Sat.Nov 16, 2024 - Fri.Nov 22, 2024

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Can drugs be blockbusters without relying on US sales?

Drug Patent Watch

The concept of a blockbuster drug, defined as a medication generating at least $1 billion in annual sales, has long been a cornerstone of the pharmaceutical industry. However, the question arises whether a drug can achieve blockbuster status without heavily relying on U.S. sales.

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Opinion: The FDA’s risky action on compounding weight loss drugs

STAT

When Makena, a drug designed to prevent preterm births, hit the market in 2011 at $1,500 per dose, it drew rife backlash. The drug was based on an active ingredient that had been available for many years at a much lower cost. Confronted with the public outcry, the FDA took an unusual step: It allowed pharmacies to continue making their own copies of the drug through the practice of pharmacy compounding, selling it at a fraction of Makena’s price.

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Study shows benefits of pharmacy sore throat service over GP consultation

The Pharmacist

A pharmacy-led sore throat treatment service in Wales has been found to result in fewer same-day antibiotic prescriptions than those given during GP consultations, according to a new study. The study, published in the Journal of Antimicrobial Chemotherapy, found that pharmacy-led sore throat treatment provides a safe, effective, and cost-efficient alternative to GP consultations.

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Soft launch of first indigenous antibiotic to combat AMR, Nafithromycin, announced by Dr Jitendra Singh

Express Pharma

Union Minister Dr Jitendra Singh formally launched the first indigenous antibiotic “Nafithromycin” for resistant infections. It is only after 2014, when Prime Minister Narendra Modi took over that our researchers received the right kind of support to explore their potential, said Dr Jitendra Singh. The antibiotic Nafithromycin has been developed with the support of the Biotechnology Industry Research Assistance Council (BIRAC), a unit of the Department of Biotechnology and has been brought to ma

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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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Keytruda represents almost half of Merck’s sales, and a new formulation could fend off rivals

PharmaVoice

A subcutaneous version of Merck’s Keytruda was as effective as the infused version in a late-stage study, but the company won’t be the first to market.

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More Trending

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Cytisine pill could be added to stop smoking guidelines

The Pharmacist

NICE is consulting on a proposal to add cytisine as a treatment option to its stop smoking guidelines. This proposal follows a review of recent evidence which suggests patients who received cytisine were 30% more likely to not smoke for six months or longer, when compared to placebo or no medication. The drug was made […] The post Cytisine pill could be added to stop smoking guidelines appeared first on The Pharmacist.

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Emcure Pharmaceuticals launches campaign addressing male anaemia

Express Pharma

Emcure Pharmaceuticals has launched a nationwide public awareness campaign to address the increasing prevalence of anaemia among Indian men. The campaign, featuring former Indian cricket captain MS Dhoni, was unveiled through a video released on International Men’s Day. It aims to educate the public on the health implications of anaemia in men and encourage early diagnosis and treatment.

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What is a ‘cure,’ really? AbbVie’s Humira creator leaps into the next phase of medicine

PharmaVoice

AbbVie’s head of R&D cures has lofty ambitions to end diseases like HIV through a community of researchers that work as one.

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STAT+: BridgeBio wins FDA approval for heart disease drug

STAT

The Food and Drug Administration approved on Friday a new medicine from BridgeBio for patients with a progressive heart disease — the first new treatment for the condition in over five years and the company’s first significant commercial product. The drug, known scientifically as acoramidis, will be sold by BridgeBio under the brand name Attruby.

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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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UK CPhOs issue advice to pharmacists on assisted dying debate

The Pharmacist

The UK’s most senior pharmacists have issued advice to those among the pharmacy professions who want to take part in the public debate around assisted dying. Chief pharmaceutical Officers (CPhOs) and other pharmacy leaders said on Wednesday that it is ‘entirely reasonable’ for pharmacists and pharmacist technicians to give their opinions and that ‘the public […] The post UK CPhOs issue advice to pharmacists on assisted dying debate appeared first on The Pharmacist.

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Lupin receives FDA approval for generic version of Adderall XR

Express Pharma

On 19 November 2024, Lupin announced that it had received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules. The approval covers dosage strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg, which are the generic equivalent of Adderall XR Extended-Release Capsules marketed by Takeda Ph

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The Dodgers’ World Series run brought attention to a rare disease. Annexon is stepping up to the plate.

PharmaVoice

The company is looking to score an FDA nod for its investigational therapy that targets a molecule linked to Guillain-Barré syndrome and other autoimmune diseases.

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STAT+: AI in drug discovery is ‘nonsense,’ but call Schrödinger ‘AI’ if you want, says CEO

STAT

Schrödinger CEO Ramy Farid wants you to know that his company isn’t an AI company…but he’ll call it that if you want to. The company, founded in 1990, started out by making software that used the basic laws of physics to laboriously and exactly predict how molecules will interact with each other in space. Those calculations, rooted in the field of computational physics, needed lots of expensive and time-consuming computing power to run, and many people abandoned those t

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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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Local systems must involve community pharmacy to improve population health

The Pharmacist

Local systems need to talk to community pharmacies about how they can help improve population health, a local pharmaceutical committee (LPC) leader has urged. Pharmacies are well placed to provide anecdotal feedback about their local communities and what they need to their local systems, Shilpa Shah said at the Public Policy Projects (PPP) Integrated Health […] The post Local systems must involve community pharmacy to improve population health appeared first on The Pharmacist.

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Reshaping pharma safety with active packaging innovations

Express Pharma

In pharmaceutical packaging, where quality and safety are requisites for a shelf-stable formulation, Cilicant has understood this concern very well and is committed to providing the right solutions to protect the formulations from the harmful effects of moisture and oxygen, which are well-known factors affecting stability. Over the years, CILICANT has established itself as an innovative manufacturer of active packaging solutions with notable patented technologies.

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The Future of Partnerships in Generic Drug Development

Drug Patent Watch

The pharmaceutical industry is undergoing significant transformations, particularly in the realm of generic drug development. Recent trends and advancements in technology, research, and collaboration are reshaping the landscape of generic drug development, leading to new opportunities and challenges for pharmaceutical companies.

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STAT+: In first meeting of FDA’s digital health advisory committee, generative AI is up for debate

STAT

Robert Califf has made no secret of the Food and Drug Administration’s struggles to regulate generative AI. Large language models and their application to health care “provide a massive example of a technology with novel needs,” FDA commissioner Califf said in an address earlier this year to the Coalition for Health AI.  This week, the agency will turn toward that challenge, focusing the first-ever meeting of its Digital Health Advisory Committee on the question of whet

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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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Proposal for temporary pharmacy in shipping container to address access issues

The Pharmacist

A temporary pharmacy could be set up in a shipping container in Warminster to address an ‘immediate need’ for services in the area while a permanent facility is developed. The proposal comes after local councillors earlier this year called for urgent action to address a pharmacy ‘crisis’ in the area. A planning application for a […] The post Proposal for temporary pharmacy in shipping container to address access issues appeared first on The Pharmacist.

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360 ONE Asset acquires stake in OneSource

Express Pharma

360 ONE Asset announced an investment in OneSource Specialty Pharma, a pharma CDMO in India. 360 ONE Asset is acquiring a stake from an existing investor. OneSource is a player in biologics, drug-device combinations, complex injectables, and soft gelatin capsules. OneSource has the expertise to develop and manufacture complex products such as GLP-1 drugs and novel biologics.

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The Future of Generic Drug Development in Emerging Markets

Drug Patent Watch

The pharmaceutical industry is undergoing a significant shift, with emerging markets offering the next growth opportunity. This growth is driven by several factors, including the increasing prevalence of chronic diseases, cost-effectiveness, and patent expirations of branded drugs.

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STAT+: Novartis buys gene therapy startup Kate Therapeutics, joining pursuit of muscular dystrophy treatment

STAT

Novartis said Thursday it purchased gene therapy startup Kate Therapeutics for up to $1.1 billion in upfront payments and milestones.  It’s a rare buyout for a field that has quieted over the last couple years, amid a wider biotech downturn and questions about both the effectiveness and profitability of these one-time treatments.  With the deal, Novartis will acquire a pipeline of preclinical gene therapies for three different genetic neuromuscular diseases, along with the under

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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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Finding hope and purpose as a millennial pharmacist

The Pharmacist

Nathan Burley argues that younger pharmacists have a distinct perspective on the challenges they face in pharmacy – that all require a strong sense of optimism to navigate. As a millennial healthcare professional, I often find myself caught between two conflicting worlds. On one hand, there’s the relentless pressure of healthcare — burnout, staff shortages […] The post Finding hope and purpose as a millennial pharmacist appeared first on The Pharmacist.

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Lupin re-launches Humrahi with focus on diabetes and heart health

Express Pharma

Global pharma major Lupin (Lupin) announced the re-launch of Humrahi at the Research Society for the Study of Diabetes in India (RSSDI) conference in New Delhi. Humrahi is now enhanced with comprehensive support for both diabetes and heart health. With diabetes and cardiovascular diseases ranking among the top health challenges globally, Humrahi represents a critical innovation that combines extensive support for diabetes management along with robust care strategies for heart health.

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CDMO Vendor Management: Best Practices

Drug Patent Watch

The pharmaceutical industry has increasingly turned to contract development and manufacturing organizations (CDMOs) to optimize their facilities and outsource non-core production. Effective CDMO vendor management is crucial for the success of these partnerships. Here, we outline best practices for selecting, qualifying, and managing CDMOs.

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With rising cancer rates in younger adults, experts emphasize better tests

STAT

Cancer cases are on the rise among people under 50 — and researchers aren’t sure why. A recent study by the American Cancer Society found that 17 out of 34 cancer types were increasing among younger people.  At the Milken Institute’s Future of Health Summit on Thursday, researchers and health care executives talked about efforts to detect cancers earlier, save lives, and get to the root of why cancers have begun to rise in this population.

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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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Latest UKHSA figures show rise in both antibiotic use and resistance

The Pharmacist

Antibiotic use rose by 2.4% year-on-year in 2023 and prescribing levels are now in line with those seen in 2019, according to national surveillance data published by the UK Health Security Agency (UKHSA). The increases were seen across the majority of antibiotic groups, with penicillins accounting for the most frequently prescribed antibiotic group in primary […] The post Latest UKHSA figures show rise in both antibiotic use and resistance appeared first on The Pharmacist.

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Lupin launches Bumetanide injection USP in the United States

Express Pharma

On 19 November 2024, Lupin announced the launch of Bumetanide Injection USP in the United States following approval from the United States Food and Drug Administration (FDA). The product is available in two formulations: 1 mg/4 mL (0.25 mg/mL) single-dose vials and 2.5 mg/10 mL (0.25 mg/mL) multiple-dose vials. Bumetanide Injection USP is a generic equivalent of Bumex Injection (0.25 mg/mL) by Validus Pharmaceuticals, LLC.

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European Pharmaceutical Review Issue 5 2024

European Pharmaceutical Review

Articles in Issue 5 of European Pharmaceutical Review include: FOREWORD ICH Q6(R1): test criteria and specifications Dave Elder David P Elder Consultancy CELL & GENE THERAPY How automation and digital technologies will unlock the full potential of advanced therapies Dr Stephen Ward CGT Catapult Hydrogel encapsulation: unlocking the potential of cell therapies for targeted treatments Dr Stephen Harrington and Francis Karanu Likarda SUSTAINABILITY Transitioning to digital product information t

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