October, 2024

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STAT+: Teva fined $503 million for disparaging a rival and using patents to thwart competition

STAT

Teva Pharmaceutical, the world’s largest generic drugmaker, was fined $503 million by European antitrust regulators for delaying competition to a blockbuster multiple sclerosis medicine. The European Commission found the company had artificially extended the patent protection of Copaxone and systematically spread misleading information about a rival product.

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Tranq dope (fentanyl-xylazine combination): A new horizon in opioid withdrawal treatment

ALiEM - Pharm Pearls

‘Dope’ is no longer heroin in an increasing number of our communities. The biggest change has been the gradual replacement of diacetylmorphine (heroin) by fentanyl and other synthetic opioids. Due in large part to the proliferation of anonymous chemical factories able to produce industrial volumes of inexpensive synthetic opioids without opium or other controlled precursors, fentanyl spilled into the United States, Canada, and Europe, heroin soon fell to market forces [1, 2].

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Upskilling and reskilling: Key to driving innovation in India’s pharma sector

Express Pharma

India’s pharmaceutical industry, the third largest globally by volume, plays a key role in improving global healthcare outcomes. The Covid-19 pandemic accelerated the digital transformation and underscored the importance of adaptability. In this evolving landscape, upskilling and reskilling have become essential as technological advancements, regulatory changes, and the demand for innovative healthcare solutions continue to grow.

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Handling Drug Patent Abandonment: Opportunities and Challenges

Drug Patent Watch

The pharmaceutical industry is known for its complex regulatory environment and lengthy product development processes. One often overlooked aspect of this industry is the potential benefits of abandoned and expired patents. These patents can provide opportunities for companies to bring new products to market at a lower cost and with reduced development time.

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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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Novel nanoemulsion-based delivery of antimycobacterial drug

European Pharmaceutical Review

A paper has a described the first reported use of nanoemulsions as a novel delivery vehicle for the oral drug bedaquline (BDQ) “with high loading efficiency as a liquid dosage form”, according to the authors. The researchers explained that in recent decades, the industry has placed significant focus on lipid-based nanocarrier formulations for oral drug delivery.

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Pharmacies must contact labetalol patients following manufacturing mix-up

The Pharmacist

Pharmacies must contact all patients dispensed a specific batch of the beta blocker labetalol that may contain the wrong medication, the Medicines and Healthcare Products Regulatory Agency (MHRA) has instructed. If batch traceability is not possible, all patients dispensed this product in the last six months must be contacted. In a class two medicines recall […] The post Pharmacies must contact labetalol patients following manufacturing mix-up appeared first on The Pharmacist.

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HIV vaccine candidate successfully optimised for industrial production

Pharmafile

Sumagen Canada Inc, a biotech company based in both South Korea and Canada has partnered with CDMO Naobios to industrialise Sumagen’s human immunodeficiency virus (HIV) -1 vaccine candidate (SAV0001) at bench scale. First of its kind in human vaccine trials, SAV001 is a whole-killed and genetically modified HIV vaccine. During phase 1 of the clinical […] The post HIV vaccine candidate successfully optimised for industrial production appeared first on Pharmafile.

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Dr Reddy’s launches BixiBat to treat chronic constipation in India

Express Pharma

Dr Reddy’s Laboratories announced the launch of Elobixibat, a first-in-class drug to treat chronic constipation, in India. Dr Reddy’s will market Elobixibat under the brand name BixiBat in India. The launch follows approval granted to Dr Reddy’s by the Central Drugs Standard Control Organisation (CDSCO) after submission of the company’s successful Phase-3 clinical trial to the Subject Expert Committee of the CDSCO.

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Rising Pharmaceutical Costs: A Major Challenge for Managed Healthcare

Drug Patent Watch

One issue continues to loom large in healthcare: the skyrocketing costs of pharmaceuticals. This challenge has become a significant hurdle for managed healthcare organizations, patients, and policymakers alike.

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The 2024 PharmaVoice 100

PharmaVoice

This year’s PharmaVoice 100 encompasses the industry’s ongoing revolutions and leaders who are not only navigating these changes, but at times, forging new paths for others to follow.

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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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Informal referrals deprive pharmacies of 'more than £115m a year'

The Pharmacist

Informal referrals to community pharmacies deprive pharmacies of more than £115 million each year, Community Pharmacy England (CPE) has estimated. This is the amount that would have been paid if existing referral routes had been used appropriately by GPs and NHS 111, rather than patients being signposted informally to their local community pharmacy.

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Opinion: I’m the director of the Center for Medicare. Here’s how we executed the first round of drug price negotiation

STAT

The historic Inflation Reduction Act of 2022 has fundamentally improved the affordability of and access to prescription drugs for millions of people with Medicare. The law laid out aggressive timelines for implementing the Medicare Drug Price Negotiation Program. As the director of Medicare, my team and I worked thoughtfully and diligently to stand up the program — on time and successfully.

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STAT+: Drug may make chemotherapies less effective in cancer patients with obesity — but many doctors are in the dark

STAT

A drug used to combat fungal infections in cancer patients comes with a big caveat — research shows the medicine can last twice as long as in people with obesity. This means chemotherapies may be less effective when interacting with the medicine, but some clinicians, and their patients, are unaware of that possibility. The information, however, is not in the label because the drug — originally manufactured by Merck — was never fully tested in this population.

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STAT+: Novo Nordisk’s Ozempic and Wegovy, long in shortage, are now listed as available by FDA

STAT

All doses of Novo Nordisk’s blockbuster diabetes and obesity treatments are listed as available on the Food and Drug Administration’s drug shortage list as of Wednesday, raising the possibility that the medications could soon be taken off the list entirely, a development that could affect compounding pharmacies and patients relying on compounded drugs.

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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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STAT+: To mitigate drug shortages, a new study suggests looking at Canada

STAT

Of 104 reports of supply chain issues with dozens of drugs, meaningful shortages were 40% less likely to occur in Canada than in the U.S., a new study found, and the difference was largely attributed to the approach taken by the Canadian government to the problem. Between 2017 and 2021, regulators in the U.S. and Canada received the same number of reports about actual or potential shortages for the same 96 medicines.

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5 questions about the next U.S. dietary guidelines, and the ‘impossible restriction’ on them

STAT

Here’s the paradox: The most influential set of rules for the foods we eat are the ones most of us ignore. But they still matter for millions of  Americans. The Dietary Guidelines for Americans, reviewed and issued by the federal government every five years, have broad impact on what goes into federal nutritional assistance programs, from WIC for women and young children to school lunches to meals for veterans or seniors.

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Opinion: Fecal transplants are saving lives — but are now at risk

STAT

Twenty years ago, a respected colleague asked me to perform a “poop transplant” on a local schoolteacher with multiply recurrent C. difficile infection.  I was incredulous and skeptical, but my colleague (a friend but a forceful one) persisted until I ultimately acquiesced.  Soon I was in a hazmat suit blenderizing stool and performing my first (subsequently named) fecal microbiota transplant, or FMT.

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How CDMOs are Transforming the Industry

Drug Patent Watch

The pharmaceutical industry has undergone significant transformations in recent years, driven by the COVID-19 pandemic and the subsequent need for rapid innovation and adaptation.

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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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See how your pharmacy compares as July Pharmacy First data released

The Pharmacist

July 2024 saw the highest number of pharmacies meeting the Pharmacy First monthly threshold since it increased to 10 consultations in May, according to the latest Pharmacy First data. Nationally, clinical pathway consultations and urgent medicine supply referrals increased overall. But minor illness referrals decreased in July 2024. Scroll down for our interactive Pharmacy First […] The post See how your pharmacy compares as July Pharmacy First data released appeared first on The Pharmacis

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First UK case of Clade IB mpox could prompt ‘quick vaccine expansion’

The Pharmacist

The first confirmed human case of Clade Ib mpox in the UK has been detected in London, the UK Health Security Agency (UKHSA) has said. But it stressed that the risk to the UK population 'remains low'. And Steve Russell, NHS national director for vaccination and screening, said there were 'plans in place to expand […] The post First UK case of Clade IB mpox could prompt ‘quick vaccine expansion’ appeared first on The Pharmacist.

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STAT+: Two generic drugmakers pay $49 million to settle price-fixing charges

STAT

Two generic drugmakers, Apotex and Heritage Pharmaceuticals, have agreed to pay a combined $49 million to settle allegations they fixed prices on numerous medicines, the first such agreements since state attorneys general began probing price-fixing in the generics industry a decade ago. In 2016, a number of states filed what eventually became the first in a trio of lawsuits against many of the largest generic companies for allegedly coordinating efforts to fix and maintain prices for dozens of m

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'Regional spikes' in scabies reported

The Pharmacist

Pharmacists have highlighted the cost to patients of treating scabies, as the Royal College of General Practitioners (RCGP) has reported 'regional spikes' in cases. In a statement issued on Friday (25 October), RCGP chair Professor Kamila Hawthorne said GPs were seeing scabies presentations at a rate 'above the five-year average and rising', with 'the north […] The post 'Regional spikes' in scabies reported 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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'More we could do' to collaborate across professions, House of Commons event hears

The Pharmacist

The barriers and opportunities involved in working collaboratively across different healthcare professions – including how pharmacists can work across the multidisciplinary team – have been explored during a House of Commons event. The event was hosted by Watford MP Matt Turmaine, sponsored by Dr Bharat Shah of Sigma Pharmaceuticals, and chaired by Professor Mahendra Patel, […] The post 'More we could do' to collaborate across professions, House of Commons event hears appeared fi

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STAT+: Pharmalittle: We’re reading about a Merck drug-label controversy, Astellas pulling an application, and more

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of deadlines, online calls, and meetings has resumed. But what can you do? The world, such as it is, continues to spin, however wobbly it may feel. So to cope, yes, we are firing up the trusty coffee kettle in brewing another cup of stimulation.

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National living wage increase will be 'huge additional cost' for pharmacies

The Pharmacist

National living wage and employer national insurance contributions will increase from April 2025, the chancellor has announced in today's Autumn Budget. But pharmacy leaders have expressed concern that pharmacies will not be able to meet these 'looming increases' unless pharmacy funding is uplifted in the next contract. Increases to living wage and national insurance contributions […] The post National living wage increase will be 'huge additional cost' for pharmacies appeared fi

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CPE 'ready to restart CPCF negotiations immediately'

The Pharmacist

Community Pharmacy England (CPE) stands ready to restart contract negotiations 'immediately', it has said following yesterday's Autumn Budget. Janet Morrison, CPE chief executive, said she told ministers on Wednesday that 'without funding relief' there will be more pharmacies closing, and more patients going without advice or medicines and therefore turning to other parts of the […] The post CPE 'ready to restart CPCF negotiations immediately' appeared first on The Pharmacist.

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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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STAT+: Health tech investments are picking up steam. Here are 5 VC leaders behind the biggest recent deals

STAT

Health tech investments are showing signs of resilience following the perilous lows of 2022 and 2023: Just this past month, two startups that analysts believe might be getting ready for IPOs raised more than $100 million in late-stage funding rounds. And deal volume hit a record high in the second quarter, largely from early-stage deals, according to a Silicon Valley Bank analysis.

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STAT+: VCs move to launch U.S.-based companies to develop drugs developed in China

STAT

As Chinese biopharma companies rise on the international stage, they are increasingly finding VC partners — in the United States. U.S. companies have long signed licensing deals with Chinese drugmakers. But increasingly American venture capitalists are building U.S.-based companies from scratch to test and ultimately seek to commercialize innovative drugs developed in China.

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STAT+: Sales of GSK’s RSV vaccine down dramatically from last year

STAT

LONDON — GSK’s once booming vaccines business met new challenges in the third quarter, as the company lowered sales forecasts for vaccines for the year.  Notably, quarterly sales of the company’s RSV vaccine, which became a blockbuster after debuting last year, fell by more than 70% year over year, in part due to narrower U.S. recommendations for who should get the shot.

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Opinion: ‘Do no harm’ is hurting 400 million long Covid patients worldwide

STAT

Imagine, for a moment, that you wake up one morning with a debilitating illness that won’t let go. Weeks and months pass, but the crushing fatigue, constant headaches, and aching muscles remain. You can’t think straight. Simply showering or doing the dishes leaves you floored for days at a time, and the unpredictable symptoms — shortness of breath, dizziness, a racing heart — ebb and flow without warning.

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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.