Drug Topics

MARCH 5, 2024

Health care professionals, industry leaders, and politicians gathered for a virtual roundtable to discuss the state of the PBM industry.

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Pharmacy Times

MARCH 5, 2024

The next-generation SRI was previously granted an Orphan Drug Designation in November 2023 and its safety and efficacy are currently being evaluated in clinical trials.

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FDA 145

Drug Topics

MARCH 5, 2024

Clobetasol propionate ophthalmic suspension 0.05% is the first ophthalmic clobetasol propionate product approved by the FDA and is the first new ophthalmic steroid on the market in over 15 years.

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FDA 138

Pharmacy Times

MARCH 5, 2024

Denosumab-bbdz (Wyost; Sandoz) and denosumab-bbdz (Jubbonti; Sandoz) are approved as interchangeable for all indications of Xgeva (denosumab; Amgen) and Prolia (denosumab; Amgen).

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FDA 139

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.

STAT

MARCH 5, 2024

The opioid overdose epidemic has burned through the U.S. for nearly 30 years. Yet for all that time, the country has had tools that are highly effective at preventing overdose deaths: methadone and buprenorphine. These medicines are cheap and easy to distribute. People who take them use illicit drugs at far lower rates, and are at far lower risk of overdose or death.

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Pharmacy Times

MARCH 5, 2024

Investigators also found that those with community-acquired, radiology-confirmed pneumonia with lower respiratory tract infections had worse outcomes.

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Vaccines 145

Drug Topics

MARCH 5, 2024

Dexcom's Stelo will be available in summer 2024.

FDA 201

FDA 201

STAT

MARCH 5, 2024

Over 2 million Americans have opioid use disorder, according to some estimates. Illicit opioids such as heroin and fentanyl were responsible for over 80,000 U.S. overdose deaths in 2023. Despite the known risks, these drugs are notoriously hard to stop using — due in large part to how debilitating withdrawal can be.

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Pharmacy Times

MARCH 5, 2024

The continuous glucose monitoring system will be available for purchase online and without a prescription starting in summer 2024.

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FDA 149

STAT

MARCH 5, 2024

Renowned Harvard University geneticist and longevity researcher David Sinclair recently made an astonishing assertion: Scientists had developed the first pill — well, a soft, beef-flavored chew — “proven to reverse aging” in dogs. Which miracle molecules delivered this supposed scientific breakthrough, he didn’t say.

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Compounding 145

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.

FDA

Fierce Healthcare

MARCH 5, 2024

Humana and Elevance Health said they are seeing a 15% to 20% reduction in data from providers after the Change Healthcare hack, company execs said during an industry conference March 5. | Both Humana and Elevance Health said the Change Healthcare cyberattack is affecting its claims data from providers. The plans are increasingly relying on Availity, a competing clearinghouse to handle claims processing.

Insurance 132

Insurance 132

STAT

MARCH 5, 2024

For the first time, anyone in the United States will soon be able to buy a continuous glucose monitor without a prescription. The Food and Drug Administration authorized Dexcom on Tuesday to start selling a new product, called the Stelo, to adults who do not use insulin. The product is scheduled to hit the market this summer.    The Stelo product is explicitly designed for people with type 2 diabetes who are not reliant on insulin, or people without diabetes who are curious about

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FDA 143

Pharmacy Times

MARCH 5, 2024

The CORe initiative is aimed at promoting inclusivity, reducing startup time for clinical trials, and facilitating data sharing to address recruitment and retention challenges in cancer research at community oncology sites.

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STAT

MARCH 5, 2024

One in eight people is postmenopausal, and about 50 million women enter menopause every year. A new essay published on Tuesday in The Lancet argues that it’s time to stop treating them like patients suffering from a disorder. The article calls for a reframing of menopause and a management approach that is not simply focused on medical interventions that relieve symptoms.

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Pharmacy Management Software

Pharmacy Times

MARCH 5, 2024

In the study, investigators found superior kidney outcomes with injectable semaglutide (Ozempic) for individuals with type 2 diabetes and chronic kidney disease.

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STAT

MARCH 5, 2024

Generative AI is having a moment. Peter Lee, who oversees Microsoft’s approach to health care and co-authored the 2023 book “ The AI Revolution in Medicine: GPT-4 and Beyond, ” calls it “the most transformative tool ever developed in all aspects of health care and medicine.” Microsoft has been collaborating with the organization OpenAI for several years, so when OpenAI released ChatGPT in November 2022, Lee quickly realized there was a need to educate the medic

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Fierce Pharma

MARCH 5, 2024

Bill Anderson, nine months into Bayer’s CEO role, has laid out his priorities for the troubled German conglomerate in the next few years—and it doesn’t involve an immediate business split-up as man | Bill Anderson, nine months into Bayer’s CEO role, has laid out his priorities for the troubled German conglomerate in the next few years—and it doesn’t involve an immediate business split-up as many investors had hoped for.

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STAT

MARCH 5, 2024

After 18 months of debate, the World Trade Organization failed to adopt a controversial proposal to waive intellectual property protection for Covid-19 diagnostics and treatments, ending a furious attempt by civil society groups to bolster global access to needed medical products. The failure was not a surprise. Since the proposal was introduced, the pharmaceutical industry — and several key countries where large drugmakers are headquartered, including the U.K. and Switzerland — su

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Vaccines 130

Pharmacy Times

MARCH 5, 2024

This designation makes CBL-514 the first drug to receive both Orphan Drug Designation and Fast Track Designation for the treatment of Dercum disease.

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FDA 123

STAT

MARCH 5, 2024

When Americans line up for flu vaccines next fall, they will almost certainly be getting vaccines that no longer contain protection against a family of flu viruses that appears to be extinct. Experts who advise the Food and Drug Administration on vaccine-related issues voted unanimously on Tuesday to recommend that the FDA approve trivalent flu vaccines for the 2024-2025 season, instead of the quadrivalent, or four-in-one, shots that have been the industry standard for the past decade or so.

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Vaccines FDA 127

Pharmacy Times

MARCH 5, 2024

Laws can help eliminate common barriers to transparency but are not the only way to achieve health care transparency.

Patient Care 139

Patient Care 139

STAT

MARCH 5, 2024

On Jan. 22, 1973, the U.S. Supreme Court handed down its decision in Roe v. Wade, declaring a Texas law prohibiting abortion, and similar laws in other states, to be unconstitutional. Not quite 50 years later, on June 24, 2022, the Supreme Court overturned the Roe decision. In Dobbs v. Jackson Women’s Health Organization, the court declared: “The Constitution does not confer a right to abortion.

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Fierce Pharma

MARCH 5, 2024

A trial of Novo Nordisk's Ozempic on diabetes and kidney disease patients found that it reduced the risk of disease progression and death by 24%.

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STAT

MARCH 5, 2024

The U.S. is making progress in reducing the public health consequences of air pollutants and fine particulate matter. But these improvements have not benefited everyone equally, according to a new study published on Wednesday in the journal Environmental Health Perspective. Researchers found an overall drop from 2010 and 2019 in death and disease linked to nitrogen dioxide (NO2), an air pollutant produced from fossil fuel burning, and fine particulate matter (PM2.5) pollution.

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Pharmacy Times

MARCH 5, 2024

Children with normal weight had different community relationships compared to children with overweight or obesity.

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STAT

MARCH 5, 2024

Some of the country’s biggest health insurers said Tuesday that up to one-quarter of their claims are run through Change Healthcare, UnitedHealth Group’s technology company that sustained a massive cyberattack two weeks ago. Speaking at investor conferences, executives from Humana, Elevance Health, and CVS Health, which owns Aetna, said the biggest impact they’re seeing is fewer bills coming in from providers.

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Insurance Hospitals 121

pharmaphorum

MARCH 5, 2024

NICE has rejected the use of AstraZeneca and Daiichi Sankyo’s Enhertu as an NHS treatment for advanced HER2-low breast cancer, a decision that the companies have described as “devastating”.

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STAT

MARCH 5, 2024

In 2003, the year Nora Volkow was appointed director of the National Institute on Drug Abuse, roughly 4,000 Americans died of opioid overdose. In the two decades since, the overdose crisis has morphed into a full-fledged public health emergency, with 80,000 Americans dying from opioid overdoses each year. But in that stretch, relatively little has changed about the way the U.S. treats opioid addiction.

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Fierce Pharma

MARCH 5, 2024

Vanda has been waiting years for an FDA hearing to contest the agency’s 2019 rejection of its sleep drug Hetlioz in jet lag disorder. | Vanda has been waiting years for an FDA hearing to contest the agency’s 2019 rejection of its sleep drug Hetlioz in jet lag disorder. Now, following a lawsuit and a protracted back-and-forth with the U.S. regulator, the FDA has crushed Vanda’s bid.

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FDA 115

Fierce Healthcare

MARCH 5, 2024

Walgreens is gearing up for a strategic review of its business, including the role of its retail pharmacy stores and its healthcare assets, as company leadership and the board plot the future direc | The drugstore retail giant making moves to improve its financial performance after a massive growth spurt in which it expanded its healthcare business segment.

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Drug Store News

MARCH 5, 2024

The on-body device delivers Udenyca, a biosimilar pegfilgrastim administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.

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Chemotherapy 110

Fierce Healthcare

MARCH 5, 2024

Houston-based Memorial Hermann Health System is partnering with Charlie Health to expand access to outpatient mental health treatment for teens and young adults. | "Partnering with Charlie Health excited us because they offer newer technology, evidence-based care in a virtual setting and data that support their treatment program," Dr. Victoria Regan, vice president, women's and children's service line at Memorial Hermann said.

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STAT

MARCH 5, 2024

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello, everyone. Damian here. I’d like to heartily recommend you  check out Part 1 of The War on Recovery , a yearlong STAT investigation into how the U.S. denies lifesaving medications to people with opioid addiction.

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pharmaphorum

MARCH 5, 2024

GSK’s PD-1 inhibitor Jemperli has been cleared for use by the NHS as a first-line treatment for a specific type of endometrial cancer, making it an option for around 580 women across England, Wales and Northern Ireland.

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