Tue.May 02, 2023

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FDA Approves Two Medications for Treatment of Schizophrenia 

Drug Topics

Otsuka America Pharmaceutical and Lundbeck’s Alify Asimtufii (aripiprazole) also was approved for maintenance monotherapy treatment of bipolar I disorder in adults.

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Opinion: Do masks work? Randomized controlled trials are the worst way to answer the question

STAT

Early in the Covid-19 pandemic, before we had vaccines and effective medical procedures, the only ways to prevent transmission of the virus were behavioral measures like face masks and social distancing. There was (and continues to be) a desperate hunger for definitive studies telling us how well specific measures would work, with specific publics, in specific settings, for specific strains of the novel and changing virus.

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Data, Collaboration Can Help Unlock the Full Potential of Value-Based Care

Drug Topics

A unified data ecosystem will provide the foundation for the next generation of patient-care technology.

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Opinion: Long waits to see a doctor are a public health crisis

STAT

In 2004, the physician search firm Merritt Hawkins first issued their Survey of Physician Appointment Wait Times. That year, the national average wait to get in to see a new physician was 21 days, an unacceptable amount of time to wait to access care. But that number has only gotten worse. In their 2022 survey , the wait for a new patient appointment increased to an average of 26 days.

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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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Treatment Landscape Surrounding TRD

Drug Topics

Key opinion leaders illustrate treatment strategies for patients diagnosed with TRD.

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STAT+: What to know about the upcoming readout of Eli Lilly’s experimental Alzheimer’s therapy

STAT

Eli Lilly is nearing the readout from a pivotal study of its experimental treatment for Alzheimer’s disease. The approval of a similar medicine earlier this year has wrung risk from the outcome, but for the same reason, expectations for strong results are higher. The Lilly drug, called donanemab, is an antibody that targets accumulated plaques in the brain called amyloid.

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Food Insecurity is a Leading Health-Related Social Need Among Patients With Diabetes

Pharmacy Times

Screening tools are becoming widely used to help clinicians address the needs of patients with diabetes to improve health outcomes.

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New Drug Pricing Policies Under Inflation Reduction Act Put More Liability on Payers, Manufacturers

Drug Topics

At the 2023 Asembia Specialty Pharmacy Summit, panelists discussed how inflation rebates and a redesign of Medicare Part D plans will impact payers and manufacturers.

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FDA Accepted sBLA for Luspatercept-aamt to Treat Anemia in Patients With Blood Cancer

Pharmacy Times

The treatment showed significant improvement in patients in patients who require frequent blood transfusions and are at risk of infection.

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Study: Ingredient found in salad bowls and burger wrappers less safe than previously thought

STAT

A compostable salad bowl seems like an Earth-friendly way to enjoy a healthy lunch. But the toxic chemicals used in containers like molded-fiber salad bowls, sandwich wrappers, and French fry pouches may be leaching into food despite efforts to make those materials safer, according to the results of a study published in March in the journal Environmental Science and Technology.

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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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Taking your biotech global? Here’s how you can navigate cultural norms

PharmaVoice

What’s so different about doing pharma business in the U.K. versus Japan? One of Moderna’s top brass shares her tips for navigating choppy cultural waters.

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Report on medical access finds one-third of Black Americans live in ‘cardiology deserts’

STAT

Many Black Americans would have to travel across county lines just to find an open spot with a cardiologist, a new analysis found. About 16.8 million Black Americans — roughly 1 in 3 — live in counties with little or no access to heart specialists, according to a report from GoodRx, a telehealth company that provides drug discounts and also researches health trends.

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Pfizer pulls off Q1 surprise with strong sales even as COVID vaccine demand plummets

Fierce Pharma

Pfizer pulls off Q1 surprise with strong sales even as COVID vaccine demand plummets kdunleavy Tue, 05/02/2023 - 09:27

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STAT+: A battle between Gilead and the U.S. government over patents on HIV prevention pills goes to trial

STAT

After years of sparring, the federal government and Gilead Sciences will square off in a Delaware courtroom this week in a bid to settle dueling claims over the rights to a pair of groundbreaking and lucrative HIV prevention pills. The case has drawn attention because a central theme is the extent to which taxpayer-funded research may be used by a pharmaceutical company to reap enormous profits, and whether the prices charged for any resulting medicine are out of reach for many Americans.

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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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How long does it take antidepressants to work?

The Checkup by Singlecare

If you’ve been prescribed an antidepressant, it’s probably because you’ve been experiencing levels of anxiety or depression that are interfering with your daily function or quality of life. This can be scary, frustrating, and exhausting, so chances are that once you begin taking an antidepressant , you want it to start working right away. Unfortunately, there is a waiting period when you start taking an antidepressant: While some take less time than others to work, you won’t be feeling the full

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Loneliness poses risks as deadly as smoking, surgeon general warns

STAT

WASHINGTON — Widespread loneliness  in the U.S. poses health risks as deadly as smoking a dozen cigarettes daily, costing the health industry billions of dollars annually, the U.S. surgeon general said Tuesday in declaring the latest public health epidemic. About half of U.S. adults say they’ve experienced loneliness, Vivek Murthy said in a report from his office.

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FDA accepts Bristol Myers Squibb’s Reblozyl sBLA for anaemia  

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted the supplemental biologics licence application submitted by Bristol Myers Squibb for Reblozyl (luspatercept-aamt) as a first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS). The regulatory body has also granted priority review to the application and set 28 August 2023 as a target date for the prescription drug user fee act (PDUFA).

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Wealth, not health: For this hospital, closing Chicago’s alarming ‘death gap’ didn’t mean more clinics

STAT

CHICAGO — When internal medicine physician David Ansell started his career in 1978 at “County,” the sprawling public hospital that treated many of this city’s poorest residents, he didn’t question why so many of them were so sick, and their cases so complicated. “I just thought these were conditions they just had,” he said in a recent interview.

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Driving Excellence, Modernization, and Harmonization in Pharmaceutical Science & Manufacturing

ISPE

Driving Excellence, Modernization, and Harmonization in Pharmaceutical Science & Manufacturing Trudy Patterson Tue, 05/02/2023 - 13:42 iSpeak Blog iSpeak Driving Excellence, Modernization, and Harmonization in Pharmaceutical Science & Manufacturing Lisa J. Graham, PhD, PE 2 May 2023 The needs of patients provide the impetus to challenge the notion of “this is the way we’ve always done it.

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For Spanish-speaking Latinas, language gaps — real or perceived — tied to discrimination during labor

STAT

The research question that pursued Jessica Valdez, an OB-GYN resident physician at the University of California, San Francisco, stemmed from her mother’s womb: How important is it to a birthing woman’s experience to be seen by health care providers who share her primary language? Valdez’s mother was 17 when she immigrated to California from Mexico in the 1970s.

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Why R&D innovation holds the key to greater patient impact

European Pharmaceutical Review

Cancer remains a global threat with around 10 million people dying from the disease each year worldwide, making it the second leading cause of death. 1,2 In the EU, an estimated 2.7 million people are diagnosed with cancer annually and the number is growing. 3 With greater scientific understanding of cancer, the industry has made significant progress in developing innovative medicines to help patients.

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STAT+: Tobacco control groups oppose a bill targeting disposable vapes — because they worry RJ Reynolds is behind it

STAT

WASHINGTON — There’s a new bill in Congress meant to crack down on the cheap disposable vapes, like Puff Bar, that are increasingly popular with kids. But nearly all of the leading tobacco-control groups don’t want anything to do with it. They say the bill is being pushed by the makers of competing vapes, namely RJ Reynolds, the maker of Vuse e-cigarettes, to take attention off of its products’ growing popularity, and to push competition out of business.

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Albertsons kicks off PSA campaign to address food insecurity

Drug Store News

Under its charitable program Nourishing Neighbors, the message encourages communities and people to come together to help more than 30 million people in the U.S. who are food insecure.

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STAT+: Legal battle between Apple and Masimo over trade secrets ends in mistrial

STAT

A California jury was unable to reach a verdict in a messy, drawn-out legal battle between Apple and patient-monitoring company Masimo. James Selna, the judge presiding, announced the case a mistrial on Monday. “While we are disappointed that the jury was unable to reach a verdict, we intend to retry the case and continue to pursue legal redress against Apple,” Masimo told STAT in a statement.

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Watch DSN: Walmart Marketplace helps expand product reach to consumers

Drug Store News

DSN spoke to Manish Joneja, senior vice president of Walmart U.S. Marketplace and Walmart Fulfillment Services, about why now is the ideal time for new sellers to join the marketplace.

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From science to strategy, this exec is painting Genmab’s bigger picture into the next decade

PharmaVoice

Martine van Vugt, recently named Genmab’s chief strategy officer and executive vice president, aims to usher in the company’s next wave of "knock your socks off" antibodies.

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Ritual enters skin care space with HyaCera

Drug Store News

HyaCera is formulated with ingredients that hydrate the skin after 90 days of use and also help minimize fine lines and wrinkles, the company said.

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GSK staffers kick off series of strikes in UK for the first time in drugmaker's history

Fierce Pharma

GSK staffers kick off series of strikes in UK for the first time in drugmaker's history aliu Tue, 05/02/2023 - 14:22

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Walgreens expands commitment to improving mental health, well-being

Drug Store News

Walgreens and Mental Health America are collaborating to address youth mental health, bringing much-needed resources to local schools.

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Poland takes its COVID-19 vaccine fight to Pfizer's shareholders, urging the company to be a good corporate citizen

Fierce Pharma

Poland takes its COVID-19 vaccine fight to Pfizer's shareholders, urging the company to be a good corporate citizen zbecker Tue, 05/02/2023 - 16:34

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Hey Jane gets covered: Telemedicine abortion provider inks contracts with Blues plans

Fierce Healthcare

Hey Jane gets covered: Telemedicine abortion provider inks contracts with Blues plans aburky Tue, 05/02/2023 - 15:53

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FDA releases draft guidance for decentralised clinical trials

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices. The publication includes recommendations for sponsors, investigators and other stakeholders regarding the implementation of DCTs to advance medical product development and research.

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Gilead, US government set for courtroom showdown over PrEP drug patents

Fierce Pharma

Gilead, US government set for courtroom showdown over PrEP drug patents esagonowsky Tue, 05/02/2023 - 08:50

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Expert: Pharmacy, Medical Benefit Adoption of Biosimilars Present Different Challenges

Pharmacy Times

Fran Gregory, PharmD, MBA, vice president of Emerging Therapies at Cardinal Health, discussed the biosimilars landscape and where biosimilars fall in the process of pharmacy and medical benefit adoption.

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