Clinical Trials: Page
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Courtesy of Eli Lilly
Lilly says diabetes shot outperformed rival Novo drug in study
The results are a boost for Lilly's drug, tirzepatide, which is being prepared for regulatory submissions later this year. But long-term heart data won't be available for some time.
By Jonathan Gardner • March 4, 2021 -
Galapagos reports long-awaited safety data for inflammation drug
The data show similar declines in sperm counts among patients on the Belgian biotech's drug, filgotinib, or a placebo. But it's unclear whether that finding will appease the FDA, which surprisingly rejected filgotinib last year.
By Jacob Bell • March 4, 2021 -
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TrendlineRadiopharmaceuticals
A series of technological advances have led to an explosion of scientific progress — and dealmaking — involving medicines that can precisely deliver radioactive materials into tumors.
By BioPharma Dive staff -
Courtesy of Eli Lilly
Lilly drug regrows hair in autoimmune disease study, but safety questions linger
The results could help baricitinib become the first treatment for alopecia areata, a leading cause of hair loss. Safety concerns have diminished the drug's prospects in arthritis, however.
By Ben Fidler • March 3, 2021 -
A closely watched schizophrenia drug fails key test
Though a mid-stage study read out negative, Neurocrine still sees a path forward for the drug, which it licensed from Takeda last summer.
By Jacob Bell • March 2, 2021 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
A play-by-play of the FDA meeting on J&J's vaccine
FDA advisers expressed growing comfort with the authorization process, offering unanimous support for J&J's shot. But the meeting also gave a window into debates likely to play out in the coming weeks and months.
By Ben Fidler , Ned Pagliarulo , Jonathan Gardner • Updated March 1, 2021 -
Moderna, Pfizer ready multi-pronged plans for coronavirus variants
Moderna has delivered a modified version of its vaccine to NIH scientists, while Pfizer has begun testing of an additional booster shot in a clinical trial, both precautionary steps against emerging strains.
By Jonathan Gardner , Ben Fidler • Updated Feb. 25, 2021 -
Elizabeth Regan/BioPharma Dive
Icon to buy contract researcher PRA Health for $12B
The cash-and-stock deal gives PRA shareholders roughly one-third ownership of the new company, which will be one of the larger providers of contract research support.
By Kristin Jensen • Feb. 24, 2021 -
Jacob Bell/BioPharma Dive
FDA review supports safety, efficacy of J&J coronavirus vaccine
In their review, agency scientists provided new details on the shot's protection against severe COVID-19 and different virus variants as well as its potential to reduce transmission.
By Ned Pagliarulo , Jonathan Gardner • Updated Feb. 24, 2021 -
FDA lays out shortened path for testing vaccines against new coronavirus variants
Lengthy trials won't be needed for updating shots against emerging viral strains, the agency told developers in newly published guidance.
By Ned Pagliarulo • Feb. 22, 2021 -
Sanofi and GSK start trial of upgraded coronavirus vaccine after first version disappoints
The companies think a new formulation will yield better results than their first attempt. But with several vaccines available, testing may be more challenging.
By Ben Fidler • Feb. 22, 2021 -
Shutterstock.com/Nikki Yoakum
Sponsored by Medidata, a Dassault Systèmes companyAccelerating virtual clinical trials
Leveraging the guidance and support of trial virtualization professionals with experience in key areas of a trial's lifecycle will undoubtedly impact overall success.
Feb. 22, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Why this week's FDA meeting on J&J's coronavirus vaccine will be important
The FDA is widely expected to authorize the drugmaker's one-dose shot. But the advisory committee meeting beforehand will offer a window into debate over several key issues.
By Ben Fidler , Ned Pagliarulo • Updated Feb. 23, 2021 -
Permission granted by Centessa Pharmaceuticals
10 biotechs become 1: Centessa launches with $250M to prove unorthodox R&D model
The new company will be led by Saurabh Saha, a former Bristol Myers executive, and Moncef Slaoui, who until recently led the U.S. government's coronavirus vaccine program.
By Ned Pagliarulo • Feb. 16, 2021 -
iStock.com/ljubaphoto
Sponsored by EthicaleReconciliation tool: A new software to facilitate Safety Data Reconciliation between clinical and safety databases
Simplify serious adverse events reconciliation operations with a customizable and GxP validated platform solution.
By Eleanor S. Segal, Luca Morbelli, Simone Suriano & Beat Widler • Feb. 16, 2021 -
Courtesy of AstraZeneca
AstraZeneca plans for adapting vaccine to coronavirus variants, but offers longer timeline than rivals
The drugmaker says between six to nine months are needed to ramp up production of an adapted shot. South Africa recently stopped using the vaccine due to its reduced potency against a common strain there.
By Jonathan Gardner • Feb. 11, 2021 -
Courtesy of Galapagos
Gilead, Galapagos halt development of experimental drug, denting research alliance
Independent reviewers found the benefits of the lung disease drug didn't outweigh its risks, marking a second major setback in six months for the companies' partnership.
By Kristin Jensen • Feb. 11, 2021 -
Permission granted by Roche
In surprise finding, Roche arthritis drug cuts risk of COVID-19 death in large UK study
U.K. researchers running the sprawling RECOVERY trial showed that adding Actemra to standard treatment can save lives, a powerfully positive result in a long-running debate about the drug's utility in COVID-19.
By Ben Fidler • Feb. 11, 2021 -
Elizabeth Regan/BioPharma Dive
Small biotech gets big win on treatment for rare swelling disorder
An oral hereditary angioedema treatment from KalVista Pharmaceuticals looks similarly effective to standard injectables, which could threaten big-selling drugs from Takeda and others.
By Jonathan Gardner • Feb. 9, 2021 -
Courtesy of AstraZeneca
New data on AstraZeneca vaccine add to worries over coronavirus variant from South Africa
South Africa will use other shots in its immunization campaign after AstraZeneca's offered "minimal protection" against the variant that's spread throughout the country.
By Ben Fidler • Feb. 8, 2021 -
Shutterstock.com/Lightspring
Sponsored by PSI CROOn target, on-time enrollment, even in a global pandemic
Completing enrollment of a phase 3 trial on-time, even through the height of COVID-19
Feb. 8, 2021 -
Jacob Bell/BioPharma Dive
PTC aims again for FDA review of Duchenne drug despite latest miss
The FDA has rejected PTC's treatment three times, but the biotech's CEO hopes the "totality" of the results it's now accrued will finally lead to a different outcome.
By Jonathan Gardner • Feb. 5, 2021 -
UK to start study testing Pfizer, AstraZeneca vaccines together
The government-funded trial will evaluate the effects of mixing vaccines and varying timing between shots.
By Kristin Jensen • Feb. 4, 2021 -
Microgen/Shutterstock.com
Sponsored by OracleBreaking down the barriers to decentralized trials
Decentralized trials are here to stay. Here's how technology has and will continue to pave the way.
By Henry McNamara, Senior Vice President and General Manager of Oracle Health Sciences • Feb. 1, 2021 -
Retrieved from National Cancer Institute on September 27, 2019
Amgen study data bolster prospects of KRAS-blocking cancer drug
Results from a mid-stage study showed Amgen's drug, sotorasib, shrank tumors in over a third of lung cancer patients, affirming earlier findings.
By Ned Pagliarulo • Updated Jan. 29, 2021 -
Courtesy of Eli Lilly
Lilly allies with Vir, GSK as coronavirus variants raise worries about antibody drugs
The emergence of new variants has made antibody drug combinations, which are harder for the virus to evade, more important and led to a unique partnership between a trio of drugmakers.
By Ben Fidler • Jan. 27, 2021
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