STAT

NOVEMBER 19, 2024

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.

Compounding 363

Compounding 363

PharmaVoice

NOVEMBER 19, 2024

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

NOVEMBER 19, 2024

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.

Vaccines 337

Vaccines 337

PharmaVoice

NOVEMBER 19, 2024

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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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

Communication

STAT

NOVEMBER 19, 2024

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 Pharmacist

NOVEMBER 19, 2024

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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The Pharmacist

NOVEMBER 19, 2024

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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STAT

NOVEMBER 19, 2024

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.

Pharmaceutical Companies 314

Pharmaceutical Companies Pharmaceutical Companies Drug Pricing 314

Express Pharma

NOVEMBER 19, 2024

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.

Diabetes 105

Diabetes Hospitals 105

STAT

NOVEMBER 19, 2024

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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pharmaphorum

NOVEMBER 19, 2024

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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STAT

NOVEMBER 19, 2024

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.

Biosimilars 277

Biosimilars Immunization Immunity Pharmaceutical Companies 277

pharmaphorum

NOVEMBER 19, 2024

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

NOVEMBER 19, 2024

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.

Drug Pricing 257

Drug Pricing Drug Development 257

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.

pharmaphorum

NOVEMBER 19, 2024

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

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The Pharmacist

NOVEMBER 19, 2024

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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Outsourcing Pharma

NOVEMBER 19, 2024

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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Express Pharma

NOVEMBER 19, 2024

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.

Packaging 91

Packaging 91

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World Pharma News

NOVEMBER 19, 2024

AstraZeneca has announced $3.5 billion of capital investment in the United States focused on expanding the Company's research and manufacturing footprint by the end of 2026. This includes $2 billion of new investment creating more than a thousand new, high-skilled jobs contributing to the growth of the US economy.

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pharmaphorum

NOVEMBER 19, 2024

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.

Labelling 81

Labelling 81

Drug Patent Watch

NOVEMBER 19, 2024

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.

Drug Development 75

Drug Development Pharmaceutical Companies Pharmaceutical Companies 75

Drug Channels

NOVEMBER 19, 2024

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.

Documentation 75

Documentation 75

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.

Pharma Times

NOVEMBER 19, 2024

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

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Outsourcing Pharma

NOVEMBER 19, 2024

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

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Big Molecule Watch

NOVEMBER 19, 2024

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.

Chemotherapy 62

Chemotherapy Labelling 62

Outsourcing Pharma

NOVEMBER 19, 2024

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

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Pharmacy Management

BioPharma Dive

NOVEMBER 19, 2024

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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Pharmafile

NOVEMBER 19, 2024

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.

Pharmaceutical Companies 59

Pharmaceutical Companies Pharmaceutical Companies 59

BioPharma Dive

NOVEMBER 19, 2024

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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The Happy PharmD

NOVEMBER 19, 2024

Pharmacies are closing at an alarming rate in 2024, and the consequences are shaking the very foundation of healthcare in this country. Nearly 2,300 pharmacies have shut their doors since the start of the year, with closures happening at a pace of around eight pharmacies a day. While a 3% drop in the number of pharmacies across the country might not seem significant on the surface, imagine if 3% of schools or hospitals closed.

Mail-Order Pharmacies 52

Mail-Order Pharmacies Independent Pharmacies Compounding Hospitals 52

BioPharma Dive

NOVEMBER 19, 2024

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.

Labelling 59

Labelling 59