STAT

JANUARY 6, 2025

After nearly a decade of machine learning innovation in the drug industry, the Food and Drug Administration Monday published its first draft guidance on the use of artificial intelligence in the development of drugs and biological products. The guidance comes as drug regulatory submissions citing AI have increased exponentially. In an interview with STAT in October, the FDA’s Tala Fakhouri, who co-leads the Center for Drug Evaluation and Research’s AI Council, said the agency has r

FDA

The Checkup by Singlecare

JANUARY 6, 2025

Rosuvastatin is a remarkable cholesterol medication with proponents rightfully touting the statins strength in reducing bad cholesterol or low-density lipoprotein (LDL) levels. Besides simply lowering LDL, the drug is approved by the Food and Drug Administration (FDA) for reducing the risk of cardiovascular events like heart attacks. The brand-name version, Crestor , has been around for years, and now, generic rosuvastatin is available as a lower cost option.

Dosage

Pharmafile

JANUARY 6, 2025

Biotech company NMD Pharma has announced that the US Food and Drug Association (FDA) have granted its Charcot-Marie-Tooth (CMT) disease treatment NMD670 orphan drug designation (ODD). NMD670 was previously granted ODD by the FDA for generalised myasthenia gravis in September 2022. NMD670 is a small molecule inhibitor of the skeletal muscle-specific chloride ion channel CIC-1. […] The post NMD Pharmas Charcot-Marie-Tooth disease treatment granted ODD by FDA appeared first on Pharmafile.

FDA

European Pharmaceutical Review

JANUARY 6, 2025

Roche and Innovent Biologics, Inc. have agreed to collaborate to advance development of an innovative DLL3-targeted antibody drug conjugate (ADC) candidate. Innovent shared that this collaboration focuses on advancing treatment options in advanced small cell lung cancer. Innovent will receive an upfront payment of $80 million. The biopharmaceutical company is eligible for up to $1 billion in milestone payments and certain royalties on net sales.

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

Patient Care

STAT

JANUARY 6, 2025

Good morning, everyone, and welcome to the new year. We are returning from an extended respite and hope that you similarly had an opportunity to power down and refresh over the past week or so. Of course, all good things must come to an end, so time to confront the usual routines once again. We understand this may be difficult, but perhaps firing up the coffee kettle for a cup of stimulation can help.

Compounding

Drug Topics

JANUARY 6, 2025

A study found that of 110 patients with long COVID, over half reported decreased QOL due to pain, discomfort, anxiety, or depression.

Drug Topics

JANUARY 6, 2025

Using the DASH Rapid PCR System, providers can yield test results in under 1 minute of hands-on time.

FDA

PharmaVoice

JANUARY 6, 2025

A first-in-class pain med and blockbusters with new indications are just a few of the possible approvals to keep an eye on in the new year.

FDA

Drug Topics

JANUARY 6, 2025

PQA Health Equity Technical Expert Panel recommendations inform measure testing, use in quality programs, and risk adjustment models

STAT

JANUARY 6, 2025

Americans want Medicaid. The waiting list to receive home- and community-based services through the state-federal health program has hovered around 700,000 people in recent years. A line that long would stretch from Cleveland to Chicago. The queue may get longer.

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.

Drug Topics

JANUARY 6, 2025

Rebecca Lahrman, PharmD, MS, BCACP, discusses her experience taking medical students for rotations in a community pharmacy.

Community Pharmacies

STAT

JANUARY 6, 2025

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Good morning! I hope you had a restful new year. I rang in 2025 with my best friends, whom I love even though they made fun of my ASMR preferences. Found family, you know!?

FDA

Drug Topics

JANUARY 6, 2025

US News & World Report nutrition experts detailed the best types of diets for maintaining patient health in 2025.

Fierce Healthcare

JANUARY 6, 2025

Axes and chainsaws, not butter knives and chisels. | The Department of Government Efficiency is promising big reform, but questions remain as to how critical federal programs will be managed.

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

FDA

Pharmacy Times

JANUARY 6, 2025

Backed by positive results in multiple clinical trials, a new drug application (NDA) has been submitted for relacorilant for consideration by the FDA.

FDA

pharmaphorum

JANUARY 6, 2025

MSD has expanded its presence in Ireland with an agreement to buy a vaccines manufacturing facility from WuXi Biologics in Dundalk.

Vaccines

Pharmacy Times

JANUARY 6, 2025

The analysis shows patients achieved deep and durable responses despite being ineligible for the CARTITUDE-1 trial.

Pharmaceutical Commerce

JANUARY 6, 2025

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jon Kostas, executive director, Association for Prescription Psychedelics (APP), provides a peek into what the association has set out to accomplish.

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Pharmacy Management Software

Pharmacy Times

JANUARY 6, 2025

Two cases of hospitalizations show mutations that may allow H5N1 to more easily target human cells.

Hospitals

pharmaphorum

JANUARY 6, 2025

Novo Nordisk has asked the FDA to block compounders from making versions of its older, once-daily GLP-1 agonist liraglutide.

Compounding

Pharmacy Times

JANUARY 6, 2025

Early diagnosis of chronic kidney disease (CKD) can help optimize treatment and manage the disease to prevent further decline.

Hospitals

Fierce Healthcare

JANUARY 6, 2025

All of the commercial prescriptions dispensed at CVS pharmacies will be processed through its CostVantage model beginning this year, the healthcare giant announced on Monday.

pharmaphorum

JANUARY 6, 2025

The NHS is dealing with a major rise in influenza cases, with the number of hospitalised patients quadrupling to around 5,000 ahead of the New Year.

Fierce Healthcare

JANUARY 6, 2025

With cash flow as a top business concern, 79% of digital health executives say their organizations will pursue investment capital in the next 12 months.

pharmaphorum

JANUARY 6, 2025

US biotech NeOnc Technologies has applied to list on the Nasdaq as it advances a portfolio of drugs to treat diseases affecting the CNS.

Pharmacy Times

JANUARY 6, 2025

Pharmacies can strategically invest in AI technologies to streamline operations and improve patient care while addressing cost challenges and maximizing return on investment in 2025.

Patient Care

pharmaphorum

JANUARY 6, 2025

Focusing too many R&D resources on one drug: The hidden costs of clinical trial-level decision-making Nicole.

Pharmacy Times

JANUARY 6, 2025

Examining the clinical applications, effectiveness, safety, and regulation of herbal supplements with a focus on the role of pharmacists.

pharmaphorum

JANUARY 6, 2025

More community hubs and changes to the NHS App are at the core of the UK government's new elective reform plan.

Fierce Healthcare

JANUARY 6, 2025

Healthcare proved to be a resilient market for mergers and acquisitions in 2024, despite deal volume declining 9% from 2023. PwC analysts are bullish that 2025 will be an active year for the health services sector.

pharmaphorum

JANUARY 6, 2025

While marketing authorisation holders (MAHs) are striving to standardise PV processes as much as possible, experience shows that they must balance the global needs with local requirements and barriers, such as resource issues at the local level.

Pharmacy Times

JANUARY 6, 2025

The pandemics aftermath left lasting tensions in health care.

Outsourcing Pharma

JANUARY 6, 2025

Orbis Medicines secures 90M Series A to develop innovative oral macrocycles, offering cost-effective alternatives to biologic drugs and targeting chronic disease markets.