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New Heart Drug From Novartis Gets FDA Approval

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on

The Aug. 12, 2005 file photo shows the logo of Swiss company Novartis in Basel, Switzerland. Swiss pharmaceutical giant Novartis AG announced a series of multibillion-dollar deals Tuesday, April 22, 2014 with other major pharmaceutical companies that it said would reduce sales but boost profitability, while affecting some 15,000 of its employees globally. (AP Photo/Keystone, Steffen Schmidt)

The Aug. 12, 2005 file photo shows the logo of Swiss company Novartis in Basel, Switzerland. (AP Photo/Keystone, Steffen Schmidt)

 

(Forbes) – It used to be that the major hurdle in getting a new drug approved was successfully completing phase 3 trials – the long-term studies needed to prove to regulators that your drug was both effective and safe. These trials can take years to run and cost hundreds of millions of dollars. Yet, despite doing successful studies for many years in preparation for phase 3, these late stage studies are not guaranteed to be successful. Many a phase 3 program has gone down in flames despite promising earlier trials. Thus, the successful completion of phase 3 and ultimately, approval of the drug by the FDA, is the cause of jubilation at the sponsoring company and especially by the hundreds of people involved in completing the successful program.

This is likely what happened yesterday at Novartis when it received FDA approval for its new drug to treat heart failure, Entresto (previously known by its code name LCZ696). This drug is the first of a new class called angiotensin receptor neprilysin inhibitors. In its development of Entresto, Novartis carried out an extensive clinical plan, the cornerstone of which being PARADIGM, an 8,442 patient trial of people with heart disease in which half of the patients received the Novartis drug and the other half received enalapril, a generic drug that is the current standard of care. The results of the trial proved remarkable as Entresto showed a 20% reduction in the risk of death from cardiovascular causes or hospitalization for worsening heart failure.

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Community

Diabetes Continues to Largely Impact Low-Income Black and Brown Communities

Communities of color, particularly Black and Brown people, are amongst the most affected by Type 2 diabetes (T2D) due to socioeconomic status, cultural, and environmental factors. More than 38 million people in the US have diabetes, with up to 95% having Type 2 diabetes. While individuals aged 45 and older are typically the age range for those being diagnosed, more and more children and young adults are developing the chronic illness, according to the CDC.

Published

on

Dr. Kevin Peterson, vice president of Primary Care at the American Diabetes Association, said in an email that the environments where Black and Brown people historically live, such as areas of high carbohydrate diets, contribute to the prevalence of this illness.
Dr. Kevin Peterson, vice president of Primary Care at the American Diabetes Association, said in an email that the environments where Black and Brown people historically live, such as areas of high carbohydrate diets, contribute to the prevalence of this illness.

By Magaly Muñoz

Communities of color, particularly Black and Brown people, are amongst the most affected by Type 2 diabetes (T2D) due to socioeconomic status, cultural, and environmental factors.

More than 38 million people in the US have diabetes, with up to 95% having Type 2 diabetes. While individuals aged 45 and older are typically the age range for those being diagnosed, more and more children and young adults are developing the chronic illness, according to the CDC.

Of the 1 in 10 people with diabetes, 16.4% of Black people and 14.7% of Hispanic people make up the highest rates among different groups.

Dr. Kevin Peterson, vice president of Primary Care at the American Diabetes Association, said in an email that the environments where Black and Brown people historically live, such as areas of high carbohydrate diets, contribute to the prevalence of this illness.

But family history can also have a part to play in someone’s diagnosis. Although it is not always a determining factor, first-degree relatives, like parents, with Type 2 diabetes can increase someone’s risk of developing the same condition.

Doctors recommend that if there is that direct link, taking precautions such as a healthy diet and exercise can minimize or eliminate the chances of having T2D.

But Peterson also acknowledged that there can be difficulties with maintaining a healthy lifestyle for Black and Brown communities.

“It can be difficult in low-income communities to access healthy eating choices, and opportunities for activity can often be limited,” Peterson said. “Being creative in finding an activity that is available in your situation, finding a friend to assist you, and identifying healthy foods that you like and are available is a struggle worth taking on.”

Food deserts are one systemic factor in how people, especially low-income communities, develop chronic illnesses that can cause irreversible damage. These deserts are areas that lack easy accessibility to fresh and healthy food options.

Dr. Lloyd Stockey, MD, Internal Medicine at Kaiser Oakland Medical Center, said low-income people of color would be less susceptible to chronic illnesses like type 2 diabetes if they had more access to nutritious food.

“When you go into lower income areas or areas where people of color live, you typically see a lot of things that affect diabetes – tobacco, alcohol and fast food,” he said. “When you go out to other more affluent areas, you see more farmers’ markets, more boutique places to eat, and healthier choices. You don’t see all of that fast food.”

One of the most important things to do when talking to patients about their diagnosis, Stockey said, is meeting them where they are at. People come from all different walks of life whether that socioeconomic status, education levels, or willingness to listen to the problems they have that are contributing to their T2D.

He’s encountered patients who know exactly what the illness is, how they want to make lifestyle changes and who want to keep up with their medicine, but then there are many who are the complete opposite. These patients can be harder to get through to but no resource is left unturned for them.

Dr. Walter Acuña, MD, Internal Medicine at Kaiser Oakland Medical Center, said it’s also important to understand people’s cultures and upbringings. He understands that Latino and Black patients might be used to certain kinds of diets that are carb heavy, but added that making little changes can prevent people from having to give up the food they love.

Acuña also explained that lower income people often have time restraints or live in neighborhoods where they don’t feel safe taking a 30-minute walk. Exercising in the living room or watching online workout tutorials are excellent alternatives and can help to improve overall health.

T2D is a lifelong chronic illness but it doesn’t have to dictate someone’s life, doctors say. As long as you’re taking your prescribed medicine, watching what you eat and actively trying to make lifestyle changes, the long term risks, like liver or kidney problems, eyesight issues or early death, can be reduced.

Continue Reading

Bay Area

Congresswoman Lee Celebrates Federal Green Transportation Investments for California

OAKLAND, CA — Congresswoman Barbara Lee (CA-12) today celebrated the Department of Transportation’s (DOT) announcement of two grants for California to expand clean transportation infrastructure. The DOT announced that Bay Area Rapid Transit (BART) will receive over $14 million to install Level 2 EV charging ports at all BART-managed parking facilities for use by customers and community members.

Published

on

Congresswoman Barbara Lee
Congresswoman Barbara Lee

OAKLAND, CA — Congresswoman Barbara Lee (CA-12) today celebrated the Department of Transportation’s (DOT) announcement of two grants for California to expand clean transportation infrastructure. The DOT announced that Bay Area Rapid Transit (BART) will receive over $14 million to install Level 2 EV charging ports at all BART-managed parking facilities for use by customers and community members. The DOT also announced that the California Department of Transportation will receive $102 million for the West Coast Truck Charging and Fueling Corridor Project to deploy charging and hydrogen fueling stations for zero-emission medium- and heavy-duty vehicles along 2,500 miles of key freight corridors in California, Oregon, and Washington.

The transportation sector is the largest source of U.S. carbon emissions. According to the United Nations’ Intergovernmental Panel on Climate Change (IPCC), a 50 percent reduction in carbon must be achieved by 2050—and as much as a 91 percent decrease by 2100—to stay within the globally accepted goal of limiting the planet’s warming to 1.5 degrees Celsius.

“Today, I am excited to announce that BART has been selected to receive this critical federal funding to help expand mobility and end fossil fuel dependence,” said Congresswoman Lee. “It is especially important the first phase of the project will prioritize deployment at stations in or near disadvantaged communities. BART is an essential part of our public transit system, and these funds will improve transit for its riders in throughout the Bay Area.”

By installing chargers at BART stations that are close to multifamily housing, workplaces, medical facilities, schools, and retail, the project will support robust EV adoption across a wide range of socioeconomic groups and road users.

Furthermore, because of discriminatory policies, highways were built near and through Black and brown communities, making these communities much more vulnerable to chronic illnesses associated with disproportionate exposure to air pollution. A reduction in gas-powered cars will be especially beneficial to communities of color and low-income communities who have been disproportionately harmed by infrastructural and environmental injustices.

The West Coast Truck Charging and Fueling Corridor Project will enable the emissions-free movement of goods connecting major ports, freight centers, and agricultural regions between the U.S. borders with Mexico and Canada.

On this funding, Congresswoman Lee said: “This funding will go a long way toward not only combatting the climate crisis, but it will create good-paying jobs as well. I thank the Department of Transportation and the Biden-Harris administration for their continued commitment to a cleaner and healthier environment.”

Last year, alongside the California delegation, Congresswoman Lee sent a letter to DOT Secretary Pete Buttigieg urging support for the grant application of the West Coast Truck Charging and Fueling Corridor Project through the Bipartisan Infrastructure Law’s Charging and Fueling Infrastructure program.

Continue Reading

California Black Media

Gov. Newsom Rejects Plans to Expand Air-Quality Monitoring in Refineries

On Aug. 19, Gov. Gavin Newsom vetoed a bill aiming to expand the State’s air-quality monitoring system to include more refineries. Newsom cited concerns regarding local control and high implementation costs. State Sen. Lena Gonzalez (D-Long Beach) authored Senate Bill (SB) 674, legislation that required real-time air monitoring of nearby petroleum refineries to keep track of sites producing biofuel and other pollutants.

Published

on

Courtesy of Gov. Newsom’s Office
Courtesy of Gov. Newsom’s Office.

By Bo Tefu, California Black Media

On Aug. 19, Gov. Gavin Newsom vetoed a bill aiming to expand the State’s air-quality monitoring system to include more refineries.

Newsom cited concerns regarding local control and high implementation costs.

State Sen. Lena Gonzalez (D-Long Beach) authored Senate Bill (SB) 674, legislation that required real-time air monitoring of nearby petroleum refineries to keep track of sites producing biofuel and other pollutants. The bill would have required communities close to refineries such as Chevron Refinery in Richmond, to get notifications when pollutants were dangerously high, requiring local governments and state agencies to address the poor conditions.

Newsom stated that although the bill had good intentions, the state had no funding to reimburse the refineries for implementing the required systems. The proposed bill obligated refineries to cover the costs of implementing the air monitoring systems, paying various fees over multiple years. However, State officials were unable to secure funding that could help expand programs that monitor air quality in all the refineries.

Oscar Espino-Padron, a senior attorney at Earthjustice, confirmed that two air quality districts in the Bay Area and South Coast Air Quality Management District supported SB 674.

Espino-Padron argued that the air quality districts would be “empowered to implement measures and to exercise their discretion to tailor this monitoring program based on when it’s appropriate in their jurisdictions.”

“It’s really a setback, not only for air quality but also for community safety,” he said.

According to SB 674, a report by the American Lung Association indicated that all 19 refineries in California are located in counties that received failing grades for particulate matter pollution. Environmental groups argued that communities are being deprived of data and information that could help them take proper and timely precautions as well as protect their families from pollution caused by the refineries.

Continue Reading

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Health

New Heart Drug From Novartis Gets FDA Approval

Published

on

The Aug. 12, 2005 file photo shows the logo of Swiss company Novartis in Basel, Switzerland. Swiss pharmaceutical giant Novartis AG announced a series of multibillion-dollar deals Tuesday, April 22, 2014 with other major pharmaceutical companies that it said would reduce sales but boost profitability, while affecting some 15,000 of its employees globally. (AP Photo/Keystone, Steffen Schmidt)

The Aug. 12, 2005 file photo shows the logo of Swiss company Novartis in Basel, Switzerland. (AP Photo/Keystone, Steffen Schmidt)

 

(Forbes) – It used to be that the major hurdle in getting a new drug approved was successfully completing phase 3 trials – the long-term studies needed to prove to regulators that your drug was both effective and safe. These trials can take years to run and cost hundreds of millions of dollars. Yet, despite doing successful studies for many years in preparation for phase 3, these late stage studies are not guaranteed to be successful. Many a phase 3 program has gone down in flames despite promising earlier trials. Thus, the successful completion of phase 3 and ultimately, approval of the drug by the FDA, is the cause of jubilation at the sponsoring company and especially by the hundreds of people involved in completing the successful program.

This is likely what happened yesterday at Novartis when it received FDA approval for its new drug to treat heart failure, Entresto (previously known by its code name LCZ696). This drug is the first of a new class called angiotensin receptor neprilysin inhibitors. In its development of Entresto, Novartis carried out an extensive clinical plan, the cornerstone of which being PARADIGM, an 8,442 patient trial of people with heart disease in which half of the patients received the Novartis drug and the other half received enalapril, a generic drug that is the current standard of care. The results of the trial proved remarkable as Entresto showed a 20% reduction in the risk of death from cardiovascular causes or hospitalization for worsening heart failure.

READ MORE

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Community

Diabetes Continues to Largely Impact Low-Income Black and Brown Communities

Communities of color, particularly Black and Brown people, are amongst the most affected by Type 2 diabetes (T2D) due to socioeconomic status, cultural, and environmental factors. More than 38 million people in the US have diabetes, with up to 95% having Type 2 diabetes. While individuals aged 45 and older are typically the age range for those being diagnosed, more and more children and young adults are developing the chronic illness, according to the CDC.

Published

on

Dr. Kevin Peterson, vice president of Primary Care at the American Diabetes Association, said in an email that the environments where Black and Brown people historically live, such as areas of high carbohydrate diets, contribute to the prevalence of this illness.
Dr. Kevin Peterson, vice president of Primary Care at the American Diabetes Association, said in an email that the environments where Black and Brown people historically live, such as areas of high carbohydrate diets, contribute to the prevalence of this illness.

By Magaly Muñoz

Communities of color, particularly Black and Brown people, are amongst the most affected by Type 2 diabetes (T2D) due to socioeconomic status, cultural, and environmental factors.

More than 38 million people in the US have diabetes, with up to 95% having Type 2 diabetes. While individuals aged 45 and older are typically the age range for those being diagnosed, more and more children and young adults are developing the chronic illness, according to the CDC.

Of the 1 in 10 people with diabetes, 16.4% of Black people and 14.7% of Hispanic people make up the highest rates among different groups.

Dr. Kevin Peterson, vice president of Primary Care at the American Diabetes Association, said in an email that the environments where Black and Brown people historically live, such as areas of high carbohydrate diets, contribute to the prevalence of this illness.

But family history can also have a part to play in someone’s diagnosis. Although it is not always a determining factor, first-degree relatives, like parents, with Type 2 diabetes can increase someone’s risk of developing the same condition.

Doctors recommend that if there is that direct link, taking precautions such as a healthy diet and exercise can minimize or eliminate the chances of having T2D.

But Peterson also acknowledged that there can be difficulties with maintaining a healthy lifestyle for Black and Brown communities.

“It can be difficult in low-income communities to access healthy eating choices, and opportunities for activity can often be limited,” Peterson said. “Being creative in finding an activity that is available in your situation, finding a friend to assist you, and identifying healthy foods that you like and are available is a struggle worth taking on.”

Food deserts are one systemic factor in how people, especially low-income communities, develop chronic illnesses that can cause irreversible damage. These deserts are areas that lack easy accessibility to fresh and healthy food options.

Dr. Lloyd Stockey, MD, Internal Medicine at Kaiser Oakland Medical Center, said low-income people of color would be less susceptible to chronic illnesses like type 2 diabetes if they had more access to nutritious food.

“When you go into lower income areas or areas where people of color live, you typically see a lot of things that affect diabetes – tobacco, alcohol and fast food,” he said. “When you go out to other more affluent areas, you see more farmers’ markets, more boutique places to eat, and healthier choices. You don’t see all of that fast food.”

One of the most important things to do when talking to patients about their diagnosis, Stockey said, is meeting them where they are at. People come from all different walks of life whether that socioeconomic status, education levels, or willingness to listen to the problems they have that are contributing to their T2D.

He’s encountered patients who know exactly what the illness is, how they want to make lifestyle changes and who want to keep up with their medicine, but then there are many who are the complete opposite. These patients can be harder to get through to but no resource is left unturned for them.

Dr. Walter Acuña, MD, Internal Medicine at Kaiser Oakland Medical Center, said it’s also important to understand people’s cultures and upbringings. He understands that Latino and Black patients might be used to certain kinds of diets that are carb heavy, but added that making little changes can prevent people from having to give up the food they love.

Acuña also explained that lower income people often have time restraints or live in neighborhoods where they don’t feel safe taking a 30-minute walk. Exercising in the living room or watching online workout tutorials are excellent alternatives and can help to improve overall health.

T2D is a lifelong chronic illness but it doesn’t have to dictate someone’s life, doctors say. As long as you’re taking your prescribed medicine, watching what you eat and actively trying to make lifestyle changes, the long term risks, like liver or kidney problems, eyesight issues or early death, can be reduced.

Continue Reading

Bay Area

Congresswoman Lee Celebrates Federal Green Transportation Investments for California

OAKLAND, CA — Congresswoman Barbara Lee (CA-12) today celebrated the Department of Transportation’s (DOT) announcement of two grants for California to expand clean transportation infrastructure. The DOT announced that Bay Area Rapid Transit (BART) will receive over $14 million to install Level 2 EV charging ports at all BART-managed parking facilities for use by customers and community members.

Published

on

Congresswoman Barbara Lee
Congresswoman Barbara Lee

OAKLAND, CA — Congresswoman Barbara Lee (CA-12) today celebrated the Department of Transportation’s (DOT) announcement of two grants for California to expand clean transportation infrastructure. The DOT announced that Bay Area Rapid Transit (BART) will receive over $14 million to install Level 2 EV charging ports at all BART-managed parking facilities for use by customers and community members. The DOT also announced that the California Department of Transportation will receive $102 million for the West Coast Truck Charging and Fueling Corridor Project to deploy charging and hydrogen fueling stations for zero-emission medium- and heavy-duty vehicles along 2,500 miles of key freight corridors in California, Oregon, and Washington.

The transportation sector is the largest source of U.S. carbon emissions. According to the United Nations’ Intergovernmental Panel on Climate Change (IPCC), a 50 percent reduction in carbon must be achieved by 2050—and as much as a 91 percent decrease by 2100—to stay within the globally accepted goal of limiting the planet’s warming to 1.5 degrees Celsius.

“Today, I am excited to announce that BART has been selected to receive this critical federal funding to help expand mobility and end fossil fuel dependence,” said Congresswoman Lee. “It is especially important the first phase of the project will prioritize deployment at stations in or near disadvantaged communities. BART is an essential part of our public transit system, and these funds will improve transit for its riders in throughout the Bay Area.”

By installing chargers at BART stations that are close to multifamily housing, workplaces, medical facilities, schools, and retail, the project will support robust EV adoption across a wide range of socioeconomic groups and road users.

Furthermore, because of discriminatory policies, highways were built near and through Black and brown communities, making these communities much more vulnerable to chronic illnesses associated with disproportionate exposure to air pollution. A reduction in gas-powered cars will be especially beneficial to communities of color and low-income communities who have been disproportionately harmed by infrastructural and environmental injustices.

The West Coast Truck Charging and Fueling Corridor Project will enable the emissions-free movement of goods connecting major ports, freight centers, and agricultural regions between the U.S. borders with Mexico and Canada.

On this funding, Congresswoman Lee said: “This funding will go a long way toward not only combatting the climate crisis, but it will create good-paying jobs as well. I thank the Department of Transportation and the Biden-Harris administration for their continued commitment to a cleaner and healthier environment.”

Last year, alongside the California delegation, Congresswoman Lee sent a letter to DOT Secretary Pete Buttigieg urging support for the grant application of the West Coast Truck Charging and Fueling Corridor Project through the Bipartisan Infrastructure Law’s Charging and Fueling Infrastructure program.

Continue Reading

California Black Media

Gov. Newsom Rejects Plans to Expand Air-Quality Monitoring in Refineries

On Aug. 19, Gov. Gavin Newsom vetoed a bill aiming to expand the State’s air-quality monitoring system to include more refineries. Newsom cited concerns regarding local control and high implementation costs. State Sen. Lena Gonzalez (D-Long Beach) authored Senate Bill (SB) 674, legislation that required real-time air monitoring of nearby petroleum refineries to keep track of sites producing biofuel and other pollutants.

Published

on

Courtesy of Gov. Newsom’s Office
Courtesy of Gov. Newsom’s Office.

By Bo Tefu, California Black Media

On Aug. 19, Gov. Gavin Newsom vetoed a bill aiming to expand the State’s air-quality monitoring system to include more refineries.

Newsom cited concerns regarding local control and high implementation costs.

State Sen. Lena Gonzalez (D-Long Beach) authored Senate Bill (SB) 674, legislation that required real-time air monitoring of nearby petroleum refineries to keep track of sites producing biofuel and other pollutants. The bill would have required communities close to refineries such as Chevron Refinery in Richmond, to get notifications when pollutants were dangerously high, requiring local governments and state agencies to address the poor conditions.

Newsom stated that although the bill had good intentions, the state had no funding to reimburse the refineries for implementing the required systems. The proposed bill obligated refineries to cover the costs of implementing the air monitoring systems, paying various fees over multiple years. However, State officials were unable to secure funding that could help expand programs that monitor air quality in all the refineries.

Oscar Espino-Padron, a senior attorney at Earthjustice, confirmed that two air quality districts in the Bay Area and South Coast Air Quality Management District supported SB 674.

Espino-Padron argued that the air quality districts would be “empowered to implement measures and to exercise their discretion to tailor this monitoring program based on when it’s appropriate in their jurisdictions.”

“It’s really a setback, not only for air quality but also for community safety,” he said.

According to SB 674, a report by the American Lung Association indicated that all 19 refineries in California are located in counties that received failing grades for particulate matter pollution. Environmental groups argued that communities are being deprived of data and information that could help them take proper and timely precautions as well as protect their families from pollution caused by the refineries.

Continue Reading

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