DALLAS, May 27, 2022 (GLOBE NEWSWIRE) -- Instil Bio, Inc. (“Instil”) (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, today announced IND clearance by the U.S. Food and Drug Administration (“FDA”) of ITIL-306, Instil’s first genetically-engineered Costimulatory Antigen Receptor TIL (CoStAR-TIL) therapy, as well as the presentation of supporting in vivo CoStAR data at the 2022 ASCO Annual Meeting.

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Instil Bio Announces IND Clearance of First CoStAR-TIL program, ITIL-306, Designed to Enhance Activity in the Tumor Microenvironment

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BOSTON, May 27, 2022 (GLOBE NEWSWIRE) -- Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, today announced it is presenting a poster on the AMPLIFY-201 study design at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting, being held in-person from June 3-7, 2022, in Chicago. AMPLIFY-201 is a Phase 1 study evaluating the safety and efficacy of ELI-002, a lymph node-targeted therapeutic cancer vaccine, as a treatment for patients with mKRAS-driven tumors who have minimal residual tumor cells following surgery to remove the tumor.

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Elicio Therapeutics Presents Design of Ongoing AMPLIFY-201 Study in Mutant KRAS-Driven Cancers at ASCO Annual Meeting 2022

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EDISON, N.J., May 27, 2022 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”) and hepatocellular carcinoma (“HCC”), announces that its Chief Medical Officer, Todd Hobbs, MD, gave a clinical presentation entitled “Recofilstat (CRV431): A liver-targeting drug candidate for NASH and HCC” today at the 5th Global NASH Congress.

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Hepion Pharmaceuticals Highlights Upcoming Phase 2 Clinical Trials of Recofilstat at 5th Global NASH Congress

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- Ex vivo data support the high frequency of myeloid cells in tumors, even when T cells are not present -

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Bolt Biotherapeutics to Present Ex Vivo Data Characterizing the Myeloid Cell Landscape in Solid Tumors at ASCO 2022

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SYDNEY, AUSTRALIA, May 27, 2022 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, is pleased to announce new interim data from Part A of the Phase II TACTI-002 trial in 1st line NSCLC has been published today in an abstract at the American Society of Clinical Oncology’s (ASCO) 2022 Annual Meeting.

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Immutep Announces Publication of TACTI-002 and TACTI-003 Abstracts at ASCO 2022

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HALIFAX, Nova Scotia, May 27, 2022 (GLOBE NEWSWIRE) -- Today, MedMira Inc. (MedMira) (TSXV: MIR) provides an update on its regulatory progress in Europe and any market accepting the CE mark. MedMira has received the CE mark for three products in 2022 and has four additional applications currently pending with the regulatory body. As of today, the Company has been informed that all applications have been accepted and will be forwarded to the Competent Authority for final CE marking. The Company anticipates the respective decisions and CE marks within the coming weeks.

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MedMira provides an update on the new In Vitro Diagnostic Medical Devices Regulation (IVDR) in the European Market

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New York, NY, and Tel Aviv, ISRAEL, May 27, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire --Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that majority-owned subsidiary 3CL Pharma will present final data from the phase 2 clinical trial of Tollovir™ in the treatment of hospitalized (severe and critical) COVID-19 patients at the Personalized Medicine World Conference (PMWC) on June 30th, 2022 at 1:30pm Pacific Time.

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Todos Medical to Present Final Data from the Tollovir Phase 2 Clinical Trial in Hospitalized COVID-19 Patients at the Personalized Medicine World...

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EDISON, N.J., May 27, 2022 (GLOBE NEWSWIRE) -- In the press release issued earlier today by Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), we've been informed by the company that in both the headline and first paragraph the name 'Recofilstat' should be 'Rencofilstat'. Completed corrected text follows.

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CORRECTING and REPLACING - Hepion Pharmaceuticals, Inc.

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IRVINE, Calif., May 27, 2022 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced that Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus, will present a corporate update at the Jefferies 2022 Healthcare Conference on Wednesday, June 8, 2022 at 8:30am PT / 11:30am ET.

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Tarsus to Present at the Jefferies 2022 Healthcare Conference

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BUFFALO, N.Y., May 27, 2022 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), a leading agricultural biotechnology company dedicated to improving human health with reduced nicotine tobacco, hemp/cannabis, and hops advanced plant technology, today announced that James A. Mish, Chief Executive Officer, and Richard Fitzgerald, Chief Financial Officer, will host meetings with investors at two upcoming investor conference events in June 2022.

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22nd Century Group (Nasdaq: XXII) to Participate in LD Micro, Roth Capital Investor Meetings

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New York, NY, and Tel Aviv, ISRAEL, May 27, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire --Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today released a corporate update from CEO Gerald Commissiong on the Company’s CLIA/CAP-certified lab Provista Diagnostics, an update on the Company’s 3CL Pharma majority-owned subsidiary progress and plans to take the Company onto a national stock exchange.

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Todos Medical Releases Corporate Update

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Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange

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ObsEva Announces Corporate Updates

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Basel, May 28, 2022 — Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Kymriah® (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. In accordance with the Accelerated Approval Program, continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Kymriah is now FDA approved in three indications and remains the only CAR-T cell therapy approved in both adult and pediatric settings1. "We are proud of today's FDA approval of a third indication for Kymriah. We hope this treatment option that has the potential for long-lasting results may help break the unrelenting cycle of treatment for patients with follicular lymphoma,” said Victor Bulto, President, Novartis Innovative Medicines US. “We are on a mission to build on our pioneering work in cell therapy and continue to innovate for patient impact.”

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FDA approves Novartis Kymriah® CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma

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A Texas family said they faced a fight for their childs life after their daughter's health plan provider denied coverage of a medication known as the most expensive drug in the world.

The family said doctors told them the one-time infusion that costs millions of dollars was their daughters best hope.

Read on to learn more about their story and how an "army" of strangers stepped in.

At 4-months old, every move Aniya Porter makes is a miracle to her parents.

Aniya Porter was born with a rare genetic disease called spinal muscular atrophy or SMA.

You go day-by-day. Is my daughter going to stop breathing? Is she going to stop attempting to stand up? Is she going to stop putting her head up? Will Porter said.

Aniya was born with a rare genetic disease called spinal muscular atrophy or SMA.

SMA progressively kills motor neurons, the nerve cells in the brain stem and spinal cord that control essential functions like talking, walking, swallowing and breathing.

We live every day wondering and hoping that nothing else happens to her, that she doesn't lose any more of her motor neurons, said Hailey Weihs, Aniyas mother.

There is treatment.

In 2019, the FDA approved a drug called Zolgensma which carries a price tag of $2.1 million. The one-time gene therapy, given through an IV, is designed to replace the function of a missing or non-working SMN1 gene in a patient to stop the progression of SMA preserving motor neurons before theyre gone.

It doesn't give back what she has already lost. That's why it's so time-sensitive, explained Weihs.

When Aniyas doctor prescribed Zolgensma, Weihs and Porter said their daughters insurance, a Medicaid provider in Texas, denied coverage of the drug.

She got the denial from her insurance and that was devastating for us, said Weihs.

As they appealed, they said Aniya started to show signs she may lose control of her muscles.

She started to stop having reflexes in her legs and then her tongue started twitching, said Porter.

Racing against time, Weihs connected with other families of kids with SMA and a lawyer who agreed to represent Aniya for free.

Aniyas attorney, Eamon Kelly, told NBC 5 Responds, All the doctors agree that Aniya Porter should receive this treatment.

Kelly, who is based in Chicago, said Aniya is the seventh child with SMA hes represented in insurance coverage battles.

In Aniyas case, he said the health plan provider said the treatment was not medically necessary because doctors believe Aniya has four copies of the SMN2 gene, also known as a backup gene, which can indicate a milder illness.

Kelly argued backup genes, along with other available therapies, would not be enough to keep Aniya from losing muscle function. However, he said cutting-edge gene therapy could help.

We have a treatment that will take a little girl that is going to have a degenerative disease that threatens her life, that will put her in a wheelchair and as long as we get it to her before she's two years old and before she loses her motor neurons, she'll walk, she'll dance, she'll live a full life. Its like science fiction, Kelly said.

The first child with SMA Kelly represented is Maisie Forrest, who received Zolgensma in 2019 when she was 20 months old.

Ciji Green, Maisies mom, said Maisie was on a ventilator 22 hours a day before getting the drug.

We met with her pulmonologist and I just wept, Green recalled. I told him she's not going to make it to two and he didn't offer any words of hope because he knew Maisie was on the decline as well.

Maisie is now 4 years old.

She touches my face and it's absolutely beautiful, said Green.

Maisie is playing, talking and crawling.

Something that I have now that I didn't have was hope, hope that I will get to see her continue to meet milestones that she was never supposed to meet, Green added.

Maisies mom and a team of volunteers known as Maisies Army introduced Aniyas parents to Eamon Kelly. Last month, Kelly represented Aniya at a Medicaid State Fair Hearing.

Aniyas family requested the hearing from Texas Health and Human Services.

A week after the hearing and a few days after NBC 5 reached out to Aniyas health plan provider, Superior HealthPlan, Superior told Aniyas family Zolgensma would be covered for Aniya.

We have fought for four months. Those have been the hardest four months of our lives, said Weihs.

On April 27, Aniyas family made the trip from their home in Abilene to Cook Childrens Medical Center in Fort Worth where Aniya received the drug.

She's going to sit up on her own, she is going to walk one day, she's going to feed herself with a spoon, she's going to walk down and she's going to get her diploma, Weihs said.

NBC 5 Responds reached out to Superior HealthPlan by phone and email. We didnt hear back.

We asked Texas Health and Human Services about options for families denied coverage for Zolgensma.

It told us, in part, Medicaid covers medically necessary services including medications, and those services are delivered through managed care organizations. If the prior authorization is denied, the provider or the member can appeal the decision and MCOs have flexibility to make medically necessary decisions. Members also have the right to access the State Fair Hearing process with or without an External Medical Review (EMR). The EMR is conducted by a third-party Independent Review Organization.

It also shared, Medicaid covers alternative therapies for spinal muscular atrophy treatment, including Spinraza (nusinersen) and Evrysdi (risdiplam). Also, some manufacturers offer patient assistance programs.

A spokesperson for Novartis, which makes Zolgensma, told NBC 5, in part, Zolgensma (onasemnogene abeparvovec) is a transformative and highly innovative gene therapy for a devastating, progressive genetic disease. This one-time gene therapy is priced based on the value it provides to patients, caregivers and health systems.

It also said, Novartis is working in partnership with governments and health care systems worldwide to identify and define new sustainable access models.

Aniyas parents said she will still see a doctor and be monitored after getting the gene therapy treatment. Theyre hopeful about her prognosis.

We just knew we couldnt give up, Weihs said.

Weihs tells NBC 5 Responds the family is now focused on helping other kids get access to a drug they believe is priceless.

I don't care how expensive it is. It's a child's life. Every baby deserves a chance, said Porter.

Novartis said more than 1,800 patients have been treated with Zolgensma worldwide.

Texas newborn screening program began screening for SMA last June. The states health and human services website reports SMA is among the leading genetic causes of death among infants and toddlers.

NBC 5 Responds is committed to researching your concerns and recovering your money. Our goal is to get you answers and, if possible, solutions and a resolution. Call us at 844-5RESPND (844-573-7763) orfill out our customer complaint form.

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Texas Family Fights to Access $2.1 Million Treatment for Baby - NBC 5 Dallas-Fort Worth

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Astrocytes make up almost half of the mammalian brain cells. They are called glial cells because scientists originally thought that these starlight-shaped structures serve as nerve glue.

Research suggests that these cells control the growth of axons, or the neuronal projections that carry electrical impulses.

However, scientists still considered astrocytes to be supporting actors behind neurons, which are the primary cells of the brain and nervous system.

Now, scientists at Tufts University in Massachusetts and other institutions realize that astrocytes may execute a significantly greater performance in brain activity.

Dr. Moritz Armbruster, a research assistant professor of neuroscience at Tufts, led a team of researchers in harnessing novel technology to study astrocyte-neuron exchanges.

To their surprise, the scientists observed electrical activity in astrocyte processes within mouse brain tissue. They reported: This represents a novel class of subcellular astrocyte membrane dynamics and a new form of astrocyteneuron interaction.

Dr. Armbruster and his fellow authors published their findings in Nature Neuroscience.

Using innovative tools, the Tufts team developed a technique to detect and observe electrical activity in brain cell interactions. These properties could not be seen before now.

Dr. Chris Dulla, corresponding author of the study, is an associate professor of neuroscience at the Tufts University School of Medicine and Graduate School of Biomedical Sciences. He explained that he and his colleagues []use viruses to express fluorescent proteins in the mouse brain, and thats what lets us measure this activity.

In an interview with Medical News Today, he elaborated:

[W]e had other experiments that made us think that this new type of activity must be happening in astrocytes. We just didnt have a way to show it[] So, we developed these new techniques to image the activity of the astrocytes and, using them, we showed that this thing that we thought must be happening actually was happening.

Neurotransmitters are chemical messengers that facilitate the transfer of electrical signals between neurons and support the blood-brain barrier. Scientists have long understood that astrocytes control these substances to support neuronal health.

This study breaks ground in showing that neurons release potassium ions, which change the astrocytes electrical activity. This modulation affects how the astrocytes control neurotransmitters.

Until now, scientists could not image potassium activity in the brain.

Neurons and astrocytes talk with each other in a way that has not been known about before, Dr. Dulla said.

Dr. Dulla maintains that human brain cells work the same way as mouse tissue. He said that mouse and human brain cells use the same proteins and molecules involved in brain activity.

Besides, using human tissue samples presents ethical challenges, Dr. Dulla noted: [We] have to be really careful and judicious [] with the experiments we design, and [we] dont get a chance to see [human tissue] samples like [we] can do with mice.

However, the professor shared that extensive databases give [scientists] a chance to just access human brain tissue without doing an experiment [themselves], but just getting the data that someone else has already done.

This wealth of information further demonstrates similarities between human and mouse cells and lets researchers deduce that the same processes are happening in each. The main difference is that human cells are larger and more abundant.

He also pointed out that the study highlights a bidirectional relationship between these brain cells, as astrocytes influence the neurons as well.

These findings about astrocyte-neuron interactions open a new world of questions regarding brain pathology, memory, and learning.

MNT also discussed this study with Dr. Santosh Kesari, who was not involved in this research. He is a neurologist at Providence Saint Johns Health Center in Santa Monica, CA, and regional medical director for the Research Clinical Institute of Providence Southern California.

Dr. Kesari said that this study confirms earlier research.

[T]his is one of many studies thats showing increasingly, how astrocytes and neurons interact, how they affect each other and then connecting the dots to how that affects brain function behavior, memory, seizures, dementia, and even in the context of brain tumors, all these cells interact. Dr. Santosh Kesari

Most medication development for brain disorders currently targets neurons. Dr. Kesari agreed that this study might shine light on a new path.

Maybe we should really be understanding the astrocyte side of things to develop drugs that may impact brain health by looking at that astrocytic role in brain disorders, he said.

The ability to image cell processes, as in this study, makes it possible to explore other activities within the brain as well.

The researchers are also screening existing drugs in hopes of manipulating astrocyte-neuron processes. Scientists could come close to repairing brain injuries or helping people increase their learning capacity if this proves successful.

They are also making their tools available to other labs to explore more areas of interest, such as breathing, headache, and many other neurological disorders.

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Researchers find new function performed by almost half of brain cells - Medical News Today

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A recent study appearing in the journaleClinical Medicinesuggests that severe COVID-19 may be associated with persistent cognitive deficits, equivalent to a decline of 10 IQ points. In this study, severe COVID-19 was defined as COVID-19 that required hospitalization and critical care.

These cognitive deficits persisted until at least 6 months after contracting the SARS-CoV-2 infection, with a gradual improvement, if any, in these cognitive symptoms. These results underscore the importance of longer-term support for patients who have recovered from severe COVID-19.

According to official data from 2020, which is the same year that this study drew its data from, about 4 in 10 adults over the age of 18 are at risk of developing severe COVID-19 in the United States.

A significant minority of individuals with a SARS-CoV-2 infection experience persistent cognitive symptoms following the initial 4 weeks after the onset of COVID-19 symptoms. Some of the common cognitive symptoms include problems with concentration, brain fog, memory, and executive function.

Although persistent cognitive symptoms are also observed in individuals with mild COVID-19, such deficits in cognitive function are more prevalent in individuals with severe COVID-19. Previous studies suggest that 36%76% of individuals with severe acute COVID-19 show cognitive deficits 6 months after illness onset.

However, further research is needed to understand the specific aspects of cognitive function that are affected after severe COVID-19 and the factors that predict these cognitive symptoms.

Previous studies characterizing persistent cognitive symptoms in COVID-19 patients have relied on self-reports, which are susceptible to bias. Other studies have used pen-and-paper neuropsychological tests to assess cognitive function.

However, these tests do not possess the sensitivity to detect small changes in cognitive function or distinguish the various domains or aspects of cognitive function impacted by a SARS-CoV-2 infection.

To address these concerns, the authors of the present study used computerized cognitive tests to objectively characterize specific domains of cognitive function impacted after severe acute COVID-19. These computerized tests also allowed the researchers to assess the magnitude of these cognitive deficits.

Individuals with COVID-19 also experience persistent mental health symptoms such as anxiety, depression, fatigue, and post-traumatic stress disorder (PTSD), which could contribute to the deficits in cognitive function.

Another objective of the present study was to determine whether these mental health symptoms mediate the persistent cognitive deficits in COVID-19 patients.

The present study involved 46 patients who were previously hospitalized for severe COVID-19 and received critical care in Addenbrookes Hospital in Cambridge, England. The former COVID-19 patients completed a series of computerized cognitive tests during a return visit to the hospital, an average of 6 months after the onset of the illness.

The performance of the 46 participants on the cognitive tests was compared with that of 460 individuals in the control group. The individuals in the control group were not hospitalized for COVID-19 and were matched for age, sex, and education levels. The researchers also used self-reports to assess symptoms of anxiety, depression, and PTSD.

The researchers found that the COVID-19 patients had a lower score and a slower response time in the cognitive tests than the matched controls. People who had COVID-19 showed more pronounced deficits in specific domains of cognition, including processing speed, attention, memory, reasoning, and planning.

Notably, the deficits in cognitive function in the COVID-19 survivors were not associated with mental health symptoms present at the time of the cognitive testing, such as depression, anxiety, and PTSD.

Instead, the performance in the cognitive tests was correlated with the severity of acute illness. For instance, cognitive deficits were more pronounced in individuals who required mechanical ventilation.

The researchers then compared the performance of COVID-19 survivors with over 66,000 individuals from the general population.

The magnitude of cognitive impairment in COVID-19 survivors was equivalent to the age-related cognitive decline expected during the 20year period between the ages of 50 and 70 years.

The studys lead author Professor David Menon, head of the Division of Anaesthesia at the University of Cambridge, says: Cognitive impairment is common to a wide range of neurological disorders, including dementia, and even routine aging, but the patterns we saw the cognitive fingerprint of COVID-19 was distinct from all of these.

Dr. Betty Raman, a cardiologist at the University of Oxford, told Medical News Today, This prospective cohort study of 46 individuals recovering from severe COVID-19 and large normative reference population by Hampshire and colleagues has shown a clear association between severity of infection and degree of cognitive impairment.

This multidimensional characterization of cognition provides a nuanced understanding of distinct patterns of cognitive impairment during the convalescent phase of severe COVID-19. Future efforts are needed to understand how this pattern varies in the context of other post-infectious syndromes and critical illness.

The study found that these cognitive deficits persisted until 6-10 months after the onset of COVID-19, and there was only a gradual improvement, if any, in cognitive performance. The persistence of these cognitive deficits highlights the importance of understanding the mechanisms underlying these symptoms.

Scientists have proposed multiple mechanisms, such as direct infection of the brain by SARS-CoV-2 and disruption of blood supply to the brain, to explain the persistent cognitive symptoms in COVID-19 patients. Among these mechanisms, systemic or whole-body inflammation has emerged as the leading candidate responsible for persistent cognitive symptoms.

Dr. Roger McIntyre, a professor of Psychiatry and Pharmacology at the University of Toronto, told MNT, Inflammatory activation appears to be mediating these findings, highlighting the hazards of lengthy immune activation. The next steps are to unravel biological mechanisms more fully and identify prevention and treatment strategies.

Discussing major questions that need to be addressed, Dr. Paul Harrison, a professor of psychiatry at the University of Oxford, said:

This study shows that these deficits can be substantial and persist more than 6 months after the acute illness. The results are convincing and important and raise further questions. For example, what happens following a less severe infection? How long do the deficits last? What causes them and, critically, how can they be treated or prevented?

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Severe COVID-19 may cause cognitive deficits equivalent to 20 years of aging - Medical News Today

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Over 150 clinical sites now activated in RESPONSE Phase 3 clinical trial

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CymaBay Reports First Quarter 2022 Financial Results and Provides Corporate Update

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SUNNYVALE, Calif., May 12, 2022 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME) (“23andMe”), a leading consumer genetics and research company, announced today that it will report financial results for the fiscal year 2022 (FY2022) fourth quarter and full year after the market closes on Thursday, May 26, 2022. The Company will webcast a conference call at 4:30 p.m. Eastern Time to discuss the quarter’s financial results and report on business progress.

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23andMe to Report FY2022 Fourth Quarter and Full Year Financial Results

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Lead Asset TMB-001 Receives Fast Track Designation in Advance of Phase 3 Study Initiation by June 30th, 2022

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Timber Pharmaceuticals Provides Business Update and Announces First Quarter 2022 Financial Results

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- Enhanced Pipeline with New Asset, GFH009, an In-licensed Next-Generation, Highly Selective CDK9 Inhibitor -

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SELLAS Life Sciences Reports First Quarter 2022 Financial Results and Provides Business Update

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