Clinical Trials: Page 38
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Biogen says experimental pain drug helps neuropathy patients in mid-stage trial
With Aduhelm approved but struggling to gain traction, Biogen is talking up its pipeline. Mixed trial results, however, may make it challenging to design a larger study that can persuade regulators to approve the pain drug.
By Jonathan Gardner • Sept. 17, 2021 -
Amgen to advance KRAS drug combination after improved results in colon cancer
Combining Amen's Lumakras with its drug Vectibix appeared to work better in treating colorectal cancer than Lumakras alone, spurring the biotech to unveil plans for a new Phase 3 trial.
By Ned Pagliarulo • Sept. 16, 2021 -
Explore the Trendline➔
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TrendlineNeuroscience drug development
Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.
By BioPharma Dive staff -
Permission granted by University of Maryland School of Medicine
New data from Israel, Pfizer show potent effect from third coronavirus shot
The much-anticipated data arrive ahead of an important FDA advisory meeting to discuss authorization of a booster dose for Pfizer's coronavirus vaccine.
By Jonathan Gardner • Sept. 15, 2021 -
Courtesy of Apellis Pharmaceuticals
Apellis eye drug succeeds in one key study, but falls short in its twin
Highly anticipated study results showed divergent outcomes for the biotech's therapy in treating a form of vision loss known as geographic atrophy. Even so, Apellis plans to soon ask for FDA approval.
By Ned Pagliarulo • Updated Sept. 10, 2021 -
Courtesy of Sanofi
Sanofi drug for rare skin disease, acquired in buyout, fails in late-stage trial
The French drugmaker bought Principia Biopharma last year for two therapies that block a protein called BTK. The second targets a much bigger disorder, multiple sclerosis.
By Jonathan Gardner • Sept. 9, 2021 -
Autism drug fails in late-stage trials, Servier says
The French drugmaker and its biotech partner Neurochlore agreed to end two Phase 3 studies early after finding no signs that treatment was effective.
By Kristin Jensen • Sept. 8, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Pfizer, Merck launch large new trials of oral COVID-19 drugs
Both companies are racing to prove their oral antivirals as treatments for COVID-19. Key clinical results could come later this year.
By Kristin Jensen • Sept. 1, 2021 -
National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.
Hint of benefit in Alzheimer's drug study fuel stock surge for Swiss biotech
A once-failed drug being developed by AC Immune and Roche appeared to slow cognitive decline in a small trial. But other study goals were missed, muddying the seemingly positive result.
By Ned Pagliarulo • Aug. 31, 2021 -
Spencer Platt via Getty Images
Pfizer drug bests Sanofi, Regeneron's Dupixent in head-to-head study
Abrocitinib, a JAK inhibitor Pfizer's developing, outperformed Dupixent in treating moderate or severe eczema. Hanging over the study's success, however, is an ongoing review by the FDA of the drug's class.
By Ned Pagliarulo • Aug. 30, 2021 -
Christopher Furlong via Getty Images
AstraZeneca reports study success for rare disease drug acquired in Alexion deal
With positive results from a Phase 3 trial in hand, the British pharma intends to soon seek regulatory approval for the Wilson disease treatment.
By Kristin Jensen • Aug. 26, 2021 -
Mario Tama via Getty Images
With new results, J&J's $1B gamble on a targeted inflammation drug faces long odds
Theravance, which agreed to co-develop a next-generation JAK inhibitor with J&J three years ago, said the experimental drug failed a mid-stage study in ulcerative colitis, leaving its future in doubt.
By Jonathan Gardner • Aug. 24, 2021 -
Alexion discontinues ALS drug trial due to 'lack of efficacy'
The decision, which follows the recommendation of a data monitoring committee, is yet another setback in the search for more treatments for the neurological disease.
By Shoshana Dubnow • Aug. 23, 2021 -
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Sponsored by PSI CROA pandemic lesson for every CRO: Empower infrastructure to handle crises
Here are some ways CROs can prepare for the worst and keep their trials moving smoothly.
Aug. 23, 2021 -
Courtesy of Eli Lilly
Lilly's new eczema drug scores in late-stage studies
Positive results help validate the $1 billion acquisition that gave Lilly access to lebrikizumab. Even so, the company could face tough competition from Regeneron and Sanofi's Dupixent.
By Jacob Bell , Ben Fidler • Aug. 16, 2021 -
Roche sets bar in early lymphoma treatment with Polivy study results
Positive data for the Swiss pharma's antibody-based drug could be a benchmark for CAR-T therapies, which other developers aim to move into early lymphoma treatment, too.
By Jonathan Gardner • Aug. 9, 2021 -
Regeneron drug extends survival in lung cancer trial, lifting company's hopes in field
The biotech also reported second quarter earnings on Thursday that widely surpassed Wall Street expectations.
By Jonathan Gardner • Aug. 5, 2021 -
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Sponsored by ICONPractical approaches to operationalizing decentralized clinical trials
When appropriate, DCTs can accelerate trial conduct, create a wealth of high-quality data and improve efficiency.
Aug. 5, 2021 -
FDA allows Novartis gene therapy trials to resume after nearly 2 year pause
After reviewing animal study data submitted by the Swiss pharma, the FDA cleared spinal injections of Zolgensma for study in older patients with SMA.
By Jonathan Gardner • Aug. 3, 2021 -
Jeenah Moon via Getty Images
Pfizer's fast progress shines spotlight on an emerging vaccine race
The big drugmaker surprised analysts and investors this week by projecting Phase 3 results next year, which could put the company on pace with a rival shot from GlaxoSmithKline.
By Jonathan Gardner • July 30, 2021 -
Permission granted by Biogen
Biogen, Ionis tout data from early study of RNA-based Alzheimer's drug
The companies said that patients treated with their experimental drug BIIB080 had reductions in a protein called tau, which research indicates is tied to Alzheimer's but isn't yet proven to impact the course of the disease.
By Jacob Bell • July 27, 2021 -
Denali drug for rare brain disease disappoints investors
New data from an early-stage study of Denali's drug for Hunter syndrome look "noisy" and even "uninterpretable," according to some analysts. Company shares fell by 15% Monday morning.
By Jacob Bell • July 26, 2021 -
Seres, after earlier success, fails a key test for microbiome drugs
A pill made of gut bacteria wasn't effective at treating ulcerative colitis in a closely watched study that was viewed as a proof point for the emerging field.
By Ben Fidler • July 22, 2021 -
Elizabeth Regan/BioPharma Dive
Cytokinetics heart drug succeeds in mid-stage study, boosting shares
Treatment with one of the biotech's drugs improved heart function in a small trial, an outcome that could help the company rebound and potentially challenge a rival medicine from Bristol Myers Squibb.
By Ned Pagliarulo • July 19, 2021 -
Permission granted by Clinical Ink
Sponsored by Clinical InkHow real-time data keeps infectious disease studies moving in times of crisis
One COVID-19 study, 1,000 seniors — ahead of schedule. Find out how eSource made it happen.
July 19, 2021 -
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Sponsored by YourwayIntegrating sourcing, packaging, labelling and distribution for efficient clinical kitting
Efficient execution of clinical trials requires the provision of medicines and all other critical materials to be carefully delivered on time to clinical sites or patient's homes.
July 19, 2021
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