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FDA Seeks to Improve Patient Communication on LASIK Benefits and Risks Through Issuance of Draft Guidance

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FDA Seeks to Improve Patient Communication on LASIK Benefits and Risks Through Issuance of Draft Guidance

July 27, 2022: :”The U.S. FDA issued a draft guidance to help ensure that information is available to patients and health care professionals to clearly communicate the benefits and risks of LASIK devices.  

“It is important to provide patients with comprehensive labeling that clearly describes the risks involved with LASIK surgery, including potential adverse effects such as dry eye, pain and discomfort, and visual symptoms,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

“These proposed labeling recommendations, based on extensive consultation with stakeholders and patients, are intended to present information about LASIK in language that is easy to read and understand and include images that convey visual symptoms that could occur following LASIK.

The draft guidance is designed to support discussions that patients should have with their eye care providers about the benefits and risks of LASIK to help them make informed decisions before proceeding with the surgery.”  

LASIK is an outpatient surgical procedure that permanently reshapes the cornea to change the way the eye focuses light rays onto the retina at the back of the eye.

LASIK surgery is intended to correct common vision problems such as nearsightedness, farsightedness, and astigmatism and to reduce a person’s dependency on eyeglasses and contact lenses. 

The draft guidance “Laser-Assisted In Situ Keratomileusis (LASIK) Lasers–Patient Labeling Recommendations,” details the FDA’s proposed recommendations for the content and format of patient labeling for LASIK devices, including general information about the surgical procedure; indications for use; benefits; procedure alternatives; contraindications, warnings and precautions; risks; what to expect before, during and after surgery; clinical study information; and manufacturer contact information.

In addition, the draft guidance proposes the inclusion of a patient decision checklist as part of the patient labeling information that physicians provide to their patients prior to the procedure.

To ensure the patient decision checklist is clearly understood by patients, the proposed checklist includes, among other information, who is a good candidate for LASIK, what to expect after surgery, and a summary of long-term risks of the procedure.

It also proposes that the patient and physician sign the checklist to acknowledge it was read and discussed. 

The FDA collaborated with external experts on research efforts that informed the recommendations in the draft guidance.

The agency, in collaboration with the National Eye Institute and the Department of Defense, conducted research as part of the LASIK Quality of Life Collaboration Project to help better understand the potential risk of problems that can occur after LASIK.

This project led to the development of the Patient-Reported Outcomes with LASIK PROWL Symptoms and Satisfaction (PROWL-SS)External Link Disclaimer, questionnaire, qualified through the FDA’s Medical Device Development Tools (MDDT) program.  

By issuing draft guidance for public comment, the FDA is encouraging feedback on the proposed labeling recommendations from patients, health care providers and stakeholders.

The FDA will continue to monitor the latest scientific data related to LASIK and work with professional medical societies and patient advocacy groups to help ensure that risk information about LASIK devices is disseminated to patients, as new information becomes available. 
 

https://www.fda.gov/news-events/press-announcements/fda-seeks-improve-patient-communication-lasik-benefits-and-risks-through-issuance-draft-guidance

Tezspire recommended for approval in the EU by CHMP for the treatment of severe asthma

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Tezspire recommended for approval in the EU by CHMP for the treatment of severe asthma

July 25, 2022: “AstraZeneca’s Tezspire (tezepelumab) has been recommended for marketing authorisation in the European Union (EU) as an add-on therapy in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the PATHFINDER clinical trial programme.

The marketing authorisation application included results from the pivotal NAVIGATOR Phase III trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy.

Tezspire is the first and only biologic for severe asthma that acts at the top of the inflammatory cascade by blocking thymic stromal lymphopoietin (TSLP), an epithelial cytokine.

Tezspire consistently and significantly reduced asthma exacerbations across Phase II and III clinical trials, which included a broad population of severe asthma patients irrespective of key biomarkers, including blood eosinophil counts, allergic status and fractional exhaled nitric oxide (FeNO).

Dr. Stephanie Korn, Senior Physician in Pneumology and Respiratory Medicine at IKF Pneumologie Mainz and Thoraxklinik Heidelberg, Germany, and investigator for the NAVIGATOR trial said: “Due to the complexity of severe asthma, about 60% of patients have multiple drivers of inflammation. 

Tezspire is a first-in-class biologic acting at the top of the inflammation cascade and a much-needed potential treatment for patients who continue to struggle with severe, uncontrolled asthma.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Despite recent advances in treatment, many asthma patients continue to experience debilitating symptoms, an increased risk of hospitalisation, and even death.

The only biologic recommended for EU approval in severe asthma patients with no phenotype or biomarker limitation, Tezspire has consistently and significantly reduced exacerbations in clinical trials, and has the potential to transform care for a broad population of severe asthma patients.”

Results from the NAVIGATOR Phase III trial were published in The New England Journal of Medicine in May 2021. There were no clinically meaningful differences in safety results between the Tezspire and placebo groups in the NAVIGATOR trial.

In clinical trials, the most common adverse events in patients who received Tezspire were pharyngitis, rash, arthralgia and injection site reactions.

Tezspire was approved as an add-on maintenance treatment of adult and paediatric patients aged 12 years and older with severe asthma in the US in December 2021 and is under regulatory review in Japan and many other countries around the world.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/tezspire-recommended-for-approval-in-the-eu-by-chmp.html

FDA Details Optimized Approach for Regulatory Oversight Tools to Better Protect Public Health

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FDA Details Optimized Approach for Regulatory Oversight Tools to Better Protect Public Health

July 22, 2022: “The U.S. Food and Drug Administration prioritizes the health and safety of American consumers and patients as well as animals and uses a variety of tools for the appropriate oversight of FDA-regulated products and establishments.

With manufacturers and supply chains dispersed around the world, the FDA works to help ensure that only products that meet our rigorous standards reach the U.S. marketplace. 

Similar to the industries we regulate, we continually seek ways to use advanced tools, including technology, to meet our regulatory mission and assess compliance with federal laws.

Enhancing our oversight approaches helps us increase the speed of information that comes to the agency and improves the efficiency of how we operate, furthering our mission to protect the public health.

As the world continues to move into the digital era, the integration of remote technologies with in-person activity provides a means for the interaction between the FDA and regulated industries to become more efficient so that the agency can have confidence in its assessments and the industry can implement innovations and quality systems in a more rapid and effective manner.

Today, the FDA is releasing a draft guidance on the expanded use of remote regulatory assessments (RRAs) and how the FDA generally intends this tool, once finalized, to be incorporated consistently across all FDA-regulated products beyond the current COVID-19 public health emergency.

These remote assessments of an FDA-regulated establishment and/or its records can help determine compliance with applicable FDA requirements, inform regulatory decisions and verify information submitted to the agency.

They have also been a valuable tool in the nation’s response to the public health emergency, as we’ve fast-tracked their wider use to help get critical medical products to the front lines in the fight against the pandemic while keeping normal business operations moving. 

Importantly, RRAs are an additional regulatory tool that does not replace inspections or other established means of obtaining information necessary for the FDA to accomplish its public health mission.

Today’s draft guidance lays out how we intend to leverage this tool to advance our mission as we further incorporate modernized approaches to protecting public health.

Over the last two years, we’ve performed more than 1,470 domestic and more than 600 foreign entity establishment RRAs.

As a result of these RRAs, we’ve identified unreported adverse events, gathered information to add products that appear to be violative to import alerts, evaluated the status of companies correcting issues from a previous inspection and helped the agency make regulatory decisions for product premarket submissions.

RRAs are effective in getting essential information to regulators, enabling the FDA to intervene when needed and use agency resources more efficiently to do so. 

The draft guidance, “Conducting Remote Regulatory Assessments Questions and Answers,” is intended to provide transparency to stakeholders about how RRAs may be used and to promote consistency in the way RRAs are conducted.

The draft guidance covers voluntary and statutorily authorized RRAs but does not change the core requirements of inspections and pre- and post-market authorities.

Except for RRAs for establishments required to comply with the Foreign Supplier Verification Programs (FSVP) regulation, an RRA does not function as an inspection. 

We intend to continue to use RRAs, as appropriate, according to a risk-based approach that best protects public health.

For example, when we are unable to deploy in-person staff due to travel restrictions, we may determine that a RRA is an appropriate tool. RRAs may also be used to efficiently assess establishments identified in product applications when these establishments have a prior history of compliance.

Where appropriate, RRAs allow the FDA to review information such as livestreams and records provided by a company without going on-site, which can make better use of limited agency resources and give industry more scheduling flexibility. 

As part of the FDA’s Fiscal Year 2023 budget request, the agency has requested additional authorities to expand the ability to use remote regulatory tools across all commodities.

The agency currently relies on voluntary cooperation for the use of these tools for non-drug establishments or when the RRA does not involve assessing a food importer’s compliance with FSVP.

Using advanced tools like RRAs can help improve the efficiency of our work, strengthens the nation’s ability to respond to future public health emergencies and promotes consistent, data-driven and risk-based oversight for FDA-regulated products.  

These modernization efforts will continue to help shape the way we perform our vital regulatory role as we optimize emerging tools and apply them consistently across FDA-regulated products.

Implementing smarter technology and business processes like RRAs helps us advance our public health mission and provide the robust oversight needed to protect patients and consumers.”

https://www.fda.gov/news-events/press-announcements/fda-details-optimized-approach-regulatory-oversight-tools-better-protect-public-health

Echosens and Novo Nordisk announce partnership to increase awareness and advance early diagnosis of NASH

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Echosens and Novo Nordisk announce partnership to increase awareness and advance early diagnosis of NASH

June 22, 2022: “Echosens, a high-technology company offering liver diagnostic solutions, and Novo Nordisk A/S, a leading global healthcare company announced a partnership to advance early diagnosis of non-alcoholic steatohepatitis (NASH) and increase awareness of the disease among patients, healthcare providers and other stakeholders.

NASH is a chronic metabolic liver disease that affects more than 115 million people worldwide.

The condition is caused by build-up of fat and inflammation in the liver. This causes progressive damage to the liver and can lead to end-stage liver disease and death.

NASH is a ‘silent’ disease due to lack of symptoms in the early stages and, as a result, it is estimated that nine out of 10 people living with NASH go undiagnosed.

To significantly increase early diagnosis, broadly accepted non-invasive tests for diagnosing people living with NASH are needed, as confirmatory diagnosis currently relies on an invasive procedure known as a liver biopsy.

Echosens and Novo Nordisk will collaborate to support additional clinical validation, generation of real-world evidence and adoption of non-invasive diagnostic tests for NASH and work together to increase awareness of the disease and the importance of early diagnosis and management.

The companies have a shared ambition of doubling diagnostic rates for people living with advanced to severe NASH by 2025.

“NASH is the more severe form of non-alcoholic fatty liver disease (NAFLD).

It has few non-specific or no symptoms in its early stage, leading to inappropriate referrals to secondary care and patients often remaining undiagnosed until irreversible complications occur,” said Dominique Legros, CEO at Echosens.

“There is a pressing need for a broader adoption of our non-invasive liver tests to improve the diagnosis of people living with NASH, and we are proud to partner with Novo Nordisk to combine our strengths and shared mission to empower medical professionals with improved ways to assess, diagnose and manage the condition.”

NASH is more common in people living with obesity (82% of people with NASH are living with obesity) and conditions related to obesity, such as type 2 diabetes (44% of people with NASH are living with type 2 diabetes).

The low diagnosis rate for NASH is partly caused by a lack of awareness of the condition and associated risk factors among at-risk patients, healthcare providers, payers and policymakers.

“At Novo Nordisk we are committed to driving change in NASH, to develop new treatment options and advance care for this serious, chronic disease.

An important step towards realizing that ambition is to ensure that we can identify the people in need of care,” said Camilla Sylvest, executive vice president for Commercial Strategy & Corporate Affairs at Novo Nordisk.

“But we cannot solve this challenge alone and through our partnership with Echosens, we hope to leverage our complementary skills to meet the needs of patients, healthcare providers and other stakeholders striving to address this ‘silent’ epidemic.”

About NASH
Non-alcoholic steatohepatitis (NASH) is the most severe form of non-alcoholic fatty liver disease (NAFLD).

It is a progressive metabolic liver disease characterised by fat accumulation and inflammation in the liver, which can lead to scarring, or fibrosis, and eventually end-stage liver disease and death.

The risk of progression to advanced liver disease, including liver cancer, is higher in people with NASH than in the general population, and NASH is predicted to be the leading cause of liver transplantation by 2030.

Moreover, NASH increases the risk of developing cardiovascular disease. Currently, no treatment is globally approved for the treatment of NASH, and people with NASH are left with very few management options.”

https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=121337

FDA Provides Educational Resources for Parents and Caregivers to Support Confidence for Imported Infant Formula Products

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FDA Provides Educational Resources for Parents and Caregivers to Support Confidence for Imported Infant Formula Products

July 14, 2022: ‘The U.S. FDA announced the availability of educational resources for parents and caregivers with questions about using the hundreds of millions of bottles worth of imported infant formula headed to the U.S. 

“Parents and caregivers should have confidence that our collective work with federal partners, manufacturers and retailers means more infant formula that is safe and nutritious, including product coming in from other countries, is on shelves nationwide.

The information and resources the agency is providing should help parents and caregivers find and understand how to use these safe, nutritious infant formula products that are comparable to those they’ve traditionally seen on store shelves,” said FDA Commissioner Robert M. Califf, M.D.

“Importantly, a combination of increased domestic production and infant formula being imported is steadily improving what parents and caregivers are seeing on the shelves.

We will continue our around-the-clock efforts to make sure that parents and caregivers have access to safe and nutritious infant formula where and when they need it.”

Flexibilities Have Resulted in More Than 520 Million Bottles Worth of Infant Formula Coming to the U.S.

Increased flexibilities regarding infant formula products announced by the FDA on May 16 have resulted in the infant formula products from nine countries, with a total estimated quantity of 23 million cans, or 35 million pounds or more than 520 million full-size, 8-ounce bottles, headed to the U.S.  

These flexibilities have been successful in helping to bring safe and nutritionally adequate infant formula products into the U.S. marketplace on a temporary basis to address the formula shortage.

Additionally, the FDA recently announced that it is developing a new framework for continued, long-term and expanded access to infant formula options for U.S. parents and caregivers beyond the current temporary flexibilities.

These products have already started to hit the U.S. market and more will appear in stores over the coming weeks and months.

The FDA is creating “Names to Know” graphics featuring the label pictures and details about imported formulas to help parents and caregivers recognize these products as they hit store shelves.

An accompanying infographic featuring the amounts of imported formula is also available.”

https://www.fda.gov/news-events/press-announcements/fda-provides-educational-resources-parents-and-caregivers-support-confidence-imported-infant-formula

Dupixent Phase 3 trial shows positive results in children with eosinophilic esophagitis

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Dupixent Phase 3 trial shows positive results in children with eosinophilic esophagitis

July 14, 2022: “A Phase 3 trial assessing the investigational use of Dupixent® (dupilumab) in children aged 1 to 11 years with eosinophilic esophagitis (EoE) met its primary endpoint of histological disease remission at 16 weeks with both higher and lower dose weight-tiered regimens.

There are no approved treatments for children with EoE under 12 years of age.

Naimish Patel, M.D.
Senior Vice President, Head of Global Development, Immunology and Inflammation, Sanofi
“We are incredibly excited to share results from this Phase 3 pivotal trial evaluating Dupixent in young children suffering from eosinophilic esophagitis – the first ever to show positive results across a variety of primary and secondary endpoints.

The lack of treatment options for children living with eosinophilic esophagitis leaves many caregivers with the stress and burden of adapting their child’s meals and their entire family’s daily schedules to ensure healthy growth and development.

In some cases, they must resort to off-label use of poorly studied treatments like steroids that can pose serious health risks when used long term. 

The faster and larger than anticipated enrollment in this trial further emphasizes the unmet treatment needs for children with EoE and underscores the significance of these first-ever positive results.”

EoE is a chronic inflammatory disease that damages the esophagus and prevents it from working properly.

The results seen with Dupixent in adults and children with EoE demonstrate that IL-4 and IL-13 are key drivers of the type 2 inflammation underlying this disease.

In children, common symptoms of eosinophilic esophagitis include acid reflux, vomiting, abdominal discomfort, trouble swallowing, and a failure to thrive.

These symptoms can impact growth and development, and can cause food-related fear and anxiety which can persist through adulthood.

Diet adjustments, which oftentimes include the elimination of many foods, is the standard treatment for EoE, as well as the use of treatments not approved for the disease.

These include proton pump inhibitors, swallowed topical corticosteroids, or in severe cases, a feeding tube, which may be used to ensure proper caloric intake and weight gain.

Of the approximately 21,000 children under the age of 12 in the U.S. currently being treated for EoE, about 9,000 do not satisfactorily respond to the unapproved therapies they have been treated with and potentially require advanced therapy.

George D. Yancopoulos, M.D., Ph.D.
President and Chief Scientific Officer, Regeneron
“Dupixent is the first medicine to alleviate key signs of eosinophilic esophagitis in children as young as 1 year of age in a Phase 3 trial.

The efficacy of Dupixent demonstrates that, in this age group, as in adults, IL-4 and IL-13 are key drivers of the type 2 inflammation underlying this debilitating disease.

Eosinophilic esophagitis can turn the basic and life-sustaining act of eating into a painful experience at a point in children’s lives when proper nutrition and achieving a healthy weight is critical to ensuring they grow and thrive.

The positive results from this Phase 3 pediatric trial show Dupixent has the potential to improve signs of eosinophilic esophagitis and support healthy weight gain in children from their first birthday.”

In the Phase 3 trial, 102 children aged 1 to 11 were randomized to receive Dupixent, in either a higher dose (n=37) or lower dose (n=31) regimen based on body weight, or placebo (n=34).

At 16 weeks, 68% of children on higher dose and 58% of patients on lower dose Dupixent achieved the primary endpoint of significant histological disease remission (peak esophageal intraepithelial eosinophil count of ≤6 eosinophils [eos]/high power field [hpf]) compared to 3% of children on placebo (p<0.0001 for both).

Additionally, children receiving higher dose Dupixent experienced the following changes at week 16:

  • 86% reduction in peak esophageal intraepithelial eosinophil count from baseline compared to a 21% increase for placebo (p<0.0001).
  • 0.88 and 0.84 reduction from baseline in disease severity and extent, respectively, as measured at the microscopic level in biopsy specimens compared to a 0.02 and 0.05 increase for placebo (both p<0.0001).
  • 3.5-point reduction in abnormal endoscopic findings from baseline compared to a 0.3-point increase for placebo (p<0.0001).
  • A numerical improvement in the proportion of days children experienced symptoms of EoE from baseline, as reported by caregivers (Pediatric EOE signs/symptoms questionnaire [PESQ-C]), compared to placebo, though not statistically significant.

    The PESQ-C is a novel endpoint developed by Sanofi and Regeneron used for the first time in this trial, designed to assess symptoms in young children through their caregivers (as signs), as children may have difficulty verbalizing their symptoms themselves.
  • As part of a prespecified exploratory analysis a 3.09 percentile increase in body weight for age percentile from baseline compared to 0.29 for placebo.

Histological, anatomic and cellular secondary endpoints were also analyzed for the lower dose group, with all being nominally significant and generally comparable with the higher dose.

More detailed results will be shared at an upcoming medical meeting, including additional data for the endpoints in the lower dose group.

Safety results were generally consistent with the known safety profile of Dupixent in its approved EoE indication for children and adults aged 12 years and older who weigh at least 40 kg.

For the 16-week treatment period, overall rates of adverse events (AEs) were 79% for Dupixent and 91% for placebo.

AEs more commonly (≥5%) observed with Dupixent compared to placebo included COVID-19 (21% Dupixent, 0% placebo; all cases were mild or moderate and did not lead to study discontinuation), rash (9% Dupixent, 6% placebo), headache (8% Dupixent, 3% placebo), viral gastroenteritis (6% Dupixent, 3% placebo), diarrhea (6% Dupixent, 3% placebo) and nausea (6% Dupixent, 0% placebo).

Rates of treatment discontinuation due to AEs prior to week 16 were 0% for Dupixent and 6% for placebo.

In May 2022, the U.S. Food and Drug Administration (FDA) approved Dupixent 300 mg weekly to treat patients with EoE aged 12 years and older and weighing at least 40 kg after granting the medicine Priority Review.

The potential use of Dupixent in children with EoE aged 1 to 11 years is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. These data will be discussed with regulatory authorities around the world, starting with the U.S. later this year.

About the Dupixent Pediatric Eosinophilic Esophagitis Trial

The Phase 3, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent in young children aged 1 to 11 years with EoE, as determined by histological and patient- or caregiver-reported measures.

At baseline, 98% of these patients had at least one co-existing type 2 inflammatory disease such as food allergy, allergic rhinitis, asthma and atopic dermatitis.

Patients received Dupixent subcutaneously at either a higher dose or lower dose regimen based on their weight (ranging from ≥5 kg to <60 kg) over a 16-week period, at which point all endpoints were assessed.

The dosing frequency ranged between every two weeks and every four weeks, based on weight.

The primary endpoint was histological disease remission.

Secondary endpoints included histopathologic measures of the severity and extent of tissue scarring in the esophagus (EoE-HSS grade and stage scores, which measure changes in eight cellular and tissue features on 0-3 scales, respectively), and abnormal endoscopic findings (EoE Endoscopic Reference Score [EoE-EREFS] on a 0-18 scale), as well as changes in caregiver-reported symptoms (proportion of days with 1 or more EoE signs [e.g. stomach pain, vomiting, food refusal] by the Pediatric EoE Sign/Symptom Questionnaire-caregiver version [PESQ-C]).

An exploratory endpoint assessed change from baseline in body weight for age percentile.

The trial is ongoing with a 36-week extended active treatment period to evaluate long-term outcomes.”

https://www.sanofi.com/en/media-room/press-releases/2022/2022-07-14-05-00-00-2479427

Bayer to present new data from the company’s growing radiology portfolio

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Bayer to present new data from the company’s growing radiology portfolio

July 11, 2022: “Bayer announced that new data from the company’s growing radiology portfolio will be presented at the 2022 European Congress of Radiology (ECR), taking place from July 13 to 17 in Vienna, Austria.

The presentations reinforce Bayer’s position as a leading company in key radiology areas and its commitment to accelerate innovation for the ultimate benefit of patients and their physicians, including leveraging the vast potential of artificial intelligence (AI).

The presentations highlight preclinical data on the novel development compound gadoquatrane, which is currently in Phase II development.

Gadoquatrane features high stability as well as high relaxivity, which is a key property for use in contrast-enhanced magnetic resonance imaging (MRI), with the potential to enable a substantially lower gadolinium (Gd) dose.

Another focus is on clinical data on Bayer’s MRI contrast agent Gadovist™ (gadobutrol), investigating the clinical efficacy of a reduced dose of gadobutrol compared to a standard dose of gadoterate in patients undergoing a steady-state contrast-enhanced MRI of the central nervous system (CNS).

Artificial intelligence is currently one of the most-discussed topics in radiology and will be one of the highlights of the ECR again this year. Bayer is committed to further driving advances in AI.

At this year’s ECR, one early research presentation by Bayer explores the potential of deep learning to achieve optimized contrast media administration utilizing a generative adversarial network.

AI can help manage the mounting workload of radiologists and their teams, ultimately striving to improve patient care.

Bayer recently announced the launch of Calantic™ Digital Solutions, a new platform delivering access to digital applications, including artificial intelligence enabled programs, for medical imaging.

The offering contains tools which aid radiologists and their teams to improve prioritization, lesion detection, quantification and productivity.

By providing access to AI radiology applications through the Calantic Digital Solutions platform Bayer will expand its comprehensive portfolio beyond contrast media, medical devices, software and services.

The new platform will support healthcare professionals at all stages of their work from diagnosis through treatment of their patients.

First launch markets will include the US and several European countries, with more regions to follow, each upon local regulatory approvals as applicable.”

https://media.bayer.com/baynews/baynews.nsf/id/Bayer-to-present-new-data-from-the-companys-growing-radiology-portfolio?OpenDocument&sessionID=1657602617

COVID-19 Spreads Faster During Cold Seasons, AMREF Africa Boss Warns Kenyans

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COVID-19 Spreads Faster During Cold Seasons, AMREF Africa Boss Warns Kenyans

July 4, 2022: “Gitahi is of the opinion that as seasons change, viruses and environments in which diseases prosper change as well, making people more susceptible to contracting a disease and COVID-19 is no exception.

According to Gitahi, cold air and insufficient sunlight notably affect our bodies’ ability to stave off respiratory infections like COVID-19.

AMREF Africa Group CEO Dr. Githinji Gitahi has reminded Kenyans that they are more likely to contract and spread COVID-19 during the cold season as compared to other seasons.

Gitahi is of the opinion that as seasons change, viruses and environments in which diseases prosper change as well, making people more susceptible to contracting a disease and COVID-19 is no exception.

According to Gitahi, cold air and insufficient sunlight notably affect our bodies ability to stave off respiratory infections like COVID-19.

Gitahi likewise added that lower temperatures keep the virus stable and infectious for longer, which means that COVID-19 can float around in respiratory droplets for longer periods of time during cold seasons.

The AMREF Africa boss correspondingly stated that during cold seasons most people get respiratory diseases in the form of the common cold but many fail to adhere to COVID-19 prevention protocols when dealing with the flu.

According to Gitahi, when suffering from a cold, some victims may experience a runny nose and when dealing with it might opt to occasionally blow their noses while blatantly disregarding COVID-19 prevention protocols and this may lead in a surge in the number of cases.

“People are blowing their noses, they are coughing, touching their noses without regarding public health measures that we advise,” he said.

“So even if someone has a cold and ends up with coronavirus, it is more likely that that person will transmit it because they are touching their noses more frequently because of the common cold so the weather contributes to infections.”

Gitahi now wants Kenyans to adhere to the Ministry of Health’s directives on taming the spread of COVID-19 such as wearing masks and social distancing in order to keep the disease at bay.

In the last 24 hours, 392 people tested positive for COVID-19 from a sample size of 3,124, translating to a positivity rate of 12.5 per cent.”

https://newsroom.amref.org/coronavirus/2022/07/covid-19-spreads-faster-during-cold-seasons-amref-africa-boss-warns-kenyans/

Avacta announces second dose escalation in Phase I study of AVA6000 Pro-doxorubicin

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Avacta announces second dose escalation in Phase I study of AVA6000 Pro-doxorubicin

Jun 29, 2022: “Avacta Group plc, a clinical stage oncology drug company and developer of powerful diagnostics based on its innovative Affimer® and pre|CISION™ platforms, announces that the first-in-human Phase I trial (ALS-6000-101) of AVA6000 Pro-doxorubicin will advance to the third dose cohort following a positive review of the safety data from the dosing of the second cohort.

Avacta’s Safety Data Monitoring Committee (SDMC), comprised of clinicians currently recruiting patients, has completed its review of the safety data from the second cohort dosed with AVA6000 at 120mg/m2 in the ongoing Phase I trial.

Following this review, the SDMC has recommended that the clinical trial continues as planned and escalates to the next dose of AVA6000 at 160mg/m2.

AVA6000 is a novel form of doxorubicin that has been modified with Avacta’s pre|CISION™ FAP-activated delivery platform to improve its safety and therapeutic index.

AVA6000 has been designed to limit cell penetration of the drug, and therefore its cell killing effect, until it is specifically activated by fibroblast activation protein α (FAP) which is in high concentration in many solid tumours compared with healthy tissues.

The resulting reduced exposure of healthy tissues to active doxorubicin has the potential to significantly increase its therapeutic index by reducing the incidence of adverse effects, including cardiotoxicity and myelosuppression.

Anthracyclines such as doxorubicin, a generic chemotherapeutic agent, with a market size that is expected to grow to $1.38bn by 2024, are widely used as part of standard of care in several tumour types, but doxorubicin’s use is limited by cumulative toxicity associated with cardiomyopathy.

Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented:
“AVA6000, and the pre|CISION platform more broadly, have the potential to deliver safer and affordable oncology drugs that could significantly improve cancer patients’ lives.

We are very pleased with the progress being made with ALS-6000-101 study and look forward to seeing more data as it emerges from the trial.”

Neil Bell, Chief Development Officer of Avacta added:
“The recommendation from the Safety Data Monitoring Committee to initiate dosing in Cohort 3 with 160mg/m2 of AVA6000 is an endorsement of the emerging safety and tolerability profile in the patients enrolled in this study to date.

We look forward to providing additional updates as the dose escalation phase of the trial progresses.”

https://avacta.com/avacta-announces-second-dose-escalation-in-the-phase-i-clinical-study-of-ava6000-pro-doxorubicin/

Sanofi Global Health launches nonprofit Impact® brand for 30 medicines in low-income countries

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Sanofi Global Health launches nonprofit Impact® brand for 30 medicines in low-income countries

July 4, 2022: “Sanofi Global Health announces the launch of Impact®, a new brand of standard of care medicines produced by Sanofi dedicated for nonprofit distribution to at-risk populations in the world’s most impoverished countries.

The Impact® brand, which includes insulin, glibenclamide and oxaliplatin amonst others, will enable the secure distribution of 30 Sanofi medicines in 40 lower-income countries.

Considered essential by the World Health Organization, the medicines cover a wide range of therapeutic areas, including diabetes, cardiovascular disease, tuberculosis, malaria and cancer.

The launch of the Impact® brand is among the steps taken since the formation last year of Sanofi Global Health, a nonprofit unit within the company aiming to increase access to healthcare through the distribution of medicines, and the building and bolstering of local healthcare systems in countries with among the lowest per capita GDP. Sanofi Global Health is the first and only global initiative to provide access to such a broad portfolio of medicines in so many countries and across multiple therapeutic areas while funding local support programs and strengthening local inclusive businesses.

Paul Hudson
Chief Executive Officer, Sanofi
“At Sanofi, we believe we have a responsibility to make a difference for the health of those most in need, and we know we have the ability and the ambition to bring about lasting change. With critical medicines, relentless drive and impactful partnerships, we can take our innovation beyond the lab and use it to strengthen health systems and access to medicines for those most vulnerable communities of patients. Sanofi Global Health aims to improve the lives of millions of people who now cannot get the help they need. Sanofi’s renewed purpose is to chase the miracles of science to improve people’s lives. And our quest to make life better for all people must include helping to provide better access to care and quality medicines for underserved populations.”

The company also announces the establishment of an Impact fund that will support startup companies and other innovators that can deliver scalable solutions for sustainable healthcare in underserved regions. By providing inclusive businesses financing and technical assistance, the fund will complement the GHU mission of leveraging global, regional and local investment to support the training of healthcare professionals and aiding communities in running sustainable care systems. The announcements come as Sanofi gathers key global health stakeholders to discuss how to build effective end-to-end health programs that are embedded in the communities in which they serve, to best reach, treat and manage patients’ health effectively and sustainably.

Jon Fairest
Head, Global Health Unit, Sanofi
“The launch of the Impact® brand and our Impact Fund are our latest steps to make our medicines available and to help bring quality, sustainable healthcare to people in the world’s poorest countries. But we know that we cannot do this alone, and so we are building partnerships at global, regional and local levels that will help to improve and establish health systems to reach our goal of a healthier, more resilient world.”

Sanofi Global Health is one of the three elements of Sanofi’s multi-tiered approach to Social impact, which includes the Foundation S – the Sanofi collective dedicated to philanthropy and a Corporate Social Responsibility strategy embedded in our business activities:

  • Foundation S is focused on efforts to fight childhood cancer, increase the health resilience of populations most affected by climate change, and provide donations of products to meet humanitarian crises. Carrying on the company’s 30-year legacy, Sanofi has also committed to donating 100,000 vials every year free of charge to support to patients with five different lysosomal storage disorders (LSDs), a group of rare genetic conditions caused by enzyme deficiencies.
  • Our company-wide CSR strategy focuses on four pillars: affordable access; innovation for vulnerable communities; planet care, in and beyond the workplace; in addition to responsible business. It is built around flagship initiatives spread across the company’s value chain, from R&D to manufacturing to commercial operations, considering every part of the organization has a role to play and a contribution to make.”

https://www.sanofi.com/en/media-room/press-releases/2022/2022-07-04-10-00-00-2473350

Pfizer Announces Commitment to Accelerate Climate Action and Achieve Net-Zero Standard by 2040

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Pfizer Announces Commitment to Accelerate Climate Action and Achieve Net-Zero Standard by 2040

 June 30, 2022: “Pfizer Inc. announced a commitment to further reduce Greenhouse Gas (GHG) emissions and aims to achieve the voluntary Net-Zero Standard by 2040, ten years earlier than the timeline described in the standard.

As part of the commitment, Pfizer aims to decrease its GHG emissions by 95% and its value chain emissions by 90% from 2019 levels by 2040 through accelerating the transition away from fossil fuels and engaging suppliers to catalyze equivalent action. 

“The window is closing to minimize the potentially catastrophic impact of climate change, which affects the health of our planet and that of people around the world,” said Pfizer Chairman and Chief Executive Officer Albert Bourla.

“With urgency of action increasing, we firmly believe that our commitment to accelerate decarbonization of our value chain and achieve the Net-Zero standard – which aligns with Pfizer’s purpose and ESG priorities – can help drive positive change and build a healthier, more sustainable world.” 

To accelerate GHG emission reductions, Pfizer recognizes that bold partner action and innovation is necessary to develop alternate technologies to enable reliable generation of heat and steam production to meet the demand of Pfizer’s manufacturing, R&D and commercial operations without fossil fuels.

In addition, Pfizer plans to transition its fleet of vehicles to hybrid and electric alternates.

Pfizer also announced today that it has signed a pledge by the U.S. Department of Health and Human Services (HHS) that calls on stakeholders in the U.S. healthcare system – including hospitals, health systems, payers, suppliers and pharmaceutical companies – to reduce GHG emissions and build a more climate resilient healthcare infrastructure.

By doing so, Pfizer commits to reduce GHG emissions and to publicly report on its progress as well as develop climate resiliency plans, among other actions.

More details on the HHS pledge can be found here.

Pfizer was recognized as one of the signatories of the pledge at a June 22 White House event. 

Pfizer’s Environmental Sustainability Journey

Pfizer’s commitment to further decarbonize builds on more than 20 years of environmental action, with the company delivering three generations of GHG reduction goals and realizing greater than a 60% reduction in company (Scope 1 & 2) emissions over the period 2000 – 2020.

Pfizer was the first in the pharmaceutical sector to have its GHG emission reduction goals recognized in 2015 by the Science Based Targets initiative (SBTi), a recognized leader in the global effort to mitigate the climate crisis. 

In 2020, Pfizer set its previous GHG emission goal to become carbon neutral by 2030 and to reduce Scope 1 & 2 GHG emissions by 46% by 2030 from a 2019 baseline, with the residual emissions addressed with verifiable carbon credits.

Pfizer continues to make progress and remains committed to reducing Scope 1 & 2 GHG emissions by 46% by 2030 as an interim milestone toward its new Net-Zero 2040 goal. 

To learn more about Pfizer’s ESG efforts, visit www.pfizer.com/ESG_Report.

Disclosure Notice: The information contained in this release is as of June 30, 2022. The Company assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking statements about the Company’s commitment to further reduce Greenhouse Gas (GHG) emissions to achieve the voluntary Net-Zero Standard by 2040, the execution of the pledge by the U.S. Department of Health and Human Services to reduce GHG emissions and build a more resilient healthcare infrastructure and other environmental-related goals and targets, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.

Risks and uncertainties include, among other things, risks related to the ability to realize the anticipated goals, including the possibility that the goals will not be realized or will not be realized within the expected time period; risks related to our supply chain and manufacturing; the uncertainties inherent in business and financial planning, including, without limitation, risks related to Pfizer’s business and prospects, adverse developments in Pfizer’s markets, or adverse developments in the U.S. or global capital markets, credit markets, regulatory environment or economies generally; the impact of COVID-19 on our business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.“

https://www.pfizer.com/news/announcements/pfizer-announces-commitment-accelerate-climate-action-and-achieve-net-zero

FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses

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FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses

June 30, 2022: “On Tuesday, the U.S. Food and Drug Administration’s independent experts on the Vaccines and Related Biological Products Advisory Committee met to publicly discuss whether a change to the current vaccine strain composition of COVID-19 vaccines for booster doses is necessary for the 2022 fall and winter seasons. 

The COVID-19 vaccines that the FDA has approved and authorized for emergency use have made a tremendous difference to public health and have saved countless lives in the U.S. and globally.

However, SARS-CoV-2, the virus that causes COVID-19, has evolved significantly, with recent surges around the world associated with the rapid spread of highly transmissible variants such as omicron. 

Currently available vaccines have helped reduce the most serious outcomes (hospitalization and death) caused by COVID-19, but results from post-authorization observational studies have shown that effectiveness of primary vaccination wanes over time against certain variants, including omicron.

And while initial booster doses have helped restore protection against severe disease and hospitalization associated with omicron, studies have also indicated waning effectiveness of first booster doses over time.

The American public can be assured that any COVID-19 vaccine authorized or approved by the FDA meets our standards for safety and effectiveness. We encourage those who are currently eligible for a booster to get one.

As we move into the fall and winter, it is critical that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most severe consequences of COVID-19. Following a thorough discussion on June 28, 2022, an overwhelming majority of the advisory committee voted in favor of including a SARS-CoV-2 omicron component in COVID-19 vaccines that would be used for boosters in the U.S. beginning in fall 2022.

Following the vote, and striving to use the best available scientific evidence, we have advised manufacturers seeking to update their COVID-19 vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a two component (bivalent) booster vaccine, so that the modified vaccines can potentially be used starting in early to mid-fall 2022. 

As we expect this coming year to be a transitional period when this modified booster vaccine may be introduced, we have not advised manufacturers to change the vaccine for primary vaccination, since a primary series with the FDA-authorized and approved COVID-19 vaccines provides a base of protection against serious outcomes of COVID-19 caused by circulating strains of SARS-CoV-2. 

Vaccine manufacturers have already reported data from clinical trials with modified vaccines containing an omicron BA.1 component and we have advised them that they should submit these data to the FDA for our evaluation prior to any potential authorization of a modified vaccine containing an omicron BA.4/5 component. Manufacturers will also be asked to begin clinical trials with modified vaccines containing an omicron BA.4/5 component, as these data will be of use as the pandemic further evolves.

The FDA has been planning for the possibility that vaccines would need to be modified to address circulating variants and previously provided guidance to industry on how to do so efficiently. As has been the case with all COVID-19 vaccines throughout the pandemic, the agency will evaluate all relevant data to inform the safety, effectiveness and manufacturing quality of modified vaccines under consideration for authorization or approval to ensure that they meet the FDA’s standards. 

In keeping with our commitment to transparency, the FDA will communicate future plans pertaining to the potential authorization or approval of COVID-19 vaccine booster doses with an omicron component.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-recommends-inclusion-omicron-ba45-component-covid-19-vaccine-booster
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