FDA deems Orchestra BioMed's sirolimus-eluting balloon a breakthrough device for coronary restenosis

Orchestra BioMed has received an FDA breakthrough device designation for its drug-eluting angioplasty balloon, designed to open up the coronary arteries of the heart after they’ve reclogged following the placement of a stent. While physically widening the artery, the company’s Virtue system delivers sustained-release sirolimus directly to the walls of the blood vessel without the use of a traditional drug coating. The porous balloon instead elutes the drug enclosed in a bioabsorbable nanoparticle, which Orchestra said allows it to avoid using a coating that may produce downstream particulates or small blood clots as well as the hazards that come with an additional permanent metal implant.

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BioNex Solutions

At BioNex Solutions, we develop instrumentation and integrated systems that solve the most demanding applications in biopharmaceutical, biotech, and academic research. Our hardware and software philosophy is to design single-purpose, high performance modules, and integrate them to produce the desired functionality.

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MedTech

Better Purification and Recovery in Bioprocessing

Article | July 12, 2022

In the downstream portion of any bioprocess, one must pick through the dross before one can seize the gold the biotherapeutic that the bioprocess was always meant to generate. Unfortunately, the dross is both voluminous and various. And the biotherapeutic gold, unlike real gold, is corruptible. That is, it can suffer structural damage and activity loss. When discarding the dross and collecting the gold, bioprocessors must be efficient and gentle. They must, to the extent possible, eliminate contaminants and organic debris while ensuring that biotherapeutics avoid aggregation-inducing stresses and retain their integrity during purification and recovery. Anything less compromises purity and reduces yield. To purify and recover biotherapeutics efficiently and gently, bioprocessors must avail themselves of the most appropriate tools and techniques. Here, we talk with several experts about which tools and techniques can help bioprocessors overcome persistent challenges. Some of these experts also touch on new approaches that can help bioprocessors address emerging challenges.

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Medical

2022 U.S. Market Research Report with COVID-19 Forecasts2

Article | August 16, 2022

The global biotechnology market is expected to grow at a compound annual growth rate (CAGR) of 13.9 percent from 2022 to 2030, with a value estimated at USD 1,023.92 billion in 2021. The market is being propelled by strong government support in the form of initiatives aimed at modernizing the regulatory framework, improving approval processes and reimbursement policies, and standardizing clinical studies. The growing presence of personalized medicine and an increasing number of orphan drug formulations are opening up new avenues for biotechnology applications and driving the influx of emerging and innovative biotechnology companies, which is driving market revenue even further. The 2022 Biotech Research and Development Market Research Report is one of the most comprehensive and in-depth assessments of the industry in the United States, containing over 100 data sets spanning the years 2013 to 2026. This Kentley Insights report contains historical and forecasted market size, product lines, profitability, financial ratios, BCG matrix, state statistics, operating expense details, organizational breakdown, consolidation analysis, employee productivity, price inflation, pay bands for the top 20 industry jobs, trend analysis and forecasts on companies, locations, employees, payroll, and much more. Companies in the Biotech Research and Development industry are primarily engaged in biotechnology research and experimental development. Biotechnology research and development entails the investigation of the use of microorganisms and cellular and bimolecular processes to create or modify living or non-living materials. This biotechnology research and development may result in the development of new biotechnology processes or prototypes of new or genetically altered products that can be replicated, used, or implemented by various industries. This report was created using the findings of extensive business surveys and econometrics. The professionals follow reports with accurate and apt information on market sizing, benchmarking, strategic planning, due diligence, cost-cutting, planning, understanding industry dynamics, forecasting, streamlining, gap analysis, and other ana

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MedTech

Wisconsin biotech companies could play key roles in long-term economic recovery from COVID-19 pandemic

Article | July 20, 2022

Whether it’s called a modern “Manhattan Project” or a medical moon shot, the concept of long-term economic recovery rests on how confident people are they won’t risk serious illness by venturing forth in public again. Wisconsin stands to be a significant part of such an undertaking, whatever it’s called. The shorter-term debate is well under way over the gradual lifting of COVID-19 emergency rules, such as the now-extended “safer-at-home” order in Wisconsin. At least a dozen states, including regional coalitions on the East and West coasts, are exploring next steps as they seek to balance responses to the virus with calls for reopening the economy, at least, in part. Wisconsin’s ability to shape longer-term responses will come from private and public resources, which range from companies engaged in production of diagnostics.

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MedTech

Biotech in 2022

Article | July 11, 2022

The robust global channel of more than, 800 gene and cell curatives presently in trials will produce clinical readouts in 2022, revealing what lies ahead for advanced curatives. The impact will be felt in 2022, no matter how you slice it. Eventually, how well industry and non-supervisory bodies unite to produce new frameworks for advanced therapies will shape the year 2022 and further. Pacific Northwest talent will continue to contribute to the advancement of gene and cell curatives in both the short and long term, thanks to its deep pool of ground-breaking scientific developers, entrepreneurial directorial leadership, largely skilled translational scientists, and endured bio manufacturing technicians. We may see continued on-life science fund withdrawal from biotech in 2021, but this can be anticipated as a strong comeback in 2022 by biotech industry, backed by deep-pocketed life science investors who are committed to this sector. A similar investment, combined with pharma's cash-heavy coffers, can result in increased junction and acquisition activity, which will be a challenge for some but an occasion for others. Over the last five years, investment interest in Seattle and the Pacific Northwest has grown exponentially, from Vancouver, British Columbia, to Oregon. The region's explosive portfolio of new biotech companies, innovated out of academic centres, demonstrates the region's growing recognition of scientific invention. This created a belief that continued, especially because Seattle's start-ups and biotech enterprises are delivering on their pledge of clinical and patient impact. Talent and staffing will continue to be difficult to find. It's a CEO's market, but many of these funds' return, and are not rising in proportion to the exorbitant prices they're paying to enter deals. This schism has become particularly pronounced in 2021. Hence, everyone in biotech is concerned about reclamation and retention.

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Spotlight

BioNex Solutions

At BioNex Solutions, we develop instrumentation and integrated systems that solve the most demanding applications in biopharmaceutical, biotech, and academic research. Our hardware and software philosophy is to design single-purpose, high performance modules, and integrate them to produce the desired functionality.

Related News

Chemotherapy or not? New discoveries help determine who will benefit from chemotherapy

medicalxpress | April 24, 2019

Case Western Reserve University researchers and partners, including a collaborator at Cleveland Clinic, are pushing the boundaries of how "smart" diagnostic-imaging machines identify cancers—and uncovering clues outside the tumor to tell whether a patient will respond well to chemotherapy. The recent findings in breast and lung cancerresearch build off work pioneered by biomedical engineering professor Anant Madabhushi, founder of the Center for Computational Imaging and Personalized Diagnostics. He is senior author on a pair of recent journal publications and joined by scientists from the Case School of Engineering, Cleveland Clinic and New York University Langone Medical Center. This work, in total, heralds a more personalized future in medical diagnoses, Madabhushi said. "And it is further evidence that information gleaned by computational interrogation of the region outside the tumors on MRI (magnetic resonance images) and CAT (computed tomography) scans is extremely valuable and can predict response and benefit of chemotherapy in lung and breast cancer patients," said Madabhushi, the F. Alex Nason Professor II of Biomedical Engineering at the Case School of Engineering.

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Gyroscope Therapeutics merges with Orbit Biomedical creating a leading retinal gene therapy company

STEVENAGE | April 12, 2019

Gyroscope Therapeutics (Gyroscope), a biotechnology company developing gene therapies for retinal diseases, announces its merger with Orbit Biomedical (Orbit), a medical device company focused on the precise and targeted delivery of gene and cell therapies into the retina. Under the Gyroscope name, the organization will become the first fully- integrated retinal gene therapy company with clinical, manufacturing and delivery capabilities. As it enters the next phase of growth towards bringing medicines to patients, Gyroscope will be led by newly appointed Chief Executive Officer, Khurem Farooq. Prior to joining the company, Khurem was the Senior Vice President of the Immunology and Ophthalmology business unit at Genentech and responsible for managing the commercial success of Lucentis and the pre-launch activities for lampalizumab for age-related macular degeneration. Khurem Farooq, Chief Executive Officer of Gyroscope Therapeutics, said: “It is an exciting time to join Gyroscope with our first clinical study in patients with geographic atrophy due to dry AMD underway. By joining forces with Orbit, we can combine our expertise in developing gene therapies and our high-quality manufacturing processes with a surgical platform that can support accurate, safe and consistent delivery of medicines that will hopefully cure eye diseases that today leave people blind.”

Read More

Promising new class of antibodies protects against HIV-1 infection

Phys.org | July 24, 2018

A group of scientists at Texas Biomedical Research Institute has zeroed in on a new defense against HIV-1, the virus that causes AIDS. Led by Ruth Ruprecht, M.D., Ph.D., the team used an animal model to show for the first time that an antibody called Immunoglobulin M (IgM) was effective in preventing infection after mucosal AIDS virus exposure. Worldwide, an estimated 90% of new cases of HIV-1 are caused by exposure in the mucosal cavities like the inside lining of the rectum or vagina.

Read More

Chemotherapy or not? New discoveries help determine who will benefit from chemotherapy

medicalxpress | April 24, 2019

Case Western Reserve University researchers and partners, including a collaborator at Cleveland Clinic, are pushing the boundaries of how "smart" diagnostic-imaging machines identify cancers—and uncovering clues outside the tumor to tell whether a patient will respond well to chemotherapy. The recent findings in breast and lung cancerresearch build off work pioneered by biomedical engineering professor Anant Madabhushi, founder of the Center for Computational Imaging and Personalized Diagnostics. He is senior author on a pair of recent journal publications and joined by scientists from the Case School of Engineering, Cleveland Clinic and New York University Langone Medical Center. This work, in total, heralds a more personalized future in medical diagnoses, Madabhushi said. "And it is further evidence that information gleaned by computational interrogation of the region outside the tumors on MRI (magnetic resonance images) and CAT (computed tomography) scans is extremely valuable and can predict response and benefit of chemotherapy in lung and breast cancer patients," said Madabhushi, the F. Alex Nason Professor II of Biomedical Engineering at the Case School of Engineering.

Read More

Gyroscope Therapeutics merges with Orbit Biomedical creating a leading retinal gene therapy company

STEVENAGE | April 12, 2019

Gyroscope Therapeutics (Gyroscope), a biotechnology company developing gene therapies for retinal diseases, announces its merger with Orbit Biomedical (Orbit), a medical device company focused on the precise and targeted delivery of gene and cell therapies into the retina. Under the Gyroscope name, the organization will become the first fully- integrated retinal gene therapy company with clinical, manufacturing and delivery capabilities. As it enters the next phase of growth towards bringing medicines to patients, Gyroscope will be led by newly appointed Chief Executive Officer, Khurem Farooq. Prior to joining the company, Khurem was the Senior Vice President of the Immunology and Ophthalmology business unit at Genentech and responsible for managing the commercial success of Lucentis and the pre-launch activities for lampalizumab for age-related macular degeneration. Khurem Farooq, Chief Executive Officer of Gyroscope Therapeutics, said: “It is an exciting time to join Gyroscope with our first clinical study in patients with geographic atrophy due to dry AMD underway. By joining forces with Orbit, we can combine our expertise in developing gene therapies and our high-quality manufacturing processes with a surgical platform that can support accurate, safe and consistent delivery of medicines that will hopefully cure eye diseases that today leave people blind.”

Read More

Promising new class of antibodies protects against HIV-1 infection

Phys.org | July 24, 2018

A group of scientists at Texas Biomedical Research Institute has zeroed in on a new defense against HIV-1, the virus that causes AIDS. Led by Ruth Ruprecht, M.D., Ph.D., the team used an animal model to show for the first time that an antibody called Immunoglobulin M (IgM) was effective in preventing infection after mucosal AIDS virus exposure. Worldwide, an estimated 90% of new cases of HIV-1 are caused by exposure in the mucosal cavities like the inside lining of the rectum or vagina.

Read More

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