Clinical Trials
-
J&J, Legend’s cancer cell therapy has early success in key clinical trial
The trial is an important test of Carvykti’s potential for earlier use in multiple myeloma and found treatment helped extend progression-free survival over standard regimens.
By Jacob Bell • Jan. 27, 2023 -
Magenta halts study of targeted conditioning drug after participant’s death
The biotech said one patient died after receiving an experimental antibody drug designed to deplete certain blood and bone marrow cells before a transplant.
By Christopher Newman • Updated Jan. 26, 2023 -
Explore the Trendline➔
Getty ImagesTrendlineOncology'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 -
Bristol Myers says CAR-T therapy curbed leukemia in long-running study
The company’s drug Breyanzi led to remission in adults with chronic lymphocytic leukemia, a blood cancer for which CAR-T therapies aren’t yet approved to treat.
By Ned Pagliarulo • Jan. 26, 2023 -
Merck reports one success, one setback from late-stage Keytruda trials
The top-selling immunotherapy bested chemo in treating bile duct cancer, but fell short in a study testing it with other drugs for metastatic prostate tumors.
By Ned Pagliarulo • Jan. 25, 2023 -
Pliant shares jump on new data for lung disease drug
A high dose of the company’s experimental medicine appeared potent in patients with idiopathic pulmonary fibrosis, an elusive target for drugmakers. The results are from a small and short clinical trial, however.
By Ben Fidler • Jan. 23, 2023 -
Roche says Tecentriq immunotherapy reduces risk of liver cancer recurrence
While the company did not reveal specific study data, the results could help Tecentriq become the first drug approved for adjuvant liver cancer treatment.
By Jonathan Gardner • Jan. 19, 2023 -
Moderna reports positive RSV vaccine results, pressuring Pfizer, GSK
The biotech’s results appear competitive to past data for RSV shots being developed by GSK and Pfizer. Moderna plans to follow those companies in asking for FDA approval.
By Delilah Alvarado • Jan. 18, 2023 -
National Institute of Allergy and Infectious Diseases. (2022). "HIV Virus" [Micrograph]. Retrieved from Flickr.
Large study of J&J’s HIV vaccine stopped after shot found ineffective
The result from the nearly 4,000-person trial is the latest setback in a long-running effort to develop a safe and effective shot for HIV infections.
By Ned Pagliarulo • Jan. 18, 2023 -
FDA approves Alzheimer’s drug from Eisai, Biogen in closely watched decision
The agency’s approval comes months after a large clinical trial showed the drug, called Leqembi, could slow the disease’s progression. Yet experts have raised concerns about its safety.
By Jacob Bell • Updated Jan. 6, 2023 -
Novocure shares soar on positive lung cancer data
A regimen involving the Swiss biotech’s electrical field-based treatment extended lives in a late-stage trial. But data comparing the medical device to standard chemotherapy is less persuasive.
By Jonathan Gardner • Jan. 5, 2023 -
Roivant reveals positive data for IBD drug, intensifying rivalry with Prometheus
The results left Wall Street analysts torn about which company holds the advantage as both race to get a new type of therapy to market.
By Jacob Bell • Jan. 4, 2023 -
Deep Dive
10 clinical trials to watch in the first half of 2023
Highly anticipated study results are expected in Alzheimer’s, obesity and Huntington’s, while a pair of high-priced acquisitions could be put to the test.
By BioPharma Dive staff • Jan. 3, 2023 -
Pfizer advances diabetes, obesity drug hopeful into mid-stage testing
The pharma dosed the first patient in a Phase 2 study testing a treatment it hopes could compete with closely-watched weight-loss drugs from Lilly, Novo Nordisk and Amgen.
By Kristin Jensen • Dec. 21, 2022 -
FDA halts planned trial of Entrada Duchenne drug
Shares in the Boston-based biotech fell on the news, which comes shortly after a deal with Vertex around another type of muscular dystrophy.
By Gwendolyn Wu • Dec. 20, 2022 -
Doubts around cancer drug target persist after Gilead, Arcus study results offer ‘mixed picture’
While long anticipated trial data were technically positive, analysts questioned whether drugs aimed at ‘TIGIT’ will prove a meaningful treatment addition.
By Ned Pagliarulo • Dec. 20, 2022 -
Government spending bill would tighten FDA oversight of accelerated drug approvals
The proposed bill would strengthen rules around confirmatory testing, help speed product withdrawals and set up a panel of agency officials to better coordinate policy.
By Jonathan Gardner • Dec. 20, 2022 -
Madrigal shares triple on positive NASH study results
The company said its experimental drug helped patients with the fatty liver disease while also improving fibrosis. One analyst called the readout a “major win” for Madrigal and the NASH field.
By Jacob Bell • Dec. 19, 2022 -
Third Harmonic halts study of lead drug over safety risk
The biotech, previously a success story this year, will end development of its chronic hives treatment and search for alternative drug candidates.
By Ned Pagliarulo • Dec. 15, 2022 -
Kymera shares jump on Sanofi’s decision to advance protein-degrading drug
Early data from a small, Phase 1 study exceeded Kymera’s expectations and, the biotech’s CEO claimed, offer “clinical validation” for its scientific approach.
By Ned Pagliarulo • Dec. 14, 2022 -
Moderna vaccine succeeds in early-stage skin cancer study with Merck’s Keytruda
The positive data are the most significant findings for the mRNA developer’s pipeline of experimental treatments outside of infectious diseases, where it has reaped billions from COVID-19 vaccine sales.
By Jonathan Gardner • Dec. 13, 2022 -
At ASH, Regeneron plays catch-up with its next cancer drugs
Two bispecific antibodies are “foundational” to the company’s plan to build an oncology business, according to a top executive. But Regeneron will have to surpass a crowd of competitors.
By Ben Fidler • Dec. 12, 2022 -
J&J’s next myeloma drug, Argenx’s second act and a new question for Bluebird: 3 ASH takeaways
The year’s biggest meeting on blood diseases kicked off this past weekend. Here are three of the most important storylines to emerge from the past few days of presentations.
By Ned Pagliarulo , Ben Fidler • Updated Dec. 12, 2022 -
Sponsored by Allucent
[Podcast] Thinking Big for Small and Mid-Sized Biotechs
This podcast series explores how to help small and mid-sized companies get innovative treatments to the people who need them.to help small and mid-sized companies get innovative treatments to the people who need them.
By BioPharma Dive's studioID • Updated Dec. 15, 2022 -
Pharvaris, pushing through trial pause, sees shares surge with new study results
Though the FDA halted testing of the biotech’s pill for hereditary angioedema in August, enough patients were already enrolled to accrue results that sent shares soaring.
By Ben Fidler • Dec. 9, 2022 -
Novartis gets second trial win for blockbuster hopeful
The company plans to seek broad approval of the oral medication, iptacopan, next year after it met its primary endpoint in a new pool of patients with the rare blood disease PNH.
By Kristin Jensen • Dec. 8, 2022