FDA announces new policy framework for development of regenerative medicine products

Today the U.S. Food and Drug Administration announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies. The framework outlined in a suite of four guidance documents builds upon the FDAs existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products. Further, two of the guidance documents propose an efficient, science-based process for helping to ensure the safety and effectiveness of these therapies, while supporting development in this area.

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FroggaBio Inc

FroggaBio is a distributor of laboratory products, supply instruments, reagents and disposables. We serve customers within academic and industrial research institutes, biotechnology and pharmaceutical companies and hospitals. Headquartered in Toronto Canada, FroggaBio represents numerous companies exclusively allowing us to offer a comprehensive line of products in biological, chemical, and diagnostic fields at very competitive prices.

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MedTech

Next-Gen Genetics Cancer Therapies Creating Investment Prospects

Article | July 16, 2022

Genetic therapeutics such as genetic engineering and gene therapy are increasingly emerging as one of the most influential and transformed biotechnological solutions around the globe in recent times. These genetic solutions are being assessed across various medical domains, including cancer treatment, neurology, oncology, and ophthalmology. Citing the trend, the genetics industry is estimated to experience a tsunami of approvals, with over 1,000 cell and gene therapy clinical trials currently underway and over 900 companies worldwide focusing on these cutting-edge therapies. Growing Cancer Encourages Advancements in Genetic Technologies With the surging cases of cancers such as leukemias, carcinomas, lymphomas, and others, patients worldwide are increasing their spending on adopting novel therapeutic solutions for non-recurring treatment of the disease, such as gene therapy, genetic engineering, T-cell therapy, and gene editing. As per a study by the Fight Cancer Organization, spending on the treatment of cancer increased to $200.7 billion, and the amount is anticipated to exceed $245 billion by the end of 2030. Growing revenue prospects are encouraging biotechnology and biopharmaceutical companies to develop novel genetic solutions for cancer treatment. For instance, Bristol-Myers Squibb K.K., a Japanese pharmaceutical company, introduced a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, Abecma, for the treatment of relapsed or refractory (R/R) multiple myeloma in 2022. Amid a New Market: Genetics Will Attract Massive Investments Despite several developments and technological advancements, genetics is still considered to be in a nascent stage, providing significant prospects for growth to the companies that are already operating in the domain. Genetics solutions such as gene therapies, gene editing, and T-cell immunotherapy are emerging as highly active treatments across various medical fields, resulting in increasing research and development activities across the domain, drawing significant attention from investors. Given the potential of genetic treatments and the focus on finding new ways to treat cancer and other related diseases, it's easy to understand why companies are investing in the domain. For instance, Pfizer has recently announced an investment of around $800 million to construct development facilities supporting gene therapy manufacturing from initial preclinical research through final commercial-scale production. Due to these advancements, cell and gene therapies are forecast to grow from $4 billion annually to more than $45 billion, exhibiting growth at a 63% CAGR. The Future of Genetics Though there is a significant rise in advancement in genetic technologies and developments, the number of approved genetic treatments remains extremely small. However, with gene transfer and CRISPR solutions emerging as new modalities for cancer treatment, the start-up companies will attract a growing amount and proportion of private and public investments. This is expected present a tremendous opportunity for biopharma and biotechnology investors to help fund and benefit from the medical industry's shift from traditional treatments to cutting-edge genetic therapeutics in the coming years.

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MedTech

5 Biotech Stocks Winning the Coronavirus Race

Article | July 12, 2022

There are quite a few companies that have found ways to grow their business during the ongoing COVID-19 pandemic. This is especially true for a number of biotechs now working on developing a potential treatment for, or vaccine against, the virus; shares of such companies have largely surged over the past couple of months. Although many of these treatments and vaccines are still have quite a way to go before they're widely available, it's still worth taking some time to look through what's going on in the COVID-19 space right now. Here are five biotech stocks that are leading the way when it comes to addressing COVID-19. Regeneron Pharmaceuticals (NASDAQ:REGN) wasn't among the initial wave of companies to announce a potential COVID-19 drug. However, investor excitement quickly sent shares surging when the company announced that its rheumatoid arthritis drug, Kevzara, could help treat COVID-19 patients.

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MedTech

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

Article | July 11, 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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Medical

Nanostructures: Emerging as Effective Carriers for Drug Delivery

Article | July 14, 2022

Natural remedies have been employed in medicine since antiquity. However, a large number of them fail to go past the clinical trial stages. In vivo instability, poor solubility and bioavailability, a lack of target-specific delivery, poor absorption, and side effects of the medication are only a few of the problems caused by the use of large-sized materials in drug administration. Therefore, adopting novel drug delivery systems with targeted medications may be a solution to address these pressing problems. Nanotechnology has received tremendous attention in recent years and has been demonstrated to help blur the boundaries between the biological and physical sciences. With great success, it plays a vital part in enhanced medication formulations, targeted venues, and controlled drug release and delivery. Limitations of Traditional Delivery Trigger the Adoption of Nanoparticles The field of nanotechnology and the creation of drug formulations based on nanoparticles is one that is expanding and showcasing great potential. It has been thoroughly researched in an effort to develop new methods of diagnosis and treatment and to overcome the limitations of several diseases' current therapies. As a result, nanoparticles are being used to improve the therapeutic effectiveness and boost patient adherence to treatment by increasing medication bioavailability, drug accumulation at a particular spot, and reducing drug adverse effects. The nanoparticles could be transformed into intelligent systems housing therapeutic and imaging agents by manipulating their surface properties, size, correct drug load, and release with targeted drug delivery. Nanostructures facilitate the release of combination medications at the prescribed dose since they remain in the blood circulation system for a long time. Therefore, they result in fewer plasma fluctuations with decreased side effects. Due to their nanoscale, these structures can easily enter the tissue system, promote the absorption of drugs by cells, make medication administration more effective, and ensure that the medicine acts at the targeted location. The Way Ahead Nanomedicine and nano-delivery systems are a comparatively new but fast-evolving science in which nanoscale materials are used as diagnostic tools to deliver drug molecules at precisely targeted sites in a controlled manner. It is finding applications for the treatment of diseases such as cardiovascular, neurodegenerative, cancer, ocular, AIDS, and diabetes, among others. With more research and technological advancement, these drug delivery solutions will open up huge opportunities for companies that work with them.

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Spotlight

FroggaBio Inc

FroggaBio is a distributor of laboratory products, supply instruments, reagents and disposables. We serve customers within academic and industrial research institutes, biotechnology and pharmaceutical companies and hospitals. Headquartered in Toronto Canada, FroggaBio represents numerous companies exclusively allowing us to offer a comprehensive line of products in biological, chemical, and diagnostic fields at very competitive prices.

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FDA Advancing Beneficial Animal Biotechnology Product Development

fda | April 03, 2019

the FDA announced its Plant and Animal Biotechnology Innovation Action Plan, which focuses on the agency’s risk-based regulatory framework. This framework will help secure confidence in the safety and performance of plant and animal-based innovative products for consumers, patients, and America’s global trading partners. Making sure these products are safe and perform as expected is critical to maintaining consumer and commercial confidence in them and realizing their potential benefits for human and animal health.

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The Farcical Battle Over What to Call Lab-Grown Meat

TheAtlantic.com | July 13, 2018

On Thursday, in a small but packed auditorium, the FDA convened a public meeting about lab-grown meat but you wouldn’t have known that if you were listening for those words. According to the FDA, it was actually about “foods produced using animal-cell culture technology.” And according to the meeting’s various speakers, it was “clean meat,” or “artificial meat,” or “in vitro meat,” or “cell-culture products,” or “ cultured meat,” or “cultured tissue” (not meat!). This is a war of words, with each one chosen to evoke specific associations. And it is a war to define lab-grown meat as either the exciting future of food or a freak science experiment.

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Have Biotech ETFs Finally Bottomed?

biotech | March 14, 2017

From Zacks: 2016 was a tough year for biotech stocks with the sector facing a lot of criticism for rising drug prices. Although shares did rally post-election in November on hopes that drug pricing would not be a key focus area under a Donald Trump presidency, the rally turned out to be short-lived following the President’s views regarding drug pricing

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the FDA announced its Plant and Animal Biotechnology Innovation Action Plan, which focuses on the agency’s risk-based regulatory framework. This framework will help secure confidence in the safety and performance of plant and animal-based innovative products for consumers, patients, and America’s global trading partners. Making sure these products are safe and perform as expected is critical to maintaining consumer and commercial confidence in them and realizing their potential benefits for human and animal health.

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The Farcical Battle Over What to Call Lab-Grown Meat

TheAtlantic.com | July 13, 2018

On Thursday, in a small but packed auditorium, the FDA convened a public meeting about lab-grown meat but you wouldn’t have known that if you were listening for those words. According to the FDA, it was actually about “foods produced using animal-cell culture technology.” And according to the meeting’s various speakers, it was “clean meat,” or “artificial meat,” or “in vitro meat,” or “cell-culture products,” or “ cultured meat,” or “cultured tissue” (not meat!). This is a war of words, with each one chosen to evoke specific associations. And it is a war to define lab-grown meat as either the exciting future of food or a freak science experiment.

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Have Biotech ETFs Finally Bottomed?

biotech | March 14, 2017

From Zacks: 2016 was a tough year for biotech stocks with the sector facing a lot of criticism for rising drug prices. Although shares did rally post-election in November on hopes that drug pricing would not be a key focus area under a Donald Trump presidency, the rally turned out to be short-lived following the President’s views regarding drug pricing

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