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FDA Warns Manufacturer for Marketing Illegal Flavored Nicotine Gummies

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FDA Warns Manufacturer for Marketing Illegal Flavored Nicotine Gummies

August 18, 2022: “The U.S. FDA issued a warning letter for marketing illegal flavored nicotine gummies – the first warning letter for this type of product.

These types of gummies are of particular public concern because of their resemblance to kid-friendly food or candy products and the potential to cause severe nicotine toxicity or even death among young children.

The manufacturer, VPR Brands LP (doing business as, “Krave Nic”), markets gummies that have 1 milligram (mg) of nicotine each and are available in three flavors – Blueraz, Cherry Bomb and Pineapple.

The packaging claims that the products contain tobacco-free nicotine.

This firm has not submitted a premarket tobacco product application (PMTA) to the FDA, and does not have a marketing authorization order to manufacture, sell or distribute these products in the U.S.

“Nicotine gummies are a public health crisis just waiting to happen among our nation’s youth, particularly as we head into a new school year,” said FDA Commissioner Robert M. Califf, M.D.

“We want parents to be aware of these products and the potential for health consequences for children of all ages – including toxicity to young children and appeal of these addictive products to our youth.

The FDA will not stand by as illegal products infiltrate the marketplace.”

The manufacturer states that each gummy contains 1 milligram of nicotine with 12 gummies (12 mg) per tin. Research indicates that ingesting 1 to 4 milligrams of nicotine could be severely toxic to a child under 6 years of age depending on the child’s body weight.

However, nicotine toxicity among youth of any age may lead to nausea, vomiting, abdominal pain, increased blood pressure and heart rate, seizures, respiratory failure, coma and even death.

Nicotine is also highly addictive and exposure during adolescence can harm the developing brain.

In a recent study published in the journal PediatricsExternal Link Disclaimer, researchers found that flavored non-tobacco oral nicotine products, including gummies and lozenges, were among the most commonly used tobacco product among youth in southern California – second only to e-cigarettes.

Use was particularly high among certain racial or ethnic, sexual or gender minority groups, and those with a history of nicotine use.

These flavored non-tobacco oral nicotine products present an increased risk to youth due to their resemblance to kid-friendly food or candy products, such as gummies or gum, the availability in youth-appealing flavors, and the ability for teenagers to conceal use from adults. 

The warning letter issued today requests a written response from the manufacturer describing how the firm intends to address any violations and bring their products into compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Failure to promptly correct violations can result in further action such as civil money penalties, seizure, and/or injunction.

Additionally, the firm must not sell or distribute violative products. The firm must submit a PMTA and receive marketing authorization from FDA before selling or distributing the product in the U.S.

In response to the increase of non-tobacco nicotine in tobacco products, including in some of the e-cigarette brands that are most popular with youth, Congress passed a federal law that went into effect on April 14, 2022, clarifying the FDA’s authority to regulate tobacco products containing nicotine from any source.

This law gives the FDA authority over products made with non-tobacco nicotine, including synthetic nicotine, and imposes requirements under the FD&C Act for manufacturers, importers, retailers and distributors of non-tobacco nicotine products.

To date, no non-tobacco nicotine product has received a marketing granted order. 

“We remain unwavering in our use of compliance and enforcement resources to curb all unlawful marketing of tobacco products, especially those that youth could easily confuse with something that they consume regularly – like candy,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products.

“Today’s action should be a wake-up call for manufacturers of these illegal products that the FDA is actively working to identify violations and to swiftly seek corrective actions.”

Efforts such as these support the FDA’s commitment to using a science-based approach to protect youth from initiating tobacco use. In addition to the FDA’s regulatory oversight, the agency recognizes the critical need for targeted youth tobacco prevention efforts designed to protect America’s kids, including mass media campaigns such as “The Real Cost.” ‘

The FDA also collaborates with the Centers for Disease Control and Prevention on the National Youth Tobacco Survey, the only nationally representative survey of middle and high school students that focuses exclusively on tobacco product use. 

https://www.fda.gov/news-events/press-announcements/fda-warns-manufacturer-marketing-illegal-flavored-nicotine-gummies

FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans

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FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans

August 16, 2022: “the U.S. Food and Drug Administration issued a final rule to improve access to hearing aids which may in turn lower costs for millions of Americans.

This action establishes a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting adjustment by an audiologist. 

The rule is expected to lower the cost of hearings aids, furthering the Biden-Harris Administration’s goal of expanding access to high-quality health care and lowering health care costs for the American public.

It is designed to assure the safety and effectiveness of OTC hearing aids, while fostering innovation and competition in the hearing aid technology marketplace. 

Today’s action follows President Biden’s Executive Order on Promoting Competition in the American Economy, which called for the FDA to take steps to allow hearing aids to be sold over the counter and set a swift 120-day deadline for action, which the FDA met.

In 2017, Congress passed bipartisan legislation requiring the FDA to create a category of OTC hearing aids, but it was not fully implemented until now.

Consumers could see OTC hearing aids available in traditional retail and drug stores as soon as mid-October when the rule takes effect.

“Reducing health care costs in America has been a priority of mine since Day One and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need,” said Health and Human Services Secretary Xavier Becerra.

“Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”

Close to 30 million adults in the U.S. could benefit from hearing aid use. Individuals with permanent hearing impairment can use hearing aids to help make speech and sounds louder, improving the ability to communicate effectively with others.

Many hearing aids can be expensive.

The final rule aims to stimulate competition and facilitate the sale of safe and effective OTC hearing aids in traditional retail stores or online nationwide, providing consumers with perceived mild to moderate hearing loss with improved access to devices that meet their needs and are less expensive than current options. 

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said FDA Commissioner Robert M. Califf, M.D.

“Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.”   

The OTC category established in this final rule applies to certain air-conduction hearing aids intended for people 18 years of age and older who have perceived mild to moderate hearing impairment.

Hearing aids that do not meet the requirements for the OTC category (for example, because they are intended for severe hearing impairment or users younger than age 18) are prescription devices. 

The FDA finalized the rule after receiving and reviewing more than 1,000 public comments on the proposed rule issued on Oct. 20, 2021.

Comments submitted by consumers, professional associations, hearing aid manufacturers, public health organizations and advocacy groups, members of Congress, state agencies, and other stakeholders are summarized in the final rule, along with the FDA’s respective responses.

In response to public comments and to assure the safety and effectiveness of OTC hearing aids, the final rule incorporates several changes from the proposed rule, including lowering the maximum sound output to reduce the risk to hearing from over-amplification of sound, revising the insertion depth limit in the ear canal, requiring that all OTC hearing aids have a user-adjustable volume control, and simplifying the phrasing throughout the required device labeling to ensure it is easily understood.

The final rule also includes performance specifications and device design requirements specific to OTC hearing aids.

Furthermore, today’s action correspondingly amends existing rules that apply to prescription hearing aids for consistency with the new OTC category, it repeals the conditions for sale for hearing aids, and it includes provisions that address some of the effects of the FDA OTC hearing aid regulations on state regulation of hearing aids.

Concurrently with issuing the final rule, the FDA also issued the final guidance, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs), to clarify the differences between hearing aids, which are medical devices, and PSAPs, consumer products that help people with normal hearing amplify sounds.  

The effective date for the final rule is 60 days following publication in the Federal Register.

Manufacturers of hearing aids sold prior to the effective date of the final rule will have 240 days after its publication to comply with the new or revised requirements.

For hearing aids that have not been offered for sale prior to the effective date, compliance with the new or revised requirements must be achieved before marketing the device, including obtaining 510(k) clearance if applicable.”

https://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans

Sanofi provides update on amcenestrant clinical development program

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Sanofi provides update on amcenestrant clinical development program

August 17, 2022: “Sanofi is discontinuing the global clinical development program of amcenestrant, an investigational oral selective estrogen receptor degrader (SERD).

The decision is based on the outcome of a prespecified interim analysis of the Phase 3 AMEERA-5 trial evaluating amcenestrant in combination with palbociclib compared with letrozole in combination with palbociclib in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer.

An Independent Data Monitoring Committee (IDMC) found that amcenestrant in combination with palbociclib did not meet the prespecified boundary for continuation in comparison with the control arm and recommended stopping the trial. No new safety signals were observed.

Trial participants will be transitioned to letrozole in combination with palbociclib or another appropriate standard of care therapy, as determined by their physician.

The company will continue to review the data and plans to share the results with the scientific community in the future. All other studies of amcenestrant, including in early-stage breast cancer (AMEERA-6), will be discontinued.

John Reed, MD, PhD
Global Head of Research and Development at Sanofi
“While we are disappointed by this outcome, our research will further the scientific understanding of endocrine therapies in people with breast cancer. 

Our sincere gratitude goes to the patients, families and healthcare professionals involved in the amcenestrant clinical development program. 

Oncology remains a priority area for Sanofi, and we will continue to pursue transformative research to develop new medicines for people living with cancer.”

In March, Sanofi announced that the Phase 2 AMEERA-3 trial had not met the primary endpoint of improving progression-free survival in patients with ER+/HER2- advanced or metastatic breast cancer.

About AMEERA-5
AMEERA-5 is a randomized, double-blind Phase 3 trial evaluating the efficacy and safety of amcenestrant in combination with palbociclib, a CDK4/6 inhibitor, in the first-line treatment of patients with ER+/HER2- advanced breast cancer.

A total of 1068 patients who had not received any prior systemic anticancer therapies for advanced disease were randomized 1:1 to receive either amcenestrant or letrozole in combination with palbociclib.

About AMEERA-6
AMEERA-6 is a randomized, double-blind Phase 3 trial evaluating the efficacy and safety of amcenestrant compared with tamoxifen in patients with hormone receptor-positive early breast cancer who have discontinued adjuvant aromatase inhibitor (AI) therapy due to treatment related toxicity.

The trial was initiated in partnership with the Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC), and the Alliance Foundation Trials (AFT).”

https://www.sanofi.com/en/media-room/press-releases/2022/2022-08-17-05-30-00-2499668

Novartis provides update on Phase III CANOPY for NSCLC

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Novartis provides update on Phase III CANOPY for NSCLC

August 15, 2022: “Novartis announced that the Phase III CANOPY-A study evaluating adjuvant treatment with canakinumab (ACZ885), an inhibitor of interleukin-1beta (IL-1β), in adult patients with stages II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC) did not meet its primary endpoint of disease-free survival (DFS) versus placebo.

No unexpected safety signals were observed.

Findings from the trial will be presented at an upcoming medical meeting.

“We made an investment in the CANOPY program based on signals of reduced lung cancer incidence and mortality observed in the CANTOS study.

These positive signals supported the study of canakinumab as adjuvant treatment for early lung cancer,” said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development, Novartis.

“While we are disappointed CANOPY-A did not show the benefit we hoped for, every trial generates scientific evidence that supports future research and development, and we look forward to continuing to pursue new therapeutic options for people living with lung cancer, whose needs remain urgent and significant.

We thank the patients and clinical investigators whose time and commitment made this research possible.”

CANOPY-A is a Phase III, multicenter, randomized, double blind study that is evaluating the efficacy and safety of canakinumab as adjuvant treatment in patients with NSCLC stages II-IIIA and IIIB (T>5cm N2), per American Joint Committee on Cancer/The Union for International Cancer Control (AJCC/UICC) 8th edition staging, whose margins are free of cancer following surgery.

In the trial, 1,382 patients were randomized 1:1 to canakinumab, 200 mg subcutaneously every three weeks, or matching placebo for up to one year.

Patients completed standard-of-care adjuvant cisplatin-based chemotherapy and radiation therapy, if applicable, prior to randomization.

About canakinumab (ACZ885) 
Canakinumab is a human monoclonal antibody that binds with high affinity and selectivity to human IL-1β and inhibits IL-1β activity by blocking its interaction with its receptors.

By inhibiting IL-1β, preliminary evidence suggests that canakinumab may suppress Pro-Tumor Inflammation to 1) enhance anti-tumor immune response; 2) reduce tumor cell proliferation, survival and invasiveness; and 3) impair angiogenesis. 

Pro-Tumor Inflammation enables tumor development by driving cancer-causing processes and suppressing anti-tumor immune responses.

About the CANOPY program 
Novartis launched the CANOPY study program after observing significantly lower than expected rates of lung cancer mortality among patients in the Phase III cardiovascular CANTOS trial.

The CANTOS trial evaluated canakinumab as a secondary prevention measure for cardiovascular events in patients following a heart attack.

Patients in the CANTOS trial also were at high risk for inflammatory cancers like lung cancer due to advanced age, smoking history, and other clinical risk factors.

Based on these findings, Novartis launched three large-scale, randomized, Phase III clinical trials and a Phase II clinical trial to investigate canakinumab as a potential treatment option in NSCLC.

Novartis and lung cancer
Lung cancer is one of the most common cancers worldwide, accounting for more than 2 million new cases diagnosed each year.

More people die of lung cancer every year than any other cancer.

There are two main types of lung cancer—small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC).

NSCLC accounts for approximately 85% of lung cancer diagnoses, and 30-55% of patients with early NSCLC develop recurrence despite resection.

Novartis is committed to working with the scientific and medical communities to reimagine the treatment of lung cancer and pursue advances in medicine that could extend the survival of people living with lung cancer. 

Novartis is developing experimental therapies that block cancer growth; learning more about ways to activate the body’s immune system; increasing understanding of the relationship between chronic inflammation and tumor growth and progression; and exploring the potential for advanced nuclear medicine to fight the disease.”

https://www.novartis.com/news/media-releases/novartis-provides-update-phase-iii-canopy-study-evaluating-canakinumab-adjuvant-treatment-non-small-cell-lung-cancer

Monkeypox: experts give virus variants new names

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Monkeypox: experts give virus variants new names

August 12, 2022: “A group of global experts convened by WHO has agreed on new names for monkeypox virus variants, as part of ongoing efforts to align the names of the monkeypox disease, virus and variants—or clades—with current best practices.

The experts agreed to name the clades using Roman numerals.

The monkeypox virus was named upon first discovery in 1958, before current best practices in naming diseases and viruses were adopted. Similarly for the name of the disease it causes.

Major variants were identified by the geographic regions where they were known to circulate.

Current best practise is that newly-identified viruses, related disease, and virus variants should be given names with the aim to avoid causing offense to any cultural, social, national, regional, professional, or ethnic groups, and minimize any negative impact on trade, travel, tourism or animal welfare.

Disease: Assigning new names to existing diseases is the responsibility of WHO under the International Classification of Diseases and the WHO Family of International Health Related Classifications (WHO-FIC).

WHO is holding an open consultation for a new disease name for monkeypox. Anyone wishing to propose new names can do so here (see ICD-11, Add proposals).

Virus: The naming of virus species is the responsibility of the International Committee on the Taxonomy of Viruses (ICTV), which has a process underway for the name of the monkeypox virus. 

Variants/clades: The naming of variants for existing pathogens is normally the result of debate amongst scientists.

In order to expedite agreement in the context of the current outbreak, WHO convened an ad hoc meeting on 8 August to enable virologists and public health experts to reach consensus on new terminology.

Experts in pox virology, evolutionary biology and representatives of research institutes from across the globe reviewed the phylogeny and nomenclature of known and new monkeypox virus variants or clades.

They discussed the characteristics and evolution of monkeypox virus variants, their apparent phylogenetic and clinical differences, and potential consequences for public health and future virological and evolutionary research.

The group reached consensus on new nomenclature for the virus clades that is in line with best practices.

They agreed on how the virus clades should be recorded and classified on genome sequence repository sites.

Consensus was reached to now refer to the former Congo Basin (Central African) clade as Clade one (I) and the former West African clade as Clade two (II). Additionally, it was agreed that the Clade II consists of two subclades.

The proper naming structure will be represented by a Roman numeral for the clade and a lower-case alphanumeric character for the subclades.

Thus, the new naming convention comprises Clade I, Clade IIa and Clade IIb, with the latter referring primarily to the group of variants largely circulating in the 2022 global outbreak.

The naming of lineages will be as proposed by scientists as the outbreak evolves. Experts will be reconvened as needed.”

https://www.who.int/news/item/12-08-2022-monkeypox–experts-give-virus-variants-new-names

FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase Vaccine Supply

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FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase Vaccine Supply

August 09, 2022: “The U.S. FDA issued an emergency use authorization for the JYNNEOS vaccine to allow healthcare providers to use the vaccine by intradermal injection for individuals 18 years of age and older who are determined to be at high risk for monkeypox infection.

This will increase the total number of doses available for use by up to five-fold.

The EUA also allows for use of the vaccine in individuals younger than 18 years of age determined to be at high risk of monkeypox infection; in these individuals JYNNEOS is administered by subcutaneous injection.

“In recent weeks the monkeypox virus has continued to spread at a rate that has made it clear our current vaccine supply will not meet the current demand,” said FDA Commissioner Robert M. Califf, M.D.

“The FDA quickly explored other scientifically appropriate options to facilitate access to the vaccine for all impacted individuals.

By increasing the number of available doses, more individuals who want to be vaccinated against monkeypox will now have the opportunity to do so.” 

JYNNEOS, the Modified Vaccinia Ankara (MVA) vaccine, was approved in 2019 for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.

JYNNEOS is administered beneath the skin (subcutaneously) as two doses, four weeks (28 days) apart.

For individuals 18 years of age and older determined to be at high risk of monkeypox infection, the EUA now allows for a fraction of the JYNNEOS dose to be administered between the layers of the skin (intradermally).

Two doses of the vaccine given four weeks (28 days) apart will still be needed.

There are no data available to indicate that one dose of JYNNEOS will provide long-lasting protection, which will be needed to control the current monkeypox outbreak. 

Data from a 2015 clinical study of the MVA vaccine evaluated a two-dose series given intradermally compared to subcutaneously.

Individuals who received the vaccine intradermally received a lower volume (one fifth) than individuals who received the vaccine subcutaneously.

The results of this study demonstrated that intradermal administration produced a similar immune response to subcutaneous administration, meaning individuals in both groups responded to vaccination in a similar way.

Administration by the intradermal route resulted in more redness, firmness, itchiness and swelling at the injection site, but less pain, and these side effects were manageable.

The FDA has determined that the known and potential benefits of JYNNEOS outweigh the known and potential risks for the authorized uses.

To support the FDA’s authorization of two doses of JYNNEOS administered by the subcutaneous route of administration in individuals younger than 18 years of age, the FDA considered the available JYNNEOS safety and immune response data in adults as well as the historical data with use of live vaccinia virus smallpox vaccine in pediatric populations.

JYNNEOS has been tested in individuals with immunocompromising conditions and has been found to be safe and effective in the trials that were performed to support approval.

It was initially developed specifically as an alternative for use in immunocompromised individuals in the event of a smallpox outbreak.

On the basis of the determination by the Secretary of the Department of Health and Human Services on Aug. 9, 2022, that there is a public health emergency, or the significant potential for a public health emergency, that has a significant potential to affect national security or the health and security of United States citizens living abroad, and the declaration on Aug. 9, 2022, that circumstances exist justifying the emergency use of vaccines, the FDA may issue an EUA to allow emergency use of unapproved vaccines or unapproved uses of approved vaccines.

The FDA will provide updates as developments occur and will continue to work with federal public health partners and industry to ensure timely access to all available medical countermeasures.”

https://www.fda.gov/news-events/press-announcements/monkeypox-update-fda-authorizes-emergency-use-jynneos-vaccine-increase-vaccine-supply

Lynparza with abiraterone granted Priority Review in US for mCRPC

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Lynparza with abiraterone granted Priority Review in US for mCRPC

August 16, 2022: “AstraZeneca’s sNDA for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been accepted and granted Priority Review in the US for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC).

Lynparza is being jointly developed and commercialised by AstraZeneca and MSD.

The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that offer significant advantages over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.

The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the fourth quarter of 2022.

In the US, prostate cancer is the second most common cancer in male patients and is projected to cause approximately 35,000 deaths in 2022.

Overall survival for patients with mCRPC is approximately three years in clinical trial settings, and even shorter in the real world.

Approximately half of patients with mCRPC may receive only one line of active treatment, with diminishing benefit of subsequent therapies.6-11

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “There remains a critical unmet need among patients diagnosed with metastatic castration-resistant prostate cancer, where the prognosis remains poor and treatment options are limited.

Today’s news is another step towards bringing forward a new, much-needed treatment option in this setting.

If approved, Lynparza with abiraterone will become the first combination of a PARP inhibitor and a new hormonal agent for patients with this disease.”

Dr. Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, MSD Research Laboratories, said: “MSD is committed to developing new treatment options for patients with metastatic castration-resistant prostate cancer, a complex disease that urgently needs more therapies.

We look forward to working with the FDA towards the goal of bringing a new option to patients with mCRPC with or without HRR gene mutations.”

The sNDA was based on results from the PROpel Phase III trial presented at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium and later published in NEJM Evidence.

These results showed Lynparza in combination with abiraterone reduced the risk of disease progression or death by 34% versus abiraterone alone (based on a hazard ratio [HR] of 0.66; 95% confidence interval [CI] 0.54-0.81; p<0.0001).

Median radiographic progression-free survival (rPFS) was 24.8 months for Lynparza plus abiraterone versus 16.6 for abiraterone alone.

The safety and tolerability of Lynparza in combination with abiraterone was in line with that observed in prior clinical trials and the known profiles of the individual medicines.12

Lynparza is approved in the US for patients with HRR gene-mutated mCRPC (BRCA-mutated and other HRR gene mutations) who have progressed following prior treatment with enzalutamide or abiraterone; and in the EU, Japan and China for patients with BRCA-mutated mCRPC who have progressed following prior therapy that included a new hormonal agent (NHA).

These approvals were based on the data from the PROfound Phase III trial.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/lynparza-granted-fda-priority-review-for-propel.html

Bayer Consumer Health leaders propose new principles for science-led self-care

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Bayer Consumer Health leaders propose new principles for science-led self-care

August 2, 2022: “Bayer has published a new paper, Science-Led Self-Care: Principles for Best Practice, that sets out five key Principles that should underpin all self-care products improving personal health and wellness.

The paper is intended to spark a conversation within the industry and its key stakeholders around the need to promote science-led self-care for the benefit of consumers.

In the wake of the pandemic and the rise of accessible, digital information – consumers are becoming increasingly interested in maintaining and managing their own health.

Enabling this shift means consumers will need to have trust that the choices they make are the best. The paper proposes that sound science is a core component to earning that trust.

“We owe it to the consumer to help them navigate the self-care landscape and identify the products and services that are grounded in science and will help them to prevent disease and live healthy lives.

Our five Principles of Science-Led Self-Care can be a blueprint for deeper discussion within our industry about how best we help consumer navigate a confusing landscape,” comments Abbie Lennox, Global Chief Regulatory, Medical, Safety and Compliance Officer, Consumer Health division of Bayer.

Bayer’s five Principles of Science-Led Self-Care are:

· The Science of the Human: Self-care products rooted in a thorough understanding of human biology, medical insights and unmet needs
· The Science of Regulation: Independent regulation, to ensure safety and efficacy through transparent communication, accurate labelling and supported claims
· The Science of Collaboration: Carefully judged collaborations focused on win-win outcomes can help to improve access to self-care, making products available more widely and empowering more consumers to take charge of their health
· The Science of Discovery: Self-care products that have been rigorously researched, founded on scientific principles and developed with a deep understanding of consumers’ unmet needs
· The Science of the Consumer-Product Experience: A seamless experience beginning with the initial search for information, continuing through to the physical interaction with the product itself that helps consumer better use self-care products

David Evendon-Challis, Chief Scientific Officer, Consumer Health division of Bayer, comments: “We believe these Principles will enable better self-care as we look to push the boundaries of how science and innovation can continue the amazing journey of people living better, healthier lives.

We think these principles can also benefit others who are committed to this vision – greater consumer confidence will help boost the reputation of the self-care industry as a whole.”

He continues: “For many companies like Bayer engaging in science-led self-care, these principles will already be a part of their process.

These are what set science-led self-care products apart. We look forward to kicking off a robust discussion with industry peers, health and medical professionals, policy makers, and consumers about how these principles can continue to evolve to contribute to better health for all.”

https://media.bayer.com/baynews/baynews.nsf/id/Bayer-Consumer-Health-leaders-propose-new-principles-for-science-led-self-care?Open&parent=news-overview-category-search-en&ccm=020

CDC host 11th International Conference on Emerging Infectious Diseases

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CDC host 11th International Conference on Emerging Infectious Diseases

August 1, 2022: “The Centers for Disease Control and Prevention (CDC) and the Task Force for Global Health will co-host in person the 11th International Conference on Emerging Infectious Diseases (ICEID) August 7-10, 2022, at the Hyatt Regency Atlanta hotel in Atlanta, GA.

Held every 3 years, the conference brings together more than 1500 public health professionals from around the world to exchange the latest information on issues affecting the emergence, spread, and control of infectious diseases.

Keynote speakers at the Opening Session, Sunday, August 7 at 5:30 pm, include:

  • Welcome and Opening Remarks 
    • Rochelle Walensky: Director, Centers for Disease Control and Prevention, and Administrator, Agency for Toxic Substances and Disease Registry
  • Communicating Science in a Changing Media Environment
    • Josh Sharfstein: Vice Dean for Public Health Practice and Community Engagement, Johns Hopkins Bloomberg School of Public Health
  • Preparing for the Next Pandemic: Lessons Learned from the Black Coalition Against COVID
    • Reed Tuckson: Co-founder, Black Coalition Against COVID
  • Lessons from the Pandemic for Future Global Health
    • Soumya Swaminathan: Chief Scientist, World Health Organization

The three-day program includes plenary and panel sessions with invited speakers, oral abstract and poster presentations, and multiple scientific and public health exhibitors—all focusing on emerging and re-emerging infections. Selected oral presentations include:

  • The Role of the Environment: How Mask Wearing Varies Across Different Settings
  • Process Evaluation in Emergency Response: Evaluating COVID-19 Screening Testing Programs in K-12 Schools
  • Strategies To Maximize COVID-19 Immunization Coverage among the General Population
  • Performance of a Commercial Rapid Influenza A and B Diagnostic Test in a Community Sample of School-aged Children: ORCHARDS – Wisconsin 2015-2020
  • Turning Farmers into Disease Detectives – How Participatory Surveillance Can Prevent Future Pandemics
  • Progress in Immunization Safety Monitoring — Worldwide, 2010–2019
  • Fatal Melioidosis in a Child — Georgia, 2021
  • Intercontinental Movement of H5 2.3.4.4 Highly Pathogenic Avian Influenza (H5N1) to the United States, 2021
  • Seroprevalence of SARS-CoV-2 among Working Dogs in Arizona, 2021
  • Risks Associated with Reusable Bronchoscopes and Urologic Endoscopes
  • Integrating Health Equity Principles in Public Health Communication and Scientific Products
  • A New Paradigm for Pandemic Preparedness: Pathogen Wargaming.”

https://www.cdc.gov/media/releases/2022/p0801-ICEID.html

New global alliance launched to end AIDS in children by 2030

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New global alliance launched to end AIDS in children by 2030

August 02, 2022: “Globally, only half (52%) of children living with HIV are on life-saving treatment, far behind adults where three quarters (76%) are receiving antiretrovirals, according to the data that has just been released in the UNAIDS Global AIDS Update 2022.

Concerned by the stalling of progress for children, and the widening gap between children and adults, UNAIDS, UNICEF, WHO and partners have brought together a global alliance to ensure that no child living with HIV is denied treatment by the end of the decade and to prevent new infant HIV infections.

The new Global Alliance for Ending AIDS in Children by 2030 was announced by leading figures at the International AIDS Conference taking place in Montreal, Canada.

In addition to the United Nations agencies, the alliance includes civil society movements, including the Global Network of People living with HIV, national governments in the most affected countries, and international partners, including PEPFAR and the Global Fund.

Twelve countries have joined the alliance in the first phase: Angola, Cameroon, Côte d’Ivoire, the Democratic Republic of the Congo (DRC), Kenya, Mozambique, Nigeria, South Africa, Uganda, the United Republic of Tanzania, Zambia, and Zimbabwe.

Consultations by the alliance have identified four pillars for collective action:

  1. closing the treatment gap for pregnant and breastfeeding adolescent girls and women living with HIV and optimizing continuity of treatment;
  2. preventing and detecting new HIV infections among pregnant and breastfeeding adolescent girls and women;
  3. accessible testing, optimized treatment, and comprehensive care for infants, children, and adolescents exposed to and living with HIV; and
  4. addressing rights, gender equality, and the social and structural barriers that hinder access to services. 

Addressing the International AIDS Conference, Limpho Nteko from Lesotho shared how she had discovered she was HIV positive at age 21 while pregnant with her first child.

This led her on a journey where she now works for the pioneering women-led mothers2mothers programme. Enabling community leadership, she highlighted, is key to an effective response.

“We must all sprint together to end AIDS in children by 2030,” said Ms Nteko. “To succeed, we need a healthy, informed generation of young people who feel free to talk about HIV, and to get the services and support they need to protect themselves and their children from HIV.

mothers2mothers has achieved virtual elimination of mother-to-child transmission of HIV for our enrolled clients for eight consecutive years—showing what is possible when we let women and communities create solutions tailored to their realities.” 

The alliance will run for the next eight years until 2030, aiming to fix one of the most glaring disparities in the AIDS response. Alliance members are united in the assessment that the challenge is surmountable through partnership.

“The wide gap in treatment coverage between children and adults is an outrage,” said UNAIDS Executive Director Winnie Byanyima.

“Through this alliance, we will channel that outrage into action. By bringing together new improved medicines, new political commitment, and the determined activism of communities, we can be the generation who end AIDS in children. We can win this – but we can only win together.”

“Despite progress to reduce vertical transmission, increase testing and treatment, and expand access to information, children around the world are still far less likely than adults to have access to HIV prevention, care, and treatment services,” said UNICEF Executive Director Catherine Russell.

“The launch of the Global Alliance to End AIDS in Children is an important step forward – and UNICEF is committed to working alongside all of our partners to achieve an AIDS-free future.”

“No child should be born with or grow up with HIV, and no child with HIV should go without treatment,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “The fact that only half of children with HIV receive antiretrovirals is a scandal, and a stain on our collective conscience.

The Global Alliance to End AIDS in Children is an opportunity to renew our commitment to children and their families to unite, to speak and to act with purpose and in solidarity with all mothers, children and adolescents.”

Dr Osagie Ehanire, Minister of Health of Nigeria, pledged to “change the lives of children left behind” by putting in place the systems needed to ensure that health services meet the needs of children living with HIV.

Nigeria, Dr Ehanire announced, will host the alliance’s political launch in Africa at a Ministerial meeting in October 2022.

About UNAIDS

The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths.

UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals.

Learn more at unaids.org and connect with us on  Facebook, Twitter, Instagram and YouTube.

About UNICEF

UNICEF works in some of the world’s toughest places, to reach the world’s most disadvantaged children.

Across more than 190 countries and territories, we work for every child, everywhere, to build a better world for everyone. Follow UNICEF on Twitter and Facebook.

About WHO

Dedicated to the well-being of all people and guided by science, the World Health Organization leads and champions global efforts to give everyone, everywhere an equal chance at a safe and healthy life.

We are the UN agency for health that connects nations, partners and people on the front lines in 150+ locations – leading the world’s response to health emergencies, preventing disease, addressing the root causes of health issues, and expanding access to medicines and health care.”

https://www.who.int/news/item/02-08-2022-new-global-alliance-launched-to-end-aids-in-children-by-2030

Bayer acquire majority share in sustainable lower carbon oilseed producer CoverCress Inc.

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Bayer acquire majority share in sustainable lower carbon oilseed producer CoverCress Inc.

August 1, 2022: “Bayer, Bunge and Chevron U.S.A. Inc. (Chevron), a subsidiary of Chevron Corporation, have signed a shareholders’ agreement in connection with Bayer’s acquisition of a 65 percent majority ownership of the winter oilseed producer CoverCress, Inc. (CCI).

The remaining 35 percent of CCI will continue ownership under Bunge and Chevron.CoverCress™ is a rotational cash crop which combines grain production with the environmental benefits of a cover crop without displacing other harvests.

Oil extracted from CoverCress™ grain is designed to achieve a lower carbon intensity score and can be made into renewable diesel with Bunge’s expertise in oilseed processing and Chevron’s proficiency in fuels manufacturing.

This farm-to-fuel supply chain represented by CCI, Bayer, Bunge and Chevron aims to give corn and soybean growers another revenue outlet by providing the world with a desirable fuel product and high-protein meal for animal feed.

“CoverCress is exciting because it has the potential to become an important source for biofuel production as a new harvested rotational crop, while giving growers an innovative option to continue effective stewardship of their land and improve soil quality by acting as a cover crop,” said Rodrigo Santos, Member of the Board of Management of Bayer AG and President of the Crop Science Division.

“As a global leader in crop science, we are committed to decarbonizing agriculture and helping farmers around the world become more sustainable through game-changing products and solutions that can impact climate change.

This investment and collaboration between industry leaders is another proof point for our efforts.”

Aligning the combined expertise of Bayer, Bunge, and Chevron with the potential held by CoverCress™ will position CCI to further develop and commercialize its namesake winter oilseed into a rotational cash cover crop with potential sustainability and carbon sequestration benefits and bring a new lower carbon fuel feedstock to the renewable diesel industry.

CCI, which will continue to operate as an independent entity, has developed CoverCress™ as a unique crop whose grain is a lower carbon, low-input source for fuel and feed.

“Since our founding in 2013 we have actively sought – and benefited from – scientific, operational, and financial support from our academic and strategic partners.

The progress we have made in converting pennycress into our novel, lower carbon intensity oilseed technology, CoverCress™, would have been much slower without this critical support,” said Mike DeCamp, CEO and president of CCI.

“Our long-standing strategic partnership with Bayer and our more recent strategic partnerships with Bunge, and Chevron have provided us with access to expertise and capital that positions CCI very well for future success.”

By leveraging expertise and backing from leaders in fuels, soybean crushing, logistics, and crop sciences, CCI will be positioned to deliver on its full potential via a supply chain that understands its crop’s production, growth, processing, and delivery needs from the ground up.

“Connecting the full value chain – from seed development to end consumer – is an important step to bringing this crop to market at scale,” said Greg Heckman, Bunge’s Chief Executive Officer.

“We look forward to helping meet the growing demand for renewable fuels with this next generation lower carbon feedstock.”

Growers in North America will soon gain access to this cash crop that provides the benefits of a cover crop as well as being harvestable for use as a renewable fuel feedstock.

“Chevron is seeking to create innovative renewable fuel feedstocks by collaborating with America’s farmers,” said Mark Nelson, Chevron’s executive vice president for Downstream & Chemicals.

“We are excited to work with Bayer and Bunge to accelerate the adoption of CoverCress™, which we believe can ultimately be used to help supply the U.S. transportation system with lower lifecycle carbon intensity fuels.”

Farmers plant traditional cover crops to protect and improve their soil, not to harvest. Developed by converting field pennycress through breeding and gene editing tools, CoverCress™ is a new low-input rotational cash crop that has the ecosystem benefits of a cover crop.

When added into corn and soybean rotations on land during the winter, CoverCress™ has the potential to decrease nitrogen loss, help store carbon in the soil and improve soil health.

CCI has been a portfolio company of Leaps by Bayer, the impact investment arm of Bayer for the past seven years.

The success that CCI has achieved in the face of high risk and uncertainty, shows the value of supporting breakthrough innovation that can solve major problems for humanity.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition.

Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.

Bayer is committed to drive sustainable development and generate a positive impact with its businesses.

At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world.

In fiscal 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros.

For more information, go to www.bayer.com.

About CoverCress Inc.
CoverCress Inc. is an innovative startup company developing a new winter oilseed crop under the CoverCress™ brand.

Founded in 2013, the company is converting the common winter annual, field pennycress, using plant breeding to improve yield and maturity combined with advanced gene editing tools to improve fiber and oil composition.

CoverCress™ seed allows corn and soybean farmers to add a new crop into their rotation on existing land during winter, while offering the ecosystem benefits of a cover crop, including improved soil health and carbon sequestration.

It generates farm revenue as a whole grain feed ingredient, or when processed, as a low carbon intensity oil for renewable fuel production, and as a high-protein meal for animal feed. Learn more at CoverCress.com

About Bunge
At Bunge, our purpose is to connect farmers to consumers to deliver essential food, feed and fuel to the world.

With more than two centuries of experience, unmatched global scale and deeply rooted relationships, we work to put quality food on the table, increase sustainability where we operate, strengthen global food security, and help communities prosper.

As the world’s leader in oilseed processing and a leading producer and supplier of specialty plant-based oils and fats, we value our partnerships with farmers to improve the productivity and environmental efficiency of agriculture across our value chains and to bring quality products from where they’re grown to where they’re consumed.

At the same time, we collaborate with our customers to create and reimagine the future of food, developing tailored and innovative solutions to meet evolving dietary needs and trends in every part of the world.

Our Company is headquartered in St. Louis, Missouri, and we have almost 23,000 dedicated employees working across approximately 300 facilities located in more than 40 countries.

About Chevron
Chevron is one of the world’s leading integrated energy companies. We believe affordable, reliable and ever-cleaner energy is essential to achieving a more prosperous and sustainable world.

Chevron produces crude oil and natural gas; manufactures transportation fuels, lubricants, petrochemicals and additives; and develops technologies that enhance our business and the industry.

We are focused on lowering the carbon intensity in our operations and growing lower carbon businesses along with our traditional business lines. More information about Chevron is available at www.chevron.com.

https://media.bayer.com/baynews/baynews.nsf/id/Bayer-expands-existing-investment-acquire-majority-share-sustainable-lower-carbon-oilseed-producer?Open&parent=news-overview-category-search-en&ccm=020

FDA Provides Update on Agency Response to Monkeypox Outbreak

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FDA Provides Update on Agency Response to Monkeypox Outbreak

July 29, 2022: “The U.S. FDA is providing an update on its multipronged response to monkeypox in the United States, including its efforts in the areas of diagnostics, vaccines and therapeutics.

The agency has also established a dedicated website to provide important information about the FDA’s ongoing regulatory activities related to monkeypox along with frequently asked questions.

The FDA will provide updates as developments occur and will continue to work with federal public health partners and industry to ensure timely access to all available medical counter measures.

“The FDA has been closely tracking reports of monkeypox transmissions in the United States with our federal public health partners and coordinating preparedness efforts accordingly,” said FDA Commissioner Robert M. Califf, M.D.

“We understand that while we are still living with COVID-19, an emerging disease may leave people feeling concerned and uncertain, but it’s important to note that we already have medical products in place, specifically an FDA-approved vaccine for the prevention of monkeypox disease and an FDA-cleared diagnostic test.

The FDA is using the full breadth of its authorities to make additional diagnostics and treatments available.

We will continue to collaborate with our partners across all sectors to expand accessibility to countermeasures and bolster the tools in our arsenal as appropriate.”

The monkeypox virus is part of the same family of viruses as variola virus, the virus that causes smallpox (a virus that has been eradicated globally).

Both monkeypox and smallpox fall into the category of “orthopoxviruses.” Monkeypox is generally not fatal and typically resolves on its own without treatment.

The current outbreak in the U.S. usually presents as a rash on the body, face or genital area.

Although there is a very low risk of dying, there have been reported complications including severe pain, at times requiring hospital admission. 

Diagnostics

Since the first case of monkeypox in the U.S. was detected, the FDA has been working with commercial laboratories and manufacturers to make monkeypox tests more readily available to consumers who need them.

The Centers for Disease Control and Prevention (CDC) has an FDA-cleared non-variola orthopoxvirus test that can detect monkeypox by a swab from a monkeypox lesion (rash or growth).

At this time, this is the only FDA-cleared test. The FDA is not aware of clinical data supporting the use of other sample types, such as blood or saliva, for monkeypox virus testing.

In July 2022, the FDA issued a safety communication advising people to use swab samples taken directly from a lesion when testing for the monkeypox virus.

The FDA-cleared monkeypox test is being offered by the CDC and throughout many laboratories that include the CDC’s public health Laboratory Response Network.

In addition, federal public health authorities have worked with industry to make the test available through five large commercial laboratories.

The agency is working closely with the CDC to increase production of its FDA-cleared test and the FDA has cleared the use of additional reagents and instruments to increase the throughput of the CDC test. 

The FDA will continue to work with the diagnostic community to augment access to accurate testing to support the response. 

Vaccines

In 2019, the FDA approved the JYNNEOS Vaccine for the prevention of smallpox and monkeypox in adults 18 years of age and older determined to be at high risk of infection. JYNNEOS is the only vaccine approved for the prevention of monkeypox in the United States.

Although clinical trials and data are limited because of the small number of cases until now, the immunological response to vaccine administration is consistent with effective prevention of the disease.

Following the emerging public health crisis closely, the FDA was aware that there were close to 800,000 doses of this vaccine pending release this fall following approval of additional manufacturing capabilities at one of the plants where the vaccine is made.

With this in mind, the agency worked with HHS partners and expedited the submission of the required application for the company’s manufacturing changes in order to make these doses available to those in need.

After accelerating the timeline for an inspection of the plant from fall to earlier this month, the FDA has finished its evaluation of the required information to validate product quality and has determined that the vaccine meets its quality standards.

On July 26, the agency approved a supplement to the biologics license for the JYNNEOS Vaccine, to allow for additional manufacturing capabilities at the facility.

Given the emerging public health need, the FDA previously facilitated the shipment of manufactured doses to the U.S. so that they would be ready to be distributed once the manufacturing changes were approved.

With the supplement approval, those manufactured doses may now be further distributed and administered. Additional doses manufactured at this plant can help address the need for this vaccine moving forward.

Therapeutics

There is no FDA-approved or authorized medicine for the treatment of monkeypox disease; however, TPOXX (tecovirimat), an antiviral medication, is being made available through the CDC under an FDA authority called Expanded Access or “compassionate use.”

The FDA continues to work with the CDC to streamline their Expanded Access Program for monkeypox to facilitate access. 

There are currently no human data demonstrating the efficacy of TPOXX for the treatment of monkeypox, or the safety and pharmacokinetic profile (which helps us understand what the human body does to a drug).

Although expanded access program is available, conducting randomized, controlled trials to assess TPOXX’s safety and efficacy in humans with monkeypox infections is essential.”

https://www.fda.gov/news-events/press-announcements/fda-provides-update-agency-response-monkeypox-outbreak

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