CLINSQUARE: CLINICAL RESEARCH COURSES
Friday, May 30, 2025
CLINSQUARE: Clinical Rsearch Courses by LIFEPRONOW
Home Blog Page 41

NICE draft guidance does not recommend tucatinib for advanced breast cancer

admin
-
0
NICE draft guidance does not recommend tucatinib for advanced breast cancer

October 26, 2021: “Tucatinib is licensed for treating HER2-positive locally advanced or metastatic breast cancer in people who have received at least 2 prior anti-HER2 treatments.

The draft guidance concludes that people taking tucatinib combination have longer before their disease gets worse and live longer overall. However, how much longer people live is uncertain.  

The cost-effectiveness estimates for tucatinib combination are higher than NICE normally considers an acceptable use of NHS resources, even when the higher weighting given to end-of-life treatments is applied.

Breast cancer is called ‘HER2-positive’ when cancer cells overexpress a protein called HER2 (human epidermal growth factor receptor 2).

This stimulates the cancer cells to grow and spread. HER2-positive tumours are typically more aggressive than other types of breast cancer. An estimated 47,000 people are diagnosed with breast cancer each year in England and around 1 in 5 breast cancers are HER2 positive.

Current treatment for HER2‑positive breast cancer which has spread to other parts of the body includes anti‑HER2 treatments such as pertuzumab with trastuzumab and docetaxel, or trastuzumab with paclitaxel.

Standard care after 2 or more anti‑HER2 treatments is chemotherapy (such as capecitabine, vinorelbine or eribulin).

Tucatinib is a type of drug called a tyrosine kinase inhibitor and works by blocking a specific area of the HER2 gene in cancer cells, which stops the cancer cells from growing and spreading.

Around 400 people would have been eligible for treatment with tucatinib in combination with trastuzumab and capecitabine.

Meindert Boysen, deputy chief executive and director of the NICE Centre for Health Technology Evaluation, said: “Unfortunately there is no cure for breast cancer that has spread to other parts of the body. There is a lack of additional anti‑HER2 treatments which can postpone the need for chemotherapy, especially for people whose cancer has spread to their brain because their treatment options are even more limited.

“Tucatinib is a promising, innovative new treatment that has the potential to increase the length of time before the disease gets worse and how long people live overall.

We will continue to work with the company as they seek to address the issues highlighted in today’s draft recommendations.” 

The draft guidance is open for public consultation until Tuesday 16 November 2021.”

https://www.nice.org.uk/news/article/nice-draft-guidance-does-not-recommend-tucatinib-for-advanced-breast-cancer

FDA Makes Progress on Efforts to Understand Presence of Asbestos in Cosmetic Products

admin
-
0
FDA Makes Progress on Efforts to Understand Presence of Asbestos in Cosmetic Products

October 25, 2021: The following quote is attributed to Linda Katz, director of the FDA’s Office of Cosmetics and Colors:

“The FDA remains dedicated to keeping consumers safe from contaminated cosmetic products.

As part of these continued efforts, the FDA’s most recent survey to assess certain talc-containing cosmetic products for the presence of asbestos found that all 50 samples tested negative for detectable asbestos.

Asbestos is a known human carcinogen, and its health risks are well-documented.

The FDA will continue its efforts to protect consumers by conducting further testing of talc-containing cosmetics products in order to assess the presence of asbestos.

The results of the next survey will be released next year.

As it has in the past, the FDA will take prompt action to inform the public and to work closely with companies to help remove any products from the market that are found to contain asbestos.”

Additional Information

  • The U.S. Food and Drug Administration today issued the final results from the agency’s year-long sampling assignment to test talc-containing cosmetic products for the presence of asbestos.

    The full Fiscal Year 2020-2021 results show that all 50 samples assessed were negative for asbestos.
  • Talc is an ingredient used in many cosmetics, from baby powder to blush.
  • In the fall of 2018, the FDA formed the Interagency Working Group on Asbestos in Consumer Products, with members from eight federal agencies to support the development of standardized testing methods for asbestos and other mineral particles of health concern in talc that could potentially affect consumer product safety.

    On February 4, 2020, the FDA held a public meeting on the preliminary recommendations from this interagency working group on testing methods for asbestos in talc and cosmetic products containing talc.
  • The FDA will conduct another talc sampling assignment in 2022, with 50 additional talc-containing cosmetic product samples selected for blinded testing and will communicate any results that indicate the presence of asbestos, if found. The final results are expected to be released next year.”

https://www.fda.gov/news-events/press-announcements/fda-brief-fda-makes-progress-efforts-understand-presence-asbestos-cosmetic-products

Novartis delivers solid Q3 results, with strong growth in Innovative Medicines.

admin
-
0
Novartis delivers solid Q3 results, with strong growth in Innovative Medicines.

October 26, 2021 – commenting on the quarter, Vas Narasimhan, CEO of Novartis, said:

“Novartis delivered strong Innovative Medicines performance, driven by the continued momentum of Cosentyx and Entresto, allowing us to raise peak sales guidance for these products.

Rejuvenation of our portfolio continues, from our key brands which include Kesimpta, Leqvio, Zolgensma and the oncology portfolio.

We are also commencing a strategic review of Sandoz to maximize shareholder value. We remain confident in the strength of our pipeline and launch brands to fuel the growth of our company in the mid to longer term.”

Key figures¹        
 Q3 2021Q3 2020% change9M 20219M 2020% change
 USD mUSD mUSDccUSD mUSD mUSDcc
Net sales13 03012 2596538 39735 88974
Operating income3 2332 41234329 1277 5082218
Net income2 7581 93243417 7125 9722926
EPS (USD)1.230.8545443.442.623128
Free cash flow4 4232 69764 10 2558 34923 
Core operating income4 4674 06910912 76911 91574
Core net income3 8303 46710910 95910 12485
Core EPS (USD)1.711.5213114.884.44107

Strategic review of the Sandoz Division

Novartis has commenced a strategic review of the Sandoz Division. The review will explore all options, ranging from retaining the business to separation, in order to determine how to best maximize value for our shareholders.

Sandoz is a global leader in generic pharmaceuticals and biosimilars. Its global portfolio covers all major therapeutic areas with a global market leadership position in biosimilars, generic antibiotics and oncology medicines.

Financials

Third quarter

Net sales were USD 13.0 billion (+6%, +5% cc) in the third quarter. Volume contributed 9 percentage points to sales growth, driven by Entresto, Cosentyx, Kesimpta and Jakavi. 

Volume growth was partly offset by price erosion of 2 percentage points and generic competition of 2 percentage points.

Operating income was USD 3.2 billion (+34%, +32% cc) predominately from higher sales and lower impairment charges, partly offset by higher investments in M&S and R&D.

Net income was USD 2.8 billion (+43%, +41% cc). EPS was USD 1.23 (+45%, +44% cc), growing faster than net income benefiting from lower weighted average number of shares outstanding.

Core operating income was USD 4.5 billion (+10%, +9% cc) benefiting from higher sales and productivity programs, partly offset by higher investments in M&S and R&D.

Core operating income margin was 34.3% of net sales, increasing by 1.1 percentage points (+1.0 percentage point cc).

Core net income was USD 3.8 billion (+10%, +9% cc). Core EPS was USD 1.71 (+13%, +11% cc), growing faster than core net income benefiting from lower weighted average number of shares outstanding.

Net cash flows from operating activities amounted to USD 4.9 billion.

Free cash flow amounted to USD 4.4 billion (+64%). This increase was driven by higher operating income adjusted for non-cash items, favorable changes in working capital and lower payments out of provisions, mainly due to legal matters in the prior year quarter.

Innovative Medicines net sales were USD 10.6 billion (+8%, +7% cc). Volume contributed 10 percentage points to sales growth. Pharmaceuticals BU sales grew +8% (cc), with continued strong growth from Entresto, Cosentyx, Kesimpta and Zolgensma.

Oncology BU grew +5% (cc) driven by strong performance from Jakavi, Promacta/Revolade and Kisqali.

Generic competition had a negative impact of 3 percentage points, mainly due to Diovan, Ciprodex and Exjade. Net pricing had a negligible impact on sales growth. Operating income was USD 2.8 billion (+40%, +38% cc).

Core operating income was USD 4.0 billion (+14%, +13% cc). Core operating income margin was 37.8% of net sales, increasing 2.0 percentage points (+1.9 percentage points cc).

Sandoz net sales were USD 2.4 billion (-1%, -2% cc). Volume increased by 7 percentage points more than offset by a negative price effect of 9 percentage points.

Sales in Europe grew +2% (cc), while sales in the US declined -20%. Global sales of Biopharmaceuticals grew +5% (cc).

Operating income was USD 440 million (+11%, +9% cc). Core operating income was USD 571 million (-13%, -15% cc). Core Operating income margin was 23.8%, decreasing 3.4 percentage points (-3.6 percentage points cc).”

https://www.novartis.com/news/media-releases/novartis-delivers-solid-q3-results-strong-growth-innovative-medicines-announces-strategic-review-sandoz

Novartis results for CANOPY-1 study support further evaluation of canakinumab in lung cancer

admin
-
0
Novartis results for CANOPY-1 study support further evaluation of canakinumab in lung cancer

October 25, 2021: “Novartis announced that the CANOPY-1 Phase III study did not demonstrate the statistically significant primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients treated with canakinumab (ACZ885) combined with pembrolizumab plus platinum-based doublet chemotherapy, compared to patients receiving placebo in combination with pembrolizumab plus platinum-based doublet chemotherapy.

The trial data, however, showed potentially clinically meaningful improvements in both PFS and OS in pre-specified subgroups of patients based on the baseline inflammatory biomarker, hs-CRP, as well as other biomarker-defined subgroups.

These data support further evaluation of canakunimab in lung cancer.

“CANOPY-1 provides critical insights into the treatment of this devastating disease, and we will continue to analyze the data and conclusions, as well as their potential clinical implications,” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis.

“While this trial did not confirm the benefit for all patients we hoped for, we are energized by the overall CANOPY-1 findings as they support our commitment to continue studying canakinumab in lung cancer.

We share our gratitude and thanks to the CANOPY-1 study patients and clinical investigators for their partnership.”

Novartis and investigators are collaborating on further data analysis and will present the full dataset at an upcoming medical meeting.

The company is continuing with the evaluation of canakinumab in lung cancer, and is applying findings to the overall lung cancer development plan.

The comprehensive CANOPY clinical trial program continues with CANOPY-A, a Phase III study investigating canakinumab as an adjuvant therapy (after surgery), and CANOPY-N, a Phase II study in the neoadjuvant setting (before surgery). 

Enrollment for both trials is ongoing.


Patients in the CANOPY-A trial more closely reflect the earlier CANTOS study population than those in the CANOPY-1 trial.

CANTOS was the first study to show that blocking the IL-1β inflammatory signal may potentially reduce lung cancer’s incidence and mortality.

Canakinumab is a potential first-in-class interleukin-1beta (IL-1β) inhibitor of the Pro-Tumor Inflammation (PTI) pathway in NSCLC.

PTI, which enables tumor development by driving cancer-causing processes and suppressing anti-tumor immune responses, is one of the potential hallmarks of cancer and targets in NSCLC.

Novartis is developing other potential PTI pathway inhibitors, which are at various stages of development, including gevokizumab.

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

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

PTI enables tumor development by driving cancer-causing processes and suppressing anti-tumor immune responses. 

Canakinumab is a potential first-in-class IL-1β inhibitor of the PTI pathway in NSCLC.

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 non-small cell lung cancer (NSCLC).

  • CANOPY-A (NCT03447769) is a double-blind, placebo-controlled Phase III trial studying canakinumab in the adjuvant setting following surgical resection and cisplatin-based chemotherapy, if required. 
    The adjuvant study is designed to determine if treatment with canakinumab can prevent cancer relapse.
  • CANOPY-N (NCT03968419) is a Phase II neoadjuvant trial evaluating canakinumab either as monotherapy or in combination with pembrolizumab among patients with resectable NSCLC prior to their planned surgery.
  • CANOPY-1 (NCT03631199) was a double-blind, placebo-controlled Phase III trial evaluating canakinumab as a first-line treatment for locally advanced or metastatic NSCLC in combination with pembrolizumab and platinum-based doublet chemotherapy.

    As reported today, the trial did not met its primary endpoints of overall survival (OS) and progression-free survival (PFS).

    CANOPY-2 (NCT03626545) was a double-blind, placebo-controlled Phase III trial investigating the role of canakinumab in combination with the chemotherapy agent docetaxel in second- or third-line therapy versus docetaxel alone in NSCLC.
  • In March 2021, Novartis announced that the trial did not meet its primary endpoint, and data were presented at the European Society of Medical Oncology (ESMO) 2021 Congress.”

    https://www.novartis.com/news/media-releases/novartis-top-line-results-canopy-1-phase-iii-study-support-further-evaluation-canakinumab-lung-cancer

Second Dupixent Phase 3 eosinophilic esophagitis trial to demonstrate significant disease improvements

admin
-
0
Second Dupixent Phase 3 eosinophilic esophagitis trial to demonstrate significant disease improvements

October 25, 2021: “Results from a second Phase 3 trial assessing the investigational use of Dupixent® (dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE) demonstrated that the trial met its co-primary endpoints in patients taking Dupixent 300 mg weekly, showing significant improvements in clinical (Dysphagia Symptom Questionnaire) and histologic disease measures compared to placebo.

EoE is a chronic and progressive type 2 inflammatory disease that damages the esophagus and impairs the ability to swallow.

In September 2020, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to Dupixent for the treatment of patients 12 years and older with EoE.

Results from the extended active treatment period (up to 52 weeks) of a previously reported Phase 3 trial studying Dupixent 300 mg weekly for 24 weeks were recently presented at the United European Gastroenterology Week Virtual 2021 congress.

Data from the clinical trial program will be submitted to regulatory authorities by 2022.

“The current standard of care for people with eosinophilic esophagitis may only provide limited relief of their symptoms. 

Efforts to develop a treatment that targets an underlying cause of the disease has eluded the field for some time, resulting in an incredible unmet need,” says Naimish Patel, M.D. Head of Global Development, Immunology and Inflammation at Sanofi. 

“We are encouraged that Dupixent, which targets IL-4 and IL-13, was able to reduce inflammation in the esophagus and provided significant relief when swallowing for patients taking the weekly dose.

We look forward to continuing to study Dupixent’s potential role in addressing the underlying type 2 inflammation that can lead to eosinophilic esophagitis.”

EoE damages the esophagus and prevents it from working properly. At times, swallowing the smallest quantity of food or taking a sip of water can be a painful and worrisome choking experience.

Those with EoE live with anxiety and frustration from having a constantly evolving list of trigger foods to avoid. Dilation (physical expansion) of the esophagus, which is used to address narrowing, is often painful.

In severe cases, a feeding tube is the only option to ensure proper caloric intake and weight gain.

People with EoE may have poor quality of life and are more likely to experience depression, especially as they age, than people without EoE. In the U.S., there are approximately 160,000 patients with EoE who are currently treated, of whom approximately 48,000 have failed multiple treatments.

“This trial gives insight into how terrible this disease can be, with more than a third of patients having previously required invasive endoscopic dilations that can temporarily reduce symptoms but carry the risk of rupturing the esophagus,” says George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. 

“Dupixent, which blocks the IL-4 and -13 pathways, has now shown compelling results across a spectrum of diseases where there has been great unmet need.

In fact, our positive Phase 3 data in six different diseases helps confirm our early hypothesis that interleukin-4 and interleukin-13 are the main drivers of allergic or type 2 inflammation and disease, whether manifested in the gastrointestinal tract as eosinophilic esophagitis, the respiratory tract as asthma or nasal polyps, or the skin as atopic dermatitis, chronic spontaneous urticaria, or prurigo nodularis.”

In this trial, 80 patients were enrolled into a Dupixent 300 mg weekly treatment group and 79 patients were enrolled into a placebo group.

The co-primary endpoints at 24 weeks assessed patient-reported measures of difficulty swallowing (change from baseline in the Dysphagia Symptom Questionnaire, or DSQ), and esophageal inflammation (proportion of patients achieving peak esophageal intraepithelial eosinophil count of ≤6 eos/hpf).

Patients treated with Dupixent 300 mg weekly experienced the following changes by week 24 compared to placebo:

  • 64% reduction in disease symptoms from baseline compared to 41% for placebo (p=0.0008).

    Dupixent patients experienced a 23.78 point improvement on the 0-84 DSQ scale, compared to a 13.86 point improvement for placebo (p<0.0001); baseline DSQ scores were approximately 38 and 36 points, respectively.
  • Nearly 10 times as many Dupixent patients achieved histological disease remission: 59% of patients achieved histological disease remission compared to 6% of placebo patients (p<0.0001).
    This was measured by the proportion of patients who achieved a peak esophageal intraepithelial eosinophil count of ≤6 eos/hpf; mean baseline peak levels were 89 and 84 eos/hpf, respectively.

Detailed results from the trial will be shared at an upcoming medical meeting.

The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved indications.

For the 24-week treatment period, overall rates of adverse events were 84% (67/80) for Dupixent 300 mg weekly and 71% (55/78) for placebo.

Adverse events that were more commonly (≥5%) observed with Dupixent every week included injection site reactions (38% 30/80 Dupixent, 33% 26/78 placebo), fever (6% 5/80 Dupixent, 1% 1/78 placebo), sinusitis (5% 4/80 Dupixent, 0% 0/78 placebo), COVID-19 (5% 4/80 Dupixent, 0% 0/78 placebo) and hypertension (5% 4/80 Dupixent, 1% 1/78 placebo).

No imbalance was observed in rates of treatment discontinuation due to adverse events between Dupixent (3% 2/80) and placebo (3% 2/78) groups prior to week 24.

Dupixent was granted Orphan Drug designation for the potential treatment of EoE in 2017. The potential use of Dupixent in EoE is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.

About the Dupixent Eosinophilic Esophagitis Trial

The Phase 3, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent in adolescents and adults with eosinophilic esophagitis.

The second trial (Part B) enrolled 240 patients aged 12 years and older with eosinophilic esophagitis, as determined by histological and patient-reported measures.

Following the first Phase 3 trial (Part A), in which Dupixent 300 mg weekly was evaluated compared to placebo, the second confirmatory trial evaluated Dupixent 300 mg weekly or every two weeks compared to placebo for a 24-week treatment period.

The clinical trial program is ongoing, with patients from the first and second trials continuing into a 28-week long-term extension trial (Part C). Full results from this trial will be available in 2022.”

https://www.sanofi.com/en/media-room/press-releases/2021/2021-10-25-07-00-00-2319486

Imfinzi plus chemotherapy significantly improved overall survival in biliary tract cancer

admin
-
0
Imfinzi plus chemotherapy significantly improved overall survival in biliary tract cancer

October 25, 2021: “

Positive high-level results from the TOPAZ-1 Phase III trial showed Imfinzi (durvalumab), in combination with standard-of-care chemotherapy, demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit versus chemotherapy alone as a 1st-line treatment for patients with advanced biliary tract cancer (BTC).

At a predefined interim analysis, the Independent Data Monitoring Committee concluded that the trial met the primary endpoint by demonstrating an improvement in OS in patients treated with Imfinzi plus chemotherapy versus chemotherapy alone. The combination also demonstrated an improvement in progression-free survival (PFS) and overall response rate, key secondary endpoints.

Imfinzi plus chemotherapy was well tolerated, had a similar safety profile versus the comparator arm and did not increase the discontinuation rate due to adverse events compared to chemotherapy alone. 

BTC is a group of rare and aggressive cancers that occur in the bile ducts and gallbladder.1,2 Incidence of BTC often depends on the prevalence of common risk factors for each type within a geographical region.

Approximately 50,000 people in the US, Europe and Japan and about 210,000 people worldwide are diagnosed with BTC each year.3-5 These patients have a poor prognosis, with approximately only 5% to 15% of all patients with BTC surviving five years.4 In December 2020, Imfinzi was granted Orphan Drug Designation in the US for the treatment of BTC.

Do-Youn Oh, MD, PhD, Professor, Division of Medical Oncology, Department of Internal Medicine at Seoul National University Hospital and Seoul National University College of Medicine, and principal investigator in the TOPAZ-1 Phase III trial, said: “Patients with advanced biliary tract cancer are in dire need of new treatments as progress in the 1st-line setting has remained largely stagnant for more than 10 years. TOPAZ-1 is the first Phase III trial to show that adding an immunotherapy to standard chemotherapy delivers a meaningful overall survival benefit for patients in this setting. Today’s exciting results are a major step forward in treating this disease and represent new hope for our patients.”

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “We are delighted TOPAZ-1 has been unblinded early due to clear evidence of efficacy for Imfinzi plus chemotherapy, which has also demonstrated a strong safety profile. We have now delivered two positive gastrointestinal cancer trials in a row for Imfinzi, following the HIMALAYA trial in liver cancer. We believe the significant survival benefit demonstrated marks a new era of immunotherapy treatment in this devastating disease, and it advances our commitment to improving long-term survival for patients across these cancers where treatment options are limited.”

The data will be presented at a forthcoming medical meeting and shared with health authorities.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/imfinzi-improved-survival-in-biliary-tract-cancer.html

WHO unveils action plan to address findings of Independent Commission on DRC SEA allegations

admin
-
0
WHO unveils action plan to address findings of Independent Commission on DRC SEA allegations

October 21, 2021: “WHO published its Management Response Plan to address the findings of the Independent Commission (IC) on allegations of sexual abuse and exploitation (SEA) during the response to the 10th Ebola outbreak in the Democratic Republic of the Congo (DRC) following the issuing of the IC’s report on 28 September.

“I am committed to ensuring that the suffering of the survivors and their families is the catalyst for a profound transformation of WHO’s culture”, said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.

“This plan outlines the changes we will make as an organisation to make good on this commitment and to create a culture in which there is no opportunity for sexual exploitation and abuse to happen, no impunity if it does and no tolerance for inaction.” 

The plan outlines short-term actions focusing on the most urgent recommendations of the IC Report: supporting the survivors and their families; completing investigations; taking urgent managerial action and launching a series of internal reviews and audits; and reforming WHO structures and culture. 

The plan also describes the actions that WHO will undertake over the next 15 months to establish and operationalise a victim- and survivor-centered approach; ensure WHO personnel and leaders are accountable for prevention, detection and response to SEA; and initiate an overhaul of WHO’s policies, procedures and practices to increase safeguards against SEA in its programmes and operations.

WHO is committed to providing livelihood support for victims and survivors of SEA, including more comprehensive medical and psycho-social support; support for learning a trade, and resources to start a small business; as well as supporting children born as a result of SEA, through educational grants and the covering of medical fees.  

Alleged managerial and potential misconduct will also continue to be investigated in respect to the failure to initiate investigation procedures as described in the IC report.

WHO has also allocated an initial US$7.6 million to strengthen its capacity to prevent, detect and respond to sexual abuse allegations in ten countries with the highest risk profile: Afghanistan, the Central African Republic, DRC, Ethiopia, Nigeria, Somalia, South Sudan, Sudan, Venezuela and Yemen. 

In addition, WHO will ensure mandatory pre-deployment training and refresher training for any further deployments; reporting channels for alerts or complaints; prompt investigation of complaints; and monitoring.

“WHO is already putting into action many of the recommendations of the Independent Commission”, said Dr Matshidiso Moeti, WHO Regional Director for Africa.

“During the current Ebola outbreak in North Kivu, as part of our first wave of deployments we sent an expert in the prevention of sexual exploitation and abuse to Beni.

Together with UN partners she is giving an in-depth two- day training to staff and NGOs and is reaching out to community leaders to raise awareness.”

In the past week, nearly 40 WHO and UN partner employees have received prevention of sexual exploitation and abuse training. Many of those trained will then cascade the training to other employees.

Almost 30 members of local community-based associations have been briefed on how to protect the population from sexual abuse and report suspected cases.

The response plan was developed with inputs from WHO staff across the organisation and from WHO Member states.

It will be updated regularly to integrate the lessons learnt during implementation, and draw on the experience of UN agencies and humanitarian and development partners.

The Prevention and Response to Sexual Exploitation, Abuse and Harassment team in the Office of the Director-General will lead the global implementation of the plan.”

https://www.who.int/news/item/21-10-2021-who-unveils-action-plan-to-address-findings-of-independent-commission-on-drc-sea-allegations

Novartis signs new initial agreement with BioNTech to support fill and finish of the mRNA Pfizer-BioNTech COVID-19 vaccine

admin
-
0
Novartis signs new initial agreement with BioNTech to support fill and finish of the mRNA Pfizer-BioNTech COVID-19 vaccine

October 21, 2021: “Novartis announced that it has signed an initial agreement to leverage its manufacturing capacity and capabilities to address the COVID-19 pandemic by expanding its support of the fill and finish of the Pfizer-BioNTech COVID-19 vaccine.

Novartis will use its sterile manufacturing facilities at its Novartis Technical Operations site in Ljubljana, Slovenia, to fill at least 24 million doses in 2022.

Under the terms of the new initial agreement, Novartis plans to take bulk mRNA active ingredient from BioNTech and fill this into vials under sterile conditions for shipment back to BioNTech for its distribution.

Subject to reaching a final agreement, Novartis plans to transfer the manufacturing process from Stein to Ljubljana site to commence the fill and finish in the first half of 2022.

The facility in Ljubljana is a state-of-the-art aseptic filling operation which manufactures and supplies a broad range of aseptic products for Sandoz, a Novartis division.

This new agreement follows a first contract signed earlier this year. Novartis started filling for BioNTech at its Stein site in Switzerland in June after the European Union’s drug regulator EMA approved the filling-and-finishing plant.

Novartis continues to offer its world-class capabilities to other companies to take over manufacturing activities including a variety of technologies such as mRNA production and others. The specifics will be disclosed when we conclude specific agreements.

The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer.

BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of Emergency Use Authorizations or equivalents in the United States (jointly with Pfizer) and other countries.

Submissions to pursue regulatory approvals in those countries where Emergency Use Authorizations or equivalent were initially granted are planned.”

https://www.novartis.com/news/media-releases/novartis-signs-new-initial-agreement-biontech-support-fill-and-finish-mrna-pfizer-biontech-covid-19-vaccine

New report sponsored by ViiV Healthcare provides roadmap to achieve health equity by 2040

admin
-
0
New report sponsored by ViiV Healthcare provides roadmap to achieve health equity by 2040

October 20, 2021: “ViiV Healthcare announced the release of Achieving health equity: a roadmap to eliminating disparities, a new report conducted by Economist Impact, a division of The Economist Group, that explores the opportunities that could be created by eliminating health disparities in the UK and US over the next 20 years, while charting a bold course for unified action.

The report, sponsored by ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. and Shionogi Limited as shareholders, breaks from previous efforts by laying out a roadmap that identifies the role of individual groups in achieving health equity and describes the concrete actions they can take to address disparities.

Healthcare disparities are defined as avoidable and unfair differences in the health of people or particular groups that negatively impact their quality of life and life expectancy. Research has shown that clear disparities exist in relation to HIV and other sexually transmitted infections (STIs), mental health, and COVID-19, and are often connected by broader overlapping social factors.

The report, which focuses on these three disease areas, explores the opportunities that eliminating health disparities over the next two decades could create and what actions are needed to achieve it in the United States and the United Kingdom – two countries with wide-ranging and ongoing health disparities in spite of radically different health systems.

Insights in the report were gathered from  desk research and a literature review, followed by in-depth interviews with a range of academics, HIV experts, and other key stakeholders.

“The COVID-19 pandemic has further exposed and intensified existing health disparities, while also serving as a wake-up call to leaders, health systems, and other stakeholders to the threat that disparities pose to individuals, communities, and society,” said Vanessa Apea, Consultant Physician in Genito-urinary and HIV medicine and Research Lead for Sexual Health, Barts Health NHS Trust, who was interviewed for the report. 

“Right now, these leaders know that people don’t have access to the same healthcare based on where they live, how much money they make or the colour of their skin – what we are missing is cohesive action.

This report provides a roadmap for that action, so that we can move forward from discussing disparities to implementing real change that will improve health equity.”

Key findings

This report revealed several key findings that provide the motivation and the pathway for action on health disparities:

  • Disparities in care are avoidable, unfair, and cost us all: Disparities create unfair economic and social circumstances for individuals, communities, and societies alike.
    They create fragility and add instability to health and social systems.
  • Addressing health disparities must be an urgent moral, social, and economic priority that is reliant on a shared vision: Without action, any meaningful progress on societal health and economic goals is at risk and will remain vulnerable to global health threats like COVID-19.
    A shared, forward-looking vision that shows us what achieving health equity looks like is critical to success.
  • Stakeholders and systems can either perpetuate or combat disparities: Inaction can be as powerful as action.
    This research lays out a clear route for various stakeholders to contribute to the pursuit of health equity, and systems for accountability and measuring progress.
  • Systems are slow to promote equity because they are often incentivised not to: Incentives for health and social care are often set up to perpetuate disparities in the US and UK. A greater focus on performance and targets centred on equity, stakeholders and systems would be more likely to both reduce disparities, achieve efficiency, and positive health outcomes.

Keith Rawlings, Senior Medical Director at ViiV Healthcare, said: “If we’re going to be successful in our goal of ending the HIV epidemic, a disease that is defined by inequality, it’s essential that we focus on more than just the development of innovative medicines.

We must also take a holistic approach towards reducing the disparities encountered by the many communities that are disproportionately impacted by HIV and focus on how society can take action to address them and achieve health equity for all.”

Next steps

ViiV Healthcare supports Economist Impact’s recommended roadmap to achieve health equity by 2040, as prioritised by the following actions:

  • Restructuring the health system to prioritise prevention for both physical and mental health: Healthcare systems are often rewarded for sticking to the status quo – a focus on treating the sick, rather than preventing illness, which contributes to worse outcomes. Payment models should prioritise prevention, equity, and sustainability in car and health systems should develop better reimbursement programs to make preventative care a priority.
  • Reimagining investment beyond the upfront cost: Health systems end up spending more in dealing with the consequences of disparities than eliminating them in the first place.
    Investments in health systems and individual communities should be examined over longer periods of time while developing better measurements of success to understand the social, health, and monetary value of eliminating disparities.
  • Making practical changes that improve collaboration: Individuals can make a difference, but their impact alone is limited without the ability to share information with others.
    Practical changes that improve collaboration, like improved data sharing practices, more efficient referral processes, and better communication between initiatives and health providers could help prioritise and realign goals around improving equity.
  • Improving our knowledge of how to best reach certain populations: Many health systems continue to use largely unchanged, outdated methods to engage stakeholders or rely on community partners to pick up the slack.
    Incorporating new best practices from outside the health sector in planning and organisational structure could expand the current knowledge of how to best reach key populations.”


    https://www.gsk.com/en-gb/media/press-releases/less-talk-more-action-new-report-sponsored-by-viiv-healthcare-provides-roadmap-to-achieve-health-equity-by-2040/

FDA Takes Additional Actions on Use of Booster Dose for COVID-19 Vaccines

admin
-
0
FDA Takes Additional Actions on Use of Booster Dose for COVID-19 Vaccines

October 20, 2021: “The U.S. Food and Drug Administration took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations.

The agency is amending the emergency use authorizations (EUA) for COVID-19 vaccines to allow for the use of a single booster dose as follows:
The use of a single booster dose of the Moderna COVID-19 Vaccine that may be administered at least 6 months after completion of the primary series to individuals:

65 years of age and older

18 through 64 years of age at high risk of severe COVID-19

18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2

The use of a single booster dose of the Janssen (Johnson and Johnson) COVID-19 Vaccine may be administered at least 2 months after completion of the single-dose primary regimen to individuals 18 years of age and older.

The use of each of the available COVID-19 vaccines as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.

To clarify that a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered at least 6 months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.

“Today’s actions demonstrate our commitment to public health in proactively fighting against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D.

“As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death.

The available data suggest waning immunity in some populations who are fully vaccinated.

The availability of these authorized boosters is important for continued protection against COVID-19 disease.”

“The amendments to the emergency use authorizations to include a single booster dose in eligible populations are based on the available data and information and follows the input from the members of our advisory committee who were supportive of the use of a booster dose of these vaccines in eligible populations,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

“We are also taking action today to include the use of mix and match boosters to address this public health need.

We will work to accrue additional data as quickly as possible to further assess the benefits and risks of the use of booster doses in additional populations and plan to update the healthcare community and public with our determination in the coming weeks.”

Authorization of Moderna COVID-19 Vaccine Booster Dose

To support the authorization for emergency use of a single booster dose of the Moderna COVID-19 Vaccine, the FDA analyzed immune response data from 149 participants 18 years of age and older from the original clinical studies who received a booster dose at least 6 months after their second dose and compared it to the immune responses of 1,055 study participants after completing their two-dose series.

The antibody response of the 149 participants against SARS-CoV-2 virus 29 days after a booster dose of the vaccine demonstrated a booster response. 

The FDA also evaluated an additional analysis from Moderna comparing the rates of COVID-19 accrued during the Delta variant surge during July and August 2021, which suggest that there is a waning of vaccine effectiveness over time.

Safety was evaluated in 171 participants 18 years of age and older who were followed for an average of approximately six months.

The most commonly reported side effects by the clinical trial participants who received the booster dose of the vaccine were pain at the injection site, tiredness, headache, muscle and/or joint pain, chills, swollen lymph nodes in same arm as the injection, nausea and vomiting, and fever.

Of note, swollen lymph nodes in the underarm were observed more frequently following the booster dose than after the primary two-dose series.

Ongoing analyses from the FDA and the Centers for Disease Control and Prevention (CDC) safety surveillance systems have identified increased risks of inflammatory heart conditions, myocarditis and pericarditis, following vaccination with the Moderna COVID-19 vaccine, particularly following the second dose.

Typically, onset of symptoms has been a few days following vaccination.

The observed risk is higher among males under 40 years of age, particularly males 18 through 24, than among females and older males. 

The Moderna COVID-19 single booster dose is half of the dose that is administered for a primary series dose and is administered at least six months after completion of a primary series of the vaccine. 

Authorization of Janssen (Johnson and Johnson) COVID-19 Vaccine Booster Dose

The authorization for emergency use of a single booster dose of the Janssen COVID-19 Vaccine is based on the FDA’s evaluation of immune response data in 39 participants from a clinical trial including 24 participants who were 18 through 55 years of age and 15 participants who were 65 years of age and older.  

The study participants received a booster dose approximately 2 months after their first dose, and the results demonstrated a booster response.

Overall, approximately 9,000 clinical trial participants have received two doses of Janssen COVID-19 Vaccine administered at least two months apart and of these, approximately 2,700 have had at least two months of safety follow-up after the booster dose. Janssen’s safety analyses from these studies have not identified new safety concerns.

Earlier analyses from the FDA and CDC safety surveillance systems suggest an increased risk of a serious and rare type of blood clot in combination with low blood platelets following administration of the Janssen COVID-19 vaccine.

This serious condition is called thrombocytopenia syndrome (TTS).

People who developed TTS after receiving the vaccine had symptoms that began about one to two weeks after vaccination. Reporting of TTS has been highest in females ages 18 through 49 years.

In addition, safety surveillance suggests an increased risk of a specific serious neurological disorder called Guillain Barré syndrome, within 42 days following receipt of the Janssen COVID-19 Vaccine.  

Authorization of “Mix and Match” Booster Dose

Today, the FDA is also authorizing the use of heterologous (or “mix and match”) booster dose for currently available (i.e., FDA-authorized or approved) COVID-19 vaccines.

Following a presentation of clinical trial data from the National Institute of Allergy and Infectious Diseases, the Vaccines and Related Biological Products Advisory Committee’s discussion of information submitted for consideration, along with the agency’s evaluation of the available data, the FDA has determined that the known and potential benefits of the use of a single heterologous booster dose outweigh the known and potential risks of their use in eligible populations.

A single booster dose of any of the available COVID-19 vaccines may be administered as a heterologous booster dose following completion of primary vaccination with a different available COVID-19 vaccine.

The eligible population(s) and dosing interval for a heterologous booster dose are the same as those authorized for a booster dose of the vaccine used for primary vaccination.

For example, Janssen COVID-19 Vaccine recipients 18 years of age and older may receive a single booster dose of Janssen COVID-19 Vaccine, Moderna COVID-19 Vaccine (half dose) or Pfizer-BioNTech COVID-19 Vaccine at least two months after receiving their Janssen COVID-19 Vaccine primary vaccination. 

In another example, Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 vaccine recipients falling into one of the authorized categories for boosters (65 years of age and older, 18 through 64 years of age at high-risk of severe COVID-19, and 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2) may receive a booster dose of Moderna COVID-19 Vaccine (half dose), Pfizer-BioNTech COVID-19 Vaccine or Janssen COVID-19 Vaccine at least six months after completing their primary vaccination.

The agency recognizes that health care providers and COVID-19 vaccine recipients will have questions about booster doses.

The individual fact sheets for each available vaccine provide relevant information for health care providers and the vaccine recipients.

The agency encourages health care providers to also follow the recommendations that will be provided by the CDC following a meeting of their Advisory Committee on Immunization Practices and formal recommendations signed by the CDC director.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-additional-actions-use-booster-dose-covid-19-vaccines

FDA Announces Investigation of Salmonella Outbreak Linked to Whole, Fresh Onions

admin
-
0
FDA Announces Investigation of Salmonella Outbreak Linked to Whole, Fresh Onions

October 20, 2021: “The following quote is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response “The FDA, along with the CDC and our state and local partners, is working to investigate a multistate outbreak of Salmonella Oranienburg infections linked to whole, fresh onions. 

“The FDA’s traceback investigation is ongoing but has identified ProSource Inc. (also known as ProSource Produce, LLC) of Hailey, Idaho as a source of potentially contaminated whole, fresh onions imported from the State of Chihuahua, Mexico. 

“To date, this outbreak has resulted in 652 illnesses in consumers across the U.S. Illness subclusters investigated in this outbreak thus far are associated with restaurants and food service locations.

That’s why as our investigation continues, we’re advising restaurants, retailers and consumers to not eat, sell, or serve red, yellow, and white onions supplied by ProSource Inc. that were imported from the State of Chihuahua, Mexico from July 1 through August 27, or products containing these onions.

ProSource Inc. has agreed to voluntarily recall such onions. 

“We are issuing this update early in our investigation as part of our continued commitment to transparency and early communication.

We will provide updates as we learn more during our continuing traceback investigation, especially if there are any updates to this critical public health advice.”

Additional Information:

  • The U.S. Food and Drug Administration, along with the U.S. Centers for Disease Control and Prevention and state and local partners, is investigating a multistate outbreak of Salmonella Oranienburg infections linked to whole, fresh onions.
  • To date, this outbreak has been associated with 652 illness, 129 hospitalizations and no deaths spanning the following states: AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WI, WV.
  • Consumers who have symptoms of Salmonella infection should contact their health care provider.
    Most people with salmonellosis develop diarrhea, fever, and abdominal cramps. More severe cases of salmonellosis may include a high fever, aches, headaches, lethargy, a rash, blood in the urine or stool, and in some cases may become fatal.
  • ProSource Inc. has agreed to voluntarily recall red, yellow, and white onions imported from the State of Chihuahua, Mexico, with import dates from July 1, 2021 through August 27, 2021. Descriptors of these onion types include, but are not limited to, jumbo, colossal, medium, and sweet onions.
  • Consumers should ask if the onions being served or sold were supplied by ProSource Inc. and imported from the State of Chihuahua, Mexico.
    If it still cannot be determined if the onions were supplied by ProSource Inc. and imported from the State of Chihuahua, Mexico, do not sell, serve, or eat them, and throw them out.
  • The FDA continues to conduct its traceback investigation to determine if additional products or suppliers have been affected. Additional information will be provided as it becomes available.”

    https://www.fda.gov/news-events/press-announcements/fda-brief-fda-announces-investigation-salmonella-outbreak-linked-whole-fresh-onions

Global Heart Hub and Novartis partner to tackle ASCVD

admin
-
0
Global Heart Hub and Novartis partner to tackle ASCVD

October 19, 2021: “Global Heart Hub and Novartis today announced the launch of the Invisible Nation program. 

Invisible Nation will bring together a worldwide network of patient organizations and other stakeholders in the cardiovascular (CV) space committed to effecting systemic change in the management of atherosclerotic cardiovascular disease (ASCVD).

The program aims to prevent many of the 15 million yearly ASCVD deaths and reduce what could soon become $1 trillion in annual CV disease cost.

Although the vast majority of ASCVD-related deaths are preventable, most countries are not yet on course to meet the World Health Organization (WHO) goal of a 25% reduction in CV mortality by 2025. 

Invisible Nation will highlight the human and societal costs of ASCVD, advocate for high-level government commitments to tackle the disease and bring forward innovative partnerships and novel access models that can fast-track a worldwide effort to reduce ASCVD-related mortality.

“Many are surprised to learn that millions and millions of people die each year from ASCVD, and they are even more surprised when they realize that this terrible loss of life is roughly 60% higher than the number of deaths attributed to cancer,” said Neil Johnson, Executive Director of the Global Heart Hub. 

“This is a shocking fact, and even more shocking is that 80% of CV events can be prevented.

Patient organizations have an opportunity – and a responsibility – to expose the realities of ASCVD, leading to a better prognosis and reduction in premature deaths. By increasing awareness, we will activate change.”

Invisible Nation will advocate for policy-shaping efforts to rewrite how governments, health systems and others can work together to change the trajectory of ASCVD and begin a generational decline in CV death.

Starting today, Global Heart Hub will begin working with patient groups and CV stakeholders to finalize the action plan and align on specific initiatives designed to help governments and health systems reach the WHO goal of a 25% reduction in CV mortality by 2025.

Novartis will assist this community-driven movement by helping network members access the information and evidence needed to engage with local health systems, health authorities and policymakers.

Alongside Invisible Nation, Novartis supports the recent Declaration of the G20 Health Ministers, which acknowledges that non-communicable diseases, such as CV disease, may increase the severity and risk of death from COVID-19.

Novartis is also committed to working with renowned thought leaders, medical societies, health authorities and non-governmental organizations around the world to highlight the urgency to treat CV disease and identify new partnership models for broader access to innovation and healthcare system transformation.

“We see Invisible Nation as a catalyst for action among patient organizations worldwide,” said Marie-France Tschudin, President of Novartis Pharmaceuticals.

“The groups that speak for the millions of people globally who die from ASCVD have a powerful mandate to ensure that it is recognized and addressed as the number one killer in the world.

Novartis is proud to partner with Global Heart Hub and take this next concrete step to reverse this health crisis and make the loss of life and financial cost of ASCVD unignorable.”

https://www.novartis.com/news/media-releases/global-heart-hub-and-novartis-partner-tackle-ascvd-global-health-crisis-and-worlds-1-killer

1...404142...157Page 41 of 157

EDITOR PICKS

POPULAR POSTS

POPULAR CATEGORY

ABOUT US

LifeProNow provides guidance and high quality contents to help job seekers to get their dream Job. All the contents are written by experienced folks and peer reviewed by experts.

Contact us: [email protected]

FOLLOW US

© LifeProNow | All Rights Reserved