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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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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SAEM Clinical Images Series: A Rash with Cranial Nerve Deficits

ALiEM - Pharm Pearls

A 48-year-old male with no significant past medical history presented to the Emergency Department with a left-sided facial rash and associated burning left eye pain that started four days prior. He was seen at an ophthalmology clinic when his symptoms started and given oral valacyclovir which he took for three days without improvement. He also endorsed left-sided facial weakness and diplopia for the last eight days.

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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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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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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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More Trending

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FDA endorses speedy approval path for Regenxbio Duchenne gene therapy

BioPharma Dive

The agency's openness to a targeted pivotal study shows it’s still willing to consider accelerated clearance for Duchenne gene therapies despite questions about their effectiveness.

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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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STAT+: RFK Jr. is exploring a plan to upend Medicare’s physician payments system

STAT

WASHINGTON  — People close to Robert F. Kennedy Jr. are exploring a proposal that could upend how physician payment is determined in America, four sources familiar with the process told STAT.

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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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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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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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Amgen picks prolific biotech founder Chang as new top scientist

BioPharma Dive

Howard Chang will take over as chief scientific officer and senior VP of research as the biotech searches for more ways to overcome the looming loss of exclusivity for some of its top-selling medicines.

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STAT+: Pharma still ‘falling short’ in providing access to low- and middle-income countries, analysis finds

STAT

Although more pharmaceutical companies are tailoring their business models to focus on low-income countries, a new analysis finds that overall industry efforts remain limited and patient access continues to suffer as a result. Notably, momentum has stalled in reaching licensing deals that are designed to make lower-cost generic drugs available in parts of the world where brand-name medicines are unaffordable, and few companies have pursued technology transfer agreements.

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Will Walgreens’ store closures derail its clinical trial aims?

PharmaVoice

Despite a plan to shutter 1,200 stores, the company’s chief clinical trials officer said the pharmacy juggernaut remains committed to drug research.

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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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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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BridgeBio heart drug approved by FDA, setting up battle with Pfizer

BioPharma Dive

The approval of Attruby for transthyretin amyloidosis with cardiomyopathy begins a battle for control of a lucrative market that investors have been skeptical BridgeBio can win.

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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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The first MASH drug could open the door for others — including GLP-1s

PharmaVoice

With only one approved drug on the market, companies like Inventiva Pharma are advancing MASH drugs and seeking a competitive edge.

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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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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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Versant startup sets out to make a new type of obesity drug

BioPharma Dive

The startup, Pep2Tango, is combining four methods of accelerating weight loss into one medicine in the hopes of developing a treatment that can improve upon drugs like Wegovy and Zepbound.

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AI-guided decisions can devastate lower-income Americans. This group wants to change that

STAT

In 2016, the Arkansas Legal Aid Center was flooded with calls. People on a Medicaid program that provided in-home care assistance were having their caregiving hours cut. Reducing the hours for somebody with quadriplegia or cerebral palsy was devastating, said Kevin De Liban, an attorney with the organization at the time. “People are lying in their own waste, people are getting bed sores from not being turned.

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Why Merck rolled the dice on an ‘unbelievable’ early-stage brain cancer drug

PharmaVoice

Merck’s acquisition of Modifi Biosciences bucks common M&A trends in pharma.

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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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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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Flagship, Pfizer alliance yields two more startup deals

BioPharma Dive

Pfizer will work with Ampersand Biomedicines and Montai Therapeutics to find drugs for obesity and lung cancer, respectively, adding to collaborations it previously formed with other Flagship startups.

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STAT+: Kura licenses leukemia drug to Japanese drugmaker

STAT

Kura Oncology has signed a global partnership with the Japanese drugmaker Kyowa Kirin to develop and sell Kura’s experimental treatment for acute leukemia, the companies said Wednesday.  Kyowa is paying $320 million to Kura in exchange for global licensing rights to the drug, called ziftomenib, which is in a late-stage clinical trial for a genetically defined type of advanced leukemia.

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Pfizer, under pressure to change, names oncology head as new R&D chief

PharmaVoice

Chris Boshoff will replace Mikael Dolsten, who’s stepping down after 15 years leading research at the drugmaker.

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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.

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Less than half of PCNs increased ARRS pay by 5.5%

The Pharmacist

Less than half of primary care networks (PCNs) have given their Additional Roles Reimbursement Scheme (ARRS) staff – such as practice pharmacists and pharmacy technicians – a pay rise of at least 5.5% since April this year, according to a new survey. Of the 129 GPs with a PCN role who responded to the survey […] The post Less than half of PCNs increased ARRS pay by 5.5% appeared first on The Pharmacist.

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CRISPR therapy from Intellia may ameliorate rare heart disorder, data suggest

BioPharma Dive

Phase 1 data indicate Intellia’s medicine could be a powerful treatment for a cardiac form of ATTR amyloidosis. But rival drugs are further ahead.

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STAT+: AHA 2024: First, a call for prevention. Then a spotlight on obesity drugs

STAT

CHICAGO — This year’s scientific sessions on the latest research in cardiovascular disease began not with the buzzy new obesity drugs but with a sobering look at progress stalling or even reversing in common chronic illnesses. The overture to the American Heart Association’s conference, coming as the organization celebrates its 100th year, began with Valentin Fuster of Mount Sinai Hospital lamenting the predicted shift in overall cardiovascular disease burden,  worsenin

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Neurogene drops high-dose arm in Rett study after death

pharmaphorum

The patient affected by a serious adverse event in Neurogene's clinical trial of Rett syndrome gene therapy has now died

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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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