Tag Archives: BioSpace

NLS Pharmaceutics Appoints Silvia Panigone, Ph.D. As Chief Operating Officer | Instant News


STANS, Switzerland, April 5, 2021 / PRNewswire / – NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) (“NLS” or “Company”), a Swiss clinical stage pharmaceutical company focused on the discovery and development of innovative therapies for patients with rare central diseases and complex nervous system disorders, announced the appointment of Silvia Panigone, Ph. .D., EMBA as Chief Operating Officer. Dr. Panigone brings to NLS more than 25 years of leadership experience in the health care industry, founded and operates ADYA Consulting, a boutique advisory firm that provides strategic counseling, access to capital, and M&A consulting services to companies in the life science sector, and serves in operational and managerials in international pharmaceutical companies and clinical research organizations.

“Silvia’s outstanding experience in product development and strategic leadership in the life science industry is a perfect fit for NLS as we pursue development of Quilience® to treat narcolepsy, and define our strategy for business development and advancement of our drug pathway,” said Alex Zwyer, Executive Director of NLS Pharmaceutics. “Its proven ability to guide emerging biotech and pharmaceutical companies from the early stages of development through a period of significant growth will be critical as we seek to drive corporate initiatives and build value within the Company. All of us at NLS give a warm welcome to Silvia. “

“I am delighted to join the NLS team and oversee the main operational activities of the Company so that we can provide patients with new treatments for rare and complex CNS disorders,” said Dr. Panigone. “NLS is focused on developing therapies intended to meet unmet medical needs, and our flagship product, Quilience, ® has the potential to be the first-line treatment for narcolepsy targeting the orexin-2 receptor, the root cause of the disorder. Given the importance of this candidate product, a top priority we are getting IND approval in the US and getting Quilience to the clinic as fast as possible. “

Prior to joining the NLS, Dr. Panigone is the managing director of ADYA Consulting Sagl, a Swiss investment boutique in the life science sector that operates globally and supports companies in corporate strategy and fundraising. He has also acted as temporary management in about one-third of ADYA’s biotech and pharmaceutical clients, and has held several Board positions in private companies, helping some to realize M&A solutions. Dr. Panigone combines a deep understanding of corporate finance as well as the drug development process and execution. Prior to ADYA, he was the former President Director Europe at I-Bankers Direct LLC, an equity funding web platform, as well as Advisor to I-Bankers Securities, Inc., a US investment banking group with more than 140 main offerings and co-managed offerings. He previously served as Fund Manager at BSI Healthcapital, a life science-focused venture capital firm, and Head of Venture Investments in the Merchant division of the Swiss-based bank, EFG International. Dr. R&D Experience Panigone’s broad range includes serving in operational and managerial positions at international level in pharmaceutical and CRO companies. At Bracco SpA, he leads international programs at both the preclinical and clinical stages with the regulatory team, intellectual property, CMC, preclinical and clinical internal experts, external providers, and KOL overseeing the development program as a Sponsor. He is also Global Project Manager at Quintiles Innovex Ltd., a leading global CRO, where he is responsible for managing a large clinical program conducted in the USA, Europe and Asia. Previously, Dr. Panigone serves as Senior Director at XoVenture, a global network of Life Science entrepreneurs and executives, Start-Up Coach for the Swiss government (Innosuisse), University Board Member Milan, and is a member of the European Narcolepsy Network (EUNN). He obtained a degree in Molecular Biology from the University of Milan, Ph.D. in Molecular Oncology at the National Cancer Institute and the Open University, London, and the Executive MBA from the Bocconi SDA School of Management, Milan.

Aabout NLS Pharmaceutics Ltd.

NLS Pharmaceutics Ltd. is a Swiss-based clinical stage biopharmaceutical company led by an experienced management team with a track record of developing and reusing candidate products to treat rare and complex central nervous system disorders. The Company’s main product candidate, Quilience® is a controlled release formulation of mazindol (mazindol CR) (mazindol CR), and is being developed for the treatment of narcolepsy. Mazindol is a triple monoamine reuptake inhibitor and partial orexin receptor 2 agonist, which has been used for many years to treat patients diagnosed with narcolepsy in a compassionate use program. The NLS completed a phase 2 study in the US evaluating mazindol CR in adult subjects with ADHD. This study met all primary and secondary end points and was well tolerated. Quilience has received the Orphan Drug Designation both in the US and in Europe for the treatment of narcolepsy.

Safe Harbor Statement

This press release contains the express or implied forward-looking statements pursuant to US Federal securities laws. For example, the NLS uses forward-looking statements when discussing Quilience® which could potentially be the first treatment for narcolepsy targeting the orexin-2 receptor, the root cause of the disorder, as well as when discussing its strategy and pipeline. , initiatives and building values, and potential benefits and approvals from Quilience®. These forward-looking statements and their implications are based on the current expectations of NLS management only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; The NLS may experience delays or bottlenecks in its launch and / or successful completion of its clinical trials; NLS products may not be approved by regulatory bodies, NLS technology may not be validated due to further advances and its methods may not be accepted by the scientific community; NLS may not be able to retain or attract key employees whose knowledge is essential to product development; Unexpected scientific difficulties may develop with the NLS process; The NLS product may become more expensive than anticipated; laboratory results may not translate to equally good results in real clinical settings; the results of preclinical studies may not correlate with the results of clinical trials in humans; The NLS patent may not be enough; NLS products can harm recipients; a change in the law could have a devastating effect on the NLS; inability to develop and introduce new technologies, products and applications in a timely manner; loss of market share and pressure on prices due to competition, which could cause NLS’s actual results or performance to differ materially from those intended in those forward-looking statements. Unless required by law, NLS has no obligation to publish any revisions to this forward-looking statement to reflect events or circumstances after the date of this agreement or to reflect unforeseen events. More detailed information about the risks and uncertainties affecting NLS is provided under the heading “Risk Factors” in the final prospectus of NLS, dated January 28, 2021, filed with the SEC, which is available on the SEC website, www.sec.gov.

Company Contact
Alex Zwyer, CEO: +41 41 618 80 00

Investor Relations Contact
David Moscowitz: +1 202-280-0888

www.nlspharma.com

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ANGLE PLC Announces Global Launch of the Clinical Services Laboratory | Instant News


  • Delivered a strategy to accelerate the commercialization of the Parsortix system and act as a demonstrator to support product deployment
  • UK and US clinical laboratories are now open and ready to provide analysis services and ongoing CTC discussions with pharmaceutical industry customers

GUILDFORD, SURREY / ACCESS / 30 March 2021 / ANGLE plc (AIM: AGL) (OTCQX: ANPCY), the world’s leading fluid biopsy company, is pleased to announce that they have completed fitout and staffing at clinical services laboratories in Guildford UK, and Plymouth Meeting PA, USA. The launch was ahead of schedule with US laboratories completing earlier than anticipated and UK laboratories opening at the anticipated timeframe. Together, these laboratories will enable ANGLE to accelerate the commercial deployment of Parsortix® systems by offering services to pharmaceutical and biotechnological customers for use in clinical trials of cancer drugs and, once the laboratory is accredited and tests validated, through the provision of Laboratory Developed Tests (LDTs) for patient care.

ANGLE samples to answer the liquid biopsy solution via a simple blood test allow longitudinal monitoring of the patient during drug trials (before, during and after drug intervention) which is not possible with tissue biopsy. This is a significant market opportunity for ANGLE. In one segment of this market, there are more than 2,000 PD-L1 / PD-1 intervention trials registered on clinicaltrials.gov, enrolling more than 300,000 patients, who would be potential targets for ANGLE’s pharmaceutical services business.

ANGLE is targeting future clinical studies for the application of the Parsortix system and has developed service capabilities in the United Kingdom and the United States to process samples on a commercial scale as part of global pharmaceutical trials. ANGLE has established dialogues with potential customers and collaborators on the application of CTC liquid biopsy analysis in cancer drug trials, with these conversations at an advanced stage.

Both UK and US laboratories will seek ISO15189 accreditation and US laboratories will also seek Clinical Laboratory Improvement Amendments (CLIA) accreditation, allowing them to market LDTs ​​for clinical use. Given the extensive clinical work that has been completed with the Ovarian Cancer Pelvic Mass Triage trial, it is anticipated that this will be ANGLE’s first LDT to be marketed.

ANGLE Founder and Chief Executive, Andrew Newland, comments: “The new clinical service laboratory is an important element in the Company’s commercial strategy and we are pleased to launch a global offering ahead of schedule. This will accelerate the commercialization of the Parsortix system and act as a demonstrator to support product implementation. As well as working with pharmaceutical company customers directly, we would like to work with contract research organizations as both a white label service and, when they wish to implement the test internally, by supplying the Parsortix system so they can immediately offer their own CTC services for cancer drug trials This will allow us to measure the commercial use of the Parsortix system in this large market. We are in follow-up discussions with potential customers and we look forward to renewing the market on the first contract in due time. “

For more information on ANGLE:

ANGLE plc

+44 (0) 1483 343434

Andrew Newland, Chief Executive

Ian Griffiths, Director of Finance

Andrew Holder, Head of Investor Relations

finnCap Ltd (NOMAD and Joint Brokerage)

Corporate Finance – Carl Holmes, Simon Hicks, Teddy Whiley

ECM – Alice Lane, Sunila de Silva

+44 (0) 20 7220 0500

WG Partners (Joint Brokers)

Nigel Barnes, Nigel Birks, Andrew Craig, Chris Lee

+44 (0) 203 705 9330

FTI Consultation

Simon Conway, Ciara Martin

Matthew Ventimiglia (USA)

+44 (0) 203 727 1000

+1 (212) 850 5624

Information communicated in this announcement is inside information for the purposes of Article 7 of Regulation 596/2015.

For Frequently Used Terms, please see the Company’s website at https://angleplc.com/investor-relations/glossary/

About ANGLE plc
CORNER is the world’s leading fluid biopsy company with sample-to-answer solutions. ANGLE’s patent-protected platform includes circulating tumor cell (CTC) harvesting technology and a downstream analysis system for highly multiplex and cost-effective protein and nucleic acid analysis.

The ANGLE cell separation technology is called Parsortix® system, and allows a liquid biopsy (simple blood test) to be used to provide the user with the desired cells in a format suitable for various types of downstream analysis. The system is based on a microfluidic device that captures cells based on their combination of size and compressibility. The system is epitope independent and can capture all types of CTC as well as cluster CTCs in viable (live) form. CTCs allow a complete picture of a cancer to be viewed as an intact cell. CTC allows analysis of DNA, RNA and protein and thus provides an analysis comparable to a tissue biopsy. Since CTC analysis is a noninvasive process, unlike a tissue biopsy, this analysis can be repeated as often as necessary. This is important because cancer develops and changes over time and there is a clear medical need for up-to-date information about its status. Additionally, live-harvested CTCs can be cultivated, which offers the potential for testing response to drugs outside the patient.

Parsortix technology is the subject of 26 patents granted in Europe, United States, China, Australia, Canada, India, Japan and Mexico with three broad patent groups being developed around the world.

The Parsortix system has the CE Mark in Europe for indicated use and, in the United States, a De Novo Filing has been made to the FDA for Parsortix® The PC1 system seeks FDA Classification Class II clearance for use with metastatic breast cancer patients. FDA clearance is seen as a global standard. ANGLE seeks to be the first FDA-approved system to harvest CTC for further analysis.

ANGLE has also completed two separate 200-subject clinical studies under a program designed to develop the ovarian cancer pelvic mass triage test, with results showing a best-in-class accuracy (AUC-ROC) of 95.1%. The pelvic mass triage trial has undergone further refinement and optimization and is currently in the process of a clinical verification study of 200 patients.

ANGLE’s technology for the evaluation of multiplex proteins and nucleic acids of all types is called HyCEADTM Ziplex® platform and is based on a patented flow through array technology. It provides low cost, highly multiplex, fast and sensitive target capture of a wide variety of sample types. The proprietary chemistry approach (the HyCEAD method) allows the capture and amplification of more than 100 biomarkers simultaneously in a single reaction. The HyCEAD Ziplex system is highly sensitive and ideal for measuring the expression of genes and other markers directly from the Parsortix harvest and used in the ovarian cancer pelvic mass triage test to achieve a best-in-class accuracy (AUC-ROC) of 95.1%.

ANGLE’s proprietary technologies can be combined to provide automated sample-to-answer results in centralized laboratories and use-site cartridge formats.

ANGLE has established formal collaborations with world-class cancer centers and major companies such as Abbott, Philips and QIAGEN, and works closely with leading CTC’s translational research customers. These Lead Opinion Leaders (KOLs) work to identify applications with medical utility (clear benefit to patients), and to secure clinical data demonstrating that usefulness in patient studies. Evidence on the benefits of the Parsortix system is growing rapidly from our own clinical studies on metastatic breast cancer and ovarian cancer and also from KOL with 41 peer-reviewed publications and many publicly available posters, available on our website.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as the Primary Information Provider in the UK. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact [email protected] or visit www.rns.com.

SOURCE: ANGLE plc

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https://www.accesswire.com/638019/ANGLE-PLC-Announces-Global-Launch-of-Clinical-Services-Laboratories

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Octapharma AG: Final data from the published NuProtect study on the immunogenicity of Nuwiq® in previously untreated patients with severe hemophilia A | Instant News


LAUGH, Switzerland, 22 February 2021 / PRNewswire / –Octapharma AG today announced the final results of the NuProtect study on Nuwiq immunogenicity® on previously untreated patients (PUP) with severe hemophilia A has been published in leading medical journals Thrombosis and Hemostasis (Liesner RJ et al. “Simoctocog Alfa (Nuwiq®) in a Previously Untreated Patient with Severe Hemophilia A: The End Result of the NuProtect Study ” https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0040-1722623).

The NuProtect Study (NCT01712438; EudraCT 2012-002554-23) is a prospective, multinational, open-label, uncontrolled phase III study initiated in March 2013 to assess the immunogenicity, efficacy and safety of Nuwiq®. The study recruited patients of all ages and ethnicities at 38 locations in 17 countries and followed patients for 100 days or up to 5 years. With a enrollment of 110 patients, the NuProtect study is the largest clinical study to investigate a single product in true PUPs.

Of the 105 PUPs that could be evaluated with severe hemophilia A who received Nuwiq® for prevention and treatment of bleeding:

  • 16.2% (17/105) of patients developed high titer inhibitors
  • 10.5% (11/105) of patients developed low titer inhibitors, five of which were transient
  • 26.7% (28/105) of patients developed any inhibitor

The NuProtect study shows that there is a low risk of inhibitor development in PUPs starting treatment with Nuwiq®, “comments Dr. Ri Liesner, NuProtect study research coordinator and clinician at Great Ormond Street Hospital for Children at London, England. “This data shows Nuwiq® may be an attractive option for people recently diagnosed with severe hemophilia A, who are children and constitute a subset of susceptible patients.. “

The development of inhibitors into replacement factor VIII (FVIII) is of concern to doctors, as well as for patients and their families, especially when they first start treatment. Inhibitors make FVIII therapy ineffective and limit treatment options.

These data complement the wealth of clinical experience in hemophilia A patients receiving Nuwiq® for the treatment and prevention of bleeding.

“Nuwiq® developed in human cell lines with the aim of minimizing the risk of inhibitors in PUPs,said Larisa Belyanskaya, Head of Hematology, MOM Octapharma. “We are delighted to share this positive data, which reflects this goal and which we hope will contribute to addressing this major treatment challenge. ”

We know that hemophilia A patients face life-long treatment decisions, “commented Olaf Walter, Board Member at Octapharma. “This data highlights Nuwiq’s potential® to reassure PUP and their families when they start treatment. This publication brings us closer to Octapharma’s goal of enabling all patients to lead healthy lives. “

Earlier this year the FDA approved the inclusion of immunogenicity data from the NuProtect study at Nuwiq.® Prescribing Information. Further publication of another analysis of the NuProtect study is planned.

Professor Anthony Chan, co-author of the publication and Professor of Paediatrics at McMaster University, Canada, said: “Congratulations and thanks to Octapharma for developing Nuwiq, sponsoring trials and providing excellent therapy for hemophilia A.

Octapharma would also like to thank all participating centers, as well as their patients and caregivers, for their contributions to this research.

About Nuwiq®

Nuwiq® (simoctocog alpha) is a 4th generation recombinant factor VIII (rFVIII) protein, produced in human cell lines without chemical modification or fusion with other proteins.1. It is cultivated without additives of human or animal origin, without antigenic non-human protein epitopes and has a high affinity for von Willebrand factor.1. Nuwiq® treatment was assessed in seven comprehensive clinical trials that included 201 previously treated patients (PTP; 190 people) with severe hemophilia A, including 59 children.1. Nuwiq® available in 250 IU, 500 IU, 1000 IU, 2000 IU, 2500 IU, 3000 IU and 4000 IU presentations2. Nuwiq® approved for use in the treatment and prophylaxis of bleeding in patients with hemophilia A (congenital FVIII deficiency) in all age groups2.

1. Lissitchkov T et al. There is Adv Hematol 2019; 10: 2040620719858471.
2. Nuwiq® Summary of Product Characteristics.

About Hemophilia A

Hemophilia A is an X-linked hereditary bleeding disorder caused by factor VIII (FVIII) deficiency which, if left untreated, can lead to bleeding in the muscles and joints and consequently to arthropathy and severe morbidity. This disorder affects about one in every 10,000 men worldwide. Prophylaxis with FVIII replacement therapy reduces the number of bleeding episodes and the risk of permanent joint damage.

About Octapharma

Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein producers in the world, developing and producing human proteins from human plasma and human cell lines.

Octapharma employs more than 9,000 people worldwide to support patient care in 118 countries with products in three therapeutic areas: Hematology, Immunotherapy and Critical Care.

Octapharma has seven R&D locations and six state-of-the-art manufacturing facilities at Austria, France, German, Mexico and Sweden, and operates more than 160 plasma donation centers Europe and United States of America.

Logo: https://mma.prnewswire.com/media/1442016/Octapharma_Logo.jpg

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Switzerland Delays AstraZeneca Vaccine Approval, Wants More Data | Instant News


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Swiss health authorities Swissmedic was rejected AstraZeneca‘s a rolling permit application for the COVID-19 vaccine a few days ago, said more data was needed “to get more information on safety, efficacy and quality.”

AstraZeneca’s Phase III clinical trial against ChAdOx1 nCoV-19 (AZD1222) demonstrated 76% efficacy after the initial dose and 82% efficacy 12 weeks later, after the second dose. The data show it actually increases efficacy by extending the time between doses. The vaccine is there approved by the European Union. and by about 40 countries, including the UK

No less, Swissmedic concludes, “The data submitted and analyzed so far have not been sufficient to permit authorization.”

Swissmedic reviews the data it receives on an ongoing basis, as it becomes available. Following Swissmedic’s provisional assessment, the regulator’s external advisory panel – the Committee on Human Medicines (HMEC) – met on Tuesday and confirmed the preliminary assessment: “The data currently available do not suggest a positive judgment regarding benefits and risks.”

An important point may be the lack of data on people aged 65 and over – a common problem that is of concern to Germany and South Korea.

To address HMEC’s ​​concerns, AstraZeneca should “among other things … transmit additional efficacy data from its Phase III trials underway in North and South America,” according to Swissmedic. After the results are analyzed, a provisional authorization can be issued quickly.

North and South American Studies started in August and plans to enroll 30,000 patients in a randomized, double-blind placebo-controlled trial. Its main completion date is March 23, 2021. The trial’s primary endpoint will determine the efficacy, safety and tolerability, and reactogenicity of the two-dose vaccine against placebo in adults between 18 and 130 years of age.

The secondary end point was designed to measure the efficacy of two doses vs placebo in terms of prevention:

  • SARS-CoV-2 infection
  • COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) and by the University of Oxford
  • COVID-19 is severe or critical
  • Emergency room visit related to COVID-19

It also plans to determine antibody response and neutralize antibody levels in serum, as well as vaccine efficacy regardless of previous infection with the SARS-CoV-2 virus. The study completion date is set for February 2023.

Pre-printed paper published in Lancet in February, one day before HMEC Swissmedic met, analyzing results from Phase III trials in the UK and Brazil, and Phase I / II trials in the UK and South Africa. The two trials involved a total of 17,177 initial seronegative trial participants aged 18 years and over to determine efficacy. Importantly, participants came from areas where the most recent variant had been identified (UK, 8,949 participants; Brazil, 6,753; South Africa, 1,476).

After 14 days, 619 of more than 17,000 participants tested positive for the virus using the nucleic acid amplification test (NAAT) and 332 of them had symptoms of infection 14 days after the second dose. Notably, there were no hospitalizations, which suggests that the vaccine may have reduced symptoms among those infected. Analysis from day 22 post administration to day 90 showed that efficacy was not reduced.

The researchers concluded that the three-month period between the first and second doses is an effective strategy for reducing the incidence of COVID-19 and “may be optimal for pandemic vaccine rollouts when supplies are short-term.”

As Swissmedic discussed the AstraZeneca vaccine, the Swiss Federal Public Health Office announced it signed agreement with Curevac and the Swedish government for 5 million doses of vaccine. It also had an initial agreement with Novavax for 6 million doses, and previously signed a contract with Modern for an additional 6 million doses (in addition to the already contracted 7.5 million). It has also contracted 5.3 million doses from AstraZeneca and 3 million for Pfizer. That’s a total of 30.8 million doses for a population of nearly 8.7 million people.

With talks ongoing to secure additional vaccines, the government’s strategy is to ensure that multiple vaccine technologies are available. That would make it possible to match vaccine strains to specific populations. With a mixture of mRNA, vector-based and protein-based vaccines, Switzerland hopes to ensure that each individual can receive the most suitable vaccine for that person, and also to support economically weaker countries.

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Novavax Starts Rolling Review for Vaccines & Other COVID News | Instant News


Less than one week after posting a positive first sight on Phase III vaccine dataMaryland-based Novavax began a rolling review process for NVX-CoV2373 authorizations in the UK, Canada, and the United States.

Last week, Novavax shared provisional data from a Phase III study in the UK that showed the vaccine candidate demonstrated 89.3% efficacy against the virus. The results include the most common types of the novel coronavirus, as well as several variants of the virus. Elaborating on that, Novavax said the efficacy of its NVX-CoV2373 vaccine is 95.6% against the original strain and 85.6% against the British variant that has swept the country. Results from the Phase IIb study in South Africa, where a particularly lethal strain raged, were not as high. Overall for that study, the results showed an efficacy of 60%. However, the Phase IIb study included HIV-positive patients. Among the immunocompromised patients included in the study, the efficacy against the South African strain fell to 49%.

Gregory M. Glenn, president of Novavax’s Research and Development unit, said a rolling review of the company’s submissions for the authorization of emergency use of its vaccines would help “speed up the review process and bring us closer to delivering a safe and effective vaccine worldwide.” rolling, the company will continue to send you additional information, including clinical and manufacturing data.

The Novavax recombinant protein-based vaccine candidate is currently in Phase III clinical development in the UK and US for the prevention of COVID-19. The NVX-CoV2373 consists of a stable prefusion protein manufactured using its proprietary nanoparticle technology and includes Novavax’s proprietary Matrix-M adjunct. Phase I data from the Phase I / II study indicated that NVX – CoV2373 produce antibodies in healthy patients, the vaccine is working as intended. The vaccine was also well tolerated in these patients, the company said.

Elsewhere in the fight against the ongoing pandemic:

CureVac Forges Alliance with the UK

German CureVac, which was earlier this week into vaccine partnerships with GlaxoSmithKline, announced this morning that it went into collaboration with the British Government to develop and produce potential vaccine candidates against the SARS-CoV-2 variant. The resulting vaccine candidate will be manufactured and distributed in the UK. CureVac said the goal of its collaboration with the government was to reduce the effects of the current pandemic and help prepare for a future SARS-CoV-2 outbreak by working on a variety of vaccine variants.

As part of the collaboration, the UK government’s Vaccine Task Force and CureVac will assess several variants of SARS-CoV-2 and produce vaccine candidates against it. Clinical studies will be accelerated to secure emergency or conditional marketing authorizations for selected vaccine candidates against the most threatening variant viruses, CureVac said.

“One of the biggest challenges we continue to face in fighting COVID-19 is the emergence of various variants, each of which has the potential to pose a significant threat to public health,” said Antony Blanc, chief business officer and chief commercial officer of CureVac. statement. “At CureVac, we believe we have the ability to rapidly adapt our mRNA technology to address current variants and prepare for the emergence of new strains. This collaboration is expected to yield our significant combined strengths to ensure the vaccine continues to win against COVID -19.”

New FDA Guidelines Planned

With increasing concerns about virus variants, FDA is developing guidelines to help vaccine, drug and testing manufacturers adapt, USA Today reported. Janet Woodcock, acting Commissioner of the FDA, noted that current treatments and testing methods are working, but that regulatory agencies want to prepare for an eventual change with the virus, even as vaccination efforts are underway across the country. Over the next few weeks, the FDA will provide manufacturers with draft guidelines on how to customize their products as needed, according to the report.

Some vaccines, such as those developed from Novavax, as well as AstraZeneca’s, which are not yet certified in the United States, show some limited efficacy against this more virulent strain. However, there are concerns that as these new strains become increasingly widespread in the US, the current vaccines from Moderna and Pfizer and BioNTech, as well as the monoclonal antibodies developed by Eli Lilly and Regeneron, may become less effective.

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