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83,386 Orion Corporation A shares converted into B shares
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Tiziana Reports Positive Data from the Clinical Study of Nasal Administration with Foralumab, its proprietary fully human anti-CD3 monoclonal…
NEW YORK and LONDON, Feb. 02, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (Nasdaq: TLSA / LSE: TILS) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, reports positive data from the exploratory clinical study in Brazil investigating nasally administered Foralumab, its proprietary anti-CD3 human monoclonal antibody, either alone or in combination with orally administered dexamethasone (“Dexa”) in COVID-19 patients. The clinical study was completed in collaboration with scientific teams at the Harvard Medical School (Boston, USA), and INTRIALS, a full-service Latin American CRO based in São Paulo, Brazil.
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Tiziana Reports Positive Data from the Clinical Study of Nasal Administration with Foralumab, its proprietary fully human anti-CD3 monoclonal...
Verona Pharma Reports Positive Phase 2 Results with pMDI Formulation of Ensifentrine in COPD
Primary and secondary lung function endpoints met
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Verona Pharma Reports Positive Phase 2 Results with pMDI Formulation of Ensifentrine in COPD
Group financial statement and annual report for 2020
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Group financial statement and annual report for 2020
Novozymes delivers resilient full-year results despite the COVID-19 pandemic and is confident about getting back to growth in 2021
Novozymes delivered flat organic sales growth in the 2020 financial year and an EBIT margin of 26.1%. In 2021 the company expects 2-6% organic growth supported by innovation, stronger commercial presence, and gradual industry recovery. EBIT margin is expected at a solid 25-26%.
CORRECTING and REPLACING — Verona Pharma Reports Positive Phase 2 Results with pMDI Formulation of Ensifentrine in COPD
LONDON and RALEIGH, N.C., Feb. 02, 2021 (GLOBE NEWSWIRE) -- In a release issued under the same headline earlier today by Verona Pharma plc (Nasdaq: VRNA), please note that all instances of the unit "µg" were mistakenly represented as "mg." The corrected release follows:
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CORRECTING and REPLACING -- Verona Pharma Reports Positive Phase 2 Results with pMDI Formulation of Ensifentrine in COPD
Immunovant Announces Voluntary Pause in Clinical Dosing of IMVT-1401
NEW YORK, Feb. 02, 2021 (GLOBE NEWSWIRE) -- Immunovant (Nasdaq: IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases, today announced a voluntary pause of dosing in its ongoing clinical trials for IMVT-1401.
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Immunovant Announces Voluntary Pause in Clinical Dosing of IMVT-1401
Medicine by Design researchers focus on promoting self-repair of the brain – News@UofT
If you asked Freda Miller 10 years ago if stem cells could be harnessed to repair brain injuries and disease, she would have said it was too early to tell.
Today, she describes the progress that she and other regenerative medicine experts have madein understanding what regulates populations of stem cells cells with the potential to turn into many different cell typesand the rapid advances those discoveries have driven.
The approaches were using allow us to find so much information on things we could only dream of before.
Miller, who is also a professor at the University of British Columbia, is leading a Medicine by Design-funded team with expertise in computational biology, neurobiology, bioengineering and stem cell biology that is investigating multiple strategies to recruit stem cells to promote self-repair in the brain and in muscle. If it succeeds, the research could improve treatments for diseases such as multiple sclerosis (MS) and cerebral palsy, as well as brain injury.
Millers team is one of 11 at U of T and its partner hospitals that are sharing nearly $21 million in funding from Medicine by Design over three years. Funded by a $114-million grant from the Canada First Research Excellence Fund, Medicine by Design is a strategic research initiative that is working at the convergence of engineering, medicine and science to catalyze transformative discoveries in regenerative medicine and accelerate them toward clinical impact.
This is the second round of large-scale, collaborative team projects that Medicine by Design has funded. The support builds on the progressmade in the first round of projects (2016-2019) and is spurring further innovation to push regenerative medicine forward. It alsoled to a 2017 publicationby many of the same researchers on Millers current project in Cell Reports that essentially provided a roadmap for how brain stem cells build the brain developmentally, and then persist to function in the adult brain.
Miller, a neuroscientist, has always been fascinated by the brain and neurons, the network of billions of nerve cells in the brain. Around 15 years ago, when she started to take an interest in the potential regenerative capabilities of stem cells, she began to wonder if she could use stem cells to treat brain injury or disease. Though too little was known about stem cells at the time, she knew that it was a question worth investigating. But she also realized that making and integrating new nerve cells, which are the working parts of brain circuits, would be a daunting task.
Even if you can convince the stem cells to make more neurons, those neurons then have to survive and they have to integrate into this really complex circuitry, says Miller. It just made sense to me that if were really going to test this idea of self-repair in the brain, we should go after something thats more achievable biologically.
So, Miller turned her attention to a substance called myelin, which covers nerves and allows nerve impulses to travel easily. In many nervous system diseases MS is a well-known example and brain injuries, damage to and loss of myelin is a main factor in debilitating symptoms. Thanks in part to the team project award from Medicine by Design, Miller leads a team that has a focus on recruiting stem cells to promote the generation of myelin.
Miller says repairing myelin, also called remyelination, will eventually help to better understand the effects of the target disease or injury, possibly even leading scientists to discover how to reverse it. Boosting myelin is a promising area of research, she adds, because its not an all-or-nothing situation.
Even a little bit of remyelination could have a big impact. You dont have to win the whole lottery; you dont have to have 100 per cent remyelination to have a measurable outcome.
The teams work is not limited to generating myelin to treat nervous system diseases or brain injury. They are also looking at how they could recruit stem cells to generate more muscle. They are specifically looking at muscular dystrophy, but Miller says the applications from that work can be used in other diseases or situations where damage to muscles has occurred, such as age-related disorders.
Millers team includes experts from diverse fields: Gary Bader, a professor at the Donnelly Centre for Cellular and Biomolecular Research and a computational biologist; bioengineers Alison McGuigan, a professor in the department of chemical engineering and applied chemistry in the Faculty of Applied Science & Engineering, and Penney Gilbert, an associate professor at the Institute of Biomedical Engineering; Sid Goyal, a professor at the department of physics in the Faculty of Arts & Science; ProfessorDavid Kaplan and Assistant ProfessorYun Li, both in the Temerty Faculty of Medicine and a senior scientist and a scientist, respectively, at SickKids; stem cell biologist Cindi Morshead, a professor and chair of the division of anatomy in the department of surgery in the Temerty Faculty of Medicine; and Peter Zandstra, a University Professor in the Faculty of Applied Science & Engineering and director of Michael Smith Laboratories at the University of British Columbia.
Miller says Medicine by Designs contribution in bringing teams like hers together is immeasurable.
There are tangible results you can measure like publications and other grants and clinical trials, Miller says. But there are a lot of intangible things Medicine by Design brings to the table like developing a culture of people from very diverse places and allowing them to do science together at a time when the biggest breakthroughs are going to be made by combining technological and biological approaches. Its hard to do that if youre on your own.
This large, interdisciplinary team effort combines data and computer modelling to look at individual stem cells in the brain and predict their behaviours. Through experimentation, they can then test if the cells behave the way they predicted, which Miller says they have had great success with. From there, the team casts a wide net, testing various ways to try to control cells behaviour with the end goal of convincing the stem cells to turn into cells that aid in healing and repair.
One approach they use is testing already approved pharmaceuticals to see if they have the desired effect on the stem cells behaviour. This approach has had success. In summer 2020, Morshead, Miller and their collaborators, led by Donald Mabbott, a SickKids senior scientist and professor in the department of psychology in the Faculty of Arts & Science, published a paper in Nature Medicine that showed that metformin, a common diabetes drug, has the potential to reverse brain injury in children who had had cranial radiation as a curative therapy for brain tumours.
Miller says that, to her knowledge, this is the first paper that demonstrates that this type of brain repair is possible in humans.
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Medicine by Design researchers focus on promoting self-repair of the brain - News@UofT
Should You Buy Brainstorm Cell Therapeutics Inc (BCLI) Stock on Tuesday? – InvestorsObserver
The market has been high on Brainstorm Cell Therapeutics Inc (BCLI) stock recently. BCLI gets a Bullish score from InvestorsObserver's Stock Sentiment Indicator.
Sentiment uses short term technical analysis to gauge whether a stock is desired by investors. As a technical indicator, it focuses on recent trends as opposed to the long term health of the underlying company. Updates for the company such as a earnings release can move the stock away from current trends.
Price action is generally the best indicator of sentiment. For a stock to go up, investors must feel good about it. Similarly, a stock that is in a downtrend must be out of favor.
InvestorsObservers Sentiment Indicator considers price action and recent trends in volume. Increasing volumes often mean that a trend is strengthening, while decreasing volumes can signal that a reversal could come soon.
The options market is another place to get signals about sentiment. Since options allow investors to place bets on the price of a stock, we consider the ratio of calls and puts for stocks where options are available.
Brainstorm Cell Therapeutics Inc (BCLI) stock is up 7.94% while the S&P 500 is lower by -0.12% as of 12:02 PM on Tuesday, Jan 26. BCLI has risen $0.46 from the previous closing price of $5.79 on volume of 3,810,664 shares. Over the past year the S&P 500 is up 18.72% while BCLI has risen 49.88%. BCLI lost -$1.02 per share in the over the last 12 months.
To screen for more stocks like Brainstorm Cell Therapeutics Inc click here.
Brainstorm Cell Therapeutics Inc is a biotechnology company. The company is developing novel adult stem cell therapies for debilitating neurodegenerative disorders such as Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig's disease), Progressive Multiple Sclerosis (PMS), and Parkinson's disease (PD). Brainstorm's NurOwn, its proprietary process for the propagation of Mesenchymal Stem Cells (MSC) and differentiation into neurotrophic factor-(NTF) secreting cells (MSC-NTF), and their transplantation at, or near, the site of damage, offers the hope of more effectively treating neurodegenerative diseases.
Click Here to get the full Stock Score Report on Brainstorm Cell Therapeutics Inc (BCLI) Stock.
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Should You Buy Brainstorm Cell Therapeutics Inc (BCLI) Stock on Tuesday? - InvestorsObserver
Stem cell and allergy clinics receive CBER untitled letters – Regulatory Focus
The US Food and Drug Administrations Center for Biologics Evaluation and Research (FDAs CBER) has issued untitled letters to a firm marketing regenerative medicine products and to a company selling extracts for immunotherapy. On 25 January, CBER warned the owner of a California-based company called The Body Building, Inc. for marketing BioGenix regenerative medicine products to treat a variety of conditions including autoimmune disease, diabetes, Parkinsons disease, autism, and cardiovascular disease. Among the claims cited by CBER is an assertion from The Body Buildings Facebook page that the stem cells are highly anti inflammatory and immediately dissipate ANY PAIN [emphasis original] in the body in any area desired. They help modulate the functioning of your immune system which helps reverse the effects of auto immune disease. The products, which the firm claims contain primitive undifferentiated stem cells, do not carry a valid biologics license from FDA, notes the regulator, who referred the letters recipient to FDAs suite of four guidance documents setting the policy framework for human cellular or tissue-based products. CBER also noted that the website is advertising an exosome product, also subject to premarket review as a drug or biological product. The agency requests a response within 30 days. In other action, CBER warned Edge Pharma, LLC, based in Colchester, VT for marketing patient specific immunotherapy vials and custom mix allergy immunotherapy vials without a biologics license. Edge Pharma had not submitted an investigational new drug application for these products; neither had the firm applied for a biologics license. The warning letter also took issue with Edge Pharmas characterization of itself as a registered 503B outsourcing facility. Wrote CBER, Please be advised that biological products subject to licensure under section 351 of the PHS Act are not eligible for the exemptions for compounded drugs under sections 503A and 503B of the FD&C Act. Edge Pharma was referred to a January 2018 guidance on mixing, diluting or repackaging biologics outside the scope of an approved BLA, and asked to respond within 20 days. CDER warns Texas firm for multiple violations Separately, FDAs Center for Drug Evaluation and Research (CDER) warned a compounding center for multiple and significant violations, including receipt of drugs from active pharmaceutical ingredient (API) suppliers who themselves have been the subject of regulatory action. Houston-based Professional Compounding Centers of America (PCCA) garnered the letter after a week-long FDA inspection in October 2019. The heavily redacted warning letter begins by detailing the agencys concerns about API sourcing. We note that an inspection of records at your facility and a review of FDA import data demonstrated that FDA has, in the past, taken regulatory action against at least 23 of your other API suppliers for the manufacture of adulterated drugs under section 501 of the FD&C Act by either listing their drugs on import alert and/or issuing them warning letters, wrote FDA in the 27 January warning letter. A 23-point numbered list of the warning letters issued to individual API suppliers follows, though suppliers identity and other key details are redacted. Enough substance was left in the list, however, to ascertain that many of the listed firms had denied FDAs attempts to schedule inspections, and some evidently had issues found on inspection such as leaving undesirable material on the floors of the facilities, failure to investigate failed test results and failing to maintain complete data. The letter tells PPCA to provide lot numbers and dates of distribution for all of its products, and more: Considering that FDA has found a pattern of drug manufacturers with serious CGMP or other adulteration violations in your supply chain, in response to this letter, also provide a detailed plan to ensure you do not receive or deliver adulterated drugs in interstate commerce, in violation of section 301(c) of the FD&C Act, 21 U.S.C. 331(c). Other violations mentioned in the warning letter include serious problems with PCCAs glycerin testing program, which leaves open the potential for contamination with DEG. This known glycerin contaminant has caused fatalities in glycerin-containing medicines such as cough syrup, noted FDA in the letter. Finally, PCCA uses its name on the labels of some repackaged APIs without clearly indicating that these drugs were produced by other firms, a fact that became apparent during the October 2019 Inspection. FDA is calling for a regulatory meeting with PCCA to review the violations.
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Stem cell and allergy clinics receive CBER untitled letters - Regulatory Focus