Clinical Trials: Page 37
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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 -
Explore the Trendline➔
National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
TrendlineCell therapy
The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.
By BioPharma Dive staff -
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 -
Westend61 / Rainer Berg via Getty Images
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 -
Courtesy of AstraZeneca
AstraZeneca, under fire, tries to repair image with new vaccine data
Updated results show the vaccine is only slightly less effective than AstraZeneca originally reported. But an unusual break with a study committee may damage perception of the shot.
By Ben Fidler • Updated March 25, 2021 -
Regeneron joins Lilly in proving lower-dose antibody drugs can thwart COVID-19
The findings could help boost the supply and reach of Regeneron's COVID-19 antibody drug, which, despite limited use, is now backed by convincing data showing it can prevent hospitalization.
By Kristin Jensen • March 24, 2021 -
Roche stops giving Huntington's disease drug in closely watched study
A disappointing recommendation from outside data reviewers raises doubts about the DNA-targeting drug's benefits and puts pressure on Roche's partner, Ionis Pharmaceuticals.
By Jonathan Gardner • March 23, 2021 -
FDA won't review Novo diabetes drug in latest case of regulatory pushback
Novo Nordisk said the FDA requested more data before starting review for a high dose of the Danish company's treatment semaglutide, extending a string of recent setbacks for drugmakers in the U.S.
By Ned Pagliarulo • March 23, 2021 -
AstraZeneca may have used 'outdated' data to describe vaccine's efficacy, NIH says
The British drugmaker said it will release updated data from the large U.S. trial within 48 hours, but the puzzling episode is another communication misstep for the company.
By Ned Pagliarulo • March 23, 2021 -
Permission granted by Roche
Roche immunotherapy notches a win in early lung cancer, pressuring Merck
New results could make Tecentriq the first immunotherapy available in the post-surgery setting, adding pressure on Merck & Co.'s Keytruda to succeed as well.
By Jonathan Gardner • March 22, 2021 -
Shutterstock.com/Stokkete
Sponsored by PSI CROTechnological adoption and human connection. Finding the balance in clinical trials
While technology can push trials ahead, in-person interactions and site relationships are, and always will be, the key to success in delivering patient-centric trials on time.
March 22, 2021 -
Shutterstock.com/Sergey Kolesnikov
Sponsored by Medidata, a Dassault Systèmes companyAdopting RBQM to ensure trial oversight in COVID and beyond
Now more than ever, a firm grasp of RBQM is needed for the success of all clinical trials.
March 22, 2021 -
Yujin Kim/BioPharma Dive
With new results, Sarepta's 2nd gene therapy holds steady
Stung by a clinical trial miss in Duchenne muscular dystrophy, the biotech now has promising, if early, data to back a gene therapy for a different rare neuromuscular disease.
By Jonathan Gardner • March 19, 2021 -
A first-of-its-kind mRNA drug falls short in cystic fibrosis
A treatment that sprays synthetic messenger RNA into the lungs failed to help cystic fibrosis patients, a blow to efforts to use the technology for more than vaccines.
By Ben Fidler • March 18, 2021 -
Kendall Davis/BioPharma Dive
Gilead, still aiming at NASH, broadens an alliance with Novo
With positive safety data in hand, the partners will advance work pairing the diabetes medicine Ozempic with two experimental treatments to see if they can reverse the liver disease, which has proven a tough target for drugmakers.
By Jonathan Gardner • March 18, 2021
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