Tue.Aug 22, 2023

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FDA Approves Pfizer RSV Vaccine for Use During Pregnancy to Protect Infants

Drug Topics

The respiratory syncytial virus vaccine (Abrysvo) is the first and only maternal RSV vaccine used to help protect infants from the virus.

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Esketamine May Boost Efficacy of Oral Antidepressants in Patients with Fluctuating Response

Pharmacy Times

Researchers sought to find a remedy for the development of treatment-resistant depression in patients whose antidepressant treatment has fluctuated in efficacy.

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MorningRX: August 22, 2023

Drug Topics

Poll finds Americans still struggle with health misinformation, CMS release new guidance on out-of-pocket Prescription Drug Cost Program, and experts call for continued masking in health care settings.

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Elevating Pharmacy Technicians: The Case for a Well-Deserved Pay Raise

Pharmacy Times

Pharmacy technicians should advocate for fair pay raises due to their crucial role, expanding skills, and cost-effectiveness over turnover.

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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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E-Cigarette Use Among Patients with CVD Rebounds After Initial Decline

Drug Topics

E-cigarettes have garnered popularity since entering the market in 2006 as a potential aid for smoking cessation, but their use has been associated with increased adverse cardiovascular events.

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FDA Approves Vaccine for Pregnant Individuals to Prevent Respiratory Syncytial Virus in Infants

Pharmacy Times

It is the first vaccine of its kind to be FDA approved, and it met multiple safety and efficacy standards through clinical trials.

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More Trending

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Certain Brain Cells May Help Humans Stay Awake Longer Without Impacting Cognition, Health

Pharmacy Times

Sleep loss is known to impact key processes such as attention, cognition, learning, memory, metabolism, and immune function.

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What infeasible trial? Lilly shows Roche how it's done with positive Retevmo readout in thyroid cancer

Fierce Pharma

It was only a few weeks ago when Roche said a phase 3 study testing its RET inhibitor Gavreto in a type of thyroid cancer was not doable. | A few weeks ago, Roche said a phase 3 study testing its RET inhibitor Gavreto in a type of thyroid cancer was not doable. Now, Eli Lilly has revealed that a similar trial of its Retevmo was not only feasible but positive.

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North Carolina hospitals sue thousands of patients, families to collect debts, analysis finds

Fierce Healthcare

Across a five-and-a-half-year period, North Carolina hospitals seeking payments brought nearly 6,000 lawsuits against roughly 7,500 patients and their family members, according to a recent analysis | The hospitals were awarded a total of $57.3 million by North Carolina's civil court system across five and a half years, with "a small subset" of hospitals and health systems leading the way.

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Medical illustrations neglect people with dark skin. A Nigerian doctor-to-be is working to change that

STAT

Medical illustration is both an art and a science. But it can have a huge cultural impact, too, as medical student and illustrator Chidiebere Ibe discovered when his illustration of a pregnant Black woman and her fetus went viral in 2021. The image was groundbreaking precisely because it shouldn’t have been. People have a wide range of skin colors, and everyone develops medical conditions; it’s common sense that medical illustrations should feature a diverse range of bodies.

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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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Employers' enthusiasm for virtual care is on the decline: Business Group

Fierce Healthcare

At the height of the COVID-19 pandemic, employers believed virtual care would have a huge, broad impact on how care is provided across the country. | As COVID-19 has receded, employers' confidence in virtual care to drive changes in care delivery has waned, according to a newly-released survey from the Business Group on Health.

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UK pumps £13M into wide-ranging group of manufacturing projects

Fierce Pharma

Improved vaccines, cutting-edge mRNA medicines and accelerated drug production are at the heart of a new funding project in the U.K., where 17 companies have been selected for government grants to | Improved vaccines, cutting-edge medicines and accelerated drug production are at the heart of a new funding project in the U.K.

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Value-based oncology platform Thyme Care clinches $60M to expand in new markets

Fierce Healthcare

Thyme Care, a value-based oncology platform, has raised $60 million in a series B round. | Powered by a team of nurse practitioners, oncology nurses and resource specialists, the company aims to help members better understand their diagnosis, manage and address symptoms and quickly connect them to care with its platform, Thyme Box.

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Opinion: The hospice industry needs major reforms. It should start with apologies

STAT

“How has the clinical work you do affected you personally?” We’d come to the Q&A part of the evening in an historic church in eastern Pennsylvania. I had traveled there at the request of a local hospice to talk about my perspective as a doctor with a long career of caring for seriously ill and dying patients. I smiled at the casually dressed older man who asked the question.

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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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Epic taps Microsoft to accelerate generative AI-powered 'copilot' tools to help clinicians save time

Fierce Healthcare

Epic is tapping into Microsoft's AI expertise to roll out more tools to help clinicians save time and access critical data at the point of care. | Epic is tapping into Microsoft's AI expertise to roll out more tools to help clinicians save time and access critical data at the point of care. These "copilot" solutions aim to help with medical note summarization, offer coding suggestions and provide access to real-world evidence for patient care.

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Spanish drugmaker Serra Pamies suffers manufacturing clampdown by EMA

Fierce Pharma

Problems with quality management, data integrity, expired raw materials and more have prompted the European Medicines Agency (EMA) to put the kibosh on manufacturing at Serra Pamies’ Reus, Spain, f | Problems with quality management, data integrity, expired raw materials and more have prompted the European Medicines Agency to put the kibosh on manufacturing at Serra Pamies’ Reus, Spain, facility.

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Opinion: How to take care of trans patients in hospice

STAT

In the United States, more than 1.6 million people identify as transgender. Of these, more than one-fifth are over the age of 65 , the vast majority of whom transitioned in the latter part of their lives. Transgender Americans are both living and dying among us: precisely why we health care providers must improve our approaches to ensuring dignified and respectful care for transgender elders, especially at the end of life.

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Most Americans support value-based care but prefer other terms, research finds

Fierce Healthcare

Most Americans support the idea of value-based care but don’t understand or resonate with the term, according to new research from United States of Care. | In total, 64% of people in a national survey supported value-based care over the fee-for-service model. Most resonated with terms and phrases other than value-based care, including “quality-focused care” and “patient-first care.

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FDA greenlights medical device to combat bladder issues

STAT

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences.  Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday.

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Teva, Glenmark ?reach $255M price-fixing settlement with DOJ, agree to offload certain meds

Fierce Pharma

After admitting to running a price-fixing scheme as part of a deal with the Department of Justice, not only will generic makers Teva and Glenmark Pharmaceuticals pay hefty fines, but they'll also b | Glenmark Pharmaceuticals will pay $30 million for similar charges. The two will also divest their generic pravastatin products and Teva is required to donate $50 million worth of generics of antifungal cream clotrimazole and antibiotic tobramycin to humanitarian organizations.

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How the first Native Hawaiian psychiatrist set a course for diversifying medicine

STAT

Benjamin Young didn’t set out to be the first Native Hawaiian psychiatrist. Nor did he go looking to be the first physician on board what would become a landmark epic voyage from Tahiti to Hawaii back in 1976, using only the stars, sun, moon, and cloud and wave patterns as guides. And Young had no clue that, toward the beginning of his career, he would be called on to start up a first-of-its-kind program at the University of Hawaii to diversify the number of Pacific Islanders and other un

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Zydus Pharmaceuticals (USA) Inc. Profile

Pharmacy Times

Zydus Pharmaceuticals (USA) Inc, has come a long way since its first commercial launch in August 2005.

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STAT+: Eli Lilly CEO donates big to Mike Pence presidential super PAC

STAT

WASHINGTON — David Ricks, who leads Eli Lilly, made a major early donation to a super PAC in support of former vice president Mike Pence — one of the first big 2024 donations from a major player in the pharmaceutical industry. Ricks in June donated $25,000 to a special political action committee called Committed to America, which was founded to support Pence.

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With new lawsuit, Boehringer Ingelheim becomes latest drugmaker to take aim at IRA

Fierce Pharma

As litigation challenging the Inflation Reduction Act (IRA) piles up, Boehringer Ingelheim has become the latest drugmaker to take aim at the new law. | Boehringer Ingelheim's Eli Lilly-partnered diabetes blockbuster Jardiance will likely make the list of drugs eligible for pricing negotiations, raising the stakes for the company's lawsuit.

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STAT+: FDA advisory panel to debate contentious data on Medtronic’s high blood pressure device

STAT

An advisory committee to the Food and Drug Administration will convene on Tuesday to evaluate the benefits of renal denervation, a one-time surgical procedure that works to reduce blood pressure. The promise — and the potential market — is enormous, but the data on how well the procedure works remains contentious. The committee will evaluate data from two companies vying for market approval: ReCor Medical, a startup owned by Japanese company Otsuka Medical Devices, and device giant

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In conversation with Regius Professor of Pharmacy Ian Wong

Hospital Pharmacy Europe

Recently appointed the UK’s only Regius Professor of Pharmacy, Ian Wong speaks to Rod Tucker about his continent-spanning pharmacy career from community and regulation to academia and beyond. He shares insight into his varied research, his special interests in epilepsy, mental health and paediatrics, and the key learnings he’s adopted along the way.

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DSN webinar: Panelists weigh in on pharmacists' expanded role as providers

Drug Store News

During a webinar sponsored by OmniSYS, several panelists weighed in on pharmacists’ contributions during the pandemic and assessed efforts needed to expand their role.

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A tale of 2 industries: FDA's Robert Califf weighs in on 'fundamental problem' causing so many shortages

Fierce Pharma

Robert Califf, M.D., is “fired up” about the spate of U.S. drug shortages that now constitutes a “national security threat,” the FDA commissioner said Tuesday. | “I did not come back to FDA to spend all my time on supply chain, but that’s what’s happened,” Commissioner Robert Califf, M.D., said in response to a question about drug shortages during a recent presentation of the Alliance for a Stronger FDA.

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UK medicines manufacturing to get innovation boost

European Pharmaceutical Review

According to UK Research and Innovation ( UKRI ), £13 million is set to fund medicine manufacturing in the UK, through a focus on innovation in intracellular drug delivery, digitalisation and automation and nucleic acid medicines. The investment aims to improve vaccines and shorten the time it takes to produce medicines. Winners of a series of competitions centering on the aforementioned topics will obtain funding for UK medicines manufacturing.

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Novartis to lay off another 100-plus employees at US HQ as global restructuring rolls on

Fierce Pharma

After cutting hundreds of jobs in New Jersey around the start of this year, Novartis is at it again. | Novartis is cutting another 103 jobs at its U.S. headquarters in New Jersey, where the pharma giant just recently executed a 285-person round of layoffs.

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STAT+: Pharmalittle: FDA approves Pfizer’s RSV vaccine for newborns; Boehringer sues over IRA

STAT

Good morning, one and all. Damian Garde here, filling in for Ed Silverman once more on another day of aberrant weather and out-of-office autoreplies. Here’s hoping yours ends with fewer open browser tabs than it began. Below find a few items to get you started, and, as always, let us know if you hear anything interesting out there. The Food and Drug Administration approved a Pfizer vaccine that aims to protect newborns against RSV by vaccinating pregnant people, STAT tells us.

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Pfizer's Abrysvo becomes first maternal RSV shot to protect newborns

Fierce Pharma

Already with an approval in hand for older adults, Pfizer’s Abrysvo has become the first vaccine for pregnant women to protect their newborns against respiratory syncytial virus (RSV). | Already with an approval in hand for older adults, Pfizer’s Abrysvo has become the first vaccine for pregnant women to protect their newborns against respiratory syncytial virus (RSV).

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Twitter to 'X' and the Evolving Social Media Landscape for Marketers: Q&A with Mikaela Walker, Marketing and Social Manager at Greater Than One

PharmExec

Amid Twitter's transformation into "X", social media expert Mikaela Walker weighs in on the rebrand's impact for pharma marketing, assesses ongoing brand safety risks, and highlights established social platforms and those gaining traction.

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Pfizer maternal RSV vaccine approved

European Pharmaceutical Review

Abrysvo is approved for pregnant individuals to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants. The US Food and Drug Administration (FDA)-approved treatment, is the first RSV vaccine indicated for infants from birth to six months of age. It is approved for use at 32 through to 36 weeks pregnancy gestation.