Clinical Trials: Page 50
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Remdesivir, chloroquine move to forefront as White House tries to speed coronavirus response
Neither drug is approved for COVID-19, but officials seek to quickly study both in hopes of finding an answer for U.S. coronavirus patients.
By Jonathan Gardner • March 19, 2020 -
In hard-hit Seattle, coronavirus pushes biotechs to a new normal
Local drugmakers are on the frontlines of a pandemic that's affecting travel, clinical research and daily operations. It's forcing them to adapt quickly.
By Jacob Bell • March 19, 2020 -
Explore the Trendline➔
Meletios Verras via Getty ImagesTrendlineOncology's research boom
More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.
By BioPharma Dive staff -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from https://www.flickr.com/photos/nihgov/49565892277/in/album-72157713108522106/.
Despite 'heroic' effort, coronavirus study finds little benefit to repurposed HIV drug
Results from the trial are the first randomized data to emerge from scores of studies testing repurposed antivirals in patients infected with the coronavirus.
By Ned Pagliarulo • March 18, 2020 -
FDA maps out plan for trials as coronavirus starts to threaten drug research
The agency is trying to get ahead of what could be widespread protocol changes to ongoing clinical trials.
By Ben Fidler • March 18, 2020 -
Sage redraws its plans for failed antidepressant drug
Hoping to chart a path forward after a damaging study setback, Sage will start three new trials of zuranolone this year.
By Ned Pagliarulo • March 18, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49535193876/in/album-72157713108522106/.Q&A
Coronavirus led one biotech to pause a key trial, as more begin to follow
Clinical trial timelines are being threatened amid social distancing and a widening outbreak. Provention Bio's decision to suspend a study on Monday was one of the first publicly disclosed examples.
By Ben Fidler • Updated March 18, 2020 -
CDC/Alissa Eckert, MS. "covid-19 coronavirus on black background". Retrieved from https://www.cdc.gov/media/subtopic/images.htm.
No White House offer for coronavirus vaccine access, CureVac says
An abrupt exit by CEO Daniel Menichella following a meeting with President Donald Trump, and the medical leave taken this week by his successor, were "pure coincidence," a board member said.
By Jonathan Gardner • March 17, 2020 -
Deep Dive
Big pharma shied away from gene therapy for years. Academia picked up the slack
The byproduct was richer licensing fees for universities and a throng of startups, but also questions on fair prices and research priorities.
By Jonathan Gardner • March 17, 2020 -
Regeneron expects its antibody cocktail for coronavirus to enter human testing in early summer
The biotech is prepping manufacturing facilities so that, once the top antibody contenders are selected, clinical production can quickly begin. By the end of the summer, the aim is to make hundreds of thousands of doses per month.
By Jacob Bell • March 17, 2020 -
Regeneron and Sanofi speed Kevzara into coronavirus trials
Positive signs from a Chinese test of Roche's Actemra support the companies' decision to start studying their anti-inflammatory drug against COVID-19.
By Jonathan Gardner • March 16, 2020 -
Fosun, Pfizer to help BioNTech join the mRNA race for a coronavirus vaccine
BioNTech, like other mRNA vaccine developers, is moving at a record pace to begin studies of vaccine hopefuls. But the field's work remains unproven.
By Ben Fidler • March 16, 2020 -
Sponsored by BBK Worldwide
Top trends shaping clinical trial patient travel and reimbursement
New services offer clinical trial sponsors unmatched convenience, flexibility, and sophistication, while delivering measurable patient enrollment and engagement results.
March 16, 2020 -
AstraZeneca and Merck's string of Lynparza successes ends in ovarian cancer
Results from a Phase 3 combination study in the tumor type read out negative, marking a rare miss for the pharmas' fast-growing cancer drug.
By Jonathan Gardner • March 12, 2020 -
Rubius scraps lead candidate as it exits rare disease drugmaking
The once richly valued biotech cited manufacturing challenges at a contractor as a factor behind delays to its red blood cell therapy for PKU disease.
By Jacob Bell • March 12, 2020 -
CDC/Alissa Eckert, MS. "covid-19 coronavirus on black background". Retrieved from https://www.cdc.gov/media/subtopic/images.htm.
Gates, Wellcome hatch $125M plan to speed coronavirus treatments
Gates Foundation, Wellcome and MasterCard aim to accelerate the study of existing and new drugs for current outbreak as well as for future pathogen threats.
By Jonathan Gardner • March 10, 2020 -
2 newer multiple myeloma drugs fall short in bid for wider market
Phase 3 trials of Bristol Myers Squibb's Emplicti and Takeda's Ninlaro showed no benefit to adding either drug to a Revlimid-based combination in newly diagnosed patients.
By Ned Pagliarulo • March 10, 2020 -
Acceleron shelves drug after disappointing readout
Despite hitting the main goal of a mid-stage neuromuscular study, Acceleron isn't convinced its drug offers meaningful improvement to muscle function or quality of life.
By Jacob Bell • March 10, 2020 -
Hospitals dipping into emergency stocks to combat coronavirus
Community spread of COVID-19 has hospitals bracing for a rush of patients and payers waiving fees for telemedicine consults and extra drug supplies.
By Shannon Muchmore • March 10, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from https://www.flickr.com/photos/nihgov/49565662436/in/album-72157713108522106/.
Tracking biopharma's response to the new coronavirus
The ongoing outbreak is a huge test for the biopharmaceutical industry and its ability to supply, develop, and test new drugs without disruption. Keep up with all of BioPharma Dive's coverage here.
By Jacob Bell • Updated July 7, 2020 -
AstraZeneca immunotherapy combination falls short in bladder cancer trial
Results from a Phase 3 bladder cancer study combining two checkpoint inhibitors failed to show a survival benefit, raising questions about other trials.
By Jonathan Gardner • March 6, 2020 -
Coronavirus spread threatens spring slate of medical meetings
The American College of Cardiology and the American Academy of Allergy, Asthma and Immunology canceled their annual meetings, previously scheduled for March.
By Ned Pagliarulo • Updated March 9, 2020 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49565158853/.
A closer look at the Ebola drug that's become the top hope for a coronavirus treatment
Trials are underway in the U.S., China and, soon, other Asian countries to test whether remdesivir, an antiviral developed by Gilead, could have potential against SARS-CoV-2.
By Ned Pagliarulo • March 5, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49565158908/in/album-72157713108522106/.
Takeda starts work on treatment for coronavirus illness
The plan is to take blood proteins of patients recovering from the novel virus and turn them into an immune-boosting therapy that mitigates or prevents illness in others.
By Jacob Bell • March 4, 2020 -
In a CRISPR first, Editas therapy used to fix genes in the body
A patient with a severe type of inherited blindness was recently treated with Editas and Allergan's CRISPR medicine, marking the first in vivo use of the gene-editing technology in adults.
By Ned Pagliarulo • March 4, 2020 -
Karyopharm shares jump on positive study data for multiple myeloma drug
The cancer biotech now plans to ask the FDA to expand Xpovio's approval into earlier lines of treatment for the blood cancer.
By Ned Pagliarulo • March 2, 2020