Vistin Pharma ASA: Invitation to Q1 2021 conference call
By Dr. Matthew Watson
Oslo, Norway, 16 April 2021
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Vistin Pharma ASA: Invitation to Q1 2021 conference call
Aprea Therapeutics to Host Virtual R&D Day on April 22, 2021
By Dr. Matthew Watson
BOSTON, April 16, 2021 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein, p53, today announced that it will host a virtual R&D Day at 1:00 p.m. ET on Thursday, April 22, 2021.
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Aprea Therapeutics to Host Virtual R&D Day on April 22, 2021
Cosmos Holdings Reports Revenue Growth of 40% to a Record $55.4 Million and Achieves Profitability for 2020
By Dr. Matthew Watson
CHICAGO, April 16, 2021 (GLOBE NEWSWIRE) -- Cosmos Holdings, Inc. (“the Company") (OTCQX: COSM), a vertically integrated, international pharmaceutical company with a proprietary line of branded and generic pharmaceuticals, nutraceuticals, OTC medications and an extensive, established European Union distribution network, today provided a business update and reported financial results for the full year ended December 31, 2020.
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Cosmos Holdings Reports Revenue Growth of 40% to a Record $55.4 Million and Achieves Profitability for 2020
Brickell Biotech Announces Presentation of US Phase 3 Open-Label Long-Term Safety Study Results for Sofpironium Bromide Gel at the Late-Breaking…
By Dr. Matthew Watson
BOULDER, Colo., April 16, 2021 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. (“Brickell” or the “Company”) (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced that results from the US Phase 3 open-label long-term (12-month) safety study of sofpironium bromide gel, 5% and 15% were selected for an oral presentation at the Late-Breaking Research Program during the American Academy of Dermatology’s (AAD) 2021 Virtual Meeting Experience (VMX) being held April 23– 25, 2021. Also, as one of the top twelve late-breaking research abstracts, Brickell has been invited to participate in a live Q&A session on April 24th from 2:00 PM – 3:00 PM CT.
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Brickell Biotech Announces Presentation of US Phase 3 Open-Label Long-Term Safety Study Results for Sofpironium Bromide Gel at the Late-Breaking...
Sanofi completes Kiadis acquisition
By Dr. Matthew Watson
This is a joint press release by Sanofi Foreign Participations B.V. (the “Offeror”), Sanofi (“Sanofi”) and Kiadis Pharma N.V. (“Kiadis”) in connection with the public offer by the Offeror for all the issued and outstanding ordinary shares in the capital of Kiadis (the “Offer”). This announcement does not constitute an offer, or any solicitation of any offer, to buy or subscribe for any securities. Any offer will be made only by means of the offer memorandum dated 10 February 2021 (the “Offer Memorandum”), approved by the Dutch Authority for the Financial Markets (Autoriteit Financiële Markten) on 10 February 2021 and recognized by the Belgian Authority for the Financial Markets (Autoriteit voor Financiële Diensten en Markten) on 11 February 2021. This announcement is not for release, publication or distribution, in whole or in part, in or into, directly or indirectly, any jurisdiction in which such release, publication or distribution would be unlawful. Terms not defined in this press release will have the meaning as set forth in the Offer Memorandum.
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Sanofi completes Kiadis acquisition
Virbac : Declaration of the number of shares and voting rights March 2021
By Dr. Matthew Watson
DECLARATION OF THE NUMBER OF SHARES AND VOTING RIGHTS
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Virbac : Declaration of the number of shares and voting rights March 2021
Apellis to Showcase Leadership in Retina at Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting
By Dr. Matthew Watson
WALTHAM, Mass., April 16, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that 10 abstracts were accepted for presentation at the virtual Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting to be held May 1-7, 2021. These abstracts feature a breadth of data, from presentations that demonstrate the potential of AI to analyze the growth of GA lesions, to new safety and efficacy data for pegcetacoplan, an investigational targeted C3 therapy, in GA.
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Apellis to Showcase Leadership in Retina at Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting
AnPac Bio Reports Record Q1 for Paid CDA-Based Cancer Testing Volume in 2021, Increasing Approximately 130% Compared to Q1, 2020
By Dr. Matthew Watson
SAN JOSE, Calif., April 16, 2021 (GLOBE NEWSWIRE) -- AnPac Bio-Medical Science Co., Ltd. (“AnPac Bio,” the “Company” or “we”) (NASDAQ: ANPC), a biotechnology company with operations in China and the United States focused on early cancer screening and detection, announced today that it experienced strong demand for its paid tests based on the cancer differentiation analysis technology (CDA) technology, or paid CDA-based tests, in the first quarter of 2021, setting a record high Q1 test volume. CDA-based tests, which are multi-cancer tests based on a novel biophysical approach, are the Company’s flagship product line and reached 5,439 paid cancer tests in Q1, an approximately 130% increase over the same period last year. While AnPac Bio offers multiple test products including various cancer screening tests, immunology tests and annual physical checkups, paid CDA-based tests had the highest test volume among all these tests in Q1, 2021.
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AnPac Bio Reports Record Q1 for Paid CDA-Based Cancer Testing Volume in 2021, Increasing Approximately 130% Compared to Q1, 2020
Auxly Receives Approval to Begin Trading on the Toronto Stock Exchange April 20, 2021
By Dr. Matthew Watson
TORONTO, April 16, 2021 (GLOBE NEWSWIRE) -- Auxly Cannabis Group Inc. (TSX.V - XLY) (OTCQX: CBWTF) ("Auxly" or the "Company"), a leading consumer packaged goods company in the cannabis products market, is pleased to announce that it has received final approval from the Toronto Stock Exchange (“TSX”) to graduate from the TSX Venture Exchange (“TSXV”) and list its common shares on the TSX.
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Auxly Receives Approval to Begin Trading on the Toronto Stock Exchange April 20, 2021
Report of transactions of shares and related securities of Bavarian Nordic by persons holding managerial responsibilities and/or persons/companies…
By Dr. Matthew Watson
COPENHAGEN, Denmark, April 17, 2021 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) has today received information about the following transactions of the company’s shares/related securities by persons holding managerial responsibilities and/or persons/companies closely associated with such.
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Report of transactions of shares and related securities of Bavarian Nordic by persons holding managerial responsibilities and/or persons/companies...
Avadel Presents New Data from its Pivotal REST-ON Phase 3 Trial of FT218, once-nightly sodium oxybate, at the 2021 American Academy of Neurology…
By Dr. Matthew Watson
DUBLIN, Ireland, April 17, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate (ON-SXB) for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced the presentation of positive secondary endpoint data at the 2021 American Academy of Neurology Annual (AAN) Meeting being held virtually from April 17-22, 2021. FT218 is currently under review at the U.S. Food and Drug Administration with a Prescription Drug User Fee Act (PDUFA) target date of October 15, 2021.
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Avadel Presents New Data from its Pivotal REST-ON Phase 3 Trial of FT218, once-nightly sodium oxybate, at the 2021 American Academy of Neurology...
VASCEPA® (Icosapent Ethyl) Reported to Impact Vulnerable Coronary Plaque Features in New Analyses of EVAPORATE Study Presented as Late-Breaking…
By Dr. Matthew Watson
Study quantified coronary plaque changes in patients administered 4 g/day of VASCEPA® (icosapent ethyl) on top of statin therapy
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VASCEPA® (Icosapent Ethyl) Reported to Impact Vulnerable Coronary Plaque Features in New Analyses of EVAPORATE Study Presented as Late-Breaking...
European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma
By Dr. Matthew Watson
European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma
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European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma
Number of Shares and Voting Rights of Innate Pharma as of April 1, 2021
By Dr. Matthew Watson
MARSEILLE, France, April 19, 2021 (GLOBE NEWSWIRE) -- Pursuant to the article L. 233-8 II of the French “Code de Commerce” and the article 223-16 of the French stock-market authorities (Autorité des Marchés Financiers, or “AMF”) General Regulation, Innate Pharma SA (the “Company” – Euronext Paris: FR0010331421 – IPH; Nasdaq: IPHA) releases its total number of shares outstanding as well as its voting rights as at April 1, 2021:
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Number of Shares and Voting Rights of Innate Pharma as of April 1, 2021
Nicox Provides First Quarter 2021 Business Update and Financial Highlights
By Dr. Matthew Watson
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Nicox Provides First Quarter 2021 Business Update and Financial Highlights
ERYTECH Announces Completion of First Cohort in a Phase 1 Investigator Sponsored Trial of Eryaspase in First-Line Pancreatic Cancer
By Dr. Matthew Watson
ERYTECH Announces Completion of First Cohort in a Phase 1 Investigator Sponsored Trial of Eryaspase in First-Line Pancreatic Cancer
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ERYTECH Announces Completion of First Cohort in a Phase 1 Investigator Sponsored Trial of Eryaspase in First-Line Pancreatic Cancer
How stress causes hair loss | National Institute on Aging – National Institute on Aging
By daniellenierenberg
From NIH Research Matters
Long-term, or chronic, stress puts people at risk for a variety of health problems. These can include depression and anxiety, as well as problems with digestion and sleep. Chronic stress has also long been linked to hair loss, but the reasons werent well understood.
Hair growth involves three stages. In growth (anagen), strands of hair push through the skin. In degeneration (catagen), hair ceases to grow, and the follicle at the base of the strand shrinks. In rest (telogen), hair falls out and the process can begin again. Hair is among the few tissues that mammals can regenerate throughout their lifetime.
The hair growth cycle is driven by stem cells that reside in the hair follicle. During growth, stem cells divide to become new cells that regenerate hair. In the resting period, the stem cells are inactive. Until now, researchers hadnt determined exactly how chronic stress impaired hair follicle stem cells.
A team led by Dr. Ya-Chieh Hsu of Harvard University studied the underlying mechanisms that link stress and hair loss. The study was supported in part by NIHs National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Results appeared in Nature, on March 4, 2021.
The researchers began by testing the role of the adrenal glands, which produce key stress hormonescorticosterone in rodents and cortisol in humans. Removing the adrenal glands from mice led to rapid cycles of hair regrowth. Hair follicle regeneration didnt slow as these mice grew older, like it did in control mice. Rather, hair follicle stem cells continued to enter the growth phase and regenerate hair follicles throughout the animals lifespans. The team was able to restore the normal hair cycle by feeding the mice corticosterone.
Subjecting mice to mild stress over many weeks increased corticosterone levels and reduced hair growth. Hair follicles remained in an extended resting phase. Together, these findings supported the role of corticosterone in inhibiting hair regrowth.
The scientists next examined how corticosterone affects hair follicle stem cells. They found that the stress hormone was not regulating stem cells directly. By deleting the receptor for corticosterone from different cells, they determined that the hormone acts on a cluster of cells underneath the hair follicle called the dermal papilla.
Further studies revealed that corticosterone prevented the dermal papilla from secreting GAS6, a molecule they showed can activate hair follicle stem cells. Delivering GAS6 into the skin restored hair growth in mice fed corticosterone or undergoing chronic stress.
Last year, findings from Hsus team advanced the understanding of how stress causes gray hair. These results reveal a key pathway involved in hair loss from chronic stress. These findings may also lead to further insights into how stress affects tissue regeneration in other parts of the body.
In the future, the Gas6 pathway could be exploited for its potential in activating stem cells to promote hair growth, says first author Dr. Sekyu Choi of Harvard University. However, further study is needed to understand whether the same mechanism is at work in people.
by Erin Bryant
This research was supported in part by NIA grant R01AG048908.
Reference: Corticosterone inhibits GAS6 to govern hair follicle stem-cell quiescence. Choi S, Zhang B, Ma S, Gonzalez-Celeiro M, Stein D, Jin X, Kim ST, Kang YL, Besnard A, Rezza A, Grisanti L, Buenrostro JD, Rendl M, Nahrendorf M, Sahay A, Hsu YC. Nature. 2021 Mar 31. doi: 10.1038/s41586-021-03417-2. Online ahead of print. PMID: 33790465.
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How stress causes hair loss | National Institute on Aging - National Institute on Aging
Cellino Biotech developing tech to help scale stem cell therapies – MedCity News
By daniellenierenberg
In response to emailed questions, Cellino Biotech CEO and Co-founder Dr. Nabiha Saklayen, talked about the formation of the company and its goal to make stem cell therapies more accessible for patients.
Why did you start this company?
I see a huge need to develop a technology platform to enable the manufacture of cell therapies at scale. We recently closed a $16 million seed financing round led by Khosla Ventures and The Engine at MIT, with participation from Humboldt Fund. Cellino is on a mission to make personalized, autologous cell therapies accessible for patients. Stem cell-derived regenerative medicines are poised to cure some of the most challenging diseases within this decade, including Parkinsons, diabetes, and heart disease. Patient-specific cells provide the safest, most effective cures for these indications. However, current autologous processes are not scalable due to extensive manual handling, high variability, and expensive facility overhead. Cellinos vision is to make personalized regenerative medicines viable at large scale for the first time.
How did you meet your co-founders?
Nabiha Saklayen.
I met my co-founder Marinna Madrid in my Ph.D. research group. We had worked together for many years and had a fantastic working relationship. I then met our third co-founder Matthias Wagner through a friend. Matthias had built and run three optical technology companies in the Boston area and was looking to work with a new team. I was thrilled when we decided to launch the startup together at our second meeting. Matthias built the first Cellino hardware systems in what I like to call Matthias garage. In parallel, I was doing hundreds of expert interviews with biologists in academia and industry, and it started to narrow down our potential applications very quickly. Marinna was doing our first experiments with iPSCs. We iterated rapidly on building new versions of the hardware based on the features that were important to industry experts, such as single-cell precision and automation. Its incredible to witness our swift progress as a team.
What specific need or pain point are you seeking to address in healthcare/life sciences?
In general, autologous therapies are safer for patients because they do not require immunosuppression. The next iteration of cell therapies would use patient-specific stem cells banked ahead of time. Anytime a patient needs new cells, such as blood cells, neurons, or skin cells, we would generate them from a stem cell bank.
Today, patient-specific stem cell generation is a manual and artisanal process. A highly skilled scientist sits at a bench, looks at cells by eye, and removes unwanted cells with a pipette tip. Many upcoming clinical trials are using manual processes to produce stem cells for about ten to twenty patients.
At Cellino, we are converging different disciplines to automate this complex process. We use an AI-based laser system comes to remove any unwanted cells. By making stem cells for every human in an automated, scalable way, we are working towards our mission at Cellino to democratize personalized regenerative medicine.
What does your technology do? How does it work?
Cellinos platform combines label-free imaging and high-speed laser editing with machine learning to automate cell reprogramming, expansion, and differentiation in a closed cassette format, enabling thousands of patient samples to be processed in parallel in a single facility.
In general, autologous, patient-specific stem cell-derived therapies do not require immunosuppression and are safer for patients. Today, patient-specific stem cells are made manually, by hand. To scale the stem cell generation process, Cellino converges different disciplines to automate this complex process. We train machine learning algorithms to characterize cells before our AI-based laser system removes any unwanted cells. By making stem cells for every human in an automated, scalable way, our mission at Cellino is to democratize personalized regenerative medicine. Thats why our vision statement is Every human. Every cell.
Whats your background in healthcare? How did you get to where you are today?
When I arrived at Harvard University for my Ph.D. in physics, I wanted to be closer to real-world applications. Biology is inherently complex and beautiful, and I was interested in developing new physics-based tools to engineer cells with precision. During my Ph.D., I invented new ways to edit cells with laser-based nanomaterials. I collaborated with many brilliant biology groups at Harvard, including the Rossi, Scadden, and Church labs. Working closely with them convinced me that lasers offer a superior solution to editing cells with high precision. That realization compelled me to launch Cellino.
Do you have clinical validation for your product?
Our immediate goal for the next year is to show that our platform can produce personalized, high-quality, R&D-grade stem cells for different patients, which has not been established in an automated manner in the regenerative medicine industry so far. There is significant patient-to-patient variability in manual cell processing, which we eliminate with our platform.
Photo: Urupong, Getty Images
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Cellino Biotech developing tech to help scale stem cell therapies - MedCity News
A Massive New Gene Editing Project Is Out to Crush Alzheimer’s – Singularity Hub
By daniellenierenberg
When it comes to Alzheimers versus science, science is on the losing side.
Alzheimers is cruel in the most insidious way. The disorder creeps up in some aging brains, gradually eating away at their ability to think and reason, whittling down their grasp on memories and reality. As the worlds population ages, Alzheimers is rearing its ugly head at a shocking rate. And despite decades of research, we have no treatmentnot to mention a cure.
Too much of a downer? The National Institutes of Health (NIH) agrees. In one of the most ambitious projects in biology, the NIH is corralling Alzheimers and stem cell researchers to come together in the largest genome editing project ever conceived.
The idea is simple: decades of research have found certain genes that seem to increase the chance of Alzheimers and other dementias. The numbers range over hundreds. Figuring out how each connects or influences anotherif at alltakes years of research in individual labs. What if scientists unite, tap into a shared resource, and collectively solve the case of why Alzheimers occurs in the first place?
The initiatives secret weapon is induced pluripotent stem cells, or iPSCs. Similar to most stem cells, they have the ability to transform into anythinga cellular Genie, if you will. iPSCs are reborn from regular adult cells, such as skin cells. When transformed into a brain cell, however, they carry the original genes of their donor, meaning that they harbor the original persons genetic legacyfor example, his or her chance of developing Alzheimers in the first place. What if we introduce Alzheimers-related genes into these reborn stem cells, and watch how they behave?
By studying these iPSCs, we might be able to follow clues that lead to the genetic causes of Alzheimers and other dementiaspaving the road for gene therapies to nip them in the bud.
The iPSC Neurodegenerative Disease Initiative (iNDI) is set to do just that. The project aims to stimulate, accelerate, and support research that will lead to the development of improved treatments and preventions for these diseases, the NIH said. All resulting datasets will be openly shared online, for anyone to mine and interpret.
In plain language? Lets throw all of our new biotech superstarswith CRISPR at the forefrontinto a concerted effort against Alzheimers, to finally gain the upper hand. Its an Avengers, assemble moment towards one of our toughest foesone that seeks to destroy our own minds from within.
Alzheimers disease was first recognized in the early 1900s. Ever since, scientists have strived to find the cause that makes a brain waste away.
The most prominent idea today is the amyloid hypothesis. Imagine a horror movie inside a haunted house with ghosts that gradually intensify in their haunting. Thats the amyloid horrora protein that gradually but silently builds up inside a neuron, the house, eventually stripping it of its normal function and leading to the death of anything inside. Subsequent studies also found other toxic proteins that hang around outside the neuron house that gradually poison the molecular tenants within.
For decades scientists have thought that the best approach to beat these ghosts was an exorcismthat is, to get rid of these toxic proteins. Yet in trial after trial, they failed. The failure rate for Alzheimers treatmentso far, 100 percenthas led some to call treatment efforts a graveyard of dreams.
Its pretty obvious we need new ideas.
A few years ago, two hotshots strolled into town. One is CRISPR, the wunderkind genetic sharpshooter that can snip way, insert, or swap out a gene or two (or more). The other is iPSCs, induced pluripotent stem cells, which are reborn from adult cells through a chemical bath.
The two together can emulate Dementia 2.0 in a dish.
For example, using CRISPR, scientists can easily insert genes related to Alzheimers, or its protection, into an iPSCeither that from a healthy donor, or someone with a high risk of dementia, and observe what happens. A brain cell is like a humming metropolitan area, with proteins and other molecules whizzing around. Adding in a dose of pro-Alzheimers genes, for example, could block up traffic with gunk, leading scientists to figure out how those genes fit into the larger Alzheimers picture. For the movie buffs out there, its like adding into a cell a gene for Godzilla and another for King Kong. You know both could mess things up, but only by watching what happens in a cell can you know for sure.
Individual labs have tried the approach since iPSCs were invented, but theres a problem. Because iPSCs inherit the genetic baseline of a person, it makes it really difficult for scientists in different labs to evaluate whether a gene is causing Alzheimers, or if it was just a fluke because of the donors particular genetic makeup.
The new iNDI plan looks to standardize everything. Using CRISPR, theyll add in more than 100 genes linked to Alzheimers and related dementias into iPSCs from a wide variety of ethnically diverse healthy donors. The result is a huge genome engineering project, leading to an entire library of cloned cells that carry mutations that could lead to Alzheimers.
In other words, rather than studying cells from people with Alzheimers, lets try to give normal, healthy brain cells Alzheimers by injecting them with genes that could contribute to the disorder. If you view genes as software code, then its possible to insert code that potentially drives Alzheimers into those cells through gene editing. Execute the program, and youll be able to observe how the neurons behave.
The project comes in two phases. The first focuses on mass-engineering cells edited with CRISPR. The second is thoroughly analyzing these resulting cells: for example, their genetics, how their genes activate, what sorts of proteins they carry, how those proteins interact, and so on.
By engineering disease-causing mutations in a set of well-characterized, genetically diverse iPSCs, the project is designed to ensure reproducibility of data across laboratories and to explore the effect of natural variation in dementia, said Dr. Bill Skarnes, director of cellular engineering at the Jackson Laboratory, and a leader of the project.
iNDI is the kind of initiative thats only possible with our recent biotech boost. Engineering hundreds of cells related to Alzheimersand to share with scientists globallywas a pipe dream just two decades ago.
To be clear, the project doesnt just generate individual cells. It uses CRISPR to make cell lines, or entire lineages of cells with the Alzheimers gene that can pass on to the next generation. And thats their power: they can be shared with labs around the world, to further hone in on genes that could make the largest impact on the disorder. Phase two of iNDI is even more powerful, in that it digs into the inner workings of these cells to generate a cheat codea sheet of how their genes and proteins behave.
Together, the project does the hard work of building a universe of Alzheimers-related cells, each outfitted with a gene that could make an impact on dementia. These types of integrative analyses are likely to lead to interesting and actionable discoveries that no one approach would be able to learn in isolation, the authors wrote. It provides the best chance at truly understanding Alzheimers and related diseases, and promising treatment possibilities.
Image Credit: Gerd Altmann from Pixabay
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A Massive New Gene Editing Project Is Out to Crush Alzheimer's - Singularity Hub