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JUVE Patent today reported the European Patent Office Opposition Division has revoked an essential mRNA vaccine patent.
As of November 21, 2023, a contested mRNA patent owned by Moderna Inc. was declared invalid.
Moderna believes Pfizer and BioNTech copied features of the company's patented technologies critical to the success of mRNA vaccines.
According to Reuters, BioNTech welcomed the decision, calling the patent office's decision "an important one, as we believe that this and others of Moderna's patents do not meet the requirements for grant and should never have been granted."
The legal dispute revolves around Moderna's patents EP 3 590 949 B1 and EP 3 718 565 B1, which protect "ribonucleic acids containing n1-methyl-pseudouracils and uses thereof" and "respiratory virus vaccines," respectively.
However, while both patents are concerned with mRNA vaccines, they have different applications.
EP 949 is concerned with claims concerning modified mRNA.
And EP 565 covers the "betacoronavirus mRNA-LNP vaccine," an improved substance for the prevention of contracting COVID and other respiratory diseases.
The unedited news article is posted at this link.
Alzamend Neuro, Inc. today announced receipt of a "Study May Proceed" letter from the U.S. Food and Drug Administration ("FDA") for the initiation of study AL001-MDD01, a Phase IIA clinical study of AL001 for the treatment of patients with major depressive disorder ("MDD"), also known simply as depression.
While a wide variety of medications have been used historically for augmentation of an antidepressant in MDD, lithium is one of the few agents that has demonstrated efficacy in multiple randomized controlled trials.
AL001 is a novel lithium-delivery system that can potentially deliver the benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium.
Alzamend's goal is to revive the utility of lithium treatment by significantly improving the benefit-to-risk relationship of lithium treatment in clinical practice.
Stephan Jackman, Chief Executive Officer of Alzamend, commented in a press release on November 20, 2023, “If we can develop a next-generation lithium product (AL001) that would not routinely require therapeutic drug monitoring, it would constitute a major improvement over current lithium-based treatments and positively impact the 21 million Americans afflicted with MDD."
"We are advancing the process and expect that the first patient will be dosed in the first quarter of 2024.”
Based on the favorable AL001 safety profile observed in the recently completed study and extensive safety data on the drug's constituent components, the AL001 development program may qualify for a Section 505(b)(2) New Drug Application pathway for FDA approval, which is available to new formulations of an approved drug.
As of November 21, 2023, the FDA has not approved a vaccine candidate targeting depression of Alzheimer's disease.
The journal Vaccines recently published the findings from a Texas A&M University survey that assessed parental intention to vaccinate children against respiratory viruses.
Published on November 17, 2023, these researchers found that about 40% of parents intended to vaccinate their children against COVID-19, 63% against influenza, and 71% against RSV.
Women showed lower intentions for COVID-19 and influenza. For COVID-19 and RSV, intentions were higher for those who thought vaccines were necessary.
Intention to vaccinate was consistently correlated with concerns about the disease, trust in health institutions, and previous vaccinations.
Moreover, the highlighted reasons for vaccine hesitancy include concerns about safety, necessity, and lack of information.
Communications contact: Simon F. Haeder, Department of Health Policy & Management, School of Public Health, Texas A&M University, College Station, TX 77843.
The journal Scientific Reports recently published a meta-analysis that confirmed cardiovascular events remain a substantial global health concern and that common influenza vaccines may benefit older people during flu outbreaks.
These researchers found compelling evidence that influenza vaccination is associated with a decreased risk of major cardiovascular events, particularly myocardial infarction (MI) and cardiovascular death.
This study shows a 26% decreased risk of heart attacks in people who received an influenza vaccination and a 33% reduction in cardiovascular deaths.
On November 19, 2023, the study revealed Pooled relative risks (RR), and their 95% confidence intervals (CI) were calculated to evaluate the associations.
A notable reduction in major cardiovascular events was observed among patients who received the influenza vaccine, with 517 cases compared to 621 cases in the placebo group (RR 0.70; 95% CI 0.55–0.91).
The stratified analysis revealed a decreased risk of MI in vaccinated patients (RR 0.74; 95% CI 0.56–0.97).
And a significant reduction in cardiovascular death events (RR 0.67; 95% CI 0.45–0.98).
These findings highlight the potential of influenza vaccination as an adjunctive strategy in cardiovascular disease prevention.
As of November 20, 2023, the U.S. CDC recommends that most people six months of age and older get one dose of any approved influenza vaccine before the flu season arrives in their community. Annual flu shots are generally available at clinics and pharmacies in the U.S.
The U.S. Food and Drug Administration (FDA) today issued a final rule to amend its regulations concerning direct-to-consumer (DTC) advertisements for human prescription drugs presented in television or radio format.
Since September 1985, the FDA has authorized pharmaceutical DTC advertising and required the advertisements to meet the same legal requirements as those directed at physicians.
Like all advertisers, pharmaceutical firms have incentives to present their products in a positive light to potential consumers.
However, the FDA says that those business incentives do not assure clear communication to consumers of the advertised drug's negative attributes.
In 2022, research data indicates that pharma companies spend about 1 billion dollars monthly.
FIERCE Pharma published a list of the top 10 pharma drug ad spenders for 2022.
Specifically, the FDA's final rule issued on November 21, 2023, implements a requirement of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by the FDA Amendments Act of 2007 (FDAAA), that in such DTC TV/radio ads, the major statement relating to side effects and contraindications must be presented in a clear, conspicuous, and neutral manner.
The FDA's final rule establishes five standards that, independently and collectively, help ensure that the major statement is presented clearly, conspicuously, and neutrally. This rule does not change the content of the major statement.
As directed by FDAAA, FDA is establishing these standards.
One of the world’s most formidable public health challenges, human immunodeficiency virus (HIV), is impacting more than 38 million people worldwide.
While there are no U.S. Food and Drug Administration (FDA) approved HIV vaccines in 2023, a novel arenaviral therapeutic vaccine candidate is being evaluated as a potential curative regimen for HIV.
HOOKIPA Pharma Inc. today announced that it has received clearance from the FDA for its Investigational New Drug (IND) application for HB-500, a novel arenaviral therapeutic vaccine for the treatment of HIV.
HB-500 is an alternating, 2-vector arenaviral therapeutic vaccine for the treatment of HIV.
One vector is based on the lymphocytic choriomeningitis virus as its arenaviral backbone; another vector is based on the Pichinde virus.
Both encode the same HIV antigens. The alternating 2-vector approach is designed to further focus the immune response against the target antigen.
HOOKIPA is responsible for advancing the HIV program through the completion of a Phase 1b clinical trial.
And Gilead Sciences, Inc. has the exclusive right to assume further program development afterward.
Joern Aldag, Chief Executive Officer at HOOKIPA, commented in a press release on November 20, 2023, “The ability to generate a potent and broad T cell response that can clear infected cells is critical for HIV control. Our novel arenaviral therapeutic vaccine (candidate) offers promise in helping to address the unmet need for a functional HIV cure.”
In November 2023, Nature Partner Journals Vaccines published the joint-preclinical research by HOOKIPA and Gilead, which served as the foundation for the IND submission.
The data show that arenaviral therapeutic vaccination was well tolerated and generated robust, high-quality, and durable immune responses (antigen-specific T cells and antibodies) in non-human primates.
Additionally, arenaviral therapeutic vaccination significantly reduced SIV viral load and clinical illness in those animals compared to placebo.
HIV, a sexually transmitted disease, is one of the world’s most formidable public health challenges.
The virus infects and kills immune cells and, without effective ongoing treatment, leaves the individual increasingly immunocompromised over time. While effective treatments have significantly extended the lives of people living with HIV and reduced the transmission of the virus, there is no cure for HIV or AIDS in 2023.
The Global Polio Eradication Initiative (GPEI) recently confirmed six countries reported additional polio cases in 2023
These countries include Pakistan, which reported its fifth wild poliovirus type 1 (WPV1) case this year.
According to the GPEI, the other countries include Chad, the Democratic Republic of the Congo (DRC), Guinea, Nigeria, and Somalia, which reported more circulating vaccine-derived poliovirus type 2 cases.
The DRC also reported four more cases involving circulating vaccine-derived poliovirus type 1.
While it has been about three months since the World Health Organization (WHO) confirmed that the spread of the poliovirus remained a Public Health Emergency of International Concern, the WHO continues to remind Member States that the risk of the emergence of polio has increased due to low vaccination coverage.
Polio is a crippling and potentially deadly disease that affects the nervous system.
Most people with polio do not feel sick. In rare cases, polio infection causes permanent loss of muscle function (paralysis). Polio can be fatal if the muscles used for breathing are paralyzed or if there is an infection of the brain.
To warn international travelers, the U.S. Centers for Disease Control and Prevention issued an updated Global Polio Alert - Level 2, Practice Enhanced Precautions, Travel Health Notice on September 11, 2023, regarding polio outbreaks and poliovirus detections in 31 countries.
The CDC says that before visiting any of these destinations, adults who previously completed the full, routine polio vaccine series may receive a single, lifetime booster dose of the polio vaccine.
As of November 2023, various polio vaccines are available worldwide.
Since the launch of the World Health Organization's (WHO) global strategy to accelerate the elimination of cervical cancer three years ago, a further 30 countries, including Bangladesh, Indonesia, and Nigeria, have introduced a Human papillomavirus (HPV) vaccine into their vacation schedules.
As of November 17, 2023, 140 countries have now introduced HPV vaccinations into national programs.
Governments and communities are leading the way by declaring commitment and developing strategies to eliminate HPV cervical cancer, a sexually transmitted disease.
On Cervical Cancer Elimination Day of Action, Member States have a renewed commitment to eliminate this vaccine-preventable cancer.
"In the last three years, we have witnessed significant progress, but women in poorer countries and poor and marginalized women in richer countries still suffer disproportionately from cervical cancer," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in a press release.
"With enhanced strategies to increase access to vaccination, screening, and treatment, strong political and financial commitment from countries, and increased support from partners, we can realize our vision for eliminating cervical cancer."
There are effective HPV vaccines that protect males and females against cancers caused by HPV.
According to the U.S. Centers for Disease Control and Prevention (CDC), these vaccines include 9vHPV, 4vHPV, and 2vHPV. In the U.S., HPV vaccination has been recommended for women since 2006 and for men since 2011.
As of August 2023, the CDC reported that in 2022, 76% of people aged 13–17 had received one or more HPV vaccine doses.
HPV vaccines are generally available at health clinics and pharmacies in the U.S.
