Clinical Trials: Page 36
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Getty / Edited by BioPharma Dive
UniQure moves Huntington's gene therapy to next phase of key trial
Safety monitors cleared the company to test a higher dose after reviewing data from 10 patients, providing some hopeful news after recent setbacks for experimental drugs targeting the genetic disease.
By Jonathan Gardner • May 27, 2021 -
'A hugely consequential decision:' How Biogen's Alzheimer's drug came to face the FDA
The FDA's decision to approve aducanumb could have far-reaching consequences for patients, Biogen and Alzheimer's research. Here's how the drug's review came about.
By Ned Pagliarulo • May 27, 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 -
Gabriel Kuchta via Getty Images
Moderna, with new results, set to seek vaccine clearance for young teens
The biotech's shot was strongly protective against COVID-19 in a study of 12- to 17-year-olds, a finding that could soon make it the second vaccine available for adolescents in the U.S.
By Ben Fidler • May 25, 2021 -
Sarah Silbiger via Getty Images
J&J's new cancer drug leads a growing pipeline of dual-targeting antibodies
Pharma and biotech companies alike see potential in using bispecific antibodies for hard-to-treat cancers like leukemia, myeloma and solid tumors.
By Jonathan Gardner • May 24, 2021 -
A biotech backs off NASH after trial failure
NGM Biopharmaceuticals has decided not to pursue a late-stage NASH program after its drug aldafermin became the latest in a long line of medicines to fail to help patients with the common liver condition.
By Jacob Bell • May 24, 2021 -
iStock.com/FatCamera
Sponsored by PRA Health SciencesAccelerating patient care through digital transformation and decentralized clinical trials
The adoption of digital health technologies (DHTs) in the industry continues to pave the way to enable decentralized clinical trials (DCTs).
May 24, 2021 -
iStock.com/vorDa
Sponsored by YourwaySupporting global decentralized and virtual clinical trials during challenging times and beyond
The risks and challenges incurred on clinical trials logistics by the COVID-19 pandemic have significantly accelerated the adoption of DCT and DTP trials models to keep site investigators and potentially vulnerable and immunocompromised patients safe from infection.
By Leandro Moreira, SVP of Corporate Development, Yourway • May 24, 2021 -
Permission granted by Bristol-Myers Squibb
Closely watched Bristol Myers immunotherapy shows benefit in melanoma
Study results prove, for the first time, that a drug blocking the protein LAG-3 can improve on another immunotherapy.
By Ned Pagliarulo • May 19, 2021 -
FDA delays a biotech's cancer cell therapy once again
Iovance, which now plans to submit its melanoma treatment to the FDA next year, separately disclosed that its CEO Maria Fardis will resign.
By Kristin Jensen • Updated May 19, 2021 -
Courtesy of Sarepta
Sarepta's Duchenne gene therapy clears study hurdle, although questions linger
A version of the treatment made at commercial scale looks similar to what Sarepta used in early testing. But the findings are no longer the last step before an approval filing, as the company once hoped.
By Ben Fidler • May 18, 2021 -
National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
Fate offers glimpse at 'natural killer' cell therapy for leukemia
The biotech's treatment is one of a wave of new treatments meant to mimic the effects of NK cell transplants in leukemia, though analysts remain skeptical.
By Ben Fidler • May 14, 2021 -
JK1991 via Getty Images
Sponsored by 81qdThe use of AI in rare disease has hidden flaws
A strategy needs to be put in place to profile patients and then form profile-specific strategies to accelerate diagnosis through HCP outreach, education, etc.
By Tim Hare VP, Head of Data Science • May 10, 2021 -
powerofforever via Getty Images
Sponsored by Koneksa HealthWearables for actigraphy measures in clinical trials
It's now possible to gather far more data, more often, more objectively, and more easily than ever before, and, with the appropriate choice, broadly expedite clinical trials utilizing actigraphy measurements.
May 10, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49535193876/in/album-72157713108522106/.
Adagio, flush with cash, launches large study of next-gen COVID-19 antibody
The privately held biotech believes its drug might treat or prevent infections from existing variants and future coronavirus strains, which could make it a competitor to marketed therapies from Regeneron and Eli Lilly.
By Kristin Jensen • May 5, 2021 -
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 -
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
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