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Laying the Foundation for CF Therapy: An Interview with Michael Boyle

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.

Beyond the Spike: The COVAXX Approach to a COVID-19 Vaccine

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 Plans $500M Expansion, 1,000 New Hires Worldwide

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.

A ‘Human’ Touch vs. COVID-19

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 Sets Sights on Late-Stage Retinitis Pigmentosa Gene Therapy Trial

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.

FDA Approves Guardant Test as First Pan-Cancer Liquid Biopsy, CDx for AstraZeneca’s Tagrisso

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.

A Unicorn Rivalry Shaping the Future of the Synbio Industry

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.

At Orchard, Moving from Pruning to Planting

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.

Massachusetts Biopharma Industry Weathers COVID-19 Impacts on Jobs, Financing

Life sciences industry job growth appears to have continued even as COVID-19 has upended the economies of Massachusetts and other U.S. states.

Quartet of COVID-19 Vaccine Candidates Head toward the Homestretch

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.

Rough Surf Ahead for California

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.

Alpine’s Gold Standard Approach to Drug Development

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.

Obsidian’s SWFT Response to COVID-19

SWFT is designed to foster collaboration and coordination between research teams by predicting scheduling and occupancy conflicts, which allows team members to adjust their schedules in order to promote social distancing in the lab and office.

AbCellera’s CEO: Flattening the Curve of Technology Development

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.

COVID-19 Puts Spotlight on Artificial Intelligence

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.

VAST Ambition When It Comes To Data Storage

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.

NeuBase Sets a Course for the Clinic

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 Picks Up Where GE Leaves Off after $21B Deal

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.

Putting COVID-19 on the ‘Map’

Adaptive Biotechnologies and Microsoft expect to have samples sequenced in June from their expanded collaboration to map population-wide adaptive immune responses to COVID-19, with plans to share their data publicly.

Athersys Stem Cell Therapy Targets Top Cause of COVID-19 Deaths

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’ New Patent Supports CRISPR-Based T-Cell Immunotherapies

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.

Top 15 Best-Selling Drugs of 2019

GEN publishes its updated annual A-List highlighting the top 15 best-selling drugs of 2019. Eleven of last year’s 15 top-selling drugs registered year-over-year sales gains, with seven of the 11 racking up double-digit increases.

‘One-Stop Shop’ for Developing Cell and Gene Therapies

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.

At Suburban N.Y. Campus, BioMed Realty Thinks Small

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.

Assessing Coronavirus Impact on Wall Street

Karen Andersen, CFA, of Morningstar shares the firm’s thinking and broader trends shaping the development of coronavirus treatments in an interview with GEN Edge.

At Laboratory for Advanced Medicine, New CEO Sharpens Commercial Focus

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.

Regeneron Hits the Accelerator

Aris Baras, MD, general manager of the Regeneron Genetics Center, discusses RGC’s latest sequencing milestone, its recent operations, and its approach to research and collaborations in an exclusive interview with GEN Edge.

Global Blood Therapeutics CEO Defends Price of Sickle-Cell Drug Oxbryta

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.
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