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

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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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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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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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Grifols linked to €7bn takeover offer from Brookfield

pharmaphorum

Private equity company Brookfield has reportedly moved closer to taking control of Grifols, after months of disruption at the Spanish pharma company.A report in Spanish newspaper El Confidencial suggests that Brookfield is preparing to make a bid to take a 65% controlling stake in the drugmaker for €10.50 per share, worth around €7 billion ($7.4 billion).

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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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H5N1 bird flu virus in Canadian teenager displays mutations demonstrating virus’ risk

STAT

The genetic sequence of the H5N1 bird flu virus that infected a teenager in British Columbia shows that the virus had undergone mutational changes that would make it easier for that version of H5N1 to infect people, scientists who have studied the data say.  There’s currently no evidence the teenager, who remains in critical condition in hospital, infected anyone else.

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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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More Trending

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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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Opinion: RFK Jr. says he isn’t an anti-vaxxer. He’s wrong

STAT

If he can make it past the Senate, Robert F. Kennedy Jr. will be the next secretary of Health and Human Services. Since the position was created, each secretary has had significant experience in public health, health care administration, or related government work. None has listed “spreading vaccine misinformation” as their primary health care experience.

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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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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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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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Syndax gets FDA okay for first-in-class leukaemia drug

pharmaphorum

Shortly after a disappointing trial readout for Syndax's menin inhibitor Revuforj in one form of leukaemia, the company has claimed FDA approval in another

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The many legal fronts of RFK Jr.’s fight against vaccines

STAT

Robert F. Kennedy Jr. took leave as chairman of Children’s Health Defense, a nonprofit known for spreading doubt about vaccines, to run for president last year. But he is still fighting in court alongside the group, putting him in an unusual position for someone nominated as Secretary of Health and Human Services.   If confirmed by the Senate, Kennedy will have power to guide the agencies he oversees toward his priorities.

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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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We should call for a new minister to improve men and boys’ health

The Pharmacist

What more can we do to improve men’s health? Pharmacist Michael Achiampong shares his personal viewpoint about improving the health of men and boys. Men and boys’ health – physical, mental and emotional – has rocketed up the healthcare agenda and public awareness like never before.1,2 There is new impetus for some long-running initiatives such as Movember3 […] The post We should call for a new minister to improve men and boys’ health 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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NIH algorithm matches patients to clinical trials

pharmaphorum

Researchers from the National Institutes of Health (NIH) are applying artificial intelligence to the recruitment of volunteers into clinical trials, aiming to solve a major obstacle in clinical research.Patient recruitment remains a major challenge for trial sponsors and can lead to delays and increased costs, and traditional methods can be time-consuming and inefficient.

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Opinion: New guidance endangers the rights of people with disabilities

STAT

Nothing brought Olivia more joy than when her daughter and grandchild visited her group home in Brooklyn in the early 2000s. Each hug and shared laugh lit up her face with pride like any mother’s, grounded in love, family, and connection. Olivia’s story should not be remarkable, but history almost denied her the chance to experience her family.

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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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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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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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GSK drug raises hopes for patients with PBC itch

pharmaphorum

GSK has reported promising phase 3 results with linerixibat in treating severe itching that plagues patients with primary biliary cholangitis

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First U.S. case of new mpox strain detected in California

STAT

California has detected the country’s first case of a new mpox strain that is spreading from person to person. The infected individual had recently traveled from Eastern Africa, where multiple countries are battling transmission of this virus. The individual was treated in a health facility in San Mateo County and is in isolation at home, the California Department of Public Health announced in a statement released Saturday.

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Tran Pham: Breaking barriers and building biopharma solutions

Outsourcing Pharma

From discovering her knack for chemistry in high school to proving her expertise in male-dominated spaces, Tran Pham has built a dynamic career in biopharma.

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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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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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Tirzepatide gets a big win in obesity-related heart failure

pharmaphorum

Eli Lilly's tirzepatide has been shown to significantly cut cardiovascular risks in patients with obesity and a form of heart failure with few treatment options, in another big win for the GLP-1 receptor agonist class.The results from the SUMMIT trial of tirzepatide in obese patients with heart failure with preserved ejection fraction (HFpEF) showed that Lilly's drug cut the risk of cardiovascular mortality and worsening heart failure events by 38% over a median follow-up of roughly two years.

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STAT+: New details on a risky medical device show need for more FDA transparency, researchers say

STAT

Tonya Brand was horrified to find a piece of metal poking out of her inner thigh while relaxing at her house in Georgia in 2011. She had no idea what it could be.  It was only after extensive imaging that her doctors realized what had happened: A medical device that had been implanted in her two years earlier to catch blood clots had broken and was now migrating to different parts of her body.

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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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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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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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J&J plots filings after psoriasis drug clears phase 3 test

pharmaphorum

Johnson & Johnson has moved a step closer to filing a potential first-in-class therapy for psoriasis after the drug hit the mark in a phase 3 trial

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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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AHA 2024: Plozasiran demonstrates promising Phase III results in FCS adults

Pharmaceutical Technology

During AHA 2024, data were presented from the Phase III trial of plozasiran targeting adults with genetically or clinically diagnosed FCS,

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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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Pfizer bags EU okay for haemophilia drug Hympavzi

pharmaphorum

Pfizer's Hympavzi has become the first once-weekly subcutaneous treatment for people living with severe haemophilia B in the EU

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