Tue.Sep 19, 2023

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Physicians say transgender sports bans are a health issue

STAT

Almost half of U.S. states have banned or restricted trans youths’ access to gender-affirming puberty blockers, hormones, and surgery — and many of the same states are also targeting trans youths’ participation in sports. Twenty-three states ban trans youths from participating in school sports consistent with their gender identity, with some laws focusing on students from kindergarten through 12th grade and others including, or exclusively applying to, students at the colleg

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The 2023 PharmaVoice 100

PharmaVoice

This year’s honorees are influential and devoted leaders lifting the pillars of the industry to new heights.

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Trending Sources

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STAT+: Artificial wombs, after years in development, reach FDA review for human trials

STAT

The artificial womb, a device aiming to save infants born way too soon, is inching closer to being tested in humans. The technology is close enough to reality that the Food and Drug Administration has decided to convene a two-day panel starting Tuesday to discuss how to best evaluate safety and effectiveness, as well as the ethical quandaries in running clinical trials.

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BeiGene and Nona Biosciences expand collaboration for antibody discovery

Pharma Times

BeiGene will utilise Nona’s Harbour Mice platform as part of the agreement - News - PharmaTimes

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Navigating Payroll Compliance: Future-Proofing Payroll in an Evolving Regulatory Landscape

Speaker: Jennifer Hill

Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.

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Opinion: A popular breast cancer genomic test underestimates risks for Black women

STAT

When a woman first learns she has breast cancer, her mind immediately floods with “what now?” questions as she grapples with how this disease will impact her life. Unfortunately, Black women also have to ask themselves, “Will my racial heritage and ethnicity affect the care I receive and chances of survival?

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The fading generics industry and essential medicine supply

pharmaphorum

The fading generics industry and essential medicine supply Mike.

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More Trending

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PBMs, PhRMA trade blame over drug costs in House hearing

PharmaVoice

Pharmacy benefit manager lobby PCMA and drugmaker lobby PhRMA pointed fingers over problems in the prescription supply chain during the House committee's second PBM hearing on Tuesday.

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Rep. Adam Smith weighs in on the country’s mental health crisis with his own story

STAT

WASHINGTON — Rep. Adam Smith (D-Wash.) knew when he hit rock bottom. “I woke up one morning in early April of 2016 and seriously considered the possibility that I might never be able to get out of bed,” he opens his recent memoir, “Lost and Broken,” which details the six years in which “crippling anxiety” and chronic pain dominated his life even as he bounced back and forth from the Capitol to northern Seattle, the district he has represented for

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Leveraging technology for better women’s healthcare outcomes

pharmaphorum

Leveraging technology for better women’s healthcare outcomes Mike.

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STAT+: FDA weighs animal data, ethical dilemmas at panel on artificial wombs

STAT

The Food and Drug Administration’s advisory panel of pediatric experts met on Tuesday to discuss advances in artificial womb technology, which aim to save the lives of premature babies. The goal of the meeting was to discuss measures for evaluating the safety and efficacy of an artificial womb. The group grappled with the limits of current animal data, as well as the ethical difficulties in running human trials.

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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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Startup AIRNA emerges from stealth to bring RNA editing to a rare disease

BioPharma Dive

AIRNA is one of several biotechs to debut plans for target alpha-1 antitrypsin deficiency in recent years, with competitors such as AlveoGene, Wave Life Sciences and Arrowhead Pharmaceuticals.

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STAT+: Pear’s shadow effect: Data from a Medicaid digital health experiment does the policy rounds

STAT

Pear Therapeutics may be gone, but one of its most important deals is still driving critical conversations about how medical apps can find a foothold in the slow-moving health care system. In recent months, representatives of the Massachusetts state Medicaid program, MassHealth, have been presenting data suggesting reSET and reSET-O, Pear’s prescription apps that treat substance use disorder and opioid use disorder, saved the state money over a one-year period from 2021 to 2022.

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PBMs, PhRMA trade blame over drug costs in House hearing

BioPharma Dive

Pharmacy benefit manager lobby PCMA and drugmaker lobby PhRMA pointed fingers over problems in the prescription supply chain during the House committee's second hearing on the PBM industry.

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STAT+: PBMs were the target of House hearing, but pharma wasn’t spared criticism

STAT

WASHINGTON — Congress wants to reform PBM business practices to help lower the cost of medicines — but don’t think they’ve forgotten drugmakers have a role in high drug prices. Two lawmakers, including a Republican, questioned PhRMA Chief Operating Officer Lori Reilly about just how much her group was spending on its major campaigns against PBMs this year.

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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Kinnate Biopharma announces 70% layoffs and pipeline restructuring

Pharmaceutical Technology

The company will suspend the development of three assets, considering strategic alternatives for two clinical programmes.

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STAT+: What happened to the House vote on health care price transparency?

STAT

You’re reading the web edition of D.C. Diagnosis.  Sign up here  to receive this newsletter in your inbox on Tuesdays and Thursdays. About last night… House leadership last night canceled a scheduled vote on a health care package that included transparency requirements for hospitals and insurers, reforms to some PBM practices, and a small site-neutral payment policy for administering drugs, Rachel writes.

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Novartis returns PD-1 antibody rights to BeiGene

pharmaphorum

Novartis returns PD-1 antibody rights to BeiGene Phil.

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Government should consider funding pharmacies in same way as GPs, report suggests

The Pharmacist

The current funding model for community pharmacy does not contain ‘the right incentives’ to deliver clinical services to patients, a new report outlining a long-term vision for the sector has suggested. A clinical future for the sector, helping to relieve the burden on general practice and other overstretched parts of the health system, formed a […] The post Government should consider funding pharmacies in same way as GPs, report suggests appeared first on The Pharmacist.

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Best Practices to Streamline Compensation Management: A Foundation for Growth

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

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Why Communication Is Important in Pharmacy Leadership

PioneerRx

Communication is key in the pharmacy industry. Whether you’re talking to patients, doctors, or wholesalers, communication is vital to your pharmacy’s success.

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To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

FDA Law Blog: Biosimilars

By Sara W. Koblitz & Kurt R. Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. On the heels of its powerful (and unprecedented) amicus brief in Paragraph IV litigation between Jazz and Avadel concerning a patent covering a Risk Evaluation and Mitigation Strategy (“REMS”) listed in the Orange Book, the Federal Trade Commission (“FTC”) is gearing up to tackle anticompetitive Orange Book listing practices.

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Caplin Steriles gets USFDA approval for Norepinephrine Bitartrate Injection

Express Pharma

Caplin Steriles has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Norepinephrine Bitartrate Injection USP, 4 mg/4 mL (1 mg/mL) Single-Dose Vial, a generic therapeutic equivalent version of (RLD), LEVOPHED injection of Hospira Inc. Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients with acute hypotensive states.

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ViiV’s injectable HIV PrEP drug Apretude gets EU okay

pharmaphorum

ViiV’s injectable HIV PrEP drug Apretude gets EU okay Phil.

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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Venus Remedies gets marketing approval for gemcitabine and docetaxel from Serbia

Express Pharma

Venus Remedies has secured marketing authorisation from Serbia for gemcitabine and docetaxel, widely used chemotherapy drugs. With this, the company has secured 511 marketing approvals for its oncology products across 66 countrles. Oncology drugs constitute the largest proportion of the Serbian pharma market (projected to reach $397.40 million in 2023), where Venus Remedies has secured five marketing approvals, all ln the oncology space.

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Older UK people back auto-enrolment in clinical trials

pharmaphorum

Older UK people back auto-enrolment in clinical trials Phil.

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CAR T therapy exhibits encouraging proficiency in R/R LBCL

European Pharmaceutical Review

Kite’s Yescarta ® (axicabtagene ciloleucel) facilitated a high response rate in transplant ineligible relapsed/refractory (R/R) large B-cell lymphoma (LBCL), Phase II study results show. Patients with R/R LBCL who had received one prior line of therapy and were deemed ineligible for high-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT) were evaluated in the trial.

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Pelican and Primordial Genetics merge to form biotech company Primrose Bio

Pharmaceutical Technology

Pelican Technology has combined business with Primordial Genetics under a deal to create a private biotechnology company Primrose Bio.

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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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Pfizer’s alopecia drug gets EU nod, chasing Lilly’s Olumiant

pharmaphorum

Pfizer’s alopecia drug gets EU nod, chasing Lilly’s Olumiant Phil.

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The Definition of Patient Safety and Implementing Technologies (PDA/FDA Joint Regulatory Conference 2023)

PharmaTech

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses the definition of patient safety and how to implement new technologies into upgraded facilities.

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Do Plan Sponsors Understand How Their PBMs Make Money?

Drug Channels

Today, the House Committee on Oversight and Accountability will hold a hearing with a subtle and not-at-all pejorative title: The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part II: Not What the Doctor Ordered. To help you prepare, I share fresh insights from a new survey of PBMs’ plan sponsor clients. As you will see, clients are somewhat more satisfied with the perceived transparency of smaller PBMs.

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New community pharmacy vision ‘a powerful tool’ for negotiator

The Pharmacist

A new vision for community pharmacy which centres on a clinical future will help form the basis of the sector’s discussions with the government and policymakers going forward. Published today by independent experts the King’s Fund and Nuffield Trust, A Vision for Community Pharmacy sets out national and local services that community pharmacy could provide […] The post New community pharmacy vision ‘a powerful tool’ for negotiator appeared first on The Pharmacist.

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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.