Biotech: Page 81
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Getty / Edited by BioPharma Dive
Sarepta, continuing its gene therapy push, helps launch a startup
The biotech has joined a group of investors to form a new gene therapy developer led by one of its longtime executives and backed with $107 million.
By Jacob Bell • Oct. 22, 2020 -
Ex-Medivation team nets $500M to take their new cancer drugmaker to Wall Street
Nuvation Bio, a large oncology startup run by former Medivation executives, is capitalizing on a boom in mergers with so-called special purpose acquisition company, or SPACs.
By Ben Fidler • Oct. 21, 2020 -
Explore the Trendline➔
Spencer Platt via Getty Images
TrendlineEmerging biotech
New biotechs continue to emerge despite a challenging market environment that has forced venture firms to build their drug startups more cautiously.
By BioPharma Dive staff -
CRISPR Therapeutics reports remissions, one death in cancer cell therapy study
The biotech is one of several attempting to develop "off-the-shelf "CAR-T therapies. While trial results show potential, high-dose treatment was paused following a patient's death.
By Jonathan Gardner • Oct. 21, 2020 -
Biogen is running out of safety nets
Third quarter earnings underscore just how vital it is that Biogen secure approval of its experimental Alzheimer's drug, given the challenges elsewhere in its business.
By Jacob Bell • Oct. 21, 2020 -
Elizabeth Regan/BioPharma Dive
With approval in sight, Vifor expands deal for partner's anti-itch drug
The company could pay as much as $440 million through a new licensing pact that gives it more commercial rights to a therapy developed by Cara Therapeutics.
By Kristin Jensen • Oct. 20, 2020 -
Early signs of survival benefit raise optimism around a small biotech's ALS drug
Newly published data show that, after joining a clinical trial, patients who were given a drug from Amylyx Pharmaceutcials lived a median 6.5 months longer than those who didn't.
By Jacob Bell • Oct. 16, 2020 -
Vertex faces first notable setback as it pushes beyond cystic fibrosis
Safety signals in a mid-stage study led Vertex to stop work on one of its experimental drugs for the inherited disorder alpha-1 antitrypsin deficiency.
By Jacob Bell • Updated Oct. 15, 2020 -
Gossamer plummets as its lead drug fails 2 studies
Despite the setback, the biotech still sees a path forward for its drug in asthma and plans to find a partner to move it into further testing.
By Jacob Bell • Oct. 13, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
FDA puts Voyager study on hold in latest gene therapy speed bump
The biotech won't be able to start human testing of an experimental Huntington's disease treatment until regulators see more manufacturing data.
By Jonathan Gardner • Oct. 13, 2020 -
Alkermes' comeback bid boosted by FDA panel backing for schizophrenia drug
While the committee's votes in favor of ALKS 3831 make an approval more likely, the drug's effects on patients also taking opioids could limit its use.
By Ben Fidler • Oct. 12, 2020 -
Moderna says it won't enforce coronavirus vaccine patents during pandemic
The biotech, a frontrunner in the coronavirus vaccine race, said it won't tie up resources defending the intellectual property covering its experimental shot as long as the pandemic continues.
By Jonathan Gardner • Oct. 8, 2020 -
Brian Tucker/BioPharma Dive
ColumnPharmacquired: Splashy deals belie a shallow pool of heart drugs left to acquire
Recent deals for MyoKardia and The Medicines Co. may be hard to follow, since venture investors and big pharma acquirers have largely ignored cardiovascular drugs.
By Jacob Bell • Oct. 8, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Vir, GSK keep pace with rivals as COVID-19 antibody drugs grab spotlight
The two companies claim their coronavirus-fighting antibody drug — the type of medicine recently used to treat President Trump — is safe enough to move into advanced testing.
By Jonathan Gardner • Oct. 6, 2020 -
With a sweetened offer, BridgeBio plans to reel in a subsidiary
After an unsuccessful buyout attempt in 2019, BridgeBio aims to acquire the roughly one-third of Eidos Therapeutics that it doesn't already own.
By Jacob Bell • Oct. 5, 2020 -
Craighead, Shealah. (2020). "White House Update on Coronavirus Testing" [Photograph]. Retrieved from Flickr.
Trump treated for COVID-19 with Regeneron, Gilead drugs
The president has received Regeneron's antibody drug, Gilead's Veklury and the steroid dexamethasone, suggesting his case may be more serious.
By Ben Fidler , Ned Pagliarulo • Updated Oct. 5, 2020 -
Permission granted by Gilead Sciences
Gilead to distribute COVID-19 drug Veklury in US, taking over from federal government
Supplies of the once scarce drug now exceed demand, leading the Trump administration to step back from controlling distribution.
By Ned Pagliarulo • Oct. 2, 2020 -
After trial failure, Genfit cuts staff and gives up on experimental NASH drug
The French biotech is looking to substantially reduce its cash burn rate as it regroups from a damaging clinical setback.
By Kristin Jensen • Oct. 1, 2020 -
Biogen's all-important Alzheimer's drug enters the review gauntlet
On Nov. 6, aducanumab will go before a panel of experts who will review it and make recommendations to the FDA. Meanwhile, the drug has also caught the attention of a powerful cost watchdog group.
By Jacob Bell • Sept. 29, 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/.
FDA delays testing of Inovio's coronavirus vaccine
The FDA has suspended the planned start of a late-stage trial of Inovio's experimental shot, dealing another setback to one of the most advanced DNA-based vaccine programs in development.
By Jonathan Gardner • Sept. 28, 2020 -
Courtesy of Galapagos
After setback in the US, Galapagos' main drug finds success elsewhere
A month after the FDA surprisingly rejected the rheumatoid arthritis drug, called filgotinib, it's been cleared by regulators in Europe and Japan.
By Jacob Bell • Sept. 28, 2020 -
Courtesy of Novavax
Novavax starts large-scale coronavirus vaccine trial in UK, as cases surge
The Maryland-based biotech is the first developer to advance a more traditional protein-based vaccine into the final stages of clinical testing.
By Ben Fidler • Sept. 25, 2020 -
Getty / Edited by BioPharma Dive
Gene therapy company Taysha completes sprint from first funding to IPO
Led by alumni of Zolgensma developer AveXis, the university spinout could have four experimental therapies in the clinic by the end of 2021.
By Jonathan Gardner • Updated Sept. 24, 2020 -
AC Immune drug fails in blow to another Alzheimer's hypothesis
Negative results for the experimental drug semorinemab dents a theory that Alzheimer's disease may be caused by tangles of the protein tau in the brain.
By Jonathan Gardner • Sept. 23, 2020 -
Amgen's KRAS drug can shrink tumors for months, but new data leave room for improvement
Study results unveiled Sunday, if replicated later this year, could be strong enough to garner an approval for Amgen's sotorasib, the first KRAS-blocking drug to get this far.
By Ned Pagliarulo • Sept. 20, 2020 -
Moderna and Pfizer, having shown speed with coronavirus vaccines, see opportunity in seasonal flu
Both companies believe the messenger RNA technology they're using in their coronavirus vaccines could be applied to create a better flu shot.
By Ned Pagliarulo • Sept. 17, 2020
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