Wed.Dec 11, 2024

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STAT+: Eli Lilly strikes Zepbound deal with Ro, amid questions about future of compounded GLP-1s

STAT

Eli Lilly, which has been directing patients to various telehealth sites as it sells its blockbuster obesity medication Zepbound, is broadening its reach, announcing a partnership Wednesday with major telehealth platform Ro Health. Under the new agreement, patients will be able to order vials of Zepbound through Ro’s app. Previously, Lilly had only made these vials, which are priced lower than its injectable pens, available to patients with prescriptions ordering directly through an onlin

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GLP-1 compounding is still in limbo. Will the FDA leave it for the next administration?

PharmaVoice

The agency has yet to make a decision about keeping tirzepatide on or off of its shortage list — letting compound pharmacies continue their lucrative operations for now.

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STAT+: Wall Street wags say a bill to force insurers or PBMs to sell pharmacies has low odds

STAT

A proposed Senate bill that would prohibit companies that control health insurers or pharmacy benefit managers from owning pharmacies rattled investors on Wednesday, but some Wall Street analysts believe the legislation is unlikely to gain much traction, at least for now. The bipartisan bill , which would require divestiture within three years, is aimed at what the lawmakers call an “inherent conflict of interest” that has forced Americans to pay more for medicines and hastened the

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Leriglitazone meets endpoint in trial for cerebral adrenoleukodystrophy

Pharma Times

Promising results set stage for European marketing authorization

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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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Gilead to test once-a-year HIV prevention shot

STAT

Gilead said Tuesday that it will soon begin Phase 3 testing for a drug it believes could prevent HIV infection with just a single shot every year. Such a medicine, if proven effective, would be the closest thing to a vaccine the HIV field has produced in four decades of research. The company plans to begin the trial next year, with an eye toward regulatory filings in late 2027.

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Using FDA Product Specific Guidances (PSGs) as a Trigger for Generic Drug Development

Drug Patent Watch

Generic drugs play a crucial role in providing affordable healthcare options to millions of patients worldwide. One of the key tools that generic drug manufacturers rely on to navigate the complex regulatory environment is the FDA’s Product Specific Guidances (PSGs). These guidances serve as a roadmap for companies looking to develop generic versions of brand-name drugs, offering invaluable insights into the FDA’s expectations for demonstrating bioequivalence and ensuring product qua

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Toripalimab can fortify Dr. Reddy’s oncology portfolio as first checkpoint inhibitor for NPC in India: GlobalData

Express Pharma

Dr. Reddy’s Laboratories has recently become the first Indian company to launch checkpoint inhibitor Zytorvi (toripalimab) in collaboration with Shanghai Junshi Biosciences. Zytorvi is an immuno-oncology therapy for recurrent or metastatic nasopharyngeal carcinoma (RM-NPC). This marks a transformative moment, bringing a next-generation PD-1 inhibitor to India and addressing significant unmet medical needs.

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iOnctura achieves new clinical milestones in uveal melanoma therapy

Pharma Times

Successful phase 1 study highlights potential of roginolisib

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How to Achieve CDMO Operational Excellence

Drug Patent Watch

Achieving operational excellence in a Contract Development and Manufacturing Organization (CDMO) is crucial to ensure the quality and consistency of products and services. This can be achieved by implementing robust controls, optimizing workflows, and fostering a culture of continuous improvement. Here are some key strategies to achieve operational excellence in a CDMO: Implementing Robust Controls Compliance with Regulatory Guidelines : Ensure compliance with strict regulatory standards set by

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Eli Lilly’s new maneuvers in GLP-1 treatment

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, hope everyone is staying warm this week wherever you are. Here in Chicago, we’re expecting an Arctic blast to hit this afternoon, which is karma for me saying how much I missed this city while I was gone.

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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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Pharmapack Europe 2025: Eco barrier packaging to launch

European Pharmaceutical Review

LOG Pharma Primary Packaging is set to present its new barrier eco line at Pharmapack Europe 2025. The new bottles for pharmaceuticals offer optimal oxygen scavenging. Our R&D team has developed a series of barrier bottles that provide exceptional protection against oxygen and moisture while being environmentally friendly and reducing costs significantly, stated LOGs Chief Executive Officer Shaul Bassi.

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ASH 2024 discussions shine spotlight on advances in haemophilia treatments

Pharmaceutical Technology

When a room of physicians at ASH 2024 was asked whether they had prescribed a gene therapy in a commercial context, only a handful said yes.

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Government recommends 2.8% pay uplift for GP and PCN pharmacists

The Pharmacist

The government has planned for a pay rise of 2.8% for pharmacists working in general practice and the NHS for 2025/26, it has been announced. In written evidence to the pay review bodies for general practice staff and NHS staff, the Department of Health and Social Care (DHSC) said it had set aside 2.8% for […] The post Government recommends 2.8% pay uplift for GP and PCN pharmacists appeared first on The Pharmacist.

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Endometriosis drug research, long underfunded, confronts familiar problems in women’s health

PharmaVoice

Despite the disease’s prevalence, endometriosis remains misunderstood, and research into drugs that might treat it draws scant funding — problems that have deep roots.

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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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NHS England 'lacks primary care strategy or expansion plan', government told

The Pharmacist

NHS England has 'no primary care strategy or expansion plan' and pockets of short-term investment in the sector have 'failed', the government has been warned. Primary care representatives including those within community pharmacy, GP, dentist, optometry and audiology have issued a damning response to the government's 10-Year Health Plan consultation.

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Respiratory syncytial virus prophylactic market to surpass $6 bn across 8MM in 2030

Express Pharma

The respiratory syncytial virus (RSV) prophylaxis market across the eight major markets (8MM*) is forecast to grow at a compound annual growth rate (CAGR) of 26.7 per cent from $582 million in 2020 to $6.2 billion in 2030, with the pediatric and adult segments accounting for $2.2 billion and $4.0 billion, respectively, according to GlobalData. GlobalDatas latest report, Respiratory Syncytial Virus Prophylaxis: Eight-Market Drug Forecast and Market Analysis Update, reveals that market growth wil

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Nearly twice as many patients in deprived areas prescribed dependency-forming meds 

The Pharmacist

The total number of patients prescribed dependency-forming medications in England fell by more than 2,000 between June and September this year, latest figures have shown. But huge variation persists between the most and least deprived areas of the country, with79.3% more patients being prescribed dependency-forming medications in the most deprived areas of the country compared […] The post Nearly twice as many patients in deprived areas prescribed dependency-forming meds appeared first on

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How to Develop a Sustainable Generic Drug Development Strategy

Drug Patent Watch

The pharmaceutical industry, particularly the generic drug sector, faces significant challenges in adopting sustainable practices. As the world grapples with the consequences of climate change, companies must adapt their operations to reduce environmental impacts while maintaining cost-effectiveness and regulatory compliance. This article outlines key considerations and strategies for developing a sustainable generic drug development strategy.

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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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Power Gummies raises ₹10 cr, aims to expand product range

Express Pharma

Power Gummies has raised Rs 10 crore in the bridge round. Led by the Jaipuria Family Office and Quadrant, the funding round was also joined by previous investors 100unicorn, DSGCP, Wipro Consumer, Venture Catalysts, Agility, Sharrp Ventures, Dhianu Das and NB Ventures. The fresh capital would be instrumental in enabling the brand to become completely sugar-free in its products, followed by expansion into no-added sugar products and an upgraded composition in the existing range.

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CDMO Selection: The Ultimate Checklist

Drug Patent Watch

The biopharmaceutical industry has witnessed a significant surge in the number of therapeutic molecules in development, leading to a corresponding increase in the number of contract development and manufacturing organizations (CDMOs). This growth has created a competitive landscape where pharmaceutical companies must carefully evaluate and select the right CDMO partner to ensure the success of their projects.

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Er-Kim and Ascendis’ endocrine therapy agreement extended in Eurasia

Pharmaceutical Technology

Er-Kim has extended its exclusive agreement with Ascendis Pharma for endocrinology treatments across multiple countries in Eurasia.

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Bayer acquires HiDoc Technologies and Cara Care® app for irritable bowel syndrome

World Pharma News

Bayer is today announcing that it plans to acquire HiDoc Technologies GmbH in the first quarter of 2025 and to start commercialization of the digital health application, Cara Care. Cara Care is the first prescribed digital health application for the treatment of irritable bowel syndrome (IBS) and offers a novel, holistic therapeutic approach for patients with IBS.(1) Patients with irritable bowel syndrome have generally already been through a lot by the time they receive a formal diagnosis, and

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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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How Pfizer management outplayed activist investor Starboard

Pharmaceutical Technology

The push to replace Albert Bourla as Pfizers CEO drew attention from the pharma industry but was soon derailed by several events.

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The Impact of USP Chapter on Endotoxin Testing

PharmaTech

Pharmaceutical Technology spoke with Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories, to get her perspective on endotoxin testing and USPs new Chapter Bacterial Endotoxins Test Using Recombinant Reagents.

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Vifor Pharma offers £23m to NHS to resolve CMA investigation

Pharmaceutical Technology

If accepted, Vifor Pharma's 23m offer will "claw back" money for the NHS and close the CMA's first-ever disparagement case.

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AbbVie Acquires Aliada Therapeutics, Gains Neuroscience Pipeline

PharmaTech

AbbVie has completed its acquisition of Aliada Therapeutics which includes Aliadas disease-modifying therapy for Alzheimers disease.

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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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Relation-GSK to drive fibrotic and osteoarthritis developments

Pharmaceutical Technology

Relation has announced two strategic collaborations with GSK, focusing on new therapeutics for fibrotic and osteoarthritis.

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FDA Grants Fast Track Designations to 2 Combination Influenza and COVID-19 Vaccine Candidates

Pharmacy Times

The combination vaccine candidates will be evaluated in 2 separate phase 1/2 clinical trials.

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ASH 2024: J&J’s Tecvayli shows promise in transplant-eligible NDMM patient

Pharmaceutical Technology

The prevailing treatment paradigm for newly diagnosed multiple myeloma (NDMM) patients who have received autologous stem cell transplantation (SCT) primarily consists of chemotherapy or Johnson & Johnsons (J&J) Darzalex in combination with chemotherapy.

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ASHP Midyear: High Costs of Gene Therapies Present Major Challenges to Implementation

Pharmacy Times

According to the report, 75% of survey participants expect pharmacists to oversee these therapies and 58% expect Medicare will require pharmacist involvement.

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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.