Jensen • April 29, 2021 -
A serious side effect puts a biotech's eye gene therapy in limbo
Adverum Biotechnologies has unmasked a Phase 2 study in which a trial participant suffered severe inflammation and vision loss — a finding that could threaten the program’s future in multiple eye diseases.
By Ben Fidler • April 29, 2021 -
Courtesy of Eli Lilly
Lilly, citing FDA feedback, won't seek speedy approval of Alzheimer's drug
The drugmaker confirmed it won't try for accelerated approval of a closely watched Alzheimer's medicine based on a single Phase 2 trial. But it's planning a lengthy new study in presymptomatic patients.
By Jonathan Gardner • April 27, 2021 -
Sarah Silbiger via Getty Images
FDA lifts hold on UniQure gene therapy study after review of cancer case
An investigation by UniQure determined the company's hemophilia gene therapy was "highly unlikely" to have caused a study volunteer's liver cancer, clearing the way for the FDA's green light.
By Jonathan Gardner • April 26, 2021 -
Vertex moves pain drug into mid-stage testing
VX-548 is Vertex's latest attempt to show that blocking a certain sodium channel can offer a new, non-addictive way to treat pain.
By Jacob Bell • April 26, 2021 -
Coronavirus vaccine makers Oxford, Novavax follow up with a promising malaria shot
A vaccine co-developed by the U.K. academic center and the Maryland biotech could be the first to meet the WHO's efficacy target for a malaria vaccine.
By Ben Fidler • April 23, 2021 -
Positive data in hand, TG Therapeutics readies MS drug for FDA review
If approved, TG's drug would join Roche's fast-selling Ocrevus and Novartis' newer entrant Kesimpta as one of a newer class of multiple sclerosis therapies.
By Jonathan Gardner • April 19, 2021 -
Permission granted by IQVIA Brand World
Sponsored by IQVIAReal World Data: How to leverage transformative data sources to reduce study costs, evaluate real world clinical outcomes
Real World Data provides increasingly significant value throughout all stages of a product's lifecycle. The time to embrace it is now. Here's why.
April 19, 2021 -
GSK stops studies testing closely watched cancer immunotherapy
The British pharma will halt enrollment in two studies testing feladilimab alongside Merck's Keytruda, dealing another blow to the company's cancer drug pipeline.
By Ned Pagliarulo • April 15, 2021 -
Permission granted by Gilead Sciences
Gilead stops Veklury study, citing enrollment challenges, changing treatment
The company said a multi-day infusion treatment that must be administered in healthcare settings no longer addresses an unmet need of non-hospitalized COVID-19 patients.
By Jacob Bell • April 13, 2021 -
Sage, Biogen drug reduces tremors but side effects could limit potential
Early Phase 2 data for a pill from the two companies' alliance appeared promising. But most patients had to cut their drug dose due to drowsiness.
By Jonathan Gardner • April 12, 2021 -
5 takeaways from AACR, one of the year's top meetings on cancer drugs
The American Association for Cancer Research's virtual conference featured fresh data on a new kind of cell therapy, an emerging immunotherapy target and a KRAS reboot.
By Ben Fidler , Ned Pagliarulo • April 12, 2021 -
Lilly gene-targeted drug shows potential for use across cancers
Study results presented at AACR showed Retevmo shrank tumors in nine different cancers, building a case for the type of tissue-agnostic label that only three other medicines have secured.
By Ned Pagliarulo • April 11, 2021 -
Courtesy of AstraZeneca
Researchers lay out hypothesis for rare side effect linked to AstraZeneca vaccine
The EMA has reiterated the benefits of the shot outweigh the risks, but the safety concerns are another hurdle to the vaccine's rollout in Europe.
By Ned Pagliarulo , Ben Fidler • April 9, 2021 -
Courtesy of Eli Lilly
Lilly claims promising finding in failed study of COVID-19 drug
Baricitinib, an oral tablet already authorized to treat COVID-19, fell short of goal in a large Phase 3 study. But Lilly also reported treatment led to a substantial reduction in death.
By Ned Pagliarulo • April 8, 2021 -
New data push a biotech's muscle disease drug closer to a key test
An experimental medicine from Scholar Rock could complement a gene therapy from Novartis and other treatments for the disease, though its benefit needs to be proven in further study.
By Jacob Bell • April 6, 2021 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Takeda, CSL to end alliance as plasma-based COVID-19 drug fails key test
An unusual partnership to develop a standardized plasma therapy for COVID-19 didn't succeed, but could be a model for collaborations should another public health crisis arise, the drugmakers said.
By Ben Fidler • April 5, 2021 -
Courtesy of BioNTech
Pfizer, BioNTech's vaccine protects 12- to 15-year-olds from COVID-19 in study
The positive finding should pave the way for broader use of the vaccine among adolescents, an important step for reaching herd immunity against the virus.
By Ben Fidler , Jonathan Gardner • March 31, 2021 -
A biotech shelves its Huntington's drugs after trial failures
Two drugs developed by Wave Life Sciences didn't appear to have an effect on disease-causing proteins, another setback for Huntington's research after disappointing results last week from Roche and Ionis.
By Jacob Bell • March 30, 2021 -
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Sponsored by Parexel BiotechHow RWE can help Biotechs optimize the value of their asset
No matter the exit strategy, the use of Real-World Evidence (RWE) can provide a framework for Biotech companies to develop insights needed for the various stakeholders.
March 29, 2021 -
Permission granted by Bristol-Myers Squibb
Bristol Myers gets late-stage win in test of new type of immunotherapy
When given together with Opdivo, Bristol Myers' new drug kept skin cancers from progressing, a rare clinical victory for a combination of immunotherapies that puts the pharma a step ahead of several rivals.
By Jonathan Gardner • March 25, 2021
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