Mon.Apr 29, 2024

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High-Fat Diet Associated with Poor Sleep Quality in Patients with T1D

Drug Topics

Researchers addressed the association of sleep quality and dietary intakes for patients with type 1 diabetes who use insulin pumps and continuous glucose monitoring.

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Recreational Cannabis Legalization Associated with Decreases in Alcohol, E-Cigarette Use

Pharmacy Times

Retail sales were associated with lower e-cigarette use, although recreational legalization also increased the frequency of cannabis use among adolescents.

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Exploring Ethical Decision-Making in Oncology Pharmacy

Drug Topics

A Q&A with Karen Fancher, PharmD, associate professor of pharmacy practice at Duquesne University School of Pharmacy, on applying ethical principles to manage complex situations in oncology pharmacy.

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FDA Accepts Supplemental New Drug Application for Tapinarof Cream, 1%, in Atopic Dermatitis

Pharmacy Times

The acceptance is based on positive data from the phase 3 ADORING 1 and ADORING 2 pivotal trials, as well as interim results from the phase 3 ADORING 3 open-label, long-term extension trial.

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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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There’s never a good time to drink raw milk. But now’s a really bad time as bird flu infects cows

STAT

Scientists who know about the types of pathogens — E. coli and Salmonella among them — that can be transmitted in raw milk generally think drinking unpasteurized milk is a bad idea. But right now, they believe, the danger associated with raw milk may have gone to a whole new level. “If I were in charge, for the moment I would forbid the selling of raw milk,” said Thijs Kuiken, a pathologist in the department of viroscience at Erasmus Medical Center in Rotterdam,

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FDA Approves Mavorixafor for Treatment of WHIM Syndrome

Drug Topics

WHIM syndrome is characterized by low levels of neutrophils and lymphocytes in the blood due to dysfunction in the CXCR4 receptor, which results in serious and frequent infections.

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More Trending

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Managing Pulmonary Arterial Hypertension: Diagnosis, Classification, and Treatment Strategies

Pharmacy Times

At Asembia's AXS24 Summit, a clinician discusses the pathophysiology and classification of pulmonary arterial hypertension.

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STAT+: AI is becoming the exclusive province of academic medicine. A new initiative aims to change that

STAT

In Kingman, Ariz., a windswept city of 35,000 at the eastern edge of the Mojave desert, data scientists are about as rare as a drenching rain. The local health clinic doesn’t have a stable internet connection, much less the software to support the latest, greatest artificial intelligence. But the clinic, a federally qualified health center called North Country HealthCare, has plenty of problems AI could help with.

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Health System Specialty Pharmacies Impact Medication Adherence, Total Cost of Care

Pharmacy Times

HSSPs improve medication adherence and reduce total health care costs by directly managing medications for complex chronic conditions like cancer, diabetes, COPD and CHF.

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STAT+: Doctors Without Borders challenges pharma by releasing costs for a key clinical trial

STAT

In a challenge to the pharmaceutical industry, Doctors Without Borders has revealed the detailed costs of a study it ran for a tuberculosis treatment regimen and maintained this is the first time that expenses incurred for an individual clinical trial had been publicized. Moreover, the charity argued that its decision should help undercut a long-standing contention by drug companies that high prices for their medicines can be justified by research costs, even though these expenses are never disc

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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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FDA Accepts sNDA for Tapinarof Cream 1% for Treatment of Atopic Dermatitis

Drug Topics

The ADORING 3 phase 3 development program is currently studying the novel, aryl hydrocarbon receptor agonist as a once-daily, cosmetically elegant, and steroid-free topical cream for adults and children with atopic dermatitis.

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FDA Approves Mavorixafor Capsules to Treat Patients With WHIM Syndrome

Pharmacy Times

The indication is for patients aged 12 years of age and older, and the treatment is intended to increase the number of mature neutrophils and lymphocytes in patients.

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STAT+: Biden cybersecurity plan for hospitals entails carrots first, then sticks, health official says

STAT

WASHINGTON — The Biden administration’s plan to improve cybersecurity at hospitals starts off with incentives, but eventually hospitals will face penalties for not adopting measures to protect patient data, HHS Deputy Secretary Andrea Palm said Monday. In February, a cyberattack against Change Healthcare, a UnitedHealth Group subsidiary that operates the largest medical claims clearinghouse in the country, left many doctors unable to get paid by Medicare.

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12 Questions with Dr Jay Shah

pharmaphorum

Get to know Dr Jay Shah, a prominent figure in the field of cardiovascular medicine, as he answers 12 intriguing questions about his role as Chief Medical Officer at Aktiia and his insights into the field.

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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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STAT+: FDA finalizes plan to regulate some lab-developed tests

STAT

The Food and Drug Administration will start actively regulating tests developed in laboratories, with some exemptions, the agency announced on Monday. The agency’s action, which is expected to face legal challenges in courts, comes after Congress failed to pass a law to regulate such tests. The tests have not faced FDA scrutiny historically, as the agency considered them low-risk.

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Here's what 'fair allocation' for GLP-1s and other weight loss drugs could look like

Fierce Healthcare

Demand for GLP-1s and other weight loss drugs has yet to subside, and a new study aims to establish an ethical framework that can be used to ensure the patients who need these therapies can access | A new study aims to establish an ethical framework that can be used to ensure the patients who need these therapies can access them amid shortages.

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STAT+: Ono Pharmaceutical to acquire Deciphera Pharma, maker of cancer drugs, for $2.4 billion

STAT

Ono Pharmaceutical of Japan said Monday it will acquire Deciphera Pharmaceuticals, a Boston-based maker of cancer drugs, for $2.4 billion.  The all-cash deal values Diciphera at $25.60 per share, or a 75% premium to its Friday closing stock price. Deciphera markets a drug called Qinlock for patients with advanced gastrointestinal stromal tumors, or GIST, a type of cancer that begins in the digestive system.

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Merck, Huma alliance bears fruit with UK bladder cancer app

pharmaphorum

A partnership between Huma Therapeutics and Merck KGaA to develop digital support tools for cancer patients has borne fruit with the launch of a bladder cancer app in the UK

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Opinion: Unseen battles: The harsh realities of veterans’ access to health care

STAT

I remember the day I left the military after six years of active-duty service. The crisp salute, the finality of it all. I was stepping into a world vastly different from the regimented life I had known. As a third-generation veteran, the military was more than a career; it was a legacy. But what I didn’t realize then was that leaving the military would mean entering a labyrinth of health care bureaucracy that seemed designed to confound and discourage.

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Japan's Ono pays $2.4B for Qinlock-maker Deciphera as biotech readies another approval run

Fierce Pharma

The price tag includes both the approved cancer drug Qinlock and another Deciphera candidate heading to the FDA’s desk in the coming months.

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STAT+: Pharma’s reputation with patient groups is sliding again thanks to prices and shortages

STAT

The pharmaceutical industry saw its reputation slip last year among patient advocacy groups thanks to growing concern about the rising prices for medicines and a lack of confidence prompted by increasing shortages, according to a new survey. Of more than 2,500 groups queried, 57% reported that the industry maintained an “excellent” or “good” reputation as it goes about the business of developing and providing medicines.

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FDA Approves Trastuzumab Biosimilar to Treat Forms of HER2-Overexpressing Cancer

Pharmacy Times

Trastuzumab is indicated for adjuvant breast cancer, metastatic breast cancer, and gastric cancer.

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STAT+: Activist investor Alex Denner, Bioverativ shareholder reach tentative settlement in insider trading case

STAT

A tentative settlement has been reached in a long-running shareholder lawsuit that accused health care activist investor Alex Denner of making nearly $50 million from insider trading in connection with the 2018 acquisition of Bioverativ. Denner, managing partner of Sarissa Capital Management, a health care hedge fund, had denied the accusations in the lawsuit filed in 2020 with Delaware’s Court of Chancery.

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X4 Pharma gets first FDA okay for WHIM syndrome drug

pharmaphorum

Patients in the US with the ultra-rare disease WHIM syndrome now have their first approved treatment, after X4 Pharma’s Xolremdi was given a green light by the FDA. Oral CXCR4 antagonist Xolremdi (mavorixafor) can be used in patients aged 12 and over with WHIM (warts, hypogammaglobulinemia, infections, and myelokathexis) syndrome, a congenital immunodeficiency characterised by low neutrophil counts that affects fewer than 1,000 people in the US.

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Philips will pay $1.1 billion to resolve U.S. lawsuits over breathing machines that expel debris

STAT

WASHINGTON — Medical device maker Philips said Monday it will pay $1.1 billion to settle hundreds of personal injury lawsuits in the U.S. over its defective sleep apnea machines, which have been subject to a massive global recall. The Dutch manufacturer did not admit any fault and said it reached the agreement to resolve any uncertainty over the cases.

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Ono swoops on Deciphera in $2.4 billion takeover

pharmaphorum

Japan’s Ono Pharma has bolstered its cancer pipeline with a $2.4 billion agreement to buy Deciphera Pharma of the US and its fast-growing gastrointestinal stromal tumour (GIST) therapy Qinlock. Ono is offering $26.50 per share in cash for the Waltham, Massachusetts-based company, saying the deal will enable it to “build a robust presence in oncology,” one of the group’s key priority areas.

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STAT+: Pharmalittle: We’re reading about MorphoSys drug risks, an AstraZeneca admission, and more

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was invigorating and inspiring, because that oh-too predictable routine of online meetings, phone calls, and deadlines has returned. But what can you do? The world, such as it is, continues to spin. So to give it a nudge in a better direction, we are firing up the coffee kettle to brew some cups of stimulation.

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J&J gets CHMP nod for Rybrevant in first-line lung cancer

pharmaphorum

CHMP backs EU approval of J&J's Rybrevant as a first-line therapy for NSCLC with EGFR exon 30 insertion mutations, filling a void left after Takeda's Exkivity was pulled from sale

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The Relationship Between Cold Chain Logistics and Cell & Gene Therapies

Pharmaceutical Commerce

A one-on-one with Thermo Fisher’s Wilfredo Marin, who dives into the value of ultra-low temperature storage, the need for flexibility in the cold chain logistics space, and more.

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FDA approves Pivya for simple UTIs

The Checkup by Singlecare

More than half of all women will have a urinary tract infection (UTI) at some point in their lives. On April 24, the U.S. Food and Drug Administration approved Pivya (pivmecillinam), a prescription medication for the treatment of uncomplicated UTIs in female adults. An uncomplicated UTI is one that affects a woman’s bladder without any structural abnormalities in the urinary tract.

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Pfizer’s Beqvez approved by FDA for haemophilia B treatment

Pharmafile

Pfizer has announced that the US Food and Drug Administration (FDA) has approved Beqvez (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate to severe haemophilia B. The post Pfizer’s Beqvez approved by FDA for haemophilia B treatment appeared first on Pharmafile.

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Oracle's move to Nashville for its world HQ signals broader ambitions for healthcare

Fierce Healthcare

"It's the center of the industry we're most concerned about, which is the healthcare industry," Oracle chairman Larry Ellison said.

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Our expanding toolbox: Designing personalised strategies in today’s new obesity medicine world

pharmaphorum

Explore the latest personalised strategies in the field of obesity medicine, including the use of GLP-1 agonists, in today's evolving landscape.

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FDA calls for adcomm to discuss Novo Nordisk's filing for weekly insulin

Fierce Pharma

For Novo Nordisk to gain approval in the United States for its groundbreaking Awiqli (insulin icodec), it will have to first pass muster with a panel of experts next month,

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