Fri.Oct 18, 2024

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FDA Adds Intravenous Fluids to List of Drug Shortages

Pharmacy Times

The additions include Dextrose 70% intravenous (IV) solution, Lactated Ringers IV Solution, and Peritoneal Dialysis Solution, which were affected by Hurricane Helene.

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STAT+: Chickenpox, shingles, Alzheimer’s? Evidence mounts for a viral cause of dementia

STAT

Pascal Geldsetzer believes in open access, in disseminating science as quickly as it happens. Even so, last summer, as he uploaded the surprising results of his latest study to the MedRxiv preprint server, the Stanford University epidemiologist was feeling something other than the usual excitement. “I was scared to put this up because it’s such a different approach from what’s generally done in epidemiology and medicine,” he said.

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Updated COVID-19 Vaccine’s Impact on Various Patient Outcomes | IDWeek 2024

Drug Topics

Researchers explored the efficacy of Pfizer-BioNTech’s updated COVID-19 vaccine for the 2023-2024 period and its efficacy in improving various patient outcomes.

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Real-World Considerations for New Therapies

Pharmacy Times

Panelists discuss how a new therapy for multiple myeloma would need to demonstrate significant improvements in efficacy, safety, or quality of life over current standards of care to warrant adoption while also considering factors such as cost-effectiveness, patient preferences, and ease of administration in their decision-making process for evaluating treatment changes.

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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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CVS ousts Karen Lynch, taps Caremark head as new CEO

Fierce Healthcare

It's a tumultuous time at industry giant CVS Health, and on Friday the company revealed a shake-up at the top that now has David Joyner stepping in as CEO. | It's a tumultuous time at industry giant CVS Health, and on Friday the company revealed a shake-up at the top that now has David Joyner stepping in as CEO.

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Acupuncture Represents Effective Nonpharmacologic Treatment for Sciatica Pain Management

Drug Topics

Acupuncture, a practice with thousands of years of history, has become increasingly accepted in mainstream medicine.

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Managing Medication Overuse Headache in Chronic Migraine

Drug Topics

Patients with chronic migraine can frequently overuse acute medications, leading to medication overuse headaches.

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Sanofi invests €300m in Orano Med's lead-based radioligands

pharmaphorum

Sanofi invests €300m in Orano Med's lead-based radioligandsSanofi has firmed up its position in the red-hot area of radiopharmaceuticals for cancer with the purchase of a €300 million ($325 million) stake in Orano Med, a subsidiary of French nuclear fuel company Orano.The transaction builds on a three-way partnership between Sanofi, Orano Med, and RadioMedix – signed in September with a €100 million upfront payment – to develop a radioligand therapy (RLT) for rare neuroendocrine tumours (NETs) c

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PBMs and Value-Based Care: A Pathway to Better Pharmacy Reimbursement

Drug Topics

David Pope, PharmD, Chief Pharmacy Officer at XiFin, joined Drug Topics to discuss value-based care and how it has changed the way pharmacy operates.

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Astellas nabs class-first FDA approval for CLDN18.2 gastric cancer med Vyloy

Fierce Pharma

After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy. | Astellas' Vyloy won an FDA approval to treat gastric or gastroesophageal junction adenocarcinoma patients whose tumors are CLDN18.2 positive. The drug was rejected earlier this year thanks to observations raised during the agency's inspection of a third-party manufacturing facility.

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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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Morning Rounds: A STAT crossword, Atul Gawande, and hearing music with hearing aids

STAT

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here. I’m recovering from the STAT Summit — in particular, recovering from this stunning view of Boston from the venue. On Wednesday evening, we had an amazing view of the almost-supermoon rising as dusk settled in during the last panel of the day.

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Can you drink while taking Nurtec?

The Checkup by Singlecare

You may have just popped a Nurtec ODT pill, ready to sip on some wine and relax after a long day. Suddenly, it hits you: “Can I even mix these two?” That moment of panic is all too familiar for many. Nurtec is a prescription drug that is FDA approved for managing migraine attacks and preventing episodic migraine, but it might not always pair with an evening drink.

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D.A. Wallach on his wife’s tragic death and creating a ‘golden record’ for medicine

STAT

D.A. Wallach met his late wife, Liz, at a Halloween party in Los Angeles hosted by the Maroon 5 star Adam Levine.  At the time, the erstwhile indie rocker never imagined that his relationship, and his career, would lead him to declare an all-out war on the U.S. health system. But then, Wallach said Thursday, she died four years ago, the day after giving birth.

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Gilead pulls Trodelvy's approval in bladder cancer after trial flop, FDA discussions

Fierce Pharma

After falling short in a confirmatory clinical trial, Gilead Sciences has decided to withdraw Trodelvy as a bladder cancer treatment in the U.S. | After falling short in a confirmatory clinical trial, Gilead Sciences has decided to withdraw Trodelvy as a bladder cancer treatment in the U.S.

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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+: Sales from controversial drug discount program rose to $63 billion last year

STAT

Prescription medicines purchased in the U.S. under a controversial government discount program amounted to $63 billion in 2023, a 23.4% increase from the previous year, according to the Health Resources & Services Administration, which oversees the program. The data mark a steady rise in sales under the 340B Drug Discount Program, which requires drugmakers to offer discounts that are typically estimated to be 25% to 50% — but could be higher — off all outpatient drugs to hospit

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FDA Places Clinical Hold on Novavax COVID-19/Influenza and Standalone Influenza Vaccine Trials

Pharmacy Times

The clinical hold is a result of a reported case of motor neuropathy in a phase 2 trial participant.

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Potential competition for RSV prophylactic Beyfortus

STAT

This story first appeared in The Readout newsletter.  Sign up for The Readout  and receive STAT’s award-winning biotech news delivered straight to your inbox.  Good morning! For those who were wise enough to attend, hope you enjoyed this year’s STAT Summit. Today, we talk about some RSV competition that’s brewing, how Alnylam’s CEO spoke about its plans with ATTR-CM, and more.

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MSD preparing to take on Beyfortus with RSV antibody

pharmaphorum

MSD reveals the data that could unlock filings for clesrovimab, a rival to Sanofi and AstraZeneca's Beyfortus for preventing infant RSV infections

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Skeletal Muscle Relaxants May Offer Benefit for Some Types of Chronic Pain

Drug Topics

Research is limited on the effectiveness and efficacy of this class of medications.

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EU drug reviewers back Novo Nordisk’s FDA-rejected hemophilia drug, snub PTC’s Translarna again

Fierce Pharma

After hitting a wall with the FDA last year, Novo Nordisk has picked up backing from European drug reviewers for its novel hemophilia treatment concizumab. | Novo Nordisk received good news from European drug reviewers on its hemophilia treatment, while PTC Therapeutics' Duchenne Muscular Dystrophy therapy was again recommended for rejection upon a re-examination.

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Patient-Level Interventions Can Increase HPV Vaccination Rates in Communities | IDWeek 2024

Drug Topics

Vaccination against HPV can prevent thousands of cases of cancer each year.

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One doctor’s quest to help people with hearing loss enjoy ‘all the richness’ of music

STAT

As a child in Jacksonville, Fla., Alex Chern built string instruments out of office supplies and tuned them, stretching rubber bands taut to change their pitch. Starting at age 7, he took violin lessons and continued playing all the way through college at Yale University. He loved playing Beethoven, expressive pieces written in F major like “Romance No. 2” or the “Spring Sonata,” and technically challenging pieces like Bach’s “Sonatas and Partitas,ȁ

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BenevolentAI CEO steps down as founders make a comeback

pharmaphorum

Jörg Möller's sojourn as CEO of BenevolentAI has come to an abrupt end, as the firm names co-founder Ken Mulvany as executive chair

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Opinion: STAT+: Genentech executive Fritz Bittenbender: Beware political soundbites

STAT

As Election Day 2024 gets closer, STAT’s First Opinion asked executives from leading biotech and pharmaceutical companies to reflect on how their industry is being portrayed in the presidential campaign — and what their hopes are for a new presidential administration. You can also read Eli Lilly chief scientist Daniel M. Skovronsky on fallacies surrounding patents, drug discovery, and affordability,   Sandoz CEO Richard Saynor  on what the 2024 conversation is missin

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Novo Holdings' $16.5B Catalent buyout in crosshairs as consumer groups ask FTC to block the deal

Fierce Pharma

Novo Holdings is encountering more resistance as it aims to close its $16.5 billion acquisition of pharma manufacturing giant Catalent by the end of the year. | A dozen consumer groups and trade unions penned a letter to Lina Khan, chair of the U.S. Federal Trade Commission, urging the antitrust agency to block Novo Holdings’ proposed $16.5 billion buyout of CDMO giant Catalent.

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Pharmacists as Key Players in Managing Chronic Conditions | ACCP 2024

Drug Topics

Pharmacist management of chronic conditions can lead to improved patient outcomes.

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Baxter to import 18,000 tons of IV product by year-end as hurricane recovery efforts continue in NC

Fierce Pharma

As recovery efforts at the North Carolina plant hit by Hurricane Helene move at an “encouraging pace,” Baxter International is laying out new details on a sweeping importation plan to help critical | Baxter has said the first IV product shipments cleared by the FDA for temporary importation are set to arrive in the U.S. this weekend. By the end of the year, the company expects nearly 18,000 tons of product from Europe and Asia to reach The States.

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STAT+: CVS Health replaces CEO as it faces a range of challenges

STAT

CVS Health has replaced Karen Lynch with David Joyner as CEO, it said Friday, part of an attempt to turn the struggling company around.  Joyner was previously the president of CVS Caremark, the company’s pharmacy benefit manager, and formerly worked at Aetna, the insurer now owned by CVS. The company said Lynch had stepped down “in agreement” with the company’s board.

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Innovative Study Design, Funding, and Community Engagement Needed to Address Systemic Racism in Childhood Asthma

Pharmacy Times

Research funding that aims to understand impacts of systemic racism on pediatric asthma should include plans to undo policies that maintain inequities created by systemic racism.

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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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Survey: Women Are Unaware of Uterine Fibroids and Their Treatment Options

Pharmacy Times

Awareness of uterine fibroids and uterine fibroid embolization can prevent unnecessary hysterectomies, especially in Black women, who are more likely to have uterine fibroids.

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STAT+: How a drug discount program intended to benefit the poor got entangled in a California rent-control fight

STAT

WASHINGTON — Californians are about to vote on an aggressive policy proposals to reform a drug discount program that is a key source of revenue for hospitals and health clinics. The group behind it? Apartment builders.  As a general rule, programs named after the sub-section of the law in which they were created are not well-known. The 340B Drug Discount Program is no exception.

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As Part of the Clinical Care Team, Pharmacists Can Enable Greater Medication Access, Boost Adherence, and Improve Health Outcomes

Pharmacy Times

Pharmacists today are an integral part of a patient’s care journey, providing clinical expertise and support that improves medication adherence, increases access to medication and advances health outcomes.

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Trends to watch at HLTH 2024

Fierce Healthcare

The HLTH 2024 conference will kick off Sunday in Las Vegas with an expected 12,000 attendees from across the industry to plot the future of healthcare innovation. | The HLTH 2024 conference will kick off Sunday in Las Vegas with an expected 12,000 attendees from across the industry to plot the future of healthcare innovation.

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