Clinical Trials: Page 17
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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 -
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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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Merck says drug acquired in $1B buyout scores in large kidney cancer study
The treatment, which Merck picked up through a 2019 acquisition of Peloton Therapeutics, helped delay disease progression in patients with advanced renal cell carcinoma.
By Jacob Bell • Aug. 18, 2023 -
Boehringer moves Wegovy competitor into late-stage testing
The German pharmaceutical company is launching three Phase 3 trials of an obesity drug called survodutide, which like Wegovy targets the GLP-1 receptor
By Ned Pagliarulo • Aug. 17, 2023 -
Permission granted by Gilead Sciences
Gilead antibody drug shows signs of potential in early lung cancer
A combination of Trodelvy and Merck’s Keytruda appears active against lung tumors, but has a high bar to clear and faces competition from AstraZeneca and Daiichi Sankyo.
By Jonathan Gardner • Aug. 17, 2023 -
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FDA lifts hold on Arcellx’s Gilead-partnered cancer cell therapy
The agency had paused testing after a patient death, but is now permitting more types of bridging treatment to help keep participants’ disease at bay.
By Jonathan Gardner • Aug. 15, 2023 -
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A biotech scraps two cancer trials in latest setback for emerging drug class
ALX Oncology’s decision to end studies in leukemia and myelodysplastic syndrome follows a similar setback from Gilead and casts further doubt on drugs known as CD47 inhibitors.
By Jonathan Gardner • Aug. 11, 2023 -
Novartis says drug helps control chronic hives in studies
The studies are another example of drugmakers exploring how so-called BTK inhibitors can be used to treat diseases outside of blood cancer.
By Kristin Jensen • Aug. 9, 2023 -
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Obesity drugs
Novo obesity drug protects heart health in large trial
2023 was a breakout year for GLP-1 drugs, which have shown dramatic weight loss benefits. Study results in August proved Novo’s Wegovy could protect the heart, too, a finding that may change obesity treatment.
By Jonathan Gardner • Updated Aug. 8, 2023 -
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Sponsored by PearsonHow the right technology and tools can accelerate progress in rare disease clinical trials
The need for more research into rare diseases is clear, but researchers face significant challenges. Fortunately, technology has created opportunities to innovate in clinical trials for rare diseases.
Aug. 7, 2023 -
Amgen says KRAS drug met goal in late-stage colon cancer trial
The company disclosed the study result alongside second quarter earnings showing Lumakras sales were flat versus the same period one year prior.
By Ned Pagliarulo • Aug. 3, 2023 -
NIAID. (2019). "T Regulatory Cells" [Microscope image]. Retrieved from Flickr.
Gilead-backed cell therapy startup Kyverna adds fresh funds for new strategy
A treatment licensed from the NIH and in clinical testing for lupus is the startup’s lead program, while its founding “Treg” cell therapy research matures, according to CEO Peter Maag.
By Ben Fidler • Aug. 3, 2023 -
Courtesy of Eli Lilly
Lilly adds to case for Mounjaro’s weight-loss benefits with new study data
The results showed that enrollees who’d already lost weight after diet and exercise shed pounds after receiving Mounjaro, while those who stopped treatment gained weight back.
By Jonathan Gardner • July 27, 2023 -
Courtesy of Biohaven Ltd.
FDA declines to review Biohaven’s latest drug in setback to pipeline
While the FDA doesn’t think the brain disease treatment merits an evaluation, Biohaven is still pushing for one and has requested a further meeting.
By Delilah Alvarado • July 27, 2023 -
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Moderna, Merck advance cancer vaccine into late-stage test
The companies are enrolling people with melanoma in a Phase 3 trial aimed at testing whether the shot can prevent disease recurrence.
By Jonathan Gardner • July 26, 2023
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