Thu.Nov 14, 2024

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Sector calls for funding uplift as NPA announces ballot results

The Pharmacist

Community pharmacy leaders across the sector have called for uplifted funding to stop pharmacy closures and ease pressures, stressing that the current arrangements are putting patient safety at risk. This comes as the National Pharmacy Association (NPA) announced that 99% of participating pharmacy owners voted to limit their services unless funding is improved.

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Opinion: How chaplains can help the fractured U.S. health care system

STAT

As a medical intern in the late 1980s, I’d occasionally see priests and rabbis on hospital wards, but we basically ignored one another. When we doctors walked into a patient’s room, they’d quickly leave, and when we exited, they’d enter. They seemed to operate in a wholly different realm. After all, we were scientific.

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Government encourages pharmacists to 'work with us'

The Pharmacist

The government has urged pharmacies to work with ministers to achieve 'a service fit for the future', following a vote by pharmacy owners in favour of collective action. The Department of Health and Social Care said it was 'committed to working with the sector and would encourage all pharmacists to work with us'. This comes […] The post Government encourages pharmacists to 'work with us' appeared first on The Pharmacist.

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STAT+: FDA scolds Merz over ‘misleading’ Instagram posts featuring interior designer Nate Berkus

STAT

The Food and Drug Administration has scolded Merz Pharmaceutical for making misleading claims on Instagram about the safety and effectiveness of an injectable treatment for smoothing facial lines, the fifth time this year the agency has taken a pharmaceutical company to task for its marketing. The regulator criticized Merz for a few reasons concerning Xeomin, which is promoted as an alternative to Botox for combating wrinkle and frown lines.

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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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September-October 2024

Safe Biologics

SAVE THE DATE: ASBM and GaBI to Present Webinar on the Biosimilar Red Tape Elimination Act October 31st On October 31st, ASBM and the Generics and Biosimilar Initiative will present a webinar focusing Senate Bill 2305, the Biosimilar Red Tape Elimination Act. Health policy experts will review current U.S. biosimilar approval and substitution policies, discuss the rationale behind them, and examine the potential consequences of the proposed changes.

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AbbVie’s stumble, Amgen’s tumble and more election fallout

STAT

Why are AbbVie executives feeling the M&A blues? What does it take to slice $12 billion from Amgen’s market value? And why are STAT’s D.C. correspondents working so hard?  We talk about all that and more on this week’s episode of the “The Readout LOUD,” STAT’s biotech podcast. It’s a “Chatty Cathy” episode!

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STAT+: Mild Alzheimer’s patients won’t save Cassava Sciences

STAT

This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up  here  to get it delivered to their inbox. As we count down toward the December readout of Cassava Sciences’ simufilam Phase 3 clinical trial in Alzheimer’s disease, it’s a good time to correct one of the more egregious misconceptions regarding the handling of patient subgroup data that has been floating persistently around the internet.

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BioNTech oncology acquisition to advance bispecific antibodies

European Pharmaceutical Review

BioNTech SE has agreed to acquire Biotheus and will gain rights to the biotech’s in-house bispecific antibody drug conjugate (ADC) capability and pipeline candidates. Specifically, BioNTech will obtain worldwide access to the late-stage PD-L1 x VEGF-A-targeting bispecific antibody BNT327/PM8002. This treatment, in combination with BNT325/DB-1305, a Trophoblast Cell-Surface Antigen 2 (“TROP2”)-targeted ADC candidate is being evaluated in an ongoing Phase I/II clinical trial.

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Threats to children from anti-vax views, Plan B with higher BMI, a dim view of tech bans for teen mental health

STAT

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Good morning. I’m back on the newsletter beat today while Theresa’s on holiday, but I’m off to Chicago soon to cover the American Heart Association’s scientific sessions. Ping me if you’ll be following the conference, too.

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Left to clean up after ‘pharma bro’ Shkreli’s arrest, former Turing CEO Ron Tilles reckons with the past

PharmaVoice

While Martin Shkreli smirked his way through a public securities fraud investigation, Ron Tilles became interim CEO of Turing Pharmaceuticals, ready or not. Here’s his story.

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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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A telehealth friend in the new Congress, and Amazon’s smile on a mental health service

STAT

Good morning health tech readers! Today, details about Amazon’s new mental health partner, another digital health company shuts down, and a deep dive on digital measures for tracking disease.

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MSD joins PD-1/VEGF push in cancer with LaNova deal

pharmaphorum

There has been a lot of talk about drugs targeting both PD-1 and VEGF stealing the crown held by MSD's Keytruda in cancer immunotherapy. Now, the company has made a move to try to make sure it isn't left behind. Its solution is a licensing deal with Chinese biotech LaNova Medicines for LM-299, which consists of an anti-VEGF antibody joined to the functional parts of a pair of anti-PD-1 antibodies.

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FDA and the Device Industry: Friends or Foes?

FDA Law Blog: Biosimilars

By Jennifer D. Newberger — “An open foe may prove a curse, but a pretended friend is worse.” When the poet John Gay wrote these words in 1727, the idea of an administrative agency like the FDA was likely the furthest thing from his mind. That he is now being quoted in a blog post to discuss the relationship between medical device companies and their regulatory oversight body shows that some ideas really do have staying power.

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AC immune announces positive trial results for early Parkinson’s treatment

Pharma Times

Therapy shows high efficacy in initial trial phase

Immunity 130
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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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Merck, facing threat to Keytruda, buys into new kind of cancer immunotherapy

BioPharma Dive

The company is paying China-based biotech LaNova Medicines $588 million for the type of dual-pronged antibody drug that recently bested Keytruda in a clinical trial.

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Osivax begins phase 2a booster trial for influenza vaccine

Pharma Times

First participant vaccinated in study of ovx836 booster dose

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Eisai wins over European regulators on Alzheimer’s drug Leqembi

BioPharma Dive

A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.

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GEP Outlook 2025

Pharma and Life Sciences Blog

GEP Outlook 2025 priyanka.katke… Thu, 11/14/2024 - 14:45 Drive Procurement and Supply Chain Success in 2025 For years, you and your team have fought an uphill battle. Supply disruptions. Cost pressures. ESG compliance. Geopolitical tensions. You name it, and you’ve had to navigate it. In 2025, many challenges will persist, but procurement and supply chain teams have a powerful tool with rapidly advancing capabilities to tackle them — artificial intelligence (AI).

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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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GSK hails survival data with revived myeloma drug Blenrep

pharmaphorum

GSK's multiple myeloma therapy Blenrep's increase in overall survival in the DREAMM-7 trial has achieved statistical significance

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FDA approves first gene therapy for treatment of aromatic L-amino acid decarboxylase deficiency

World Pharma News

The U.S. Food and Drug Administration approved Kebilidi (eladocagene exuparvovec-tneq), an adeno-associated virus vector-based gene therapy indicated for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency. Kebilidi is the first FDA-approved gene therapy for treatment of AADC deficiency.

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AstraZeneca doubles down on US manufacturing with $3.5 billion investment

Outsourcing Pharma

AstraZeneca has become the latest big pharma company to devote new cash to its US manufacturing muscle this year as it unveils a $3.5 billion infusion into US sites.

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FDA grants accelerated approval for PTC’s AADC deficiency gene therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted accelerated approval for PTC Therapeutics’ KEBILIDI, the first gene therapy in the US that is directly delivered to the brain.

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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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NHC Fall International Patient Forum

Putting Patients First Blog

NHC Fall International Patient Forum Event Time: 1:00 - 2:30 p.m. ET Event Location: Virtual Home Register About the Event The NHC International Patient Forum (IPF) builds awareness and capacity in the U.S. patient community to be better informed, involved, and influential in international discussions and decision-making. The IPF offers all NHC members the opportunity to share information and strategic thinking on international issues affecting patient health and well-being.

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Adaptimmune nears second sarcoma approval as Phase II trial hits endpoints 

Pharmaceutical Technology

Adaptimmune’s Phase II IGNYTE-ESO trial investigating experimental T cell therapy lete-cel has achieved its primary endpoint.

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Syncona aims Slingshot at biotech's 'translational gap'

pharmaphorum

Syncona launches Slingshot Therapeutics with a mission to find promising projects in academia and translate them into development projects.

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EMA rethinks stance, committee now recommends Leqembi for Alzheimer’s disease

Pharmaceutical Technology

Following a re-evaluation, the EMA has recommended Eisai and Biogen’s Alzheimer’s therapy Leqembi for a subgroup of patients.

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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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The ‘Warm Body’ Hiring Mistake: Stop Filling Pharmacy Roles Just to Keep the Doors Open

The Script

Our team at Rx relief explains the "Warm Body" hiring mistake & how you can avoid making it going forward.

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AstraZeneca doubles down on US manufacturing with $3.5 billion investment

Outsourcing Pharma

AstraZeneca has become the latest big pharma company to devote new cash to its US manufacturing muscle this year as it unveils a $3.5 billion infusion into US sites.

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PTC wins US approval of gene therapy for fatal enzyme disorder

BioPharma Dive

Kebilidi is the first approved gene therapy that can be directly administered to the brain. Its OK secures a priority review voucher for PTC.

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Tirzepatide prevents type 2 diabetes in 99% of prediabetic patients for 3 years

Outsourcing Pharma

Results from the SURMOUNT-1 trial show that weekly injections of tirzepatide could stop the progression from pre-diabetes to type 2 diabetes in 99% of participants.

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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.