Michael Boyle, MD, president and CEO of the Cystic Fibrosis (CF) Foundation, explains how interest in gene therapy and genome editing is growing, as the Foundation strives to leave no CF patient behind in its search for a cure.
COVAXX’s UB-612 program focuses on developing its Multitope Peptide-based Vaccine against SARS-CoV-2, constructed from a peptide-based platform first deployed by parent company United Biomedical. COVAXX has launched a Phase I trial of UB-612 in Taiwan, with a U.S. Phase I trial and a readout of data in non-human primates planned this fall.
Cytiva—which employs more than 7,000 people worldwide—will carry out its expansion across its global product manufacturing and distribution network, which encompasses 13 sites across the U.S. and the rest of the Americas, as well as Asia and Europe.
Should clinical trials prove positive, Humanigen envisions applying for a BLA, and based on the strength of its data obtaining emergency use authorization (EUA) for lenzilumab, followed by a launch of initial commercial activities as soon as the fourth quarter.
AGTC CEO Sue Washer told GEN the change will not hurt the development program, despite the start of the trial being pushed back a few months from AGTC’s earlier estimate of a planned launch by the end of 2020.
The approval makes Guardant360 CDx the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) to identify patients with specific EGFR alterations.
Zymergen and Ginkgo Bioworks both use vast metagenomic databases, machine learning, and robust automated laboratories to design microbes custom-suited to manufacture a desired good.
CEO Bobby Gasoar, MD, PhD, made his presence felt at Orchard Therapeutics in May, leading the company in carrying out a strategic plan that included eliminating about 25% of its workforce, or 60 jobs, and narrowing its near-term R&D pipeline programs to four.
Life sciences industry job growth appears to have continued even as COVID-19 has upended the economies of Massachusetts and other U.S. states.
Three distinguished experts interviewed by GEN, and two investment firms that track biopharma stocks, agreed that four leading COVID-19 vaccine candidates showed sufficient promise in early clinical studies to warrant interest in upcoming trials: AZD1222 by AstraZeneca, the University of Oxford, and its spinout Vaccitech; BNT162b1, the most advanced of four vaccine constructs by Pfizer and BioNTech; mRNA-1273 by Moderna; and Ad5-nCoV by CanSino Biologics.
California’s life science industry faces some formidable headwinds: The development of new drugs and vaccines against COVID-19, and the voter referendum set for November on whether to extend state bonding authority for the state’s stem cell agency, the California Institute for Regenerative Medicine. BIOCOM recently released a report highlighting the economic impact of the state’s life science industry.
Mitchell H. Gold, MD, has gone from heading Dendreon, whose pioneering prostate cancer immunotherapy failed to meet initial sales expectations, to success as Founder and Managing Partner of life sciences investment firm Alpine BioVentures, and Executive Chairman and CEO of Alpine Immune Sciences.
Precision M&A: Invitae Eyes Growth in Personalized Cancer Tests, Services with Up-to-$1.4B ArcherDx Acquisition
The combined company plans to bring germline and somatic testing, liquid biopsy technologies and services, as well as tumor tissue genomic profiling onto a single platform.
Proceeds from the financing are set to go toward expanding its capacity and investing in technologies designed to complement and extend its proprietary antibody discovery engine, as well as toward expanding its staff and facilities.
After Final Medicare LCD from Palmetto GBA, OncoCyte Pursues Private Coverage for NSCLC Stratification Test
The final LCD is particularly encouraging news for OncoCyte, which reasons that about 70% of its patient volume for DetermaRx will be people aged 65 and up.
The power of AI in COVID-19 is that it is being used to generate actionable information – some of which would be impossible without AI—much more quickly than before.
The developer of an all-flash data storage platform—the world’s first to use quad-level cell optimized flash architecture—says it will use the new funding to expand operations overseas, grow its workforce, and step up development of innovative products.
Pittsburgh developer of next-gen antisense oligonucleotide therapies says data generated from a pharmacokinetic study in non-human primates (NHPs) and in vitro pharmacodynamics studies in patient-derived Huntington’s disease (HD) cell lines supports its decision to advance the development of its lead programs in Huntington' disease and myotonic dystrophy type 1, and expand its pipeline into other indications.
Cytiva will also look to grow through expanded activity in cell and gene therapies—and additional work with customers working toward COVID-19 drugs, vaccines, and tests.
Athersys says it is working as fast as it can to launch a pivotal trial of its MultiStem® adult-derived "off-the-shelf" stem cell product in acute respiratory distress syndrome (ARDS), after the clinical program received the “Highly Relevant” designation for COVID-19 from BARDA. [Athersys]
Cellectis says the U.S. patent issued to the company this month will facilitate the development of future development of future T-cell immunotherapy treatments based on CRISPR-Cas.
A former GlaxoSmithKline campus in Upper Merion Township, PA and an adjacent property are being transformed into a $1.2 billion co-working campus focused on cell and gene therapy development.
The development surge for up-and-coming life sciences companies now occurring in New York City is also unfolding in suburban Westchester County, where representatives of two life-sci lab space projects addressed a coalition of industry stakeholders, investors, business and academic leaders.
With a new CEO at the helm, the Laboratory for Advanced Medicine (LAM) is preparing for the launch of its first liquid biopsy—a blood test designed to detect early-stage liver cancer, expected to win approvals starting in China this year.
Ted W. Love, MD, president and CEO of Global Blood Therapeutics (GBT), defended the list price of his company’s recently-approved sickle-cell disease drug Oxbryta™ (voxelotor) before an audience of investors in New York.