Drug Topics

MARCH 25, 2024

In a poster presented at the 2024 American Pharmacists Association Annual Meeting and Exposition, researchers assessed state-level regulations for PBMs.

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Pharmacy Times

MARCH 25, 2024

The combination tablet (Opsynvi; Johnson & Johnson) can also be used for individuals with pulmonary arterial hypertension who are being treated with stable doses of macitentan and tadalafil as separate tables.

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FDA 139

Drug Topics

MARCH 25, 2024

Researchers presented their findings on hypersensitivity caused by antibiotics as well as the best ways pharmacists can test for it.

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STAT

MARCH 25, 2024

It’s been four years since Covid-19 emerged, igniting a pandemic that killed millions of people and brought the world to its knees. A key factor in taming the pandemic was the creation of effective vaccines , which have saved millions of lives. You’d think developing a successful vaccine would be an unmitigated win, from a financial perspective.

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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.

Drug Topics

MARCH 25, 2024

Jeffrey Reese, president at Reese Pharmaceutical, discusses what sets ColoTest apart from other at-home colorectal cancer screening tests.

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MARCH 25, 2024

When a patient is going through end-stage heart failure, the best treatment is to get a heart transplant. The basic steps are familiar: First a patient gets on the waiting list, and then the wait begins for the offers. In recent years, access to donor hearts has gone up thanks to a change in heart allocation policy, but there are still gender- and race-based disparities in the acceptance rate of a donor heart offer by transplant teams, according to new research published Monday in the Journal of

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STAT

MARCH 25, 2024

The health care sector is a notorious laggard when it comes to technology. It was slow to use computers, digitize patient data, and share information electronically. While most of the world instantly interacts via Zoom and Slack, hospitals — even today — are still sending faxes. But something different is happening with generative AI. Health systems, drugmakers, and insurers are racing to build the technology into their operations, aligning themselves with corporate giants such as

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Fierce Pharma

MARCH 25, 2024

Even as Germany's BioNTech deals with ongoing declines of its revenue and share price, it's facing another serious concern: U.S. | Even as Germany's BioNTech deals with ongoing declines of its revenue and share price, it's facing another serious concern: U.S. officials are pressing the company to pay royalties linked to the commercialization of its lucrative Pfizer-partnered COVID-19 vaccine.

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Pharmacy Times

MARCH 25, 2024

The indication is for adults and adolescents with moderate to severe immune compromise due to medical conditions or immunosuppressive medications and treatments.

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Immunization FDA 139

Fierce Pharma

MARCH 25, 2024

In 2023, Eli Lilly CEO David Ricks received a 24% boost in pay from $21.4 million to $26.6 million. The increase coincides with the company's booming sales.

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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

Pharmacy Times

MARCH 25, 2024

Vitamin A regulates stem cell differentiation to manage wound healing, although risk of tumor growth may increase if differentiation does not occur.

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STAT

MARCH 25, 2024

WASHINGTON — The Supreme Court on Tuesday will hear opening arguments in an abortion medication case that pharmaceutical companies warn could upend the industry and paralyze new drug development. Industry players were initially reluctant to weigh in on the fate of mifepristone , approved by the Food and Drug Administration in 2000 for abortion up to seven weeks of pregnancy.

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Fierce Healthcare

MARCH 25, 2024

Providence has launched the first public salvo in a spat with Blue Shield of California over ongoing contract negotiations. | Providence has launched the first public salvo in a spat with Blue Shield of California over ongoing contract negotiations.

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STAT

MARCH 25, 2024

Chick-fil-A, one of the largest fast-food restaurants in the U.S., is easing its commitment to using chickens raised without any antibiotics, a step that was criticized over concerns it could increase the risk of spreading antibiotic resistance among humans. In a statement, the company said it will instead switch to chickens that are raised without the use of antibiotics that are considered important to human health.

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Labelling 134

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Fierce Pharma

MARCH 25, 2024

With the FDA expected this week to approve a first-in-class treatment from Merck for pulmonary arterial hypertension (PAH), Johnson & Johnson has beaten its New Jersey rival to the punch with a | With the FDA expected this week to approve a first-in-class treatment from Merck for pulmonary arterial hypertension (PAH), Johnson & Johnson has beaten its New Jersey rival to the punch with a nod from the U.S. regulator for its newest PAH treatment.

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STAT

MARCH 25, 2024

NEW YORK — Over 30 years ago, Gregg Gonsalves and other AIDS activists persuaded Congress to create the accelerated approval pathway, allowing regulators to speed access to drugs for thousands of dying patients. These days, though, Gonsalves sounds uneasy — if not mournful — of the world he helped build.  “We’re approving drugs faster and faster — [the FDA is] one of the fastest regulatory agencies in the world — we know less and less about t

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Fierce Healthcare

MARCH 25, 2024

The Congressional Budget Office (CBO) addressed a series of questions from lawmakers on health policy priorities ranging from pharmacy benefit management to Medicare spending. | The Congressional Budget Office addressed a series of questions from lawmakers on health policy priorities ranging from pharmacy benefit management to Medicare spending.

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MARCH 25, 2024

LONDON — Novo Nordisk said Monday it would acquire the German firm Cardior Pharmaceuticals in a deal worth up to $1.1 billion, picking up additional drug candidates for its pipeline of cardiometabolic medicines.   Cardior focuses on targeting RNA to address the root causes of heart disease. Its lead candidate, known CDR132L, is in Phase 2 development as a treatment for health failure.

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Fierce Pharma

MARCH 25, 2024

Nearly five years after an FDA approval for Soliris in neuromyelitis optica spectrum disorder (NMOSD), AstraZeneca’s follow-on C5 drug Ultomiris has entered the rare neurological disease, as well.< | Nearly five years after an FDA approval for Soliris in neuromyelitis optica spectrum disorder (NMOSD), AstraZeneca’s follow-on C5 drug Ultomiris has entered the rare neurological disease, as well.

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STAT

MARCH 25, 2024

Since the Food and Drug Administration approved methadone for treating opioid use disorder in 1972, its distribution has been strictly regulated. The regulations were put in place to ensure public and patient safety. But they made it hard for people to get the treatment they need. Until recently, most people had to visit a methadone clinic in person for an initial exam and then come in five to six days a week to take their doses under the watchful eye of a health care professional.

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pharmaphorum

MARCH 25, 2024

Novo Nordisk has agreed to buy Cardior Pharmaceuticals for $1.1 billion, adding expertise in RNA therapeutics and a heart failure therapy in mid-stage trials.

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Fierce Pharma

MARCH 25, 2024

The four years since the start of the COVID-19 pandemic have yielded many advances against the coronavirus, including Moderna and Pfizer’s groundbreaking mRNA vaccines. | The agency granted emergency use authorization to Invivyd's Pemgarda, a monoclonal antibody for those who are immunocompromised and unlikely to receive adequate protection from marketed mRNA vaccines.

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Immunization Vaccines FDA 115

Fierce Healthcare

MARCH 25, 2024

Four in five nonprofit hospitals are spending less on community benefit areas like financial assistance than what they are estimated to receive in tax breaks, according to the latest annual report | Even after accounting for discounted care and community benefit investments, the money 2,425 nonprofit hospitals saved through tax breaks in 2021 would be enough to wipe out the medical debt of everyone living in California, Texas, New York and Pennsylvania, the Lown Institute found.

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Hospitals 114

Fierce Pharma

MARCH 25, 2024

When it comes to questioning drug patents, the U.S. Federal Trade Commission (FTC) isn’t backing down. | After filing a challenge in November against more than 100 patents in the FDA’s Orange Book—and persuading several drugmakers to retract their intellectual property (IP) protections in the process—the U.S. Federal Trade Commission is now calling out uncooperative companies in court.

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Pharmafile

MARCH 25, 2024

AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Ultomiris (ravulizumab-cwvs) as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). This approval follows positive results from the phase 3 CHAMPION-NMOSD trial, which were published in […] The post FDA approves AstraZeneca’s Ultomiris for NMOSD treatment appeared fir

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The Checkup by Singlecare

MARCH 25, 2024

Your kidneys are responsible for filtering water and waste from urine and blood. About 15% of American adults have kidney disease, which impairs this process. Chronic kidney disease (CKD) increases a person’s risk of anemia, infections, nutrient deficiencies, and depression. If you have CKD or are on dialysis, you may need to eat a renal diet that protects you from kidney damage by limiting phosphorus, potassium , and sodium.

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STAT

MARCH 25, 2024

The public will soon find out whether the federal government is willing to meet the health insurance industry’s demands and deposit more money into the bank accounts of next year’s Medicare Advantage plans. Budget officials within the Biden administration started reviewing final payment regulations for 2025 Medicare Advantage plans last week after more than 42,000 public comments rolled into the federal government’s inbox.

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pharmaphorum

MARCH 25, 2024

Three digital health technologies (DHTs) used to support patients with psychosis can be used by the NHS while additional evidence of their benefits is gathered.

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MARCH 25, 2024

Good morning, everyone, and welcome to another working week. We hope the weekend respite was refreshing and invigorating, because that oh-so familiar routine of online meetings, phone calls, and deadlines has predictably returned. But you knew this would happen, yes? After all, the world, such as it is, continues to spin. So time to give it a nudge in a better direction with a cup or two of stimulation.

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PharmaVoice

MARCH 25, 2024

As the new weight loss drugs take the world by storm, companies in other areas are battening the hatches for when slimmer patients need fewer medical interventions.

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MARCH 25, 2024

New biotech newsletter launching this Thursday. Don’t miss out. Hey there. Today, we discuss the implications of the Supreme Court’s forthcoming mifepristone evaluation on the FDA and the biopharma industry. We also examine how Covid-19 vaccine makers are faring today, and more.

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pharmaphorum

MARCH 25, 2024

FDA has turned down a pair of marketing applications for Regeneron’s CD20xCD3 bispecific antibody odronextamab to treat two common forms of non-Hodgkin lymphoma

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STAT

MARCH 25, 2024

When Vertex Pharmaceuticals moved from Cambridge to Boston’s Seaport a decade ago, it signaled that what was then a sea of parking lots could be a booming business district, and galvanized a wave of new development. Now, Vertex may be on the move again. With the lease on its two-building campus on Fan Pier set to expire in 2028, the company is reevaluating its real estate options — and considering leaving its prominent headquarters for another spot in the neighborhood.

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pharmaphorum

MARCH 25, 2024

The March meeting of the EMA’s human medicines committee saw an approval recommendation for Novartis’ Fabhalta, on track to become the first oral monotherapy for rare disease paroxysmal nocturnal haemoglobinuria (PNH) in the EU.

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