Clinical Trials: Page 29
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Mario Tama via Getty Images
J&J ends hepatitis B, HPV vaccine work with Bavarian Nordic
The companies' hepatitis B program never reached clinical testing, while J&J said it would no longer develop an HPV vaccine because of the "widespread uptake" of effective shots from other companies.
By Ned Pagliarulo • May 9, 2022 -
Elizabeth Regan/BioPharma Dive
Argenx drug succeeds in trial, beats sales forecasts
The biotech reported positive results from a study meant to expand Vyvgart's use to another immune disorder, while sales from the drug's first quarter on the market exceeded expectations.
By Kristin Jensen • May 5, 2022 -
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 -
Stock via Getty Images
Pfizer cleared to restart hemophilia gene therapy trial
While a voluntary pause in dosing new patients will remain in place, the FDA's decision puts the study back on track to deliver data in 2023.
By Jonathan Gardner • May 3, 2022 -
Sarah Silbiger via Getty Images
FDA rejects two China-developed cancer drugs
The regulator cited concerns around single-country trials in turning back Hutchmed's pancreatic cancer treatment, while manufacturing issues held up Junshi and Coherus' throat cancer medicine.
By Jonathan Gardner • May 2, 2022 -
Courtesy of Vertex Pharmaceuticals
Vertex surprised by FDA halt of diabetes cell therapy study
The regulator determined Vertex had "insufficient information" to test higher doses of the therapy, which showed promise in the first two patients treated.
By Ned Pagliarulo • May 2, 2022 -
DNY59 via Getty Images
Ionis, AstraZeneca change a key trial, fueling more questions about a genetic heart disease
The partners increased the size and length of a large study in transthyretin amyloidosis cardiomyopathy, a decision that has implications for Alnylam, which is testing two of its drugs for the disease.
By Ben Fidler • May 2, 2022 -
Courtesy of Eli Lilly
Lilly's closely watched diabetes drug scores in obesity trial
Called tirzepatide, the drug significantly lowered weight loss in a large study, findings that add to growing evidence that a class of medicines originally meant for diabetes may effectively treat obesity.
By Jonathan Gardner • April 28, 2022 -
Roche stumbles in latest setback for an emerging group of breast cancer drugs
The Phase 2 failure marks the second negative result in two months for a closely watched group of medicines, known as SERDs, that are being developed by several large pharmaceutical companies.
By Jonathan Gardner • April 25, 2022 -
Jolygon via Getty Images
How a surprise finding made an Alnylam study one of biotech's most 'polarizing' trials
A study testing Alnylam's drug Onpattro in a deadly heart condition was once seen as a sure bet. Now the trial is the source of much debate, and its outcome could influence how future treatments for the disease are developed.
By Ben Fidler • April 25, 2022 -
Sarah Silbiger via Getty Images
FDA panel supports agency push to raise approval bar for certain cancer drugs
Though agency advisers were hesitant to label an entire drug class, they backed the FDA's interest in demanding randomized trials of PI3 kinase-blocking drugs, a decision that could impact future research.
By Jonathan Gardner • April 22, 2022 -
Bristol Myers scraps $2B Nektar partnership after trial failures
The companies have halted testing in kidney and bladder cancer, one month after ending a skin cancer study. Nektar executives are now preparing plans to conserve cash.
By Jonathan Gardner • April 18, 2022 -
AbbVie, Genmab, with new data, prep FDA application for dual-acting cancer drug
Fresh trial results intensify competition with Roche to deliver the first lymphoma drug that marries antibody technology with an immunotherapy pathway.
By Jonathan Gardner • April 14, 2022 -
Justin Sullivan via Getty Images
FDA clears Gilead to restart some studies of top cancer drug
The agency's OK is a needed reprieve for Gilead, whose dealmaking strategy in oncology has come under scrutiny from analysts and investors.
By Ben Fidler • April 12, 2022 -
AACR 2022: NK cell promise, more TIGIT questions and extending CAR-T's reach
This year's meeting on early cancer research featured promising study results from German biotechs BioNTech and Affimed as well as details from a "practice-changing" lung cancer trial.
By Ben Fidler , Ned Pagliarulo • April 11, 2022 -
William Walker/BioPharma Dive
Sponsored by Janssen Oncology[Podcast] Breaking Down Barriers: How Bladder Cancer Innovations Benefit Patients and Treatments for Other Diseases
Recent breakthroughs in bladder cancer treatment are helping patients combat one major challenge to current options — the bladder permeability barrier. These treatments also have implications for other cancers and diseases. This podcast explains how.
By BioPharma Dive's studioID • Updated Feb. 9, 2023 -
Courtesy of Vertex Pharmaceuticals
Vertex gets positive trial results for non-opioid painkiller in boost to pipeline
After several attempts at designing a drug for acute pain, Vertex has a candidate it's ready to take into late-stage testing following two successful Phase 2 studies.
By Ned Pagliarulo • March 31, 2022 -
Sarah Silbiger via Getty Images
FDA advisers narrowly side against an experimental ALS drug, likely lowering its approval chances
The panel of independent experts found clinical trial evidence generated by the drug's developer, Amylyx Pharmaceuticals, insufficient to establish the treatment's effectiveness.
By Jacob Bell • Updated March 30, 2022 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Adagio plans comeback for COVID drug, but is it too late?
The biotech said it will ask the FDA for approval of its antibody treatment after positive results from two trials. But relatively few participants were exposed to omicron, potentially raising questions about its utility.
By Jonathan Gardner • March 30, 2022 -
Roche's top immunotherapy prospect fails study in tough-to-treat lung cancer
A drug regimen including Roche's closely watched tiragolumab didn't outperform standard treatment in its first large trial, a setback for therapies aimed at a protein called TIGIT.
By Ben Fidler • March 30, 2022 -
Jeenah Moon via Getty Images
Pfizer inflammatory disease drug hits goal in second study
The drugmaker said etrasimod, an experimental medicine acquired via its Arena buyout, improved remission rates in the second of two studies meant to support its approval in ulcerative colitis.
By Ned Pagliarulo • March 29, 2022 -
Sarah Silbiger via Getty Images
Deep Dive // ALS drug development
How a long shot ALS drug came before the FDA
A negative vote from independent experts appears to lower the chances of Amylyx's medicine winning FDA approval. Still, FDA officials have cited flexibility and noted the difficulty of its forthcoming decision.
By Jacob Bell • March 28, 2022 -
Permission granted by Biogen
Biogen shelves ALS drug after early-stage trial failure
The study setback raises questions over how well a type of genetic medicine can work in adults with central nervous system disorders like ALS.
By Jonathan Gardner • March 28, 2022 -
Permission granted by Mateusz Bartkowiak (QIAGEN)
Sponsored by QIAGENHow to accelerate reliable and novel answers with expert-curated biomedical and clinical data
Accelerate your path to novel, reliable answers with expert-curated biomedical and clinical data.
March 28, 2022 -
Sarah Silbiger via Getty Images
FDA rebuffs MEI, Kyowa Kirin as another cancer drug class draws scrutiny
The companies said the FDA is now requiring results from a randomized study in the latest sign the agency is raising the bar for accelerated approval of so-called PI3K inhibitors.
By Jonathan Gardner • March 25, 2022 -
Spencer Platt via Getty Images
Pfizer claims study success for drug key to Arena buyout
Etrasimod, the basis of the $7 billion acquisition and a potential rival to Bristol Myers Squibb's Zeposia, has cleared the first of two trials in ulcerative colitis.
By Kristin Jensen • March 23, 2022
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