Biosimilars Group Pushes For Medicine Access Measures

Law360 (December 1, 2020, 9:47 PM EST) — A biosimilars and generic-drug industry trade group has urged federal lawmakers to set their sights on measures to ensure that patients can more easily get their hands on biosimilars, rein in allegedly anti-competitive conduct related to brand-name medicines and make updates to Medicare Part D.  

In Monday letters to all members of the U.S. House of Representatives and U.S. Senate, the Association for Accessible Medicines President and CEO Dan Leonard laid out what it wants Congress to focus on and support moving forward, emphasizing the importance of expanding the ability of patients to get access to biosimilars, 

“Ensuring the generics…

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UChicago Medicine and UIC researchers to study expanded access to rapid COVID-19 testing

Researchers at the University of Chicago Medicine and the University of Illinois at Chicago (UIC) are launching an investigational study to determine the effects of increased education and access to rapid, FDA-approved COVID-19 testing on community perceptions, access, and use of COVID-19 testing resources.

The study will be funded by $2M in support from the National Institutes for Health RADx-UP program. A part of the Rapid Acceleration of Diagnostics (RADx) initiative, the RADx Underserved Populations (RADx-UP) program supports research that aims to better understand COVID-19 testing patterns among underserved and vulnerable populations; strengthen the data on disparities in infection rates, disease progression and outcomes; and develop strategies to reduce the disparities in COVID-19 testing.

The research will be led by Ayman Al-Hendy, MD, professor of obstetrics and gynecology at UChicago Medicine, and Renee Taylor, PhD, professor of occupational therapy and Nahed Ismail MD, PhD, D(ABMM), D(ABMLI), professor of pathology and medical director of clinical microbiology at the University of Illinois at Chicago. The investigators plan to leverage existing university-community partnerships and expertise in clinical microbiology, community engagement, and epidemiological infrastructures to expand access to rapid COVID-19 testing.

“There are testing deserts in Chicago, where many people don’t have easy or affordable access to testing,” said Taylor. “We can reach individuals who maybe don’t have health insurance or are concerned about having a COVID-19 test on their medical record and provide them with an easy and private opportunity to get tested.”

The project includes collaboration with community members to co-create advertisements to recruit other participants into the trial as well as a mobile health web app, called the mHealth Literacy and Outreach Suite, that will allow individuals to not only privately order testing, but also learn how to prevent the spread of COVID-19 and care for themselves if they fall ill.

Investigators are also sending out kits so participants can collect their own samples and send them to be tested at UIC. Sample collection can be performed rapidly at home with a nasal swab, without the discomfort of the typical nasopharyngeal swab, before sending the sample to the central lab for testing.

The team hopes that the privacy offered by these options, as well as the community advocacy, will help improve the public perception of receiving a COVID-19 test.

“Many people don’t trust the test, are concerned about the expense, or are worried that they’ll be forced out of work or forced to isolate if they have a positive test, which is creating a lot of stigma,” said Ismail. “We need to expand our testing in a community setting where people have some privacy, and the mHealth Suite provides that, as well as overcoming issues of cost.”

Al-Hendy credits the skills of the interdisciplinary team and their pooled community networks for making this collaborative effort possible. “The collaboration between UIC and UChicago Medicine will allow this project to reach many underserved populations,” he said. “Our two institutions already both have robust relationships within our local communities, which will help expand the

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New Northwestern Medicine location provides patients local access to highest level of thoracic surgery care

Patients in Chicago’s northwest suburbs now have local access to the surgery team that performs state-of-the-art minimally invasive and robotic chest surgery, treatment for cancers of lung and esophagus, and lung transplantation at Northwestern Memorial Hospital.

Dr. Ankit Bharat, who performed the United States’ first double lung transplant on a patient with COVID-19, began to see patients in McHenry on Oct. 20.

        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        

 

The new office location at Northwestern Medicine McHenry Hospital will be open to patients who have diseases of the chest, including the airways, lungs, esophagus, diaphragm and chest wall. Bharat and his surgical partners will receive referrals from medical oncologists, pulmonologists and other physicians who care for patients in the McHenry County area.

“Our goal is to provide unparalleled care of the highest quality to our patients, close to home,” Bharat said. “We are committed to providing the entire gamut of treatments for both simple and complex problems in the chest.”

“Our patients can have appointments and follow-up care in McHenry, and if they need specialized surgeries we perform them in Chicago. This approach provides patients the best of both worlds — convenience for appointments and access to highly advanced surgeries when they’re needed.”

Nick Rave, president of Northwestern Medicine McHenry Hospital, said patients will benefit from the relationships between the physicians and hospital teams.

“Our patients want the peace of mind that they’re doing all they can to address their health issues,” Rave said. “By bringing these experienced thoracic surgeons to McHenry, we’re making it easier for people who are already balancing family life, work and a health diagnosis.”

        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        

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More US patients to have easy, free access to doctor’s notes

More U.S. patients will soon have free, electronic access to the notes their doctors write about them under a new federal requirement for transparency.

Many health systems are opening up records Monday, the original deadline. At the last minute, federal health officials week gave an extension until April because of the coronavirus pandemic.

Britta Bloomquist of Duluth, Minnesota, has been reading her clinical notes for years, first struggling through red tape and more recently clicking into a secure online patient website.

“It means information about your care can no longer be hidden from you. And you have a say in your care,” said Bloomquist, 32, who has a rare type of arthritis that took years to diagnose.

WHAT’S CHANGING?

Patients have long had a right to their medical records, including doctor notes, but obtaining them could mean filling out requests, waiting for a response and paying fees. A 2016 law said delays and barriers must be removed.

If you already use a patient portal such as MyChart to email your doctor or schedule an appointment, you may soon see new options allowing you to view your doctor’s notes and see your test results as soon as they are available. You may get an email explaining where to look, how to share access with a caregiver and how to keep other eyes off your information.

Many people won’t notice a change. About 15% of health care systems already are letting patients read doctor notes online without charge. That means about 53 million patients already have access to their doctor’s notes.

WILL THIS HELP ME?

Studies have shown that patients who read their notes understand more about their health, take their medications as prescribed more often and feel more in control of their care.

That’s true for Bloomquist. Diagnosed with a rare type of arthritis called ankylosing spondylitis, she had extensive surgery to straighten her right leg in 2018. She gets regular drug infusions and sees multiple specialists. It’s a lot to remember.

“I’ve become a health nerd,” Bloomquist said. “Reading the notes has kept me on the same page as my providers about what’s going on.”

WILL I UNDERSTAND THE JARGON?

You may have to look up terms. Or ask you doctor to translate at your next visit. And doctor’s notes tend to use abbreviations. “SOB” means short of breath, by the way. “BS” can mean bowel sounds.

And brace yourself if your weight is an issue.

“I’m a heavy-set person, OK? And their favorite word to use is obese,” said Rosie Bartel, 71, of Chilton, Wisconsin. “You have to get used to that. Doctors use that word.”

To Bartel, who became more involved in her care after getting an infection in the hospital, reading notes means she’s doing what she can to prevent errors and stay healthy.

“I don’t have to remember everything said to me in a 15-minute appointment,” she said.

WHAT IF I SPOT AN ERROR?

Patients do find mistakes in their notes and some errors

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Supreme Court changes fuel moves to protect abortion access

A vast swath of West Texas has been without an abortion clinic for more than six years. Planned Parenthood plans to change that with a health center it opened recently in Lubbock.

It’s a vivid example of how abortion-rights groups are striving to preserve nationwide access to the procedure even as a reconfigured Supreme Court — with the addition of conservative Justice Amy Coney Barrett — may be open to new restrictions.

Planned Parenthood has made recent moves to serve more women in Missouri and Kentucky, and other groups are preparing to help women in other Republican-controlled states access abortion if bans are imposed.

“Abortion access in these states now faces its gravest ever threat,” said Alexis McGill Johnson, Planned Parenthood’s president. She said the new health center in Lubbock “is an example of our commitment to our patients to meet them where they are.”

The clinic opened on Oct. 23 in a one-story building that had been a medical office and was renovated after Planned Parenthood purchased it. To avoid protests and boycotts that have beset some previous expansion efforts, Planned Parenthood kept details, including the clinic’s location, secret until the opening was announced.

Planned Parenthood says the health center will start providing abortions — via surgery and medication — sometime next year. Meanwhile, it is offering other services, including cancer screenings, birth control and testing for sexually transmitted infections.

Planned Parenthood closed its previous clinic in Lubbock, a city of 255,000 people, in 2013 after the Texas Legislature slashed funding for family planning services and imposed tough restrictions on abortion clinics.

That law led to the closure of more than half the state’s 41 abortion clinics before the Supreme Court struck down key provisions in 2016. There were no clinics left providing abortion in a region of more than 1 million people stretching from Amarillo in the Texas Panhandle south to Lubbock and the oil patch cities of Odessa and Midland.

Women in Lubbock faced a 310-mile (500-kilometer) drive to the nearest abortion clinic in Fort Worth.

Anti-abortion activists have been mobilizing to prevent the return of abortion services to Lubbock — and are not giving up even with the new clinic’s opening.

“Lubbock must not surrender to the abortion industry,” said Kimberlyn Schwartz, a West Texas native who attended Texas Tech University in Lubbock and is now communications director for Texas Right to Life.

Her organization has backed a petition drive trying to persuade the City Council to pass an ordinance declaring Lubbock a “sanctuary city for the unborn.” Abortion opponents hope that designation would lead to either enforcement efforts or lawsuits seeking to block abortion services.

Thus far, the City Council has declined to adopt the ordinance, but activists say they have enough signatures to place it on the ballot in a local referendum.

Texas is one of several red states where Planned Parenthood has sought to expand abortion access. Earlier this year, its health center in Louisville, Kentucky, began providing abortions after obtaining

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More US Patients to Have Easy, Free Access to Doctor’s Notes | Political News

By CARLA K. JOHNSON, AP Medical Writer

More U.S. patients will soon have free, electronic access to the notes their doctors write about them under a new federal requirement for transparency.

Many health systems are opening up records Monday, the original deadline. At the last minute, federal health officials week gave an extension until April because of the coronavirus pandemic.

Britta Bloomquist of Duluth, Minnesota, has been reading her clinical notes for years, first struggling through red tape and more recently clicking into a secure online patient website.

“It means information about your care can no longer be hidden from you. And you have a say in your care,” said Bloomquist, 32, who has a rare type of arthritis that took years to diagnose.

Patients have long had a right to their medical records, including doctor notes, but obtaining them could mean filling out requests, waiting for a response and paying fees. A 2016 law said delays and barriers must be removed.

If you already use a patient portal such as MyChart to email your doctor or schedule an appointment, you may soon see new options allowing you to view your doctor’s notes and see your test results as soon as they are available. You may get an email explaining where to look, how to share access with a caregiver and how to keep other eyes off your information.

Many people won’t notice a change. About 15% of health care systems already are letting patients read doctor notes online without charge. That means about 53 million patients already have access to their doctor’s notes.

Studies have shown that patients who read their notes understand more about their health, take their medications as prescribed more often and feel more in control of their care.

That’s true for Bloomquist. Diagnosed with a rare type of arthritis called ankylosing spondylitis, she had extensive surgery to straighten her right leg in 2018. She gets regular drug infusions and sees multiple specialists. It’s a lot to remember.

“I’ve become a health nerd,” Bloomquist said. “Reading the notes has kept me on the same page as my providers about what’s going on.”

WILL I UNDERSTAND THE JARGON?

You may have to look up terms. Or ask you doctor to translate at your next visit. And doctor’s notes tend to use abbreviations. “SOB” means short of breath, by the way. “BS” can mean bowel sounds.

And brace yourself if your weight is an issue.

“I’m a heavy-set person, OK? And their favorite word to use is obese,” said Rosie Bartel, 71, of Chilton, Wisconsin. “You have to get used to that. Doctors use that word.”

To Bartel, who became more involved in her care after getting an infection in the hospital, reading notes means she’s doing what she can to prevent errors and stay healthy.

“I don’t have to remember everything said to me in a 15-minute appointment,” she said.

Patients do find mistakes in their notes and some errors are serious enough to affect their care,

Read more

MHRA Grants HAE Patients Early Access to BioCryst’s Berotralstat in United Kingdom

RESEARCH TRIANGLE PARK, N.C., Oct. 30, 2020 (GLOBE NEWSWIRE) — BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted oral, once-daily berotralstat a positive scientific opinion through the Early Access to Medicines Scheme (EAMS).

Under the EAMS, hereditary angioedema (HAE) patients in the UK aged 12 years and older can gain access to berotralstat for the routine prevention of recurrent attacks of HAE before the drug is granted marketing authorization by the European Commission (EC).

HAE is a serious, and potentially life-threatening, rare genetic illness characterised by periodic episodes of acute swelling of the skin, pharynx, larynx, gastrointestinal tract, genitals and/or extremities.

Medicines included in the EAMS are those that have a high unmet need, are intended to treat, diagnose or prevent seriously debilitating or life-threatening conditions where there are no adequate treatment options, and are likely to offer significant advantage over methods currently used in the UK. Under the scheme, the MHRA provides a scientific opinion on the benefit-risk balance of the medicine, based on the data available when the EAMS submission was made.

“There are many patients in the UK that don’t have a realistic option for effective HAE prophylaxis. The addition of berotralstat through the EAMS will bring a much needed option for HAE patients suffering with this debilitating disease,” said Dr. Sorena Kiani, Consultant Immunologist at Royal London Hospital, London.

“HAE patients around the world are waiting for an oral, once-daily therapy to prevent attacks and reduce their burden of therapy. With this decision by the MHRA, the wait for many HAE patients in the UK can end sooner,” said Jon Stonehouse, chief executive officer of BioCryst.

The European Medicines Agency (EMA) is reviewing the marketing authorisation application (MAA) for berotralstat under the centralized procedure. An opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected approximately 12 months from MAA validation, which the company announced on March 30, 2020.

About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including ORLADEYO(berotralstat), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company’s website at www.BioCryst.com.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements are identified by use of terms such as “expect,” “will,” and similar words, although

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IU School of Medicine partnering to increase greater access to psychiatric care in Northwest Indiana | Local News



STOCK_IU_Northwest

Indiana University Northwest




MERRILLVILLE — A new partnership is seeking to bring greater access to psychiatric care in Northwest Indiana.

The IU School of Medicine in collaboration with the Northwest Indiana GME Consortium is launching a new psychiatry resident program at IU Northwest to train psychiatrists in a four-year program.

The program, accredited by the Accreditation Council for Graduate Medical Education, will accept four residents each year.


IUN to offer degree exploration, admissions advice in virtual open house

It is the first psychiatry residency program in northern Indiana and the third in the IU School of Medicine, IU School of Medicine Northwest — Gary campus director Elizabeth Ryan said in a news release.

“The program contributes to a goal of recruiting medical students to the Northwest-Gary campus, upon medical school graduation transitioning to a Northwest Indiana-located residency program and retaining these physicians to serve in the Region,” Ryan said.

The United States Health Resources and Services Administration has designated Northwest Indiana as a high-needs geographic health professional shortage area, according to an IU School of Medicine news release.


250% spike in NWI COVID cases, rising positivity rates indicate worst is yet to come, professor says

The program’s partners say they hope the new cohort can help ease this gap.

Residents in the new program will be integrated into the network of Northwest Indiana GME Consortium partners, like Regional Health Systems in Merrillville.

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Biden vs. Trump: ObamaCare, access to health care in rural US impacts voters’ decisions

Kathleen Wishnick left the hustle and bustle of Sacramento for a new life in the rural deserts of Arizona more than 15 years ago.

She said her family wanted a “place in the middle of nowhere” and they found it in the small town of Arivaca, which boasts a population of about 684 people.

The peaceful setting has its perks, Wishnick told Fox News, but when it comes to health care, access is almost nonexistent.

“The roads when it rains are iffy…sometimes ambulances can’t get in… people said to us, ‘Well you won’t have any health services,’ I said well it’s just a helicopter ride away, but when it happens to you, you tend to rethink that just a little bit,” she said.

ARIZONA’S BATTLEGROUND COUNTIES START TALLYING EARLY BALLOTS

Kathleen Wishnick lives in Arivaca, Arizona, home to around 684 people. She says access to health care can be a challenge, as the nearest hospital is over an hour away (Stephanie Bennett/Fox News).

Kathleen Wishnick lives in Arivaca, Arizona, home to around 684 people. She says access to health care can be a challenge, as the nearest hospital is over an hour away (Stephanie Bennett/Fox News).

Wishnick says the town does have a clinic, but it’s only open certain days a week and has just two doctors. For more advanced procedures or to see a specialist, it involves driving to the closest hospital about an hour away.

With only days until the 2020 presidential election, the topic of health care access, insurance and affordability is front and center in Wishnick’s mind — and she is not alone.

According to the Kaiser Family Foundation, about 2.8 million Arizonans live in areas that the federal government says has a health care shortage — ranking 9th in the country overall.

“I believe everyone in Arizona and across the United States should have access to care,” Dr. Daniel Derksen, associate vice president for health sciences at the University of Arizona and director of the Arizona Center for Rural Health, told Fox News. “We are certainly spending enough as a nation and spending enough as a state to cover every single person with the care that they need, so that they get it when they need it, such as during a COVID-19 pandemic.”

Arivaca, Arizona is about 60 miles south of Tucson (Stephanie Bennett/Fox News).

Arivaca, Arizona is about 60 miles south of Tucson (Stephanie Bennett/Fox News).

THE PRESIDENTIAL ELECTION COMES DOWN TO THESE 9 STATES

Derksen said the Affordable Care Act – or ObamaCare – which former Vice President Joe Biden wants to protect and expand, is a good thing and would be harmful to rural residents to lose.

“We need to make sure that coverage is built upon not torn away … we need to build on the gains made, not throw things away and especially during a time where people really need the health care and access,” he added. “The Affordable Care Act does protect individuals from being charged more or being denied coverage or dropped from coverage once they exceed a certain amount.”

He said that about 20 million Americans could lose their health care – and more than half a million Arizonians – if provisions in the health care act went away.

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doTERRA Partners With World Bank in Kenya to Expand Access to Funding for Small-Scale Farmers

Development project will support fisheries and high-value agriculture chains

doTERRA Co-Impact Sourcing in Kenya

doTERRA Co-Impact Sourcing initiatives in Kenya provide smallholder farmers and harvesters with a stable income, regular agricultural training, and improved resources that encourage self-reliance.
doTERRA Co-Impact Sourcing initiatives in Kenya provide smallholder farmers and harvesters with a stable income, regular agricultural training, and improved resources that encourage self-reliance.
doTERRA Co-Impact Sourcing initiatives in Kenya provide smallholder farmers and harvesters with a stable income, regular agricultural training, and improved resources that encourage self-reliance.

PLEASANT GROVE, Utah and NAIROBI, Kenya, Oct. 20, 2020 (GLOBE NEWSWIRE) — doTERRA and its supply chain partners have connected with World Bank to improve access to funding for smallholder farmers in Kenya. The project is part of a broader plan called the Kenya Marine Fisheries and Socio-Economic Development Project (KEMFSED) that will support fisheries value chains, as well as high-value agriculture chains, including essential oil crops, within coastal fishing communities.

“When discussing the success of our farming initiatives in the region with representatives from World Bank, we began to brainstorm ways that we could work together to expand opportunities for even more individuals,” said Taylor MacKay, doTERRA strategic sourcing manager. “World Bank recognized our ability to truly support farmers and local communities through our Co-Impact Sourcing initiatives, and saw doTERRA as an implementation partner that could help them do even more in the region. It has been amazing to see this project take shape from the ground up—from idea generation to recommending other implementing organizations—we’re grateful for the opportunity to participate together in meaningful change.”

The KEMFSED project is slated to run for five years with an overall goal of enhancing livelihoods for individuals involved while safeguarding the integrity of associated ecosystems. If successful, the project has the potential to serve as a model for similar programs around the world.

One of doTERRA’s primary goals in Kenya is the formation of thriving cooperative farming groups within various communities across the region. In addition to providing opportunities for smallholder farmers, doTERRA is committed to supporting development projects improving overall community health and well-being. Learn more about doTERRA Co-Impact Sourcing and community development projects in Kenya.

About doTERRA

dōTERRA® International is an integrative health and wellness company and the world leader in the Global Aromatherapy and Essential Oils market. dōTERRA sources, tests, manufactures and distributes CPTG Certified Pure Therapeutic Grade® essential oils and essential oil products to over eight million dōTERRA Wellness Advocates and customers. Through industry leading responsible sourcing practices, dōTERRA maintains the highest levels of quality, purity and sustainability in partnership with local growers around the world through Cō-Impact Sourcing®. The dōTERRA Healing Hands Foundation®, a registered 501(c)(3) non-profit organization, offers resources and tools to global sourcing communities and charitable organizations for self-reliance, healthcare, education, sanitation, and the fight against human trafficking. Through the life-enhancing benefits of essential oils, dōTERRA is changing the world one drop, one person, one community at a time. To learn more, visit www.doterra.com.

Contact:
Kevin Wilson
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ddd7b30d-9027-4b91-859d-c3f3652e6ce7

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