Sat.Feb 04, 2023 - Fri.Feb 10, 2023

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State policymakers can protect American innovation and help Americans live longer, healthier lives

PhRMA

For the second year in a row, life expectancy is on the decline in America. The leading causes of death across the United States include cancer and chronic diseases. Even when patients are able to manage these conditions — e.g., overall cancer survivability has increased 33% since 1991 — their quality of life may still be diminished.

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Is ChatGPT Healthcare's Next Big Thing?

Drug Topics

Artificial intelligence has the potential to revolutionize and improve medicine. However, in order for widespread implementation, certain challenges and obstacles must first be overcome.

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Opinion: Mindstrong’s demise and the future of mental health care

STAT

One of the shinier entrants to have emerged in the world of mental health startups abruptly announced last week it would wind down, right in the middle of an ongoing crisis in mental health care. Mindstrong, which had raised a total of $160 million from a who’s-who of blue-chip investors, and was led for a while by a former National Institute of Mental Health director, simply couldn’t find a way to make money delivering the low-cost, high-quality care it had promised.

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Scottish biotech aims to cure common cold

Pharmafile

Scottish biotech company ScotBio has announced that it has seen “promising initial results” from its attempts to extract a cure for the common cold from algae. The Livingston-based company is assessing how waste molecules from spirulina, an algae often consumed as a superfood, could be used as a cure for the common cold, COVID-19 and various other viruses.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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CVS Health to acquire Oak Street Health for $10.6B

Drug Store News

CVS Health will acquire Oak Street Health in an all-cash transaction at $39 per share, representing an enterprise value of approximately $10.6 billion.

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COVID-19 Omicron Variant Associated with Lower Risk of Severe Illness vs Delta Variant

Drug Topics

Vaccination greatly reduces the probability of experiencing severe COVID-19 in both variants. Adults between the ages of 40 to 59 years saw the most significant reduction in risk when compared to individuals in other age categories.

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4D Molecular’s Fabry gene therapy program on FDA clinical hold

Pharmaceutical Technology

4D Molecular Therapeutics (4DMT), the California-based biotechnology company focused on developing gene therapies for rare and large market diseases, has had the FDA place a clinical hold onto its Fabry disease (FD) gene therapy program (4D-310). 4DMT had paused enrollment of patients to two of its trials for 4D-310 last month following a significant adverse event where three patients experienced kidney issues; however, these were treated and resolved in a four-week period. 4DMT has stated that

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10 signs of inflammation to watch out for

The Checkup by Singlecare

At some point in your life, you have probably experienced inflammation in your body. Maybe you fell on your knee and then it swelled up. Or you might have had an allergic reaction to a food or were exposed to poison ivy that caused your skin to become inflamed. Inflammation is often caused by an injury, infection, or disease. “Inflammation is the body’s natural response to injury or infection,” says Dung Trinh, MD, owner and founder of Healthy Brain Clinic.

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Vitamin D Use Connected to Reduced Risk of Diabetes in Adults with Prediabetes

Drug Topics

According to adjusted analyses, vitamin D reduced the risk of diabetes by 15% with a 3-year absolute risk reduction of 3.3%.

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Opinion: The fungal crisis is here and desperately needs addressing

STAT

Fungus-caused infections — real ones, not the ones sparking the zombie apocalypse on the popular show “The Last of Us” — pose a growing threat in the United States and around the world. Mississippi has become the latest state to report residents infected with Candida auris, a highly contagious fungus that thrives in hospitals and nursing homes.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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UK MHRA approves Takeda’s dengue vaccine Qdenga

Pharmaceutical Technology

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]). The vaccine candidate has been approved for active immunisation against the infection in people from four years of age. Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes.

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AstraZeneca’s Forxiga approved in EU for chronic heart failure

Pharmafile

AstraZeneca has announced that its drug, Forxiga, has been approved in the EU for the treatment of symptomatic chronic heart failure. This follows an approval from the EMA’s Committee for Medicinal Products for Human Use in December. The drug is already approved in the EU for the treatment of type 2 diabetes as well as chronic kidney disease. It has also received regulatory approvals in Britain, Japan and Turkey, as well as the US and now the EU.

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State of the Union: Drug Prices, Affordable Care, and Cancer A Priority for Biden Administration

Drug Topics

President Biden's 2023 State of the Union address highlighted some key areas of health care in which he hopes to make progress.

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STAT+: Pharma loses a court battle in its bid to block states from importing drugs from Canada

STAT

In a setback to the pharmaceutical industry, a federal judge has tossed a lawsuit that sought to prevent state governments from importing medicines from Canada. The decision is likely to embolden more states to now consider the approach as they look to lower the cost of prescription drugs In a 26-page opinion , U.S. District Court Judge Timothy Kelly ruled that drug companies failed to prove they would face a “concrete risk of harm” from a federal rule that would allow states to im

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Risk-sharing agreements are growing at a rate of 24%

Pharmaceutical Technology

On November 22, 2022, the FDA approved CSL Behring’s Hemgenix (etranacogene dezaparvovec), the first gene therapy treatment for hemophilia B, with a staggering manufacturer price of $3.5 million, according to GlobalData’s Price Intelligence (POLI), making it the most expensive drug in the world. This is not the first treatment to come with a high price tag.

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NCPA endorses reintroduction of Senate FTC/PBM bills

Drug Store News

NCPA issued gratitude to Sens. Cantwell and Grassley for their efforts to "pull back the curtain on PBMs and push for FTC review of anticompetitive PBM practices.

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Can Patient-Centered Prescription Labels Increase Medication Adherence?

Drug Topics

Researchers evaluated how changes in USP labeling standards have affected adherence across multiple classes of drugs.

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STAT+: Bayer, facing investor ire, appoints an outsider CEO

STAT

Bayer named former Roche executive Bill Anderson as its new CEO on Wednesday, potentially ending a dramatic and difficult chapter during which its current chief executive, Werner Baumann, presided over the disastrous $63 billion purchase of the agriculture firm Monsanto. Anderson will take over April 1, becoming the first American to run the 160-year-old conglomerate, which invented aspirin and later played a major role in the development of hormonal contraceptives, hemophilia clotting factors,

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Feinstein Institutes researchers discover new protein for sepsis treatment

Pharmaceutical Technology

Researchers at the Feinstein Institutes for Medical Research have discovered a new protein that can be a potential therapeutic target for lethal sepsis. Led by Feinstein Institutes researcher Haichao Wang, the new study focuses on detecting protein mediators that might contribute to uncontrolled immune responses to lethal infections. It explores the monoclonal antibody detection that may work against procathepsin-L (pCTS-L), a pro-inflammatory protein mediator, as the potential remedy.

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Farming, pharmaceutical and health pollution fuelling rise in superbugs, UN warns

The Guardian - Pharmaceutical Industry

Sewage, poor sanitation and a lack of regulation give rise to antimicrobial resistance and threaten global health, report says Pollution from livestock farming, pharmaceuticals and healthcare is threatening to destroy a key pillar of modern medicine, as spills of manure and other pollution into waterways are adding to the global rise of superbugs, the UN has warned.

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COVID-19 Currently A Leading Cause of Death Among Children and Young People

Drug Topics

A 2021 morbidity study found that COVID-19 was among the leading causes of death in children and young people.

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Study suggests DNA sequencing could reduce infant deaths, often caused by genetic disease

STAT

Researchers who believe genomics can transform human health love to recount success stories. They’ll tell you about the 3-month-old boy whose heart was failing until researchers pinpointed what was ailing him. Or the baby girl who could have had a life-threatening reaction to anesthesia had researchers not sequenced her DNA ahead of time. But a new study focuses on a much more somber set of stories: those of infants who died with genetic diseases and who in some cases could have been trea

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Can you drink coffee while taking beta blockers?

The Checkup by Singlecare

If you’re one of the nearly 50% of Americans with hypertension, your healthcare provider may prescribe a beta blocker like Lopressor ( metoprolol ), Inderal ( propranolol ), or Tenormin ( atenolol ) to lower your blood pressure. Beta blockers are medications that limit the effects of epinephrine, a hormone that constricts blood vessels and increases the rate and force of heart contractions, according to the Mayo Clinic.

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COVID Benefits Are Changing

DiversifyRx

While COVID will be sticking around, many of the patient financial COVID benefits will be going away soon. The COVID-19 pandemic has brought about numerous changes in the way we live and access healthcare. The emergency COVID measures that are currently active now have an expiration date: May 11, 2023. This means that in just a matter of months, the benefits we’ve come to rely on may no longer be available.

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On the Precipice of the World’s First RSV Vaccine: What’s Taking So Long?

Drug Topics

RSV cases spiked to unprecedented levels this season. Why were these infections so frequent and severe, and why has vaccine development taken so long?

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STAT+: 5 health tech startups targeting chronic kidney disease to watch

STAT

There’s been a surge in funding for health tech startups trying to treat or stave off the worst symptoms of chronic kidney disease, a costly and often deadly condition that affects 37 million people in the U.S. alone. Chronic kidney disease develops when the kidneys are so damaged they can’t filter blood as well as needed. People with diabetes, high blood pressure, and other metabolic conditions are at especially high risk of developing the condition.

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AbbVie reports rise in full-year 2022 net revenues

Pharmaceutical Technology

AbbVie has reported full-year 2022 net revenues of $58.054bn, representing a 3.3% rise on a reported basis and 5.1% on an operational basis. The company reported an increase of 1.6% on a reported basis in global net revenues to $15.121bn for the fourth quarter (Q4) of 2022. For the full-year, worldwide net revenues from the Immunology portfolio stood at $28.924bn, increasing 14.4% on a reported basis.

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Disruptive Factors Shape RA Landscape

Pharmaceutical Commerce

As the range of treatment options for rheumatoid arthritis (RA) continues to grow and biosimilars are poised to enter the arena, the need for expert strategies to improve therapy selection and address the access, affordability, and adherence challenges patients face is coming into sharper focus.

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The Variants of COVID-19

Drug Topics

XBB, a less severe but more contagious strain of COVID-19, has taken over as the dominant Omicron strain.

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Opinion: Pregnant people with substance use disorders need treatment, not criminalization

STAT

Though it may be hard for many to fathom, even pregnant people and new parents can have active substance use disorders. They need support, not criminalization. The addiction and overdose crisis, which now claims more than 100,000 lives a year , shows little sign of abating, and emerging data highlight its startling impact on pregnant people: Overdose is now a leading cause of death during or shortly after pregnancy.

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So Much More than Just Paperwork – The Importance of Design Controls for Device Start-ups

The FDA Law Blog

By Adrienne R. Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. For founders new to the medical device industry, especially with device types that are often considered novel, the learning curve can be steep.

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Rite Aid Healthy Futures commits $1M to EmbraceRace

Drug Store News

Healthy Futures will support EmbraceRace’s continued creation of self-directed online resources for parents and guardians interested in learning and strengthening their caregiving practices.

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Digital Therapies Poised for Breakthrough in Migraine Treatment

Drug Topics

The number of digital therapeutics available for migraine is likely to expand.

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Seizure drug offers hope of expanding the pool of donor hearts

STAT

The moment a donor heart is cut off from its blood supply, transplant teams are on a race against the clock to remove it, transport it, and sew it into the recipient, all within four hours. A new way of reprogramming donor hearts could give them more time. A study published Wednesday in Science Translational Medicine finds that when valproic acid, a medication to treat seizures, is infused in donor hearts, it could significantly extend — potentially double — the safe storage time o

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