Tue.Nov 19, 2024

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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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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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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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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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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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STAT+: Why the crowded market for ambient AI medical scribes might be ripe for consolidation

STAT

Ambient AI medical scribes are about the easiest — and hottest — way into health care for AI-based startups. Just take a look at this graphic that lists 35 companies who are (or at one point were) trying to use ambient voice for translating the audio of doctors’ visits into written notes.  The area is both well within the capabilities of AI tools and also — theoretically — doesn’t directly affect patient care.

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'The great prescribing debate': What should clinical supervision look like?

The Pharmacist

Three models of clinical supervision were explored at the Royal Pharmaceutical Society (RPS) conference earlier this month, in a session chaired by Susan Roberts, the associate director for pharmacy at NHS Education for Scotland. The session was badged as 'The great prescribing debate' and heard about approaches being used to support pharmacists to develop into […] The post 'The great prescribing debate': What should clinical supervision look like?

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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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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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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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A win for Apellis, a setback for Astellas

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Morning! Lots today from the American Heart Association’s annual meeting, plus former National Cancer Institute chief Ned Sharpless launches a new biotech called Jupiter.

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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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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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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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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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STAT+: Pharmalittle: We’re reading about a key Merck drug trial, cheap Wegovy in China, and more

STAT

Top of the morning to you, and a fine one it is. Clear blue skies and cool breezes are wafting over the Pharmalot campus, where the official mascots are snoozing after foraging for their breakfast. This means we are free to focus on the matters at hand — rummaging through our to-do list and making cups of stimulation. Our choice today is Mexican cinnamon.

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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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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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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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Large Chains’ Position in 2025’s Part D Pharmacy Networks: Supermarkets Take the Lead in a Shrinking PDP Market

Drug Channels

In Medicare Part D in 2025: Preferred Pharmacy Networks Fade in a Collapsing PDP Market , I documented the Inflation Reduction Act’s (IRA) disruption to Medicare Part D prescription drug plans (PDPs). Today, we examine the seven largest retail chains’ participation in the 12 major 2025 Part D networks that the five largest plan sponsors will offer. As always, we provide you with a handy table for tallying each chain’s participation and changes from 2024 to 2025.

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AGI Greenpac’s Specialty Glass Plant in Bhongir achieves IGBC Platinum rating

Express Pharma

AGI Greenpac, a packaging products company in India, has received the Indian Green Building Council (IGBC) Platinum rating for its Specialty Glass Plant in Bhongir. This certification recognises the plant’s sustainability practices, including measures in energy and water conservation, waste management, and eco-friendly design. The Bhongir facility incorporates various energy efficiency measures.

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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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FDA says no to Astellas' geographic atrophy drug

pharmaphorum

Astellas has suffered another major setback with geographic atrophy (GA) treatment Izervay, this time in the US. The company has received a complete response letter (CRL) from the FDA for a proposed update to the labelling for Izervay (avacincaptad pegol) that sought to include the results of the phase 3 GATHER2 trial and improve the drug's competitive profile against rival Syfovre (pegcetacoplan) from Apellis.

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Eli Lilly announces positive Phase 2 results for Muvalaplin against heart disease

Outsourcing Pharma

Muvalaplin significantly lowered lipoprotein(a) levels, reducing the risk of cardiovascular events in high-risk adults.

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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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FDA approves CAR-T Cell Therapy for Refractory B-cell Precursor Acute Lymphoblastic Leukemia

Big Molecule Watch

On November 8, 2024 Autolus, Inc. (“Autolus”) announced that the FDA has approved AUCATZYL (obecabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (“ALL”). AUCATZYL is a CAR T cell therapy designed to specifically recognize and bind CD19-positive B-cells in precursor ALL patients.

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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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Great Place To Work® and Fortune Name Chiesi Group No. 23in 2024 World’s Best Workplaces™ List

Pharmafile

18 November 2024 – Manchester, UK – Chiesi Group, an international biopharmaceutical company focused on research, has been named one of the 25 World’s Best Workplaces™ in 2024 by Great Place To Work® (GPTW) and Fortune magazine, ranking 23rd on this year’s list.The news marks the first time any European pharmaceutical company has achieved the […] The post Great Place To Work® and Fortune Name Chiesi Group No. 23in 2024 World’s Best Workplaces™ List appeared first on Pharmafile.

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C Ray Therapeutics raises $100 million to develop radiopharmaceuticals

Outsourcing Pharma

The financing round will fund the improvement of the companyâs technology platform for the discovery and development of innovative radionuclide drug conjugates.

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New PAGB research highlights importance of self-care for easy-to-treat conditions

Pharma Times

The census found that 56% of people visit their GP for a UTI and 27% for thrush

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Astellas application rejected by FDA; Cytokinetics strikes licensing deal with Bayer

BioPharma Dive

The agency turned back Astellas’ attempt to update its drug Izervay’s labeling. Elsewhere, former NCI director Ned Sharpless founded a new startup and Novartis licensed another radiopharma drug.

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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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Potential Legal Action Against PD-1 Inhibitor Label Restrictions for Gastric Cancers

PharmExec

Ron Lanton, Partner, Lanton Law, discusses potential challenges that will come as a result of the FDA’s recent move to tighten label restrictions on PD-1 inhibitors for gastric cancers.

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Incyte shares sink on setback for drugs acquired in $750M buyout

BioPharma Dive

The company paused testing of one candidate acquired in its April deal for Escient and scrapped another in a blow to its diversification plans.

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Looking to history to prepare for America’s uncertain future

pharmaphorum

Listen to an insightful podcast interview with Jesse Mendelsohn as he discusses looking to history to prepare for America's uncertain future. Explore valuable insights and perspectives on the topic.

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Under-the-skin Keytruda comparable to infused version in Phase 3 study, Merck says

BioPharma Dive

Merck plans to discuss the data with regulators as it lags rivals Roche and Bristol Myers in bringing forward a subcutaneous form of its cancer drug.

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Alentis Therapeutics to Advance Anti-Claudin-1 ADCs to Treat Solid Tumors on $181.4 Million Financing

PharmaTech

Financing from OrbiMed, Novo Holdings, Jeito Capital, and others will enable Alentis Therapeutics to advance its pipeline of Claudin-1-targeted ADCs for treating solid tumors.

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