Clinical Trials: Page 6
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Moderna claims positive results in early study for combo COVID, flu shot
The company is planning to start a Phase 3 trial of the vaccine this year, and is targeting a regulatory approval in 2025.
By Delilah Alvarado • Oct. 4, 2023 -
Novartis’ closely watched rare disease drug scores in kidney disorder
Called iptacopan, the experimental medicine has now scored positive results in three late-stage clinical trials, the latest in an uncommon kidney disorder known as IgA nephropathy.
By Jacob Bell • Oct. 2, 2023 -
Trendline
COVID-19 vaccines
The urgency of the pandemic’s first two years is giving way to questions of how to sustain public health responses and prepare for what could come next. In the U.S., health officials are urging booster shots and preparing for private sector distribution of vaccines.
By BioPharma Dive staff -
Obesity drugs
Structure boosted by early data for experimental obesity drug
Shares in the biotech surged on Phase 1 trial results for an oral GLP-1 drug, reflecting investor enthusiasm for the weight loss medicines.
By Ned Pagliarulo • Sept. 29, 2023 -
J&J cancer drug combo beats Tagrisso in closely watched trial
Interim results from a study called “Mariposa” found that a regimen of two J&J medicines improved progression-free survival versus AstraZeneca’s widely used therapy.
By Ned Pagliarulo • Sept. 28, 2023 -
ALS drug development
BrainStorm’s ALS therapy not effective, FDA panel finds
Expert advisers to the agency voted 17-1 that Brainstorm's clinical trial data did not show the company's stem cell treatment to be effective for treating ALS.
By Ned Pagliarulo • Updated Sept. 28, 2023 -
Immunovant data show potential for autoimmune disease drug
Much anticipated clinical trial data for Immunovant’s experimental FcRn inhibitor could catalyze business development decisions for its parent, Roivant Sciences.
By Ned Pagliarulo • Sept. 26, 2023 -
Novartis radiopharmaceutical drug succeeds in first-line gut cancer study
Novartis has made a large investment in targeted radiotherapies, sparking competition from fellow pharma companies and young biotechs.
By Jonathan Gardner • Sept. 25, 2023 -
AstraZeneca and Daiichi’s next cancer medicine scores in breast tumors
Results show that the medicine helped patients who progressed on earlier-line treatments live longer than those receiving chemotherapy without their disease getting worse, according to a Friday announcement.
By Jonathan Gardner • Sept. 22, 2023 -
Seagen’s cancer drug succeeds in ‘must-win’ trial
Compared to chemotherapy, a combination of Seagen’s Padcev and Merck’s Keytruda was significantly better at keeping bladder cancer patients alive longer and their disease from progressing.
By Jacob Bell • Sept. 22, 2023 -
Latest trial win supports expanded use of Bristol Myers’ Opdivo in lung cancer
The drug, which is already cleared as a neoadjuvant lung cancer treatment, could better compete with Merck’s Keytruda if it gains approval in the adjuvant setting for non-small cell tumors.
By Delilah Alvarado • Sept. 22, 2023 -
FDA panel backs Alnylam drug despite doubts over benefit
“There is a light wind for benefit, and no wind for risk,” said one adviser who voted with eight others to recommend the biotech’s drug Onpattro for cardiomyopathy of ATTR amyloidosis.
By Jonathan Gardner • Updated Sept. 14, 2023 -
After IPO success, Acelyrin hits trial setback with inflammation drug
Acelyrin’s share value collapsed Tuesday after its lead drug fell short in the company’s first big trial test since it raised $540 million in a May IPO.
By Kristin Jensen • Sept. 12, 2023 -
Daiichi Sankyo, with new data, to seek FDA approval of lung cancer drug
The HER3-targeting treatment could become the next antibody-drug conjugate to emerge from Daiichi Sankyo’s laboratories, after the AstraZeneca-partnered Enhertu.
By Jonathan Gardner • Sept. 11, 2023 -
In advocates’ push for superbug funding, ‘$6 billion is nothing’
The PASTEUR Act could be heading for another setback, but advocates say they see a future for funding research into antimicrobial resistance.
By Karissa Waddick • Sept. 8, 2023 -
Alnylam says hypertension drug succeeded in mid-stage study
The trial found two higher doses of Alynlam’s RNAi therapy lowered blood pressure better than placebo. But analysts say results from a different study will be more important for the drug’s future.
By Jacob Bell • Sept. 7, 2023 -
Wave readies clinical testing for first RNA editing therapy
The biotech, one of several advancing RNA editing medicines, expects to obtain “proof-of-mechanism” data in patients with the inherited disorder alpha-1 antitrypsin deficiency by next year.
By Kristin Jensen • Updated Sept. 5, 2023 -
Roche claims study success for targeted drug in early lung cancer
The Swiss pharma said, without details, that it observed “unprecedented” results that could make Alecensa the first treatment specifically available after surgery for ALK-positive lung tumors.
By Ben Fidler • Sept. 1, 2023 -
FibroGen’s Duchenne drug fails second trial in latest study setback
The failure marks another Phase 3 miss for the drug, pamrevlumab, and follows a restructuring and CEO switch for the struggling biotech.
By Delilah Alvarado • Aug. 30, 2023 -
Bayer reports positive early data for Parkinson’s cell therapy
The treatment, developed by a biotech Bayer acquired in 2019, appeared safe in a small trial and showed signs of an effect on disease progression.
By Jacob Bell • Aug. 28, 2023 -
Merck kicks off Phase 3 tests for PCSK9 cholesterol pill
The company plans to enroll roughly 17,000 people in three Phase 3 trials of the drug, including a large cardiovascular study set to begin later this year.
By Delilah Alvarado • Aug. 25, 2023 -
Obesity drugs
Novo, with new data, builds case for using Wegovy to protect heart health
After trial results showed the obesity drug can prevent heart attacks, the company now has data indicating it can help people with heart failure, too.
By Jonathan Gardner • Aug. 25, 2023 -
Roche’s surprise study results spur new optimism for TIGIT drugs
Data inadvertently published from a closely watched lung cancer study suggest a drug blocking the protein TIGIT may help extend survival, a finding that boosted shares of other developers.
By Jonathan Gardner • Aug. 23, 2023 -
Fulcrum rejoins sickle cell drug race as FDA lifts study hold
The biotech, which aims to develop an alternative to existing medicines and emerging gene-based treatments, will focus further testing on sicker patients.
By Ben Fidler • Aug. 22, 2023 -
FDA partially halts leukemia studies of Gilead cancer drug
The hold is the latest setback for a drug that was the center of Gilead’s $5 billion acquisition of biotech Forty Seven in 2020.
By Jonathan Gardner • Aug. 21, 2023 -
Moderna builds case for updated COVID shot ahead of latest booster push
But the demand for booster shots ahead of an expected surge of infections this fall remains an unanswered question weighing heavily on Moderna’s future outlook.
By Jonathan Gardner • Aug. 18, 2023