SOUTH SAN FRANCISCO, Calif., Aug. 18, 2021 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV), today announced it has selected a fourth core inhibitor candidate, ABI-4334 (4334), that has been optimized for potency, to advance into clinical development. The company is conducting preclinical work, with the aim of completing regulatory filings and initiating clinical studies as soon as possible in 2022.

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Assembly Bio Selects Fourth HBV Core Inhibitor Candidate for Advancement Into Clinical Development

CAMBRIDGE, Mass., Aug. 18, 2021 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (Nasdaq: CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, announced today it has appointed Lini Pandite, MBChB, MBA to its board of directors. As a board-certified oncologist and current Chief Medical Officer at Shattuck Labs, Dr. Pandite brings extensive expertise in oncology drug development and clinical application, diversifying the breadth of expertise represented on the board.

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Codiak BioSciences Appoints Lini Pandite, MBChB, MBA to Board of Directors

GLOBAL CELL & GENE THERAPY SECTOR ON PACE FOR ANNUAL RECORDS IN PRODUCT APPROVALS AND FINANCINGS, SAYS ALLIANCE FOR REGENERATIVE MEDICINE

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Global Cell & Gene Therapy Sector on Pace for Annual Records in Product Approvals and Financings, Says Alliance for Regenerative Medicine

Third Quarter Revenues Increased by 88% Compared to the Same Period Last Year

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Digipath Announces Results for Third Fiscal Quarter 2021

Expanded Facility Capacity Provides Additional Growth Working Capital Availability at Low Cost of Capital Expanded Facility Capacity Provides Additional Growth Working Capital Availability at Low Cost of Capital

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Better Choice Company Increases Term-Loan Credit Facility Capacity to $7.5 Million at LIBOR Plus 250 Basis Points

CHICAGO, Aug. 18, 2021 (GLOBE NEWSWIRE) -- Cosmos Holdings, Inc. (“the Company") (OTCQX: COSM), an international pharmaceutical company with a proprietary line of branded and generic pharmaceuticals, nutraceuticals, OTC medications and medical devices, and an extensive, established European Union distribution network, today announced that the Company has entered into a debt exchange agreement with its senior lender (Lender) to further reduce the Company’s debt. Under the terms of the agreement, the Company will issue the Lender 321,300 shares of common stock at $5.00 per share in exchange for the principal amount of debt of EUR $1.35 million (US $1.60 million). An additional EUR $1.00 million of debt (US $1.19 million) will be converted effective upon approval of listing of the Company’s common stock to Nasdaq Capital Market in exchange for 238,000 shares of common stock at $5.00 per share, or at market value upon listing if the price is above $5.00 per share at the time of conversion. With this conversion, the Company has reduced the remaining balance of its senior debt to EU $350,000 (US $414,000).

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Cosmos Holdings Announces Voluntary Conversion of Debt to Equity by the Company’s Senior Lender, Further Enhancing the Balance Sheet

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ProMIS Neurosciences Inc. Announces Upsize of Previously Announced Public Offering of Units to US$17.5M

COPENHAGEN, Denmark – August 18, 2021 - Bavarian Nordic A/S (OMX:  BAVA, OTC: BVNRY) will announce its 2021 first half results on Wednesday, August 25, 2021.

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Bavarian Nordic to Host First Half 2021 Results Conference Call and Webcast

Basel, 18 August 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel, advancing the company's commitment to personalised healthcare through tests that determine which patients are most likely to benefit from specific and targeted therapies. The VENTANA MMR RxDx Panel is the first companion diagnostic test to aid in identifying patients whose solid tumours are deficient in DNA mismatch repair (MMR), who may be eligible for JEMPERLI (dostarlimab-gxly) monotherapy, an anti-PD-1 immunotherapy from GSK. The test evaluates a panel of MMR proteins in tumours to provide important treatment information to clinicians.MMR is a naturally occurring mechanism that scans our DNA, correcting errors that cause disease. When MMR is deficient (dMMR), cells mutate, which can lead to cancer. While MMR deficiency is most common in endometrial cancer, other high prevalence dMMR tumour types include gastric, colorectal, small intestine, cervical and neuroendocrine cancers. In the U.S., prevalence of dMMR across patients with solid tumours has been estimated at 14 percent.3 PD-1 inhibitors can be effective treatment in cancers with MMR deficiency."As the first companion diagnostic of its kind, this test can help qualify patients with solid tumours that are deficient in MMR who have progressed in their disease and who have no other suitable treatment options,” said Thomas Schinecker, CEO Roche Diagnostics. “Based on the results of our MMR biomarker test, these patients may be eligible to receive GSK’s JEMPERLI. We are pleased that our innovative companion diagnostic label continues to grow to serve more patients.”FDA approval of the VENTANA MMR RxDx Panel provides clinicians with access to a fully automated panel of MMR biomarkers tested by immunohistochemistry (IHC), enabling impactful treatment decisions for patients. JEMPERLI was approved by the FDA on 17 August 2021 for the treatment of adult patients with dMMR recurrent or advanced solid tumours, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. This indication received accelerated approval based on tumour response rate and durability of response. Continued approval for this indication may depend on verification and description of clinical benefit in a confirmatory trial(s).The VENTANA MMR RxDx Panel and JEMPERLI were earlier approved by the FDA for use in endometrial cancer in April 2021.Read more about Roche innovation in MMR biomarker testing. About the VENTANA MMR RxDx PanelThe VENTANA MMR RxDx Panel is a label expansion of Roche’s current on-market VENTANA MMR IHC Panel. The VENTANA MMR RxDx Panel is intended for the assessment of expression of MMR proteins in formalin-fixed, paraffin-embedded (FFPE) tumour tissue stained with OptiView DAB IHC Detection Kit and ancillary reagents in the panel for VENTANA anti-MLH1 (M1), VENTANA anti-MSH2 (G219-1129) and VENTANA anti-MSH6 (SP93) and OptiView DAB IHC Detection Kit with the OptiView Amplification Kit and ancillary reagents for VENTANA anti-PMS2 (A16-4) on a BenchMark ULTRA instrument. DNA mismatch repair (MMR) proteins have been clinically proven to be predictive biomarkers for PD-1 targeted therapy; specifically, a loss of expression of one or more MMR proteins might predict an increased likelihood of response to such therapy.4,5,6 PD-1 inhibitors can be effective in cancers with MMR deficiency.4,6 MMR is a conserved molecular mechanism that functions to correct the improper base substitutions that spontaneously occur during DNA replication. Defects in the MMR machinery have been attributed to mutations in the MMR proteins.About RocheRoche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person.Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights.Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.All trademarks used or mentioned in this release are protected by law.References[1] Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020:70(1):7-30.[2] Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019:69(1):7-34[3] Lorenzi M, Amonkar M, Zhang J, et al. Epidemiology of microsatellite instability high (MSI-H) and deficient mismatch repair (dMMR) in solid tumors: a structured literature review. J Oncol. 2020. doi.org/10.1155/2020/1807929[4] Lee YC, S Lheureux, and AM Oza. Treatment strategies for endometrial cancer: current practice and perspective. Curr Opin Obstet Gynecol. 2017:29:47-58.[5] GSK website, https://www.gsk.com/en-gb/media/press-releases/data-from-garnet-study-indicates-robust-activity-of-dostarlimab-in-patients-with-advanced-or-recurrent-endometrial-cancer/[6] Kato M, Takano M, Miyamoto M, et al. DNA mismatch repair-related protein loss as a prognostic factor in endometrial cancers. J Gynecol Oncol. 2015:26(1):40-45.Roche Group Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com

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Roche receives FDA approval for first companion diagnostic to identify dMMR solid tumour patients eligible for anti-PD-1 immunotherapy

WATERTOWN, Mass., Aug. 18, 2021 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), today announced that the Company granted non-statutory stock options to new employees as inducement awards outside the Company’s 2017 Equity Incentive Plan in accordance with NASDAQ Listing Rule 5635(c)(4).

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Kala Pharmaceuticals Reports Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)

NEW HAVEN, Conn., Aug. 18, 2021 (GLOBE NEWSWIRE) -- BIOASIS TECHNOLOGIES INC. (TSXV:BTI; OTCQB:BIOAF), (the “Company” or “Bioasis”), a pre-clinical, research-stage biopharmaceutical company developing its proprietary xB3™ platform technology for the delivery of therapeutics across the blood-brain barrier (“BBB”) and the treatment of central nervous system (“CNS”) disorders in areas of high unmet medical need, including brain cancers and neurodegenerative diseases, today announced the appointment of Shadow Lake Group Inc. and its affiliate SLG Europe BV (“SLG”) as Business Development advisor.

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Bioasis Technologies Inc. Announces the Appointment of Shadow Lake Group as Business Development Advisor

BOSTON, Aug. 18, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for NUZYRA® (omadacycline) for the treatment of infections caused by Nontuberculous Mycobacteria (NTM). This orphan drug designation includes NTM pulmonary disease caused by Mycobacterium abscessus complex (MABc), which is the focus of an ongoing Phase 2b study initiated by Paratek.The FDA’s Office of Orphan Drug Products grants orphan status to drugs and biologics that demonstrate promise for the treatment of diseases or conditions affecting fewer than 200,000 people in the United States. Orphan drug designation provides Paratek with certain development incentives, including tax credits for qualified clinical testing, exemptions from certain FDA application fees, and potential market exclusivity, if approved.“The orphan drug designation is an important regulatory milestone that further validates our efforts to investigate the utility of NUZYRA, a once-daily, broad-spectrum antibiotic currently approved for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia, as a potential therapy option for patients afflicted with M. abscessus pulmonary disease, an orphan disease for which there are no approved therapies,” said Randy Brenner, Chief Development and Regulatory Officer of Paratek. “Earlier this year, we initiated our Phase 2b clinical study that is designed to examine the efficacy and safety of NUZYRA in patients with M. abscessus pulmonary disease. These clinical data will continue to build upon the expanding data and publications about NUZYRA and its potential utility in NTM abscessus.About NTM AbscessusPulmonary infections caused by M. abscessus, an orphan disease with no FDA-approved antibiotic therapies, affects approximately 11,500 patients in the United States. Patients with pulmonary disease caused by M. abscessus have a myriad of symptoms including severe fatigue, fever, cough, and shortness of breath. The standard of care typically involves a combination of multiple antibiotics, most of which are intravenous, which can often require life-long treatment that is complicated by long-term tolerability challenges and multiple adverse events.About the Phase 2b NTM StudyThe Phase 2b study is a placebo-controlled, randomized monotherapy study of NUZYRA in patients with M. abscessus pulmonary disease who are in the early treatment phase and are not receiving other antibiotic treatments. The U.S.-based study will enroll approximately 75 subjects, randomized in a 1.5 to 1 ratio. The primary study endpoints are improvement in symptoms and safety and tolerability following 12 weeks of treatment. Due to the small numbers of patients with this orphan disease, Paratek expects the study will take about two years to complete enrollment.More information can be found at clinicaltrials.gov under the study ID number (NCT04922554).About Paratek Pharmaceuticals, Inc.Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.The company’s lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.In 2019, Paratek was awarded a contract from BARDA, valued at ~$285 million, to support the development and U.S.-based manufacturing of NUZYRA for the treatment of pulmonary anthrax.For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.About NUZYRANUZYRA® (omadacycline) is a novel once-daily antibiotic with both oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.Indications and UsageNUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms:Community-Acquired Bacterial Pneumonia (CABP) caused by the following: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the following: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae.UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.Important Safety InformationContraindicationsNUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients.Warnings and PrecautionsMortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality.The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth.Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs.Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.NUZYRA is structurally similar to tetracycline-class of antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected.Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.Adverse ReactionsThe most common adverse reactions (incidence =2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation.Drug InteractionsPatients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA. Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations.Use in Specific PopulationsLactation: Breastfeeding is not recommended during treatment with NUZYRA.To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-727-2835 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Please see full Prescribing Information for NUZYRA at www.NUZYRA.com.Forward Looking StatementsThis press release contains forward-looking statements related to our overall strategy, products, prospects, NTM disease, our clinical studies for NTM, real world data of NUZYRA for NTM patients and the potential for NUZYRA to fill an unmet medical need for NTM patients. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2020 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

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Paratek Pharmaceuticals Announces FDA Orphan Drug Designation for NUZYRA® (omadacycline) for the Treatment of Infections Caused by Nontuberculous...

– Toripalimab plus chemotherapy met primary endpoint with significant improvement in PFS compared to chemotherapy alone –

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Coherus and Junshi Biosciences Announce Positive Interim Results of CHOICE-01, a Phase 3 Clinical Trial Evaluating Toripalimab in Combination with...

MELBOURNE, Australia, Aug. 18, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) today releases details of two ancillary studies under the ProstACT program that significantly extend the evaluation of Telix’s TLX591 antibody-directed 177Lu (lutetium) therapeutic platform into areas of unmet medical need across the full prostate cancer treatment journey.

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Telix Expands Prostate Cancer Activity with GenesisCare Collaboration

STRATHROY, Ontario, Aug. 18, 2021 (GLOBE NEWSWIRE) -- Eve & Co Incorporated (“Eve & Co”, “we”, “us” or the “Company”) (TSX-V: EVE; OTCQX: EEVVF), through its wholly-owned subsidiary, Natural MedCo Ltd. (“NMC”) is pleased to announce that it has made gross revenues of $4.0 million in the first six months of 2021, successfully surpassing its gross revenues of $3.8 million for the entire 2020 financial year.

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Eve & Co. Announces Revenues of $4.0M in the First Half of 2021 and Financial Results for the Six Months Ended June 30, 2021

– Toripalimab plus chemotherapy met primary endpoint with significant improvement in PFS compared to chemotherapy alone –

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Junshi and Coherus Biosciences Announce Positive Interim Results of CHOICE-01, a Phase 3 Clinical Trial Evaluating Toripalimab in Combination with...

Oslo, Norway, 19th of August 2021

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Vistin Pharma ASA: Second quarter and first half 2021 financial results

The increasing prevalence of new coronavirus variants is raising questions about how well protected those who've already had their COVID-19 shots are against evolving forms of the SARS-CoV-2 virus. Here, microbiology and infectious disease specialist William Petri of the University of Virginia answers some common questions about COVID-19 booster shots.

1. What is a booster shot?Boosters are an extra dose of a vaccine given to maintain vaccine-induced protection against a disease. They are commonly used to bolster many vaccines because immunity can wear off over time. For example, the flu vaccine needs a booster every year, and the diphtheria and tetanus vaccine every 10 years.

Boosters are often identical to the original vaccine. In some cases, however, the booster shot has been modified to enhance protection against new viral variants. The seasonal flu vaccine, most notably, requires an annual booster because the flu virus changes so rapidly.

3. Why aren't booster shots recommended for everyone yet?While vaccine-induced immunity may not last forever, it is not clear when a booster will be needed.

Encouragingly, all of the currently authorized COVID-19 vaccines induce a robust immune memory against the coronavirus. The vaccine teaches your immune system's memory B cells to produce antibodies when you're exposed to the virus. Researchers have detected high levels of memory B cells in the lymph nodes of people who received the Pfizer vaccine for at least 12 weeks after they got the shot.

Studies also suggest that authorized COVID-19 vaccines are continuing to offer protection even against emerging strains of the coronavirus. Among one study's participants, the Johnson & Johnson vaccine had 73% and 82% efficacy 14 days and 28 days post shot, respectively, at warding off severe disease from the beta variant. Another study found the Pfizer vaccine to be 88% effective against the delta variant.

4. How will I know if I need a booster?You may need to wait for an outbreak in people who have been vaccinated. Researchers are still figuring out the best way to measure the strength of someone's vaccine-induced immunity. The COVID-19 vaccines have been so effective that there are not many failures to test.

The best candidate to measure are certain antibodies the vaccine induces the immune system to make. They recognize the spike protein that allows the coronavirus to enter and infect cells. Evidence supporting the importance of anti-spike antibodies includes a study showing that the somewhat more effective mRNA vaccines like Pfizer and Moderna generate higher antibody levels in the blood than the adenovirus vector vaccines like Johnson & Johnson and AstraZeneca. In a preliminary study that has not yet been peer-reviewed, anti-spike antibody levels were lower in people who caught COVID-19 after they were vaccinated with the Oxford-AstraZeneca vaccine.

Medical workers would love to be able to give patients a blood test that would tell them how well protected they are or aren't against COVID-19. That would be a clear indication as to whether a booster shot is needed.

But until researchers know for sure how to measure vaccine-induced immunity, the next indication that boosters may be needed are breakthrough infections in older adults who have already been vaccinated. People over the age of 80 make lower levels of antibodies after vaccination, so their immunity may wane sooner than that of the general population. The elderly would also most likely be the most susceptible to new viral variants that evade the protection current vaccines provide.

5. Who does the FDA and CDC recommend get a third shot?An extra shot may be necessary for certain immunocompromised people. In one study, 39 of 40 kidney transplant recipients and a third of dialysis patients failed to make antibodies after vaccination. Another study identified 20 patients with rheumatic or musculoskeletal diseases on medications that suppress the immune system who also did not have detectable antibodies. Both of these studies were done after patients received the full vaccine dose.

Currently, the CDC recommends that the following people consider getting a third dose:

Those who are immunocompromised may wonder if the vaccine they received is successfully generating immunity in their body. A preliminary study that has not yet been peer-reviewed did find that a test that specifically targets the anti-spike antibodies the vaccines trigger may be helpful in determining whether the vaccine worked. But for now, the FDA does not recommend antibody tests to assess immunity.

6. Does my third dose need to match my first two?Likely not. Recent research has shown that mRNA vaccines, like Pfizer and Moderna, can be mixed with adenovirus-based vaccines like AstraZeneca with comparable results.

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The Covid booster shot is not for everyone. It's only meant for severely immunocompromised people - ETHealthworld.com

Inflamed mouse stem cells located in the basal layer (red) of the epidermis and FOS (green), a near-universal stress response factor essential to inflammatory memory. Credit: Christopher Cowley

When a tissue experiences inflammation, its cells remember. Pinning proteins to its genetic material at the height of inflammation, the cells bookmark where they left off in their last tussle. Next exposure, inflammatory memory kicks in. The cells draw from prior experience to respond more efficiently, even to threats that they have not encountered before. Skin heals a wound faster if it was previously exposed to an irritant, such as a toxin or pathogen; immune cells can attack new viruses after a vaccine has taught them to recognize just one virus.

Now,a new studyinCell Stem Celldescribes the mechanism behind inflammatory memory,also commonly referred to as trained immunity,and suggests that the phenomenon may be universal across diverse cell types.

This is happening in natural killer cells, T cells, dendritic cells from human skin, and epidermal stem cells in mice, says Samantha B. Larsen, a former graduate student in the laboratory ofElaine Fuchsat The Rockefeller University. The similarities in mechanism are striking, and may explain the remitting and relapsing nature of chronic inflammatory disorders in humans.

When thinking about our immune system, we default to specific immunitythat cadre of T cells and B cells trained, by experience or vaccination, to remember the specific contours of the last pathogen that broke into our bodies. But theres a less specific strategy available to many cells, known as trained immunity. The impact is shorter-lived, but broader in scope. Trained immunity allows cells to respond to entirely new threats by drawing on general memories of inflammation.

Scientists have long suspected that even cells that are not traditionally involved in the immune response have the rudimentary ability to remember prior insults and learn from experience. The Fuchs lab drove this point home in a 2017 study published inNatureby demonstrating that mouse skin that had recovered from irritationhealed 2.5 times faster than normal skin when exposed to irritation at a later date.

One explanation, the Fuchs team proposed, could be epigenetic changes to the skin cell genome itself. During inflammation, regions of DNA that are usually tightly coiled around histone proteins unravel to transcribe a genetic response to the attack. Even after the dust settles, a handful of these memory domains remain openand changed. Some of their associated histones have been modified since the assault, and proteins known as transcription factors have latched onto the exposed DNA. A once nave cell is now raring for its next fight.

But the molecular mechanism that explained this process, and how the cell could use it to respond to types of inflammation and injury that it had never seen before, remained a mystery.

So the Fuchs lab once again exposed mice skin to irritants, and watched as stem cells in the skin changed. We focused on the regions in the genome that become accessible during inflammation, and remain accessible afterwards, says Christopher Cowley, a graduate student in the Fuchs lab. We call these regions memory domains, and our goal was to explore the factors that open them up, keep them open and reactivate them a second time.

They observed about 50,000 regions within the DNA of thestem cellsthat had unraveled to respond to the threat, but a few months later only about 1,000 remained open and accessible, distinguishing themselves as memory domains. Interestingly, many of these memory domains were the same regions that had unraveled mostprodigiouslyin the early days of skin inflammation.

The scientists dug deeper and discovered a two-step mechanism at the heart of trained immunity. The process revolves around transcription factors, proteins which govern the expression of genes, and hinges on the twin transcription factors known as JUN and FOS.

The stimulus-specific STAT3 transcription factor responds first, deployed to coordinate a genetic response to a particular genre of inflammation. This protein hands the baton to JUN-FOS, which perches on the unspooled genetic material to join the melee. The specific transcription factor that sounded the original alarm will eventually return home; FOS will float away as the tumult quiets down. But JUN stands sentinel, guarding the open memory domain with a ragtag band of other transcription factors, waiting for its next battle.

When irritation strikes again, JUN is ready. It rapidly recruits FOS back to the memory domain, and the duo charges into the fray. This time, no specific transcription factor is necessary to respond to a particular type of inflammation and get the ball rolling. The system unilaterally activates in response to virtually any stressalacrity that may not always benefit the rest of the body.

Trained immunity may sound like a boon to human health. Veteran immune cells seem to produce broader immune responses; experienced skin cells should heal faster when wounded.

But the same mechanism that keeps cells on high alert may instill a sort of molecular paranoia in chronic inflammation disorders. When the Fuchs lab examined data collected from patients who suffer from systemic sclerosis, for instance, they found evidence that JUN may be sitting right on the memory domains of affected cells, itching to incite an argument in response to even the slightest disagreement.

These arguments need not always be disagreeable, as animals benefit by healing their wounds quickly and plants exposed to one pathogen are often protected against others, says Fuchs. That said, chronic inflammatory disorders may owe their painful existence to the ability of their cells to remember, and to FOS and JUN, which respond universally to stress.

The scientists hope that shedding light on one possible cause of chronic inflammatory disease may help researchers develop treatments for these conditions. The factors and pathways that we identify here could be targeted, both in the initial disease stages and, later, during the relapsing stages of disease, says Cowley. Larsen adds: Perhaps these transcription factors could be used as a general target to inhibit the recall of the memories that cause chronic inflammation.

Reference: Establishment, maintenance, and recall of inflammatory memory by Samantha B. Larsen, Christopher J. Cowley, Sairaj M. Sajjath, Douglas Barrows, Yihao Yang, Thomas S. Carroll and Elaine Fuchs, 27 July 2021, Cell Stem Cell.DOI: 10.1016/j.stem.2021.07.001

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Genetic conditions occur when there is a mutation in one or multiple genes. Read on to know about some of the common genetic blood disorders.

Written by Editorial Team | Updated : August 5, 2021 10:01 PM IST

Genes form the blueprint of our body, i.e., it instructs our physical and functional attributes and makes us who we are! Let's just pause for a moment to understand that these genes are also responsible at times for genetic anomalies or disorders that may affect the health of an individual.

These genetic conditions occur when there is a mutation in one or multiple genes. You can inherit a gene mutation from one or both the parents or may also acquire it during your lifetime. These conditions if go undetected, does lead to a lifelong battle for many. However, early diagnosis can help clinicians plan prompt treatment and management options to improve the quality of life of affected individuals. Hence, it is imperative to have a comprehensive genetic evaluation of the baby right after birth to check for any hidden disorders that are not apparent at the time of birth.

Dr Chirayu Padhiar, Senior Medical Director, LifeCell International Pvt Ltd shares insights on the common genetic blood disorders in the country and also discusses the available diagnosis as well as treatment options. He says, "genetic diversity along with founder effects and consanguineous marriages have been attributed to the high prevalence of genetic disorders in India. Thalassemia and sickle cell anaemia are two major genetic blood disorders that result in a long-lasting impact on the health and wellbeing of the affected individuals."

Sickle cell anaemia is a type of sickle cell disease in which haemoglobin, the protein that transports oxygen throughout the body, is affected, which in turn jeopardises proper blood flow throughout the body. It is an inherited blood disorder that is passed down through families via mutated genes.

Red blood cells are normally disc-shaped and flexible enough to move freely through blood vessels. However, when a person is diagnosed with sickle cell disease, their red blood cells are usually crescent or "sickle" shaped. Since these cells cannot easily pass through blood vessels, they can obstruct blood flow to the rest of your body.

Symptoms of sickle cell disease usually appear in early childhood, at about 5-6 months of age. This disorder is distinguished by a low count of red blood cells (anaemia), infections, swelling in the hands and feet, and periodic episodes of pain. Symptoms vary from person to person. Some people experience only minor symptoms, while others are frequently hospitalised for more serious complications.

Couples who have a prerequisite knowledge that they have the disorder, or are 'carriers of the mutated gene should consider genetic counselling and testing to prevent passing the disorder to their children. This knowledge helps to make the right reproductive decisions for a healthy pregnancy and baby. Parents of newborns can also consider newborn screening right after birth to provide the early and right treatment.

As sickle cell disease is a chronic illness, patients usually take drugs their entire life. The drugs are not a curative treatment for the disorder but help manage the symptoms that accompany the disease. Frequent blood transfusions may also be prescribed. Depending on the severity of the disease and availability of the donor blood stem cell transplant may also be carried out.

Recent studies also show the emergence of stem cell transplants as a curative treatment for Sickle Cell Anemia. The Indian healthcare market touted to be as advanced as its western counterparts, has been successful in numerous stem cell transplants as a curative treatment for sickle cell anaemia.

Thalassemia is an inherited blood disorder that occurs when the body does not produce enough haemoglobin. It occurs due to a defective gene that is involved in the production of haemoglobin. When thalassemia is referred to as 'alpha' or 'beta', it refers to the portion of haemoglobin that is not produced by default in the body. When there is insufficient haemoglobin, the body's red blood cells do not function properly and do not last for long, resulting in a significantly lower number of healthy red blood cells in the bloodstream.

Children are affected by this condition when they inherit the defective gene from one or both parents. When a child inherits the defective gene from both parents, the child will develop thalassemia major. The affected child may develop symptoms of severe anaemia within the initial years of their life.

However, if the child inherits only one defective gene, then the child has thalassemia minor and is a carrier. This fact, thus, underlines the importance of genetic counselling and prenatal tests in carriers.

Not all affected individuals will show symptoms. In fact, some symptoms may start appearing in later stages of childhood or adolescence. People with less severe conditions may not know until being diagnosed with mild symptoms of anaemia, fatigue, the appearance of yellow skin, delayed growth, or iron overload.

India has the largest number of children with thalassemia major in the world. The figure becomes more staggering with about 1 to 1.5 lakhs children and almost 42 million carriers of beta-thalassemia. The majority of children with moderate to severe thalassemia develop symptoms within the first two years of their life. Blood tests help reveal anaemia and the presence of abnormal haemoglobin. Advanced genetic tests can also be used to analyze mutated genes to diagnose the severity and type of condition. Additionally, detection of an enlarged spleen might also be an important factor in diagnosis.

Couples planning a baby or in early pregnancy can choose a genetic carrier screening to assess the risk of passing on the thalassemia or other genetic conditions to their babies.

Depending on the severity and the type of thalassemia, the doctors may recommend transfusions, medications, or surgeries to remove the spleen or transplants. Mild forms of thalassemia including thalassemia minor, don't usually require any specific treatment. Hematopoietic (blood) transplants can be curative in thalassemia major cases. However, a majority of the patients are unable to find HLA-matched siblings. Moreover, with a growing number of one-child families and a meagre 25% chance of finding an HLA-matched sibling, finding a suitable donor may become a challenge. An increasing number of parents are, therefore, turning towards alternative stem cell preservation models including community banking, in order to gain access to a repository of unrelated cord blood units.

India has pioneers in stem cell banking and genetic testing like LifeCell which excel in prenatal and newborn screening, helping couples understand their child's health status. Timely diagnosis has helped many couples make better reproductive decisions and provide the prompt and right treatment to their children. Most importantly, having a positive outlook towards life, gaining support from friends and family, and consulting your doctor regarding optimal lifestyle and management choices can help simplify your journey.

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Common Genetic Blood Disorders And How They Are Treated - TheHealthSite