Thu.Dec 19, 2024

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STAT+: FDA confirms shortage of weight loss drug tirzepatide is over, gives compounders a grace period

STAT

The Food and Drug Administration on Thursday confirmed that a shortage of Eli Lilly’s obesity drug tirzepatide has been resolved, a move that will soon put a stop to companies making cheaper copies of the injection. The agency said it would give these compounders a grace period of 60 to 90 days before enforcing rules that would put a halt to their work, in an effort to avoid disruption for patients.

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Pharmacy First: A year of the service in England

The Pharmacist

The launch of Pharmacy First in England this year was hailed a significant milestone for the sector and a game-changer for increasing patient access to healthcare. Pharmacies across the country have stepped up to the task, providing thousands of consultations and countless support to patients. But it has not come without its challenges. It started […] The post Pharmacy First: A year of the service in England appeared first on The Pharmacist.

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Trending Sources

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STAT+: Feds accuse CVS of filling ‘thousands’ of illicit opioid prescriptions

STAT

CVS Health was accused of contributing to a nationwide epidemic of opioid addiction and overdose by filling illegal opioid prescriptions and billing federal health insurance programs, according to a lawsuit unsealed Wednesday by the U.S. Department of Justice. The lawsuit alleged that, since October 2013, CVS knowingly filled prescriptions for “dangerous and excessive quantities” of controlled substances that lacked a legitimate medical purpose, were not valid, and were not issued

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India’s pharma industry showcased at CPHI & PMEC India 2024

Express Pharma

CPHI & PMEC India 2024 concluded successfully at the India Expo Centre in Greater Noida, Delhi-NCR, from November 26th to 28th. The three-day event brought together pharmaceutical innovations in machinery, analytical instruments, laboratory technologies, equipment, and ingredients. With over 60,000 attendees from 120 countries and more than 2,000 exhibitors, the event set new records for participation and exhibits.

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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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STAT+: Health plan formularies lowered barriers to fair access to some drugs, analysis finds

STAT

Most of the formularies run by some of the largest health plans in the U.S. generally provide “fair access” to 11 treatments for several serious diseases, although transparent coverage information is often lacking for some medicines, a new analysis has found. Almost uniformly, the 11 formularies made the drugs available fairly when judged on three criteria: eligibility based on clinical data, restrictions placed on prescribers, and step therapy, which requires patients to try other

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STAT+: Gilead plans to halt free access to an HIV drug, worrying patient advocates

STAT

Gilead Sciences will no longer provide four HIV medicines for free as part of a patient assistance program starting at the end of January, alarming community activists who worry the move will limit access and, consequently, impede nationwide efforts to combat the infectious disease. The list includes Truvada, a widely prescribed medicine that is used to treat and prevent HIV, but for which lower-cost generic versions are now available.

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Merck’s RSV antibody could soon paddle into the rough waters of a crowded market

PharmaVoice

A new antibody from Merck would join a market teeming with new entries, but plenty of regulatory and financial uncertainty.

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Opinion: AI’s dangerous mental-health blind spot

STAT

As we approach the end of 2024, First Opinion is publishing a series of essays on the state of AI in medicine and biopharma.  “ How far away was Oswald from Kennedy? ” “ Major depressive disorder.

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Responsible antibiotic use: How the industry can lead the way for evidence-backed guidelines

Express Pharma

Antibiotics have long been essential in treating common infections and supporting complex medical interventions like surgeries, cancer chemotherapy, and organ transplants. However, the misuse and overuse of these critical drugs have catalysed a global health crisis: antimicrobial resistance (AMR). The 2023 annual report from the Indian Council of Medical Research (ICMR) has raised an alarm (1) , revealing increasing antibiotic resistance for common infections, including urinary tract infections

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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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Biotech stocks hammered after Fed rate projections

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning. This is my last newsletter this year. Meghana will be writing the one tomorrow, and then we will be off for the next two weeks. Wishing everyone happy holidays and I’ll see you in the new year.

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Lonza expands Capsule Manufacturing Capacity in India and China

Express Pharma

Lonza, a global manufacturing partner for the pharmaceutical, biotech, and nutraceutical sectors, has announced capacity expansions at its facilities in Rewari, India, and Suzhou, China. The expansion includes additional hard gelatin capsule (HGC) production lines to support the manufacture of high-quality capsules for the pharmaceutical and nutraceutical industries.

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Five innovations shaping the future of pharmacy and therapeutics

The Pharmacist

2024 was a transformative year in pharmacy and therapeutics, marked by groundbreaking advances that promise lasting impacts on healthcare. Dr Joo Gonalves PhD presents his pick for this years top five pharmacy innovations, illustrating how they set new standards for patient care and pharmaceutical development. The key pharmacy innovations witnessed throughout 2024 reflect a growing […] The post Five innovations shaping the future of pharmacy and therapeutics appeared first on The Pharmacis

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NICE recommendation for KORSERDU®▼ (elacestrant) marks ‘step-change’ in the treatment of ESR1-mutated metastatic breast cancer

Pharmafile

19 December 2024 London, UK, Menarini Stemline UK today welcomed final draft guidance from the National Institute for Health and Care Excellence(NICE) recommending use of the first tailored treatment for locally advanced and metastatic breast cancer that has acquired mutations in the ESR1gene, estimated to benefit around 1,000 patients in England and Wales each […] The post NICE recommendation for KORSERDU(elacestrant) marks step-change in the treatment of ESR1-mutated metastatic breast c

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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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Irregular sleep patterns may increase risk of heart attack and stroke

The Pharmacist

Adults who have irregular sleep patterns are 26% more likely to have a major cardiovascular event than those with a regular sleep-wake cycle, a new study shows. Going to bed and waking up at different times was found to be detrimental to cardiac health and strongly associated with an increased risk of heart attacks and […] The post Irregular sleep patterns may increase risk of heart attack and stroke appeared first on The Pharmacist.

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Why a healthy search strategy can power pharma brand growth

pharmaphorum

Discover how implementing a healthy and effective search strategy, focusing on Google, can significantly boost growth and success for pharmaceutical brands.

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Primary care clinicians spend 4.1 million hours per year with dementia patients, report suggests

The Pharmacist

Clinicians in general practice spend almost 4.1 million hours a year with dementia patients, a figure that is expected to increase by 43% by 2040, the Alzheimers Society has suggested. Research by the charity which highlights the economic burden of the condition on the NHS, also found that people with dementia visit the GP between […] The post Primary care clinicians spend 4.1 million hours per year with dementia patients, report suggests appeared first on The Pharmacist.

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Zepbound, Mounjaro shortages are resolved, FDA confirms

BioPharma Dive

The FDA’s decision will close a lucrative market opportunity for compounding pharmacies, although the agency will give a limited grace period before taking any enforcement actions.

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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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A quarter of PCNs have premises to provide care face-to-face

The Pharmacist

One quarter of primary care networks (PCNs) have a dedicated physical estate to provide face-to-face care to their patients, according to a survey carried out by our sister title, Pulse PCN. The results found that of the 227 PCN representatives who responded, 26% said they had a premises for face-to-face care. Most of these (20%) […] The post A quarter of PCNs have premises to provide care face-to-face appeared first on The Pharmacist.

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How small molecule-focused CDMOs can navigate the impact of the Inflation Reduction Act

pharmaphorum

Explore how small molecule-focused Contract Development and Manufacturing Organisations (CDMOs) are adapting to the impact of the Inflation Reduction Act (IRA), shifting legislative landscape, and changes in the investment landscape.

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MSD makes obesity play in up to $2bn deal for Hansoh’s GLP-1RA asset

Pharmaceutical Technology

MSD has entered an exclusive global licence agreement with Hansoh Pharma for a preclinical oral small molecule GLP-1RA.

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Roche sticks with Parkinson’s drug despite second study failure

BioPharma Dive

Even with another mid-stage setback, Roche believes there were enough positive signs to “merit further exploration” of the drug, which it’s been developing with Prothena for more than a decade.

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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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Neuralink rival Precision raises $102m, and other financings

pharmaphorum

Neuralink rival Precision Neurosciences raises $102m for its brain-computer interface tech, plus financings for Redesign, DeepLife, TG0 and Tuva.

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Shashvi Remedies develops breakthrough breast cancer formulation with promising results

Express Pharma

Shashvi Remedies, a Mumbai-based pharma company, has developed a new formulation poised to make significant strides in breast cancer treatment. Breast cancer, now the most common malignancy worldwide, surpassing lung cancer, accounts for millions of lives lost annually. According to the World Health Organisation (WHO), one in five cancer cases globally is due to breast cancer, making it the leading cause of cancer incidence among women in 2020.

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Ottimo raises $140m for its PD-1/VEGF cancer drug

pharmaphorum

Ottimo raises $140m for PD-1 and VEGF-targeting jankistomig, which the startup says is differentiated from bispecific antibodies in the class.

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Key trends in pharma and supply chain management for 2025

Express Pharma

o9, an enterprise AI software platform provider, has shared insights on emerging supply chain management (SCM) trends and challenges across industries, with focus on pharmaceuticals. In the pharma sector, supply chain risk management is becoming increasingly critical. With pharma supply chains relying on third-party partners for logistics, contracts, and manufacturing, enhanced visibility across multi-tiered networks is essential.

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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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Mesoblast finally pushes GvHD cell therapy over finish line

pharmaphorum

At its third attempt, Mesoblast has secured FDA approval for the first-ever mesenchymal stem cell (MSC) therapy, Ryoncil for acute GvHD in children.

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How big pharma keeps affordable drugs out of reach – video

The Guardian - Pharmaceutical Industry

Pharmaceutical corporations claim high prices are the cost of innovation, but the reality is far more complicated and troubling. In 2030, the patents of some of the worlds best-selling drugs will expire, an event called the 'patent cliff', and companies are doubling down on tactics such as 'evergreening' patents and pay-for-delay deals to keep prices high and competition out.

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Novartis sheds MorphoSys staff, sites after pelabresib delay

pharmaphorum

Novartis has confirmed it will shut down two MorphoSys sites in Germany and the US, with the loss of around 330 jobs, by the end of next year.

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