Drug Topics

MARCH 6, 2023

Endometriosis has been linked with autoimmune diseases such as rheumatoid arthritis and inflammatory bowel disease, but more definitive research is needed

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The FDA Law Blog

MARCH 6, 2023

By Véronique Li, Senior Medical Device Regulation Expert — A year ago, we blogged about a proposed rule that would replace the Quality System Regulation (QSR) at 21 C.F.R. Part 820 with a newly named Quality Management System Regulation (QMSR) (see here ). The proposed rule was published on February 23, 2022 and was first heralded by FDA in 2018 and introduced in the Spring 2018 regulatory agenda.

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Drug Topics

MARCH 6, 2023

Now that more states are legalizing cannabis for medical and recreational use, pharmacists must step up to educate and counsel customers on safe use

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Pharmaceutical Technology

MARCH 6, 2023

Incannex Healthcare has collaborated with New Jersey-based pharma company Catalent for the development and manufacturing of a cGMP-grade psilocybin drug product for clinical trials and potential commercial use. The drug product is designed for use in the psilocybin-assisted psychotherapy drug development programme of Incannex for generalised anxiety disorder.

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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 6, 2023

Significant differences in the use of insulin pump and/or CGM technology were noted based on demographic and socioeconomic factors

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Fierce Healthcare

MARCH 6, 2023

How providers like UAB, Parkland Hospital are supporting at-risk mothers using a device already in their pockets aburky Mon, 03/06/2023 - 12:22

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STAT

MARCH 6, 2023

NEW ORLEANS — A new medicine represents a dramatic advance for patients with a rare condition called pulmonary arterial hypertension — and a return to heart disease for Merck, which long had a legendary presence in cardiology. The medicine, sotatercept, substantially increased the distance that patients could walk over the course of six minutes and reduced the risk that their condition would worsen, that they would die, and that they would need new treatments, according to data pre

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The Checkup by Singlecare

MARCH 6, 2023

Over-the-counter medications can be taken without a prescription, but it is still possible to overdose on these drugs. Taking more than the recommended amount of even OTC pills can result in serious side effects—and even lead to death if not treated quickly and effectively. Benadryl , an antihistamine used for a variety of purposes in adults and children, is a common over-the-counter medication that has been in the news lately because of something called “ the Benadryl challenge.

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STAT

MARCH 6, 2023

LONDON — The first gene-edited children were born in China five years ago , but it’s unlikely to happen again there anytime soon. That was the message Chinese scientists delivered Monday on the opening day of the Third International Summit on Human Genome Editing in London. While the widely condemned experiment conducted by He Jiankui violated two existing Chinese regulations dating back to 2003 — which prohibit genetically altered embryos from being implanted into people fo

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Hospital Pharmacy Europe

MARCH 6, 2023

Increased physical activity as a nonpharmacological intervention lowers the risk of hospitalisation across a wide range of health conditions In a study by US and UK researchers, it was found that increased physical activity lowers the risk of hospitalisation for a wide range of health conditions, highlighting the potential value of this non-pharmacological intervention.

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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

STAT

MARCH 6, 2023

It has been more than 11 years since Julia Young was diagnosed with advanced ovarian cancer, and two years since it spread to her lymph system. By her own account, she has already beaten the odds for how long most women survive the deadly disease. Still, when doctors told her last year that the cancer was growing despite two operations, radiation therapy, and a fifth regimen of chemotherapy, the retired business-meeting facilitator decided to do something unorthodox: spend $83,000 out of pocket

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Vaccines FDA Immunization Chemotherapy 98

Hospital Pharmacy Europe

MARCH 6, 2023

An essential oil mixture used as a nasal spray gave rise to significant improvements in those with allergic sino-nasal symptoms An essential oil nasal spray gave rise to a 40% reduction in total sino-nasal symptoms according to data presented in an abstract presented at the American Academy of Allergy and Immunology (AAAAI) at San Antonio and published in a supplement to the Journal of Allergy and Clinical Immunology.

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STAT

MARCH 6, 2023

Hospital systems are turning to cross-market mergers to satiate their thirst for growth and avoid antitrust heat. But hospitals are also still signing other lower-profile deals, which experts believe inevitably lead to higher insurance premiums and create more medical bill stress for people in those communities. “Smaller mergers just don’t get the attention they deserve because they affect fewer people,” said Vivian Ho, a health economist at Rice University who studies hospi

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Hospital Pharmacy Europe

MARCH 6, 2023

Rucaparib improves progression-free survival in metastatic, castration-resistant prostate cancer with BRAC alteration compared to usual care Using rucaparib in metastatic, castration-resistant prostate cancer and BRAC alteration leads to improved progression-free survival compared to physician’s choice of treatment according to the findings of a randomised trial by the TRITON3 investigators.

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Pharmacy Management Software

STAT

MARCH 6, 2023

Issues of fairness and justice echo across the health ecosystem, including drug development. Much of the conversation on improving equity in the development of novel therapeutics centers on increasing diversity in clinical trials. A key step in that direction begins with ensuring more equitable representation among clinical investigators. Engaging, recruiting, and retaining a diverse set of participants for clinical trials is critically important, as drugs can have different effects on people de

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Hospital Pharmacy Europe

MARCH 6, 2023

Omaveloxolone has received FDA approval for patients with the rare, progressive genetic neurodegenerative disorder Friedreich’s ataxia In a press release by the manufacturer , Reata, their drug omaveloxolone (brand name SKYCLARYS ) has become the first treatment to be approved for the treatment of Friedreich’s ataxia, an ultra-rare, genetic, progressive neurological disorder.

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STAT

MARCH 6, 2023

In opposing a fix to the 2022 Inflation Reduction Act, a leading voice in the effort to move the U.S. biopharmaceutical system toward European-style price controls cited “complicated details” in his reasoning for changing the law, adding that “getting it straight is critically important.” I couldn’t agree more.

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Fierce Healthcare

MARCH 6, 2023

Hospital-at-home steps out of the COVID-era through new Atrium Health, Best Buy partnership aburky Mon, 03/06/2023 - 17:17

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Hospitals 115

STAT

MARCH 6, 2023

A novel drug for the most common cause of dwarfism accelerated children’s growth in a small but closely watched clinical trial, the company BridgeBio said Monday, advancing the latest treatment in what has been a polarizing field of study. BridgeBio’s drug, a pill called infigratinib, increased the pace of growth by about 3 centimeters per year from baseline for a cohort of 10 children with achondroplasia, a rare genetic disorder that results in dwarfism and can lead to serious med

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Pharmafile

MARCH 6, 2023

US biotech firm Moderna has chosen Harwell Science Campus in Oxfordshire for its new UK R&D facility. The campus is already home to more than 70 organisations and sits within the UK’s ‘golden triangle’, an area rich in life sciences facilities, between Oxford, Cambridge and London. Other companies based at this campus include the UK Health Security Agency (UKHSA), the Rosalind Franklin Institute, Oxford Nanopore, Agilent Technologies and Karus Therapeutics, among others.

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STAT

MARCH 6, 2023

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of online meetings, phone calls, and deadlines has returned. But you knew this would happen, yes? After all the world, such as it is, keeps spinning no matter what. So time to give it a nudge in a better direction with a cup or three of stimulation.

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Fierce Healthcare

MARCH 6, 2023

Hospitals hope new Congress doesn't bring new DSH cuts to safety-net hospitals rking Mon, 03/06/2023 - 15:48

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STAT

MARCH 6, 2023

NEW ORLEANS – On Saturday a new study showed that Nexletol, the cholesterol-lowering medicine made by Esperion Therapeutics, prevented heart attacks among people who cannot or will not take potent cholesterol-lowering statins. The question now is whether those benefits are going to be enough to make sales of Nexletol take off. They have been basically dead in the water since the oral medicine was approved three years ago.

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Outsourcing Pharma

MARCH 6, 2023

Mutation in the progranulin (GRN) gene is just one of several hereditary factors that can cause frontotemporal dementia, a rare and rapidly progressive neurodegenerative disease.

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STAT

MARCH 6, 2023

NEW ORLEANS — Aptly or paradoxically, thousands of the world’s leading cardiologists descended on the home of beignets, bouillabaisse, and beers sold to-go for a weekend-long dive into the latest developments in the science of keeping hearts beating healthily. While some noisy new data on a cholesterol drug consumed much of the oxygen, and the dawn of a new era of obesity treatment hung over the proceedings, there was time enough at the American College of Cardiology’s annua

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Fierce Healthcare

MARCH 6, 2023

Lower margins, softer liquidity sets the stage for hospital dealmaking in 2023 dmuoio Mon, 03/06/2023 - 13:56

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STAT

MARCH 6, 2023

Dear Readers, Let me call your attention to an important new series at STAT: “The Obesity Revolution.” Over the coming days and months, we’ll examine a class of obesity drugs that is transforming patients’ lives, dividing medical experts, and spurring one of the biggest business battles in years.

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European Pharmaceutical Review

MARCH 6, 2023

Harwell, the UK’s leading science and innovation campus in Oxfordshire will be the location of the Moderna Innovation and Technology Centre (MITC). This milestone follows the finalisation of Moderna’s ten-year strategic partnership with the UK government, announced in December 2022. Moderna is the latest organisation to join Harwell’s Health Tech cluster.

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Fierce Pharma

MARCH 6, 2023

ACC23: Bayer and J&J's Xarelto reduces ischemia risk for PAD patients after revascularization surgery kdunleavy Mon, 03/06/2023 - 07:09

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Fierce Healthcare

MARCH 6, 2023

Transcarent to acquire part of AI-powered primary care startup 98point6 pminemyer Mon, 03/06/2023 - 10:55

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Fierce Pharma

MARCH 6, 2023

Eisai, Biogen's high-stakes Leqembi filing nets FDA priority review—and an AdComm hearing zbecker Mon, 03/06/2023 - 11:08

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Fierce Healthcare

MARCH 6, 2023

Bacterial co-infections cause twofold increase in mortality in COVID patients: study fdiamond Mon, 03/06/2023 - 08:43

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Fierce Pharma

MARCH 6, 2023

ACC23: J&J's combo pill of Opsumit plus tadalafil improves blood flow in PAH patients kdunleavy Mon, 03/06/2023 - 08:29

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European Pharmaceutical Review

MARCH 6, 2023

With nearly 10 million new cases of dementia of every year 1 , the increasing prevalence of Alzheimer’s disease (AD), the most common form of the condition, has prompted researchers and the pharmaceutical industry to seek novel, effective solutions. Presence of amyloid beta plaques are one of the hallmarks of AD. Keen to learn more about lecanemab’s promising potential to treat the disease, EPR caught up with Dr Michael Irizarry, Senior Vice President of Clinical Research and Deputy Chief Clinic

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