Sat.Dec 02, 2023 - Fri.Dec 08, 2023

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The weight loss market looks unstoppable. How high could it go?

PharmaVoice

Market expectations for obesity drugs are soaring and competition is heating up. But hitting the heights will require overcoming payer and other issues.

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In historic decision, FDA approves a CRISPR-based medicine for treatment of sickle cell disease

STAT

The Food and Drug Administration on Friday approved the world’s first medicine based on CRISPR gene-editing technology, a groundbreaking treatment for sickle cell disease that delivers a potential cure for people born with the chronic and life-shortening blood disorder. The new medicine , called Casgevy, is made by Vertex Pharmaceuticals and CRISPR Therapeutics.

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Trending Sources

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New £20m NIHR project announced to combat HIV in England

Pharma Times

In England, an estimated 4,500 people are living with undiagnosed HIV - News - PharmaTimes

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SAEM Clinical Images Series: Bulge in the Belly

ALiEM - Pharm Pearls

A 45-year-old male status-post right nephrectomy secondary to a renal mass presented to the emergency department with right-sided flank pain. He endorsed low-grade intermittent right-sided flank pain since the nephrectomy one year prior, associated with an increasingly enlarging mass extending laterally from his right abdomen. Over the course of the past several days, the mass had become larger and more painful.

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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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4 historic FDA approvals from 2023

PharmaVoice

This year’s many firsts included a vaccine for RSV and a drug that slows Alzheimer’s disease.

Vaccines 265

More Trending

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Lung cancer screening recommended in Scotland, Wales and Northern Ireland

Pharma Times

The disease is one of the leading causes of cancer deaths in the UK - News - PharmaTimes

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SAEM Clinical Images Series: Penile Lesion with a Poor Prognosis

ALiEM - Pharm Pearls

A 49-year-old male presented to the emergency department of an academic hospital with the chief concern of penile pain. Prior medical history is notable for end-stage renal disease on hemodialysis three times per week, but the patient has not been dialyzed in the past four days, hypertension, insulin-dependent diabetes mellitus, heart failure with reduced ejection fraction (59% two months prior), seizure disorder, prior pulmonary embolism (eight months prior), a left nephrectomy seven months ago

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Transforming blood cancer care to make a difference for patients

PharmaVoice

AstraZeneca’s Gemma Satterthwaite talks to the company’s ambition to transform the entire care experience for patients with blood cancers.

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‘Last roll of the dice’ for a near-term HIV vaccine fails

STAT

A study billed as the last chance to develop an HIV vaccine this decade has been shut down, investigators announced Wednesday at a conference in Harare, Zimbabwe. The trial, known as PrEPVacc, was testing two different vaccine regimens on about 1,500 volunteers in East and Southern Africa. After multiple other high-profile trials failed , a PrEPVacc investigator described the study this summer as “ the last roll of the dice ” for an HIV vaccine until the 2030s.

Vaccines 363
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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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Cambridge researchers redesign future mRNA therapeutics

Pharma Times

One-third of patients who received Pfizer’s COVID-19 vaccine had unintended immune responses - News - PharmaTimes

Immunity 159
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Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

FDA Law Blog: Biosimilars

By Larry K. Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. On October 10th, based on ability to pay, the U.S. District Court for the Western District of Texas imposed a $275,000 civil penalty on Zarzamora Healthcare LLC, in San Antonio, and its pharmacist-owner.

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The FDA is poised to approve the first CRISPR drug. Here’s what’s next in gene editing.

PharmaVoice

A look at the fast-evolving pipeline for gene editing therapies.

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New England Journal of Medicine reckons with its racist past and complicity in slavery

STAT

The New England Journal of Medicine, the world’s oldest continually published medical journal, publicly reckoned with its history and complicity surrounding slavery and racism Wednesday, publishing the first of a series of essays by independent historians on the role the prestigious publication has played in perpetuating racist thinking in medicine that continues to this day.

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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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Study reveals motor neuron region is affected in ALS

Pharma Times

The neurological condition currently affects one in 300 people in the UK - News - PharmaTimes

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CRISPR therapy for sickle cell approved by FDA in gene editing milestone

BioPharma Dive

In addition to clearing Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy, the FDA also granted an early OK to Bluebird bio’s sickle cell treatment Lyfgenia.

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Real Chemistry’s CEO on biopharma’s outlook in 2024

PharmaVoice

Shankar Narayanan, CEO of marketing consulting firm Real Chemistry, weighs in on where the industry is headed in the New Year.

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STAT+: J&J to emphasize cancer drugs and stop much of its vaccine research

STAT

Eight months into his tenure, Johnson & Johnson’s R&D chief is putting a big emphasis on medicines for cancer, treatment-resistant depression, and autoimmune disease. To sharpen that focus, R&D chief John Reed told STAT that the company is de-emphasizing two areas that have been mainstays for the drug and medical device giant: infectious disease and vaccines, as well as medicines targeting kidney disease and rare eye conditions.

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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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KCL molecular communication system to revolutionise drug delivery

Pharma Times

The platform safely and effectively replicates the electric signalling process compounds - News - PharmaTimes

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‘It’s not worth risking your life’: fears over painkiller Nolotil grow for Brits in Spain

The Guardian - Pharmaceutical Industry

Links between the deaths of UK patients and the popular drug have spurred on action among expats in Jávea and beyond As Britain faced widespread frosts last week, there were blue skies, a warm breeze and temperatures above 20C on white sand beaches dotted with palm trees in Jávea on the Costa Blanca. About 5,000 Britons live in this small town, once walled and fortified to protect it from marauding pirates.

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The fortunes and flops of pharma M&A

PharmaVoice

Hindsight offers a better perspective on why some deals are fruitful and others fail.

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STAT+: CVS’s new drug payment plan won’t lower patients’ prices, experts warn

STAT

CVS Health is promising to simplify how its pharmacies get paid for drugs. But that doesn’t mean the drugs will get cheaper. The country’s biggest pharmacy chain said it’s switching to a system where pharmacy benefit managers, employers, and other insurers pay for drugs based on the cost of the drug plus a set markup and dispensing fee.

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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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Secretary of state sets out priorities for UK health and social care systems

Pharma Times

The commitments will make health systems faster, simpler and fairer for patients - News - PharmaTimes

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Breaking: Pharmacy supervision consultation launches

The Pharmacist

The Department of Health and Social Care (DHSC) has today launched its consultation into pharmacy supervision. It proposes to: enable pharmacists to authorise pharmacy technicians to carry out, or supervise others carrying out, the preparation, assembly, dispensing, sale and supply of medicines enable pharmacists to authorise any member of the pharmacy team to hand out […] The post Breaking: Pharmacy supervision consultation launches appeared first on The Pharmacist.

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ASBM and GaBI Webinar Examines Policy Challenges to Interchangeable Biosimilars

Safe Biologics

On November 30, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted I nterchangeable Designation for Biosimilars- Ensuring Continuity of Patient Care: Upholding Interchangeability Status for Biosimilars. The webinar was the fourth in a series covering key health policy issues. The most recen t of the webinars, hosted July 29th, examined the negative impact of the Inflation Reducation Act’s Medicare drug price setting provisions.

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STAT+: Pfizer plans to depart BIO

STAT

WASHINGTON — Pfizer has decided to leave the Biotechnology Innovation Organization, according to two sources familiar with the decision. The departure is a blow to BIO, which represents members ranging from small biotech startups to massive pharmaceutical companies. The group on Tuesday announced its new CEO, rare disease advocate and biotech executive John Crowley.

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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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NIHR invests £55m to tackle health inequalities and outcomes

Pharma Times

Millions of people in the UK are set to benefit from the second wave of funding - News - PharmaTimes

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CRISPR eyes autoimmune disease in revamp of cell therapy plans

PharmaVoice

The gene editing biotech is shelving two of its most advanced cancer drugs, and joining a growing group of companies exploring cell-based medicines for inflammatory diseases like lupus.

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October 2023 Newsletter

Safe Biologics

ASBM Statement: In Shocking Reversal, CMS Wants to Allow Medicare Part D Plan Sponsors to Substitute Non-Interchangeable Biosimilars On November 6, 2023, the Centers for Medicare and Medicaid Services (CMS) announced a proposed Rule that would permit Medicare Part D plan sponsors to substitute non-interchangeable biosimilars in place of the biologic medicines now used to treat many chronic conditions such as rheumatoid arthritis, Crohn’s disease and cancer.