Clinical Trials: Page 28
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Alnylam follows rivals with new study results for kidney disease drug
An experimental medicine the company is developing with Regeneron has shown early promise treating IgA nephropathy, a disease that’s become a competitive target among drugmakers.
By Jonathan Gardner • June 9, 2022 -
Moderna says 'bivalent' booster sparks stronger immune response against omicron
The biotech claims study results could position its reformulated vaccine as a booster in the fall, though it’s unclear how well the shot can prevent sickness caused by omicron or newer strains of the variant.
By Kristin Jensen • June 8, 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 -
SciePro via Getty Images
Roche keeps the faith in new cancer immunotherapy despite trial setbacks
An ambitious development plan has so far resulted in two late-stage disappointments, but the Swiss drugmaker remains confident there's more to come from its combination treatment.
By Jonathan Gardner • June 7, 2022 -
Courtesy of American Society of Clinical Oncology / Todd Buchanan
ASCO 2022: Gilead's tough weekend, bispecific progress and 'gamma delta' cell therapy
The biotech's highly anticipated breast cancer data were upstaged by a rival, while presentations from Roche, J&J and Adicet Bio highlighted emerging alternatives to CAR-T treatment.
By Ben Fidler , Ned Pagliarulo • June 6, 2022 -
Stock via Getty Images
'Dramatic' study results for AstraZeneca, Daiichi drug suggest new way to treat aggressive breast cancer
A quarter century after Roche's Herceptin became an option for HER2-positive breast cancer, positive study results for Enhertu could push doctors to consider a new classification of "HER2 low" disease.
By Ben Fidler • June 5, 2022 -
Justin Sullivan via Getty Images
Detailed study data show modest benefit to Gilead breast cancer drug
Gilead previously said the closely watched study succeeded but hadn’t shared specifics, raising questions about the effect of the treatment, called Trodelvy.
By Jacob Bell • June 4, 2022 -
Permission granted by Bristol-Myers Squibb
Bristol Myers' autoimmune drug shows potential in lupus
Positive Phase 2 results could help boost company executives' arguments that the drug, called deucravacitinib and under FDA review in psoriasis, will become a top-seller.
By Jonathan Gardner • June 1, 2022 -
Permission granted by Biogen
Sage, Biogen drug meets goal in postpartum depression study
The results will help support an application for FDA approval, which the companies plan to submit early next year. They are already seeking an OK for their treatment in major depressive disorder.
By Ned Pagliarulo • June 1, 2022 -
Meletios Verras via Getty Images
Adicet data hints at early promise for 'gamma delta' cell therapy
Four of six lymphoma patients in a small trial went into remission, an early but encouraging sign for an emerging form of cellular immunotherapy.
By Ben Fidler • May 27, 2022 -
Erik S. Lesser via Getty Images
Merck study results signal blood cancer potential for new type of immunotherapy
Bristol Myers beat Merck to the first approval of a so-called LAG-3 inhibitor. But Merck is advancing its own and data to be presented at ASCO show it could help treat Hodgkin's lymphoma.
By Jonathan Gardner • May 26, 2022 -
Retrieved from National Cancer Institute on September 27, 2019
Mirati matches Amgen with updated data for KRAS-blocking cancer drug
Fresh study results showed similar rates of response and progression-free survival with Mirati's experimental adragasib as with Amgen's approved Lumakras. The new data might raise safety questions, however.
By Ned Pagliarulo • Updated May 27, 2022 -
3 cancer drug studies to watch at next month's ASCO meeting
Detailed results from important studies of AstraZeneca’s breast cancer drug Enhertu, Gilead’s Trodelvy and Roche’s TIGIT blocker are among the most anticipated late-breaking data set to be presented next month.
By Ben Fidler , Ned Pagliarulo • May 26, 2022 -
Responding to outbreak, Moderna starts early work on monkeypox vaccine
One day after the U.S. began releasing supplies of an approved Bavarian Nordic shot, Moderna said it's beginning development of its own vaccine against the virus.
By Jonathan Gardner • May 24, 2022 -
Springworks shares fall despite drug trial's success
The biotech plans to seek FDA approval for its soft-tissue tumor treatment after positive study results. But investors still sent the stock down by nearly 10%.
By Ned Pagliarulo • May 24, 2022 -
Jeenah Moon via Getty Images
Pfizer, Lilly bolster cases for experimental ulcerative colitis drugs
The two companies are each developing new types of medicines that they hope can soon win FDA approval for treating the autoimmune disease.
By Ned Pagliarulo • May 24, 2022 -
Courtesy of Pfizer
Pfizer says 3 doses of its COVID-19 vaccine works in youngest children
The drugmaker, along with partner BioNTech, plans to submit the new data to the FDA this week. The agency has scheduled a meeting for outside experts to review the data in mid-June.
By Jonathan Gardner • May 23, 2022 -
Permission granted by Biohaven Pharmaceuticals
Biohaven hits setback as it moves beyond migraine
The company's experimental treatment for spinocerebellar ataxia is one of several drugs meant to form the pipeline of the "New Biohaven" that will be spun out after Pfizer's planned acquisition.
By Jacob Bell • May 23, 2022 -
Elizabeth Regan/BioPharma Dive
Concert drug helps regrow hair in study, boosting shares
There are no treatments specifically approved for alopecia areata. Concert follows Pfizer and Eli Lilly in reporting positive late-stage results for drugs the companies are developing for the autoimmune disorder.
By Ned Pagliarulo • May 23, 2022 -
National Institute of Allergy and Infectious Diseases. (2017). "Human Respiratory Syncytial Virus" [Micrograph]. Retrieved from Flickr.
Trial setback casts doubt on a biotech's respiratory virus drug
As vaccines for respiratory syncytial virus progressed, Enanta used its hepatitis C know-how to develop an antiviral pill. Yet data in lower-risk patients raise questions of whether it can work.
By Jonathan Gardner • May 19, 2022 -
Danielle Ternes/BioPharma Dive
Gene therapy safetyScientists home in on cause of Duchenne gene therapy side effect
An unusual collaboration among gene therapy developers suggests certain mutations could be behind "peculiar" side effects experienced by several patients treated in clinical trials.
By Jonathan Gardner • Updated May 18, 2022 -
Permission granted by Gilead Sciences
Gilead, having resolved manufacturing issues, forges ahead with HIV drug
The company can now resume testing in nearly a dozen studies that were paused due to FDA concerns about interactions between the drug, lenacapavir, and the glass vials in which it was contained.
By Jacob Bell • May 17, 2022 -
Permission granted by Bristol-Myers Squibb
Bristol Myers' Opdivo comes up short in bladder cancer trial
The top-selling immunotherapy failed to improve survival in first-line urothelial carcinoma, a tumor type that's proved difficult to treat with drugs like Opdivo.
By Ned Pagliarulo • May 16, 2022 -
Permission granted by Bristol-Myers Squibb
Key Bristol Myers drug holds up in long-term psoriasis study
Deucravacitnib, forecast by Bristol Myers to hit $4 billion in peak sales, is under FDA review with an approval decision due by September. The agency's view of its safety will be key to its future.
By Jonathan Gardner • May 12, 2022 -
Permission granted by Sekar Kathiresan
In first, Verve gets clearance to test base editing inside the body
Regulators in New Zealand have allowed human testing to proceed, another milestone for the gene editing technology. Verve plans to soon ask for approval to begin testing in the U.S. and U.K., too.
By Kristin Jensen • May 11, 2022 -
iStock via Getty Images
Roche cancer immunotherapy fails another trial, casting doubt on emerging drug class
A treatment combination involving Roche's anti-TIGIT medicine tiragolumab missed its goal in a Phase 3 lung cancer study that was viewed as a proof point for the drug class.
By Ben Fidler • May 11, 2022
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