Biotech: Page 86
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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 -
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 -
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 -
Vaccine makers, in bid for transparency, disclose detailed plans of coronavirus vaccine trials
Moderna was the first to share the so-called study protocol of its Phase 3 trial, spurring Pfizer and AstraZeneca to quickly do the same.
By Ned Pagliarulo • Updated Sept. 19, 2020 -
Kendall Davis/BioPharma Dive
Arrowhead shares soar on liver disease data from four patients
Encouraged by the early study results, Arrowhead plans to ask regulators to streamline its clinical trials, which could pressure rivals Vertex and Dicerna.
By Jonathan Gardner • Sept. 16, 2020 -
Jacob Bell/BioPharma Dive
Merck pays Seattle Genetics $1.7B as antibody cancer drugs continue comeback
Merck's deal for Seattle Genetics' antibody-drug conjugate comes as Gilead agreed to acquire rival developer Immunomedics in the biotech industry's largest buyout of 2020.
By Ben Fidler • Sept. 14, 2020 -
Permission granted by Gilead Sciences
Gilead to buy cancer drugmaker Immunomedics for $21B
The acquisition capped an active year of dealmaking for Gilead, which under CEO Daniel O'Day aims to become as well known for its cancer drugs as its HIV and hepatitis C medicines.
By Ned Pagliarulo • Updated Sept. 14, 2020 -
Intra-Cellular roars back on success in bipolar depression
Widening the number of eligible patients could make Intra-Cellular's schizophrenia pill a blockbuster, analysts forecast.
By Jacob Bell • Sept. 9, 2020 -
Grail, Illumina's well-funded liquid biopsy spinout, prepares for IPO
The company claims its test may help avert deaths from cancers that would otherwise kill later on, but will have a tough task convincing doctors and payers of its merit.
By Nick Paul Taylor • Sept. 9, 2020
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