Clinical Trials: Page 34
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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 -
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 -
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 -
Shutterstock.com
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 -
Getty
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 -
RgStudio via Getty Images
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 -
Merck details an immunotherapy 'milestone' in early breast cancer
Three months after a rare FDA rejection, Merck has data showing Keytruda can slow the return of triple-negative breast cancer but not, as of yet, proving whether the drug extends lives.
By Ben Fidler • July 15, 2021 -
Permission granted by Celldex
Celldex pins its hopes for a comeback on skin disease drug
After several setbacks, most notably the failure of a brain cancer vaccine, Celldex has a chance at reinvention should early drug results pan out for the 16-year-old biotech.
By Ben Fidler • July 9, 2021 -
Maddie Meyer via Getty Images
Moderna puts seasonal flu vaccine ambitions to the test
Having proved mRNA's might in COVID-19, the biotech company aims to develop similar vaccines for other respiratory illnesses caused by influenza, RSV and metapneumovirus.
By Ned Pagliarulo • July 7, 2021 -
As Arrowhead falters, lungs remain a tough target for RNA drugs
The biotech's decision to pause testing of a cystic fibrosis drug is the latest reminder of the difficulty of delivering RNA medicines into the lungs.
By Ben Fidler • July 6, 2021 -
Courtesy of Eli Lilly
Lilly, Boehringer say diabetes drug first to succeed in hard-to-treat heart failure
The results are a potentially significant finding that could help change how heart failure patients with preserved ejection fraction are treated, and will support the companies' application for the drug's approval.
By Ned Pagliarulo • July 6, 2021 -
Courtesy of CureVac AG
CureVac vows to seek vaccine approval despite low efficacy in COVID-19 study
Final results from CureVac's large Phase 3 study showed an overall efficacy of just 48%, although the German biotech emphasized stronger protection against more severe disease and in younger adults.
By Ned Pagliarulo • July 1, 2021 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Roche partner sees promise for anti-COVID 19 pill in early study
A pill from Atea Pharmaceuticals rapidly reduced the amount of virus in the blood of patients with COVID-19, a step forward in drugmaker efforts to develop easier-to-take treatments for the disease.
By Kristin Jensen • June 30, 2021 -
Pfizer's neuroscience spinout scores in schizophrenia
Cerevel Therapeutics on Tuesday revealed positive results from an early-stage study of one of its drugs, doubling the price of the company's stock.
By Jacob Bell • June 29, 2021
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