Sat.Apr 01, 2023 - Fri.Apr 07, 2023

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FDA requires prepaid mail-back envelopes for opioid analgesics

Pharmafile

The FDA has announced that it will require opioid analgesic manufacturers to provide prepaid mail-back envelopes in outpatient pharmacies and dispensers as an additional disposal option for patients.

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A drug just launched for a disease discovered only 10 years ago

PharmaVoice

Pharming just landed an FDA approval for a treatment targeting an ultra-rare immunodeficiency disorder discovered only a decade ago — and it’s already in the hands of patients.

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FDA publishes report stating Global Pharma’s eye drops broke safety norms

Pharmafile

The FDA has published a report revealing that Global Pharma’s plant in India’s Chennai city failed to achieve safety norms throughout multiple observations. In February 2023, the eye drops, under the brand names EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears, were recalled after a recommendation from the FDA, which then stopped the import of the products to the US.

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MedPAC proposal threatens access to medicines in Part B

PhRMA

Next week, the Medicare Payment Advisory Commission (MedPAC) will vote on a number of policy proposals for changing Medicare Part B. One of the proposals would recommend that Congress adjust the payment for Part B medicines with accelerated approval , including medicines for serious and life-threatening diseases like cancers, rare diseases and HIV. This could compromise patient access to medicines, which is the opposite of what accelerated approval is designed to do.

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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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Cytokinetics Announces Discontinuation Of ALS Drug Trial

Drug Topics

The biopharmaceutical company says it is “extremely disappointed” with the results of the COURAGE-ALS study, which failed to meet primary or secondary endpoints.

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Hospitals pledge to protect patient privacy. Almost all their websites leak visitor data like a sieve

STAT

Every hospital in America promises to protect the privacy of its patients and the details of their medical care. And almost every one of them uses sophisticated data tools to track and share the personal information of visitors as soon as they start clicking on their websites. A new study found that 99% of U.S. hospitals employed online data trackers in 2021 that transmitted visitors’ information to a broad network of outside parties, including major technology companies, data brokers, an

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ICYMI: PhRMA President and CEO Stephen J. Ubl discusses patient affordability

PhRMA

PhRMA president and CEO Stephen J. Ubl spoke recently at The Hill’ s event, “ Pathways to Patient Affordability.” He spotlighted patients’ affordability challenges, the unintended consequences we’re already seeing from the government price setting provisions in the Inflation Reduction Act (IRA) and how policymakers can address harmful pharmacy benefit manager (PBM) practices.

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Examining the Link Between Infections and Cognitive Decline in Older Adults

Drug Topics

Both acute and chronic infection can increase the risk of cognitive decline and dementia in older adults.

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After Johnson & Johnson loses again in bankruptcy case, it's game on for talc lawsuits

Fierce Pharma

After Johnson & Johnson loses again in bankruptcy case, it's game on for talc lawsuits kdunleavy Mon, 04/03/2023 - 06:44

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6 megadeals made up 40% of digital health funding in Q1 as smaller startups face rough waters: Rock Health

Fierce Healthcare

6 megadeals made up 40% of digital health funding in Q1 as smaller startups face rough waters: Rock Health hlandi Tue, 04/04/2023 - 14:40

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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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CMS coverage policy is detrimental to Alzheimer’s patients

PhRMA

This week marks a somber anniversary for patients with Alzheimer’s. Last year, the Centers for Medicare & Medicaid Services (CMS) finalized a national coverage determination (NCD) that, for the first time ever, uses a coverage with evidence development (CED) policy that forces Medicare patients into highly restrictive research studies to simply gain access to new Alzheimer’s medicines that have been approved by the U.S.

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Senate Finance Committee Urges PBMs To Make Big Changes

Drug Topics

Members of the Senate Finance Committee are pushing PBMs to modernize the rules regarding out of pocket costs and competition.

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J&J opens its wallet with whopping $8.9B talc settlement offer

Fierce Pharma

J&J opens its wallet with whopping $8.

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STAT+: ‘True disruption’: Mark Cuban’s company will sell brand-name diabetes medicines from J&J

STAT

For the first time, Mark Cuban’s Cost Plus Drug Company is selling medicines made by a large drug manufacturer directly to consumers at a greatly reduced price, the latest sign that the billionaire is trying to make good on his vow to disrupt the opaque pharmaceutical supply chain. Until now, the company has focused on selling generic versions of brand-name medicines.

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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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States can support access to medicine as COVID-19 Public Health Emergency ends

PhRMA

The United States will soon reach an important milestone in the COVID-19 pandemic: the official end of the federal public health emergency (PHE). According to the U.S. Department of Health and Human Services (HHS), the COVID-19 PHE will expire on May 11, 2023. This significant transition has been made possible, in part, by the biopharmaceutical industry’s continuing efforts to research, develop and manufacture safe, effective treatments and vaccines for COVID-19.

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FDA Officially Withdraws Approval of Makena After Lengthy Debate

Drug Topics

The FDA has finally decided to withdraw approval of Makena and its generics after Covis Pharma volunteered to remove the drug from market in March.

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From 'transformative' to 'tremendous fear': Takes on ChatGPT in healthcare at ViVE 2023

Fierce Healthcare

From 'transformative' to 'tremendous fear': Takes on ChatGPT in healthcare at ViVE 2023 hlandi Tue, 04/04/2023 - 06:25

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1 in 6 people experience infertility worldwide, according to WHO report

STAT

One in six people across the globe face infertility at some point in their lifetime, according to the first new estimates from the World Health Organization in a decade. The prevalence is “staggering,” Pascale Allotey, director of sexual and reproductive health and research at WHO, said at a press conference Monday. The report estimates that 17.8% of adults in high-income countries and 16.5% in low- and middle-income countries experience infertility.

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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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Arkansas puts patients first with new share the savings law

PhRMA

Recently, Arkansas became the latest state to enact a law so that many patients aren’t paying more for their medicines than their insurance company or pharmacy benefit manager (PBM). The policy, commonly referred to as “share the savings,” requires insurers and the PBMs they work with to share the rebates, discounts, and other price concessions they receive from manufacturers directly with patients at the pharmacy counter.

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Amazon Teams Up With Pharma Giants For Coupons On Branded Drugs

Drug Topics

The new feature automatically applies manufacturer-sponsored coupons directly to an eligible patient’s order. So far, only a few pharma companies have made their coupons available through Amazon.

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Wellness Support Group Shows Promise in Reducing Burnout

Pharmacy Times

Discussions are led by a variety of experienced preceptors to provide insight, strategies, and resources for pharmacy residents.

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STAT+: The biotech scorecard for the second quarter: 24 stock-moving events to watch

STAT

Here is STAT’s biotech scorecard, our regular ledger of stock-moving biotech events, for the second quarter: When is “mid-year”? This is not an existential question. Practically speaking, when a drugmaker, let’s say Bridge Bio , tells investors that an important readout of all-cause mortality data from a clinical trial of its heart drug acoramidis is coming “mid-2023,” does that mean the end of June or the beginning of July?

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Connecting with Patients at Home

Pharmacy Is Right For Me

There are so many different types of careers within the field of pharmacy—from research and drug development to pharmacy informatics! To learn about some of the more unique career settings in the industry, check out the Novel Pharmacy Practice Settings page —where you can explore these unique career pathways such as integrated health-community paramedicine.

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What is a Patient Advocate?

Drug Topics

Health care advocates provide a vital service for patients who are managing chronic conditions.

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FDA authorizes InflaRx's anti-inflammation drug for most serious COVID despite phase 3 miss

Fierce Pharma

FDA authorizes InflaRx's anti-inflammation drug for most serious COVID despite phase 3 miss aliu Tue, 04/04/2023 - 16:48

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Opinion: I declined to share my medical data with advertisers at my doctor’s office. One company claimed otherwise

STAT

I care deeply about privacy, and as a professional researcher, I take meticulous notes. During my recent maternity leave, I spent most of my hands-free time trying to figure out why my doctors were trying to give my medical data away to advertisers — even after I opted out.

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Empowering Women: 5 Compelling Reasons Women Pursue a Career in Pharmacy

Pharmacy Is Right For Me

Pharmacy is a field of study and practice that may have historically been male-dominated, but now an estimated 65% of pharmacists in the United States are women! And there are many benefits to women who pursue pharmacy as a career. Job stability and growth Pharmacy is a rapidly growing field that’s expected to continue to grow in the coming years. The Bureau of Labor Statistics projects that the employment of pharmacists will increase by 3% from 2020 to 2030.

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Half of All Meningococcal Vaccination Appointments Were Delayed or Canceled During COVID-19 Pandemic

Drug Topics

Data reveal 50% of meningitis vaccination appointments were delayed or canceled amid the COVID-19 pandemic, leading authors of a survey to highlight the need for “urgent action” to maintain routine vaccination levels among children.

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New bipartisan bill aims to tie doc pay to inflation amid industry concerns

Fierce Healthcare

New bipartisan bill aims to tie doc pay to inflation amid industry concerns rking Thu, 04/06/2023 - 16:13

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Updates on 503A Compounding: Legal and Regulatory Developments

Pharmacy Times

Part 1 of this 2-part series examines USP and revisions for sterile and nonsterile compounding, veterinary compounding, FDA inspections of 503A pharmacies, and the interstate distribution of compounded prescriptions post Wellness Pharmacy v. FDA.

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Opinion: In a world of synthetic biology, publishing virus DNA sequences may mean perishing

STAT

The wholly synthetic mRNA vaccines for Covid-19 saved nearly 20 million lives in just their first year of use, according to data published in 2022 by The Lancet. That success stands as the most prominent example of the power of synthetic biology, a field whose possibilities have excited me since I first heard the term more than 15 years ago. As scientists gain increasing dexterity in manipulating the basic elements of life, they are designing not only other synthetic vaccines, but also therapies

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Novel Agents Generate Excitement for Hematologic Malignancies

Drug Topics

During a session at the 2023 HOPA Annual Conference, Rebecca Champion, PharmD, BCOP, highlighted new therapies in the market for hematologic malignancies with a focus on bispecific antibodies and chimeric antigen receptor T-cell therapies.

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CMS finalizes changes to Medicare Advantage star ratings, prior authorization reforms

Fierce Healthcare

CMS finalizes changes to Medicare Advantage star ratings, prior authorization reforms rking Wed, 04/05/2023 - 16:14

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