Fri.Mar 17, 2023

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Continued Antidepressant Use Helps Pregnant Women Manage Severe Mental Illness

Drug Topics

There was a lower probability of initiating psycholeptics and experiencing postpartum psychiatric emergencies in study patients who continued using antidepressants

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JAMA’s new editor settles in, bringing open access and other changes

STAT

ST. LOUIS — It’s been eight months since Kirsten Bibbins-Domingo, a general internist, cardiovascular researcher, and epidemiologist became the 17th editor in chief of the Journal of the American Medical Association and its network of journals. Bibbins-Domingo, who previously worked at the University of California, San Francisco, was named this week as a member of the 2023 STATUS List of people making a difference in health care and life sciences.

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Attempting To Eradicate Polio For Good

Drug Topics

Polio prevalence has been reduced by 99.99% in the past 35 years. But the disease continues to exist in countries like Pakistan and Afghanistan, where it seeds outbreaks elsewhere.

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‘I’m terrified’: Patients scramble for treatment after 13 ketamine clinics shut down

STAT

Around 4:30 p.m. last Friday, Ketamine Wellness Centers CEO Kevin Nicholson sent an email: In 30 minutes, the company would no longer be in business, he said. The message went out to some patients and to all of the employees of his company’s clinics across nine states — what had, up until moments before, been one of the largest ketamine clinic chains in the country.

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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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FDA Approves Drug Combo for Young Glioma Patients

Drug Topics

A combination of dabrafenib with trametinib was approved by the FDA for treatment of pediatric patients 1 year and older with low-grade glioma & BRAF V600E mutation who require systemic therapy.

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STAT+: Moderna CEO made $398 million in 2022, but still pledges to give most to charity

STAT

Moderna CEO Stéphane Bancel is starting to reap gargantuan gains from the stock he first got when he started with the company a decade ago, although nearly all of this chunk of his fortune remains earmarked for unknown charities. Bancel made $398 million in 2022 based on the actual realized gains of stock that was exercised and sold, according to STAT’s calculations from Moderna’s annual compensation disclosure filed this week.

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Opinion: The staggering financial burden of a proposed HIPAA rule

STAT

The already beleaguered U.S. health care system is facing a new and costly threat that will affect patient care and ultimately may lead to hospital closures : paying for and processing a torrent of medical record requests. While the news media in 2022 focused on hospitals’ billions of dollars of losses , negative operating margins, and other daunting post-pandemic challenges , a set of costly modifications to the HIPAA Privacy Rule proposed by the Department of Health and Human Services m

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GOSH and Leucid to manufacture novel CAR T therapy

European Pharmaceutical Review

In a first-of-its-kind commercial agreement, Great Ormond Street Hospital NHS Foundation Trust (GOSH) will work with Leucid Bio to manufacture LEU011, a lateral Chimeric Antigen Receptor (CAR) targeting NKG2D ligands. The CAR T therapy will be used in clinical studies for solid tumours and haematological malignancies. Under the agreement the parties will work together at state-of-the-art cleanroom facilities at the Zayed Centre for Research into Rare Disease in Children.

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STAT+: To prevent emergency C-sections, researchers turn to AI to predict the course of childbirth

STAT

After more than a decade as an OB-GYN, Darine El-Chaâr still finds late-stage emergency C-sections to be hard. Labor can drag on for days without a baby being born, at which point the situation grows dangerous. “Many times I walk to the operating room, and I’m like, I’m so sorry that you got so far and now this is where you are,” said El-Chaâr, a physician at the Ottawa Hospital Research Institute.

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Can you drink while taking Mounjaro?

The Checkup by Singlecare

Similar to Ozempic, Mounjaro (tirzepatide) is a medication approved to treat Type 2 diabetes. It is prescribed alongside exercise and a balanced diet to manage high blood sugar levels. After its approval in 2022, healthcare providers also prescribed Mounjaro off-label for weight loss. When living with diabetes or trying to lose weight, there are special considerations around alcohol—how it affects your blood sugar and your waistline.

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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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STAT+: Pharmalittle: Sanofi cuts price on a popular insulin by 78%; Califf criticizes insurers for doing too little on drug research

STAT

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is exceedingly modest. We plan to promenade with the official mascot, catch up on our napping, and hope to have a listening party with Mrs. Pharmalot. So far, the rotation includes this , this and this.

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How to treat itchy eyes

The Checkup by Singlecare

If you’ve ever experienced dry, red, burning, itchy, or watery eyes, you know you need fast relief when this allergy symptom hits. Thankfully, there are many effective treatments. In fact, there are so many options that it can be overwhelming to narrow it down to the best allergy medicine for itchy eyes. Here, learn what your options are, along with expert advice on how to pick the most effective itchy eye medication for you.

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LCRF, Daiichi Sankyo and AstraZeneca enter research collaboration

Pharmaceutical Technology

The Lung Cancer Research Foundation (LCRF) has announced a new research partnership with Daiichi Sankyo and AstraZeneca. This collaboration is intended to fund up to three research grants that are focused on antibody-drug conjugates (ADCs) for improving the outcomes for lung cancer patients. ADCs are designed for targeting cancer cells specifically and selectively provide a highly potent payload that may limit healthy cells’ damage.

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FDA approves nasal spray to treat migraine

The Checkup by Singlecare

On March 10, the U.S. Food and Drug Administration approved Zavzpret, the first calcitonin gene-related peptide (CGRP) antagonist nasal spray to treat acute migraine (with or without aura) in adults. This could mean faster—and more effective—treatment for many of the 40 million people in the U.S. who experience migraine. Read on to see what we know about this new medication and when it will be available.

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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+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.   That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Sun Pharma settles at $75m in industry-wide price-fixing case

Pharmafile

Sun Pharma has decided a settlement of $75m as part of a case surrounding various pharma companies fixing their prices. Sun Pharma and subsidiary, Taro Pharmaceutical, have agreed the settlement which will end their involvement in this case. There is also a chance that this upfront sum could be adjusted upward by around $20m, depending on various clauses in the settlement agreements, according to court documents which were filed last week.

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North Carolina Blues plan says food-as-medicine program resulted in better outcomes for diabetes patients

Fierce Healthcare

North Carolina Blues plan says food-as-medicine program resulted in better outcomes for diabetes patients fdiamond Fri, 03/17/2023 - 15:06

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Dial enlists actress Melissa Fumero for latest product launch

Drug Store News

To launch its new body wash collection, which consists of 15 established and new scents and an upgraded formula, the brand is joining forces with actress Melissa Fumero.

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FDA approves Novartis’ Tafinlar and Mekinist combination

Pharmafile

The FDA has approved Novartis’ combination therapy, Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of BRAF V600E low-grade glioma (LGG) in paediatric patients over the age of one. Liquid formulations of the drugs have also been approved to make administration easier across various approved indications.

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Bobbie Labs intros Bobbie Organic Gentle baby formula

Drug Store News

Bobbie Organic Gentle, slated for a late Spring 2023 launch, will be the first and only American-made, EU-style organic product with 100% lactose, the company said.

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MHRA to trial stem cell robot for cell therapies

European Pharmaceutical Review

The Medicines and Healthcare products Regulatory Agency (MHRA) ’s UK Stem Cell Bank is trialling an innovative new robot that grows stem cells. “The UK is only the second country where this technology has been tested” The MHRA’s UK Stem Cell Bank is testing the stem cell propagation robot over a 12-month period to see whether the cells produced by the fully automated Intelligent Cell Processing System meet the standards needed for them to be used in the manufacture of potentially life-savi

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Thomas Jefferson University to offer master's in health professions education to support rising interest in academia

Fierce Healthcare

Thomas Jefferson University to offer master's in health professions education to support rising interest in academia agliadkovskaya Fri, 03/17/2023 - 15:38

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First FcRn blocker approved in UK for myasthenia gravis

European Pharmaceutical Review

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for VYVGART ® (efgartigimod alfa-fcab). It is the first neonatal Fc receptor (FcRn) blocker to be approved in the UK for adults with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. VYVGART is the first neonatal Fc receptor (FcRn) blocker to be approved in the UK for adults with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor

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Albertsons unveils redesign of Open Nature brand

Drug Store News

Open Nature has launched 12 new plant-based products, including dairy-free yogurt alternatives, non-dairy cheese alternatives and non-dairy frozen desserts.

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Meningococcal ABCWY Vaccine Meets Endpoints in Trial

Drug Topics

The vaccine, developed by GSK, is "very encouraging" step in fight to treat meningococcal disease

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Grove Collaborative debuts virtual health and wellness hub

Drug Store News

Grove Wellness is an online hub that offers a curated assortment of high-quality and affordable health and wellness products, the company said.

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At SXSW 2023, OpenAI's Greg Brockman and 23andMe's Anne Wojcicki dive into the potential for AI in healthcare

Fierce Healthcare

At SXSW 2023, OpenAI's Greg Brockman and 23andMe's Anne Wojcicki dive into the potential for AI in healthcare hlandi Fri, 03/17/2023 - 13:16

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Astellas, Pfizer look to broaden Xtandi’s patient base with new prostate cancer win after 8 years

Fierce Pharma

Astellas, Pfizer look to broaden Xtandi’s patient base with new prostate cancer win after 8 years aliu Fri, 03/17/2023 - 10:22

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House lawmakers seek to ban spread pricing in Medicaid in latest PBM reform effort

Fierce Healthcare

House lawmakers seek to ban spread pricing in Medicaid in latest PBM reform effort rking Fri, 03/17/2023 - 16:25

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Sanofi answers the call, joining Eli Lilly, Novo Nordisk in cutting insulin prices

Fierce Pharma

Sanofi answers the call, joining Eli Lilly, Novo Nordisk in cutting insulin prices kdunleavy Fri, 03/17/2023 - 09:07

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The ACA slimmed coverage gaps between racial and ethnic groups: study

Fierce Healthcare

The ACA slimmed coverage gaps between racial and ethnic groups: study pminemyer Fri, 03/17/2023 - 16:21

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News Roundup: March 13 to March 17

Drug Topics

Your weekly roundup of the latest news from Drug Topics®.

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Ascertain's predictive AI preeclampsia algorithm marks continued focus on femtech amid cooling markets

Fierce Healthcare

Ascertain's predictive AI preeclampsia algorithm marks continued focus on femtech amid cooling markets aburky Fri, 03/17/2023 - 14:44

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People on the move … March 17

Drug Store News

Important personnel changes you should know this week about SpartanNash, Maesa and more.

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