Fri.Nov 01, 2024

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Survey: 50% of Active Drug Shortages in the United States Persist for 2 or More Years

Pharmacy Times

ASHP investigators determined the severity and impact of ongoing drug shortages, with approximately 99% of respondents reporting that they experienced a shortage.

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HLTH24: Execs weigh in on what is broken in primary care and what's working

Fierce Healthcare

Everyone agrees primary care is crucial to a functioning healthcare ecosystem and to a healthy society. | Everyone agrees primary care is crucial, yet it isn't working as well as it should be. A panel of primary care executives considered the drawbacks of the traditional model and opportunities for the sector at HLTH last month.

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Argenx' Vyvgart launch in CIDP picks up as the company barrels toward 10 indications by 2030

Fierce Pharma

Just a few months into a new launch in chronic inflammatory demyelinating polyneuropathy (CIDP), agrenx’ Vyvgart is already making headway in the rare disease space, just one of the long-term growt | So far, argenx's Vyvgart has reached 300 patients with chronic inflammatory demyelinating polyneuropathy (CIDP) after securing an FDA approval in the disease in late June.

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IVIG Prescriptions Guideline-Appropriate in Majority of French Adults With Severe Immune Thrombocytopenia

Pharmacy Times

Intravenous immunoglobulin prescriptions deemed non-compliant according to French national guidelines were more common in younger patients.

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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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Lexicon's type 1 diabetes drug voted down by FDA adcomm

pharmaphorum

FDA advisors vote against Lexicon Pharma's type 1 diabetes and chronic kidney disease therapy sotagliflozin ahead of December verdict

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Vitamin D Supplementation Could Aid Pediatric Obstructive Sleep Apnea

Pharmacy Times

Low levels of vitamin D was linked with increased obstructive Apnea-Hypopnea Index scores.

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Novo Nordisk's semaglutide delivers in phase 3 MASH study, teeing up filings

Fierce Pharma

With a positive readout for metabolic dysfunction-associated steatohepatitis (MASH) now in the bag, Novo Nordisk is gearing up to pursue yet another indication for its star GLP-1 medicine semagluti | Novo Nordisk on Friday revealed that its star GLP-1 semaglutide met the mark in a late-stage MASH study. The positive results build on the thesis that GLP-1s could become a foundational piece in the treatment paradigm for the fatty liver disease, according to analysts at William Blair.

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Emerging Frontiers: The Gut Microbiome Plays an Important Role in Enhancing Cancer Immunotherapy and Treatment Outcomes

Pharmacy Times

Gut microbiome research is no longer an obscure field in cancer care.

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A sickle cell cure exists. But patients need more than just gene therapy.

PharmaVoice

Almost a year after two historic approvals, Pfizer is pulling a sickle cell disease treatment from the market, and the outlook for patients feels shakier. But there’s still hope in the pipeline.

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Verastem Oncology submits NDA for ovarian cancer treatment

Pharmaceutical Technology

Verastem Oncology has concluded the rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for a combination of avutometinib and defactinib for low-grade serous ovarian cancer (LGSOC).

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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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STAT+: Key senators propose using ‘site-neutral’ pay to boost rural hospitals

STAT

WASHINGTON — The hospital industry has pushed back against Medicare payment reforms for years, arguing that the policies would financially hurt rural hospitals.  Two key senators on Friday released a plan to get around that issue by reinvesting some of the money saved from payment reforms to help rural and safety-net hospitals. Hospitals that keep providing services like trauma centers, labor and delivery units, and burn units would get financial bonuses, too.

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Cash Pricing Success Story: Sandpoint Super Drug

Drug Topics

Learn how one pharmacy used RxCash+ to lessen the stress of cash pricing and spend more time on patient care.

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Report: Medicare Part D Premiums Rise an Average of 11% Nationwide

Pharmaceutical Commerce

Analysis finds that while basic Part D coverage costs have decreased by 4%, mid- and high-tier plans have seen hikes of 4% and 21%, respectively.

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Infliximab Monotherapy Effective as Combo Therapy for Treating Inflammatory Bowel Disease

Drug Topics

Researchers from Celltrion USA presented their post hoc analysis from the LIBERTY studies at the American College of Gastroenterology 2024 Annual Scientific Meeting.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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After prior settlements, Apotex and Heritage hand over a combined $49M to resolve longstanding price-fixing claims

Fierce Pharma

After prior settlements, Apotex and Heritage hand over a combined $49M to resolve longstanding price-fixing claims fkansteiner Fri, 11/01/2024 - 10:19

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Opinion: STAT+: Precision medicine can’t fulfill its promise without better diagnostics

STAT

It’s been 13 years since  the term “precision medicine” was coined , and its promise — the ability to treat the right patient with the right medicine in the right dose at the right time — remains as compelling as ever. But we haven’t yet fulfilled this promise. Why? In my previous role as head of precision medicine at Novartis, I realized the biggest challenge to making precision medicine a reality was not the development of the medicines themselves

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Navigating FDA Compounding Regulations: Tirzepatide's Removal From the Shortage List and Its Impact on 503A and 503B Facilities

Pharmacy Times

Martha Rumore, PharmD, Esq, discusses the legal and regulatory complexities surrounding tirzepatide compounding following FDA’s removal of the drug from the shortage list, which prompted a lawsuit and led to ongoing uncertainty for 503A and 503B facilities regarding enforcement discretion and future compounding restrictions.

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Weekly Semaglutide Injection Reduces Knee Osteoarthritis Pain

Drug Topics

In a recent clinical trial, weekly semaglutide demonstrated promise as a nonsurgical, nonopioid intervention for reducing knee osteoarthritis pain.

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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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Carfilzomib, Lenalidomide, and Dexamethasone: A Curative Approach for Smoldering Multiple Myeloma

Pharmacy Times

In the results, 31% of patients maintained undetectable measurable residual disease 4 years after treatment.

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FDA Roundup: Agency Highlights from October 2024

Drug Topics

Check out these important FDA updates from the month of October 2024.

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Artera unveils AI co-pilots to ease patient communication headaches

Fierce Healthcare

Health tech company Artera built new artificial intelligence products to help administrative staff communicate with patients faster while also easing their workload. | Health tech company Artera built new artificial intelligence products to help administrative staff communicate with patients faster while also easing their workload.

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Top 10 rare disease pharma sees 10.4% rise in therapy start

Outsourcing Pharma

A new case study released by AllazoHealth reveals that a leading rare disease pharmaceutical company achieved a 10.4% increase in therapy initiation, driven by AI-enabled patient outreach and personalized communications.

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Francisco Partners plans to buy medical software company AdvancedMD for $1.1B

Fierce Healthcare

Private equity firm Francisco Partners plans to buy medical software company AdvancedMD from Global Payments for $1.125 billion dollars, the companies announced Wednesday. | Private equity firm Francisco Partners plans to buy medical software company AdvancedMD from Global Payments for $1.125 billion dollars, the companies announced Wednesday.

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Best Practices for Educating Patients on Holistic Weight Management Approaches | NCPA 2024

Drug Topics

A conversation with Melody Hartzler, PharmD, at the 2024 National Community Pharmacists Association Annual Convention and Expo.

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Abzena’s advanced drug development showcased at CPHI Milan

Outsourcing Pharma

At CPHI Milan 2024, Abzena showcased its latest innovations in cell line development and ADC manufacturing, featuring the advanced AbZelectPRO platform and ThioBridge linker technology.

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In FDA adcomm, Lexicon gets another thumbs down for type 1 diabetes hopeful Zynquista

Fierce Pharma

Despite its unique ability to block sodium-glucose linked transporter 2 (SGLT2) in the kidneys and SGLT1 in the intestines, Lexicon’s Zynquista (sotagliflozin) has had difficulty negotiating r | Despite its unique ability to block sodium-glucose linked transporter 2 (SGLT2) in the kidneys and SGLT1 in the intestines, Lexicon’s Zynquista (sotagliflozin) has had difficulty negotiating regulatory hurdles.

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Eisai, Biogen eye 2025 approval for Leqembi autoinjector

pharmaphorum

Eisai and Biogen complete their rolling application in the US for a subcutaneous formulation of Alzheimer's disease therapy Leqembi

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Strategies for Incorporating Vaccinations into Pharmacy Workflows

Pharmacy Times

Carrie Koenigsfeld, PharmD, FAPhA, discusses how pharmacists can incorporate RSV vaccination education and recommendations into daily pharmacy workflows, including prescription pick-ups, consultations, and routine MTM sessions.

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US court upholds Avadel’s narcolepsy drug approval amid exclusivity battle 

Pharmaceutical Technology

The US District Court upholds the FDA’s approval of Avadel’s Lumryz, dismissing Jazz’s challenge over market exclusivity for its own drug.

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Pharmacists’ Roles in MM Management

Pharmacy Times

Panelists discuss how pharmacists play a crucial role throughout the multiple myeloma patient journey, from diagnosis to treatment, by contributing to medication management, patient education, adverse effect monitoring, and the development and implementation of order sets and clinical pathways within electronic medical record systems, thereby enhancing treatment efficacy and patient safety.

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'It was a good lesson': FDA reconsiders CAR-T boxed warning on secondary cancers, Peter Marks says

Fierce Pharma

An FDA announcement last year of an investigation into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry. | An FDA investigation last year into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry.

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FDA Grants Orphan Drug Designation to CAP-002 to Treat Patients With Developmental and Epileptic Encephalopathy

Pharmacy Times

If approved, the investigational intravenous gene therapy will be the first disease-modifying therapy for developmental and epileptic encephalopathy (DEE).

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Pharma Pulse 11/1/24: Targeting Patients Without Cookies, Personalized Diabetes Care Approaches & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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