Tue.Feb 07, 2023

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Vitamin D Use Connected to Reduced Risk of Diabetes in Adults with Prediabetes

Drug Topics

According to adjusted analyses, vitamin D reduced the risk of diabetes by 15% with a 3-year absolute risk reduction of 3.3%.

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4 Attributes of a Great Pharmacy Technician

Pharmacy Tech Scholar

What Makes a Great Pharmacy Technician? Our students commonly ask us for tips on getting a job after completing our PTCB-recognized education program. Being marketable… The post 4 Attributes of a Great Pharmacy Technician appeared first on Pharmacy Tech Scholar.

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BLA for Sandoz Proposed Denosumab Biosimilar Accepted by FDA

Drug Topics

The Biologics License Application of a proposed biosimilar of denosumab, a drug that could treat several bone diseases and issues, has been accepted by the FDA.

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United by inequity: The healthcare disparities plaguing rare disease patients and Black Americans

PharmaVoice

Guided by her personal experiences, Tamar Thompson is aiming to improve rare disease care through her advocacy work at Alexion, AstraZeneca Rare Disease.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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NDA for Zuranolone for Depression Accepted by FDA

Drug Topics

Zuranolone, a fast-acting neuroactive steroid that can take effect in 14 days, has been assigned a PDUFA action date of Aug. 5, 2023 by the FDA. It can be used to treat patients with major depressive disorder and postpartum depression.

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Vertex pricing under fire—again—as activists press 4 governments for Trikafta generics

Fierce Pharma

Vertex pricing under fire—again—as activists press 4 governments for Trikafta generics fkansteiner Tue, 02/07/2023 - 10:08

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STAT+: Pharma loses a court battle in its bid to block states from importing drugs from Canada

STAT

In a setback to the pharmaceutical industry, a federal judge has tossed a lawsuit that sought to prevent state governments from importing medicines from Canada. The decision is likely to embolden more states to now consider the approach as they look to lower the cost of prescription drugs In a 26-page opinion , U.S. District Court Judge Timothy Kelly ruled that drug companies failed to prove they would face a “concrete risk of harm” from a federal rule that would allow states to im

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Payers' price transparency data still not user-friendly, say researchers

Fierce Healthcare

Payers' price transparency data still not user-friendly, say researchers fdiamond Tue, 02/07/2023 - 15:14

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UK MHRA approves Takeda’s dengue vaccine Qdenga

Pharmaceutical Technology

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]). The vaccine candidate has been approved for active immunisation against the infection in people from four years of age. Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes.

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AstraZeneca’s Forxiga approved in EU for chronic heart failure

Pharmafile

AstraZeneca has announced that its drug, Forxiga, has been approved in the EU for the treatment of symptomatic chronic heart failure. This follows an approval from the EMA’s Committee for Medicinal Products for Human Use in December. The drug is already approved in the EU for the treatment of type 2 diabetes as well as chronic kidney disease. It has also received regulatory approvals in Britain, Japan and Turkey, as well as the US and now the EU.

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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 gives first RMAT designation to a cardiac gene therapy

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-A501, an adeno-associated virus (AAV)-based gene therapy for Danon disease. “RP-A501 is the first cardiac gene therapy to receive RMAT designation from the FDA,” commented Dr Gaurav Shah, Chief Executive Officer at Rocket Pharmaceuticals.

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Farming, pharmaceutical and health pollution fuelling rise in superbugs, UN warns

The Guardian - Pharmaceutical Industry

Sewage, poor sanitation and a lack of regulation give rise to antimicrobial resistance and threaten global health, report says Pollution from livestock farming, pharmaceuticals and healthcare is threatening to destroy a key pillar of modern medicine, as spills of manure and other pollution into waterways are adding to the global rise of superbugs, the UN has warned.

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New mouse study shows genes aren’t only way to pass obesity to next generation

STAT

From the color of our eyes to our odds of developing cancer, we’re all shaped by the genetic legacy of our ancestors. But a new study in mice provides the clearest evidence yet that acquired traits can be passed down from one generation to the next in mammals without DNA changes, challenging centuries of evolutionary dogma and raising fresh questions about the factors that affect our health.

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State of the Union expected to lay out priorities for telehealth, insurer pay parity

Fierce Healthcare

State of the Union expected to lay out priorities for telehealth, insurer pay parity rking Tue, 02/07/2023 - 15:36

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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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Senators probe telehealth companies for tracking and monetizing sensitive health data

STAT

A bipartisan group of senators fiercely criticized several prominent telehealth startups for failing to protect sensitive health information, citing an investigation by STAT and The Markup which found dozens of telehealth companies sharing patient data with Facebook, Google and other major advertising platforms. “This data is extremely personal, and it can be used to target advertisements for services that may be unnecessary or potentially harmful physically, psychologically, or emotional

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So Much More than Just Paperwork – The Importance of Design Controls for Device Start-ups

The FDA Law Blog

By Adrienne R. Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. For founders new to the medical device industry, especially with device types that are often considered novel, the learning curve can be steep.

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STAT+: Angry at Vertex pricing of cystic fibrosis drugs, families in four countries seek to override patents

STAT

In a bid to expand access to pricey cystic fibrosis treatments, a coalition of families and activists are petitioning four governments — South Africa, India, Brazil, and Ukraine — to make it possible to obtain generic versions of a medicine sold by Vertex Pharmaceuticals. And the coordinated effort underscores the growing global battle over equal access to medicines.

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An Inflection Point for Healthcare

Fierce Healthcare

An Inflection Point for Healthcare mteefey Tue, 02/07/2023 - 15:27

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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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Opinion: The tyranny of the inbox: What it’s like to be a PCP with OCD

STAT

Like so many health care workers, I have seriously considered giving up my clinical practice multiple times — even more since the onset of the pandemic. For me, wanting to bail out of my job as a primary care physician has nothing to do with the risk of contracting Covid-19 or any other communicable disease. The real reason is best summarized by the unimaginably annoying Lamb Chop’s Play-Along Song.

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Giant’s electric vehicle fleet hits streets of Philadelpia

Drug Store News

The electric vans will fulfill Giant Direct customer deliveries while reducing the company’s environmental footprint.

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STAT+: Chinese DNA giant’s U.S. affiliate looks to rival Illumina, touting $100 genome and high-power sequencers

STAT

Complete Genomics, a U.S. firm affiliated with Chinese sequencing giant BGI, on Tuesday announced plans to launch a new line of sequencers it says can decode DNA in larger amounts — and at lower costs — than any instrument on the market. The company claims the sequencer, dubbed DNBSEQ-T20, can read up to 50,000 human genomes a year, 2.5 times the max output of a line of new high-end sequencers that Illumina , the market leader, recently launched.

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What are patient assistance programs?

The Checkup by Singlecare

The rising cost of living in the United States is making it harder to pay for prescription medicines, even among individuals with health insurance. For the uninsured or underinsured, high drug costs may mean forgoing a much-needed medication altogether. In fact, more than 1 in 4 Americans struggle to afford their meds, according to a poll conducted by the Kaiser Family Foundation.

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The Vitamin Shoppe opens 1st franchise location in Indiana

Drug Store News

The Vitamin Shoppe plans to open at least 12 new franchise stores this year with local partners.

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What do your stress test results mean?

The Checkup by Singlecare

If you’ve been told that you need a stress test, you probably have some concerns. That’s understandable—being told that you need an evaluation of how your heart works can be stressful. You can rest assured that these tests are common, especially if you have any risk factors for cardiac disease. Still, as you prepare for your test, you may want to know what stress tests are like, and what to expect at the doctor’s office when you get the test done.

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TheracosBio receives FDA OK for Brenzavvy

Drug Store News

Brenzavvy is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes.

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Opinion: 2022 was a breakthrough year for understanding rare diseases. 2023 needs to be better

STAT

Major advances in the study and treatment of rare diseases occurred in 2022, from a better understanding of just how many of these diseases exist to the start of new clinical trials that may lead to new therapies. For the last decade or so, the number of accepted rare diseases has stood between 7,000 and 8,000, though the number had been ticking up.

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Food Lion set to open latest West Virginia store

Drug Store News

Food Lion’s newest store will have a large selection of organic, gluten-free and plant-based items to choose from.

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STAT+: Former Sen. Richard Burr to join health care practice at law and lobbying firm

STAT

WASHINGTON — Former Sen. Richard Burr is the latest participant in Washington’s revolving door between Congress and industry. Burr, who was the lead Republican on the Senate health committee until his retirement in January, will be starting as a senior policy adviser and chair of a new health policy strategic consulting practice at DLA Piper, the firm announced Tuesday.

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Sally Hansen’s Good.Kind.Pure line preps for picnic season

Drug Store News

The Dessert Charcuterie collection from Sally Hansen’s Good.Kind.Pure line was inspired by charcuterie boards filled with berries and pastries.

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STAT+: How one biotech investor is changing his calculus now that Medicare can negotiate drug prices

STAT

NEW YORK — Biotech investors don’t often publicly lay out their strategies, but an executive with a top investment firm on Tuesday offered a rare glimpse into the math he and others like him are doing after Democrats empowered Medicare to negotiate drug prices. Peter Thompson, a general partner at investment giant OrbiMed Advisors who has spent around four decades in oncology drug development, laid out several ways the law will steer capital to a packed audience at a New York City

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CVS Health reportedly inching closer to Oak Street Health acquisition for $10.5B

Drug Store News

CVS Health's acquisition of primary care provider Oak Street Health could be announced this week.

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In State of the Union, Biden pitches addiction, mental health care policies as opportunities for bipartisanship

STAT

WASHINGTON — President Biden strived with Tuesday night’s State of the Union address to find a plank of bipartisan support in a split Congress, with health care priorities holding up the frame.  The president, halfway through his term, pointed to a slew of populist policies he still hopes Congress could achieve, from battling the addiction crisis to improving mental health care access and bolstering support for at-home caregivers.

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Upsher-Smith opens manufacturing facility in Minnesota

Drug Store News

Upsher-Smith is now offering contract manufacturing, packaging and serialization capabilities.