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GlaxoSmithKline plc (GSK) and California-based Vir Biotechnology, Inc. announced that the European Medicines Agency (EMA) had started a rolling review of data on an investigational compound known as Sotrovimab (VIR-7831), a dual-action SARS-CoV-2 monoclonal antibody.
The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1, indicating that the epitope is highly conserved and less likely to mutate over time. Sotrovimab, which incorporates Xencor’s Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.
The EMA will evaluate all data on Sotrovimab, including evidence from clinical trials, as they become available.
The EMA's decision to start the rolling review is based on the interim analysis of efficacy and safety data from the Phase 3 COMET-ICE clinical trial, which evaluated Sotrovimab as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization. The interim analysis demonstrated an 85% reduction in hospitalizations over 24 hours or deaths in those receiving Sotrovimab.
The companies submitted an Emergency Use Authorization application for Sotrovimab to the US Food and Drug Administration. Sotrovimab is also under review by other global regulators, including Health Canada. Sotrovimab has not been granted a marketing authorization anywhere globally.
In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses. GSK is collaborating with several organizations on COVID-19 vaccines by providing access to our adjuvant technology. For further information, please visit www.gsk.com/about-us.
Bellevue-based Viome announced its proprietary mRNA analysis technology combined with its next-generation AI platform had been designated a Breakthrough Device by the Food and Drug Administration (FDA) for early detection of oral cancer and throat cancer.
Making saliva the new liquid biopsy, Viome analyzes samples for the presence of Oral Squamous Cell Carcinoma and Oropharyngeal Cancer.
Viome has employed unique mRNA analysis technology and breakthrough machine learning techniques to accurately discover the interactions between microbial activities and human gene expression in the progression of these cancers.
Founded in Washington during 2016, Viome has become a global healthcare company, developing precision nutrition, precision drugs, and precision vaccines to help people live a disease-free life.
The U.S. Food and Drug Administration issued a new report titled “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the agency’s inspectional activities during the COVID-19 pandemic.
Its detailed plan to move toward a more consistent state of operations, including the FDA’s priorities related to this work going forward.
“Like most organizations around the world, the FDA experienced unprecedented and unique challenges during the SARS-CoV-2 pandemic. In particular, our inspection, surveillance, and compliance activities were significantly impacted,” commented Acting FDA Commissioner Janet Woodcock, M.D., in an FDA press statement.
“The FDA fully understands the importance of getting back to a more consistent state of inspectional capacity. This plan provides the public with a transparent picture of both the successes and challenges we’ve faced in these areas over the past year, as well as our plan moving forward."
"We want to assure the American public that we have used a variety of tools to oversee the regulated industry and ensure that Americans continue to have access to safe food and high-quality FDA-regulated products," concluded Dr. Woodcock.
Based in Maryland, the FDA will continue to leverage and maximize every available tool and resource to meet its inspectional responsibilities while achieving optimal public health outcomes.
Basel-based Roche announced on May 5, 2021, that the European Commission has approved Tecentriq® (atezolizumab) as a first-line treatment for adults with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations.
“We are delighted to bring Tecentriq to people in the EU with this specific type of lung cancer,” commented Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development, in a press statement.
“Tecentriq monotherapy has been shown to improve overall survival in people with high PD-L1 expression, when compared to chemotherapy, and therefore represents a new treatment option for people living with this difficult-to-treat disease.”
Tecentriq is now the first and only single-agent cancer immunotherapy with three dosing options, allowing administration every two, three, or four weeks, giving physicians and patients greater flexibility on how they manage their treatment.
Roche has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across different settings in lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers.
This includes studies evaluating Tecentriq both alone and in combination with other medicines and studies in metastatic, adjuvant, and neoadjuvant settings across various tumor types.
Founded in 1896, 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.
Urgent international support is needed to prevent a worsening humanitarian catastrophe in countries across South Asia, announced the International Federation of Red Cross and Red Crescent Societies (IFRC) on May 5, 2021.
In Nepal, many hospitals are full and overflowing with COVID-19 patients.
Southern towns near the Indian border are unable to cope with the growing number of people needing medical treatment. Nepal is recording 57 times more COVID-19 cases than this time last month.
Across Nepal, 44% of tests recently returned positive results according to government authorities, indicating many thousands of infections are undiagnosed.
Nepal Red Cross Chairperson, Dr. Netra Prasad Timsina, said in an IFRC statement, “What is happening in India right now is a horrifying preview of Nepal’s future if we cannot contain this latest COVID surge that is claiming more lives by the minute."
“Every effort is being made to save lives right now across Nepal with increased medical treatment. Nepal Red Cross volunteer health teams are also reducing record infections by helping with testing, vaccinations, handwashing, mask-wearing, and isolating infected people."
“It is beyond distressing to see that people cannot say goodbye to their loved ones as cremations are taking place at record levels due to these new COVID variants, which are striking down people of all ages in Nepal.”
All South Asian countries have started vaccinating people who are most at-risk, yet in Nepal, only 1% of the population has received two doses of a COVID-19 vaccine, as of May 5th.
The IFRC's Asia Pacific Director Alexander Matheou added, "This coronavirus has no respect for borders. Nepal urgently needs support, to save more lives and treat people who are suffering. We will not succeed in overcoming this terrible disease until vaccines are available to protect everyone, regardless of nationality or income.”
Novavax, Inc. today announced that it had finalized an advance purchase agreement (APA) with Gavi, the Vaccine Alliance (Gavi), for the Novavax COVID-19 Vaccine.
Under the new APA, Novavax is expected to manufacture and distribute 350 million vaccine doses of NVX-CoV2373 to countries participating under the COVAX Facility. NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the coronavirus that causes COVID-19 disease.
Under the APA, Novavax expects to deliver doses with antigen and adjuvant manufactured at facilities directly funded by the $400 million investment Novavax received from the Coalition for Epidemic Preparedness Innovations.
Under a separate APA with Gavi, the Serum Institute of India is expected to manufacture and deliver the balance of the 1.1 billion doses of the Novavax COVID-19 vaccine.
Stanley C. Erck, President, and CEO, Novavax, commented in a press release issued on May 6, 2021, "This arrangement is the culmination of a collaboration among CEPI, Gavi, Serum Institute, and Novavax, who are partnering in our urgent mission to deliver significant amounts of vaccines to all countries, regardless of income level."
Gaithersburg-based Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases.
Cambridge-based Moderna, Inc. (Nasdaq: MRNA) announced financial results and provided business updates for the first quarter of 2021, and highlighted pipeline progress. Total revenue was $1.9 billion for the three months ended March 31, 2021, compared to $8 million for the same period in 2020. Net income was $1.2 billion.
A total of 102 million experimental Moderna COVID-19 vaccine doses were produced, generating a significant amount of the Company's revenue.
The Company increased its 2021 supply forecast to between 800 million and 1 billion vaccine doses, And Moderna confirmed it is making investments to increase global supply for COVID-19 Vaccine to up to 3 billion doses in 2022.
On December 18, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization enabling the mRNA COVID-19 Vaccine Moderna to be distributed in the USA for use in individuals 18 years of age and older.
Furthermore, Moderna plans to initiate a rolling submission to the FDA for a Biologics License Application in the U.S. during May'21. The FDA is the regulatory authority with oversight of the safety, effectiveness, and quality of vaccines used in the USA.
“In the first quarter, the Moderna team delivered on its supply commitments to help protect more than 100 million people. This accomplishment translated into our first profitable quarter in the company’s history, after 10 years of scientific innovation and several billion dollars invested to make our mRNA platform a reality,” commented Stéphane Bancel, Chief Executive Officer of Moderna, in a press release.
Moderna will host a live conference call and webcast at 8:00 a.m. ET on Thursday, May 5, 2021. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 7487119.
The Japanese government intends to extend the ongoing State of Emergency in Tokyo, Kyoto, Hyogo, and the Osaka area. The COVID-19 emergency will be expanded to Aichi and Fukuoka, reported KyodoNews today.
Tokyo's governor Yuriko Koike informed news reporters the COVID-19 outbreak had not improved enough to lift the restrictions. Tokyo continues to report the majority of COVID-19 cases. The updated guidelines are posted in Japanese.
The current State of Emergency launched on April 25th, 2021, and was scheduled to end on May 11th, 2021.
On May 6th, Japan's government reported two passengers who arrived at the airport were quarantined with the SARS-CoV-2 coronavirus, and 27 asymptomatic pathogen carriers were also identified.
The status of the Tokyo Olympic Games this summer has recently become an issue in Japan, with polls showing most residents (72%) favoring either postponement or cancellation.
The US Centers for Disease Control and Prevention (CDC) issued a Level 2 Travel Alert on May 3, 2021, confirming vaccine-derived polio outbreaks in many countries in Africa.
The CDC's 'Practice Enhanced Precaution' Alert recommends that all travelers to these African countries be vaccinated fully against polio.
Since 2000, the inactivated polio vaccine is most often given in the USA, says the CDC.
Poliovirus outbreaks have been reported in the following African countries (map). And, before traveling to these countries, adults who completed their routine polio vaccine series as children should receive a single, lifetime adult booster dose of polio vaccine.
Although wild-type polio was eradicated in Africa in 2020, vaccine-derived poliovirus can cause outbreaks in low vaccination areas. The Polio vaccine protects against both wild-type and vaccine-derived poliovirus infection.
To learn more about vaccine-derived polio, visit this CDC webpage.
