Wed.Nov 13, 2024

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Canadian teen’s bird flu infection is not the version found in cows

STAT

A Canadian teenager who is in critical condition after contracting H5N1 bird flu was infected with a version of the virus that is different from the one circulating in dairy cattle in the United States, Canadian authorities announced Wednesday. The National Microbiology Laboratory in Winnipeg confirmed the infection was indeed caused by the H5N1 virus.

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Primary care player Forward shutters after raising $400M, rolling out CarePods

Fierce Healthcare

Primary care player Forward is abruptly shutting down its operations, closing its locations and canceling scheduled visits, the company publicly announced Wednesday. | Primary care player Forward is abruptly shutting down its operations, closing its locations and canceling scheduled visits, the company publicly announced Wednesday.

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Trending Sources

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What Will Happen if Millions of Americans Lose Access to GLP-1s at the Same Time?

Pharmacy Times

There has never been such widespread and popularized use of compounded products due to shortages. Will consumers rise up with pitchforks if the party is shut down?

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U.S. drug overdose deaths on pace to fall below 100,000 this year 

STAT

U.S. drug overdose deaths are plummeting, putting the country on pace for its first year with fewer than 100,000 overdose deaths since 2020 — a powerful, if bleak, symbolic milestone. Reported drug deaths fell nearly 17% during the 12-month period ending in June, to 93,087,  according to new statistics released this week by the Centers for Disease Control and Prevention.

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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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J&J sues HRSA for blocking controversial 340B rebate plan

Fierce Healthcare

Johnson & Johnson is escalating its fight with the federal government over its controversial plan to change how it doles out drug discounts to hospitals. | Johnson & Johnson is escalating its fight with the federal government over its controversial plan to change how it doles out drug discounts to hospitals. J&J is suing the Health Resources and Services Administration for blocking the implementation of its new 340B rebate model.

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The Supreme Court Decisions Impacting Pharmacy Industry, Agency Interactions | ASPL 2024

Drug Topics

Selina Coleman, JD, Partner in Life Sciences Health Industry Group at Reed Smith LLP, discussed recent developments in Supreme Court decisions impacting pharmacy operations.

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BMS, Merck, Amgen and more must look to M&A to offset looming patent lapses: Leerink

Fierce Pharma

As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term. | As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term, according to a new loss of exclusivity report from Leerink Partners.

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As adult survivors of congenital heart defects grow in numbers, so does need for care and research

STAT

Until Jennifer Cortes joined a patient advocacy group of adults who have congenital heart defects, she’d never met anyone outside her family who was living with such a complex, life-changing condition. Because she hears that sentiment so often in her volunteer work with the group, she has a ready answer. “I tell them they’re not alone.

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AstraZeneca and Merck's Koselugo delivers phase 3 trial win in adults with NF1, teeing up filings

Fierce Pharma

Four years after winning an FDA approval for Koselugo to treat children with the rare disorder neurofibromatosis type 1 (NF1), AstraZeneca is touting a trial result that could allow the company and | Four years after scoring an FDA approval to treat children with NF1, AstraZeneca says its Merck-partnered Koselugo has shown promise in adults.

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STAT+: FDA is still struggling with a lack of inspectors, but doesn’t have a plan, watchdog finds

STAT

In the wake of the Covid-19 pandemic, the Food and Drug Administration continues to struggle with a lack of investigators needed to inspect domestic and foreign pharmaceutical manufacturing plants and has not yet developed a plan to keep needed staff, a U.S. government watchdog found. Between November 2021 and this past June, the vacancy rate among investigators increased to 16% from 9%.

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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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Black, Hispanic Patients Underrepresented in Food Allergy Immunotherapy Trials

Drug Topics

Researchers compared the racial and ethnic representation of participants in food allergen trials with patients who experience food allergies.

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BioNTech acquires its Chinese cancer drug partner

STAT

This story first appeared in The Readout newsletter.  Sign up for The Readout  and receive STAT’s award-winning biotech news delivered straight to your inbox.  Good morning, lots of news this morning that we’ll get straight into.

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FDA Aligns with Pharmacists in Ensuring Integrity of Drug Supply Chain | ASPL 2024

Drug Topics

An FDA representative gave a presentation on her organization’s recent updates regarding drug supply chain rules and regulations.

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STAT+: Buoyed by billion-dollar deals, its stock is up 50% this year. How did Boston Scientific get its mojo back?

STAT

The day after completing its latest billion-dollar deal, Boston Scientific dispatched food trucks to hand out fried chicken sandwiches and burritos to Silk Road Medical employees in California and Minnesota, before holding a town hall-style meeting to welcome them into the fold. That September day was a big one for the teams at  Silk Road , which makes stroke-prevention devices.

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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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PTC gets FDA okay for first brain-delivered gene therapy

pharmaphorum

More than two years after its approval in Europe, PTC Therapeutics' gene therapy for rare genetic disorder AADC deficiency will soon be made available to patients in the US.The FDA has approved PTC's eladocagene exuparvovec – known as Upstaza in Europe – under the Kebilidi trade name in the US. It is cleared for both children and adults with AADC (aromatic L-amino acid decarboxylase) deficiency, a fatal disease that causes severe disability and suffering from the first months of life.

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Two Asthma Assessments That Pharmacists Should Know

Med Ed 101

Two tests are commonly used in asthma assessments to monitor symptom control and airflow and this blog post will discuss their use and how they determine appropriate treatment options. Important tests pharmacists should know include the Asthma Control Test and a Peak Expiratory Flow. We will discuss them below. Asthma Control Test The first of two […] The post Two Asthma Assessments That Pharmacists Should Know appeared first on Med Ed 101.

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Sanofi wins appeal in spat with NICE over Sarclisa

pharmaphorum

Sanofi has taken a small step towards potentially overturning a recent rejection by NICE for NHS use of Sarclisa as a treatment for relapsed and refractory multiple myeloma (RRMM).The drugmaker has won an appeal against NICE's recent final draft guidance on Sarclisa (isatuximab) as a regimen alongside Bristol-Myers Squibb/Celgene's Imnovid (pomalidomide) and dexamethasone (Isa-Pd) for relapsed RRMM.

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The decentralized clinical trials market will grow to $25 billion by 2032

Outsourcing Pharma

Driven by the effects of the COVID-19 pandemic, the market for decentralized clinical trials has seen a push that will lead it to more than triple in size within the next decade.

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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 seek approval for first drug to treat high-risk smoldering myeloma

Pharmafile

Earlier in November, Johnson & Johnson innovative medicine have applied to the US Food and Drug Agency (FDA) and the European Medicines agency (EMA) for the approval of a new indication for DARAZALEX FASPRO (daratumumab and hyluronidase-fihj). DARAZLEX FASPRO would be used as a monotherapy for the treatment of high-risk smoldering multiple myeloma in adult […] The post J&J seek approval for first drug to treat high-risk smoldering myeloma appeared first on Pharmafile.

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'It's a Horrible Thing': Pneumonia Survivor Advocates for Pneumococcal Vaccination in Minority Communities

Pharmacy Times

Karyne Jones highlights the importance of pneumococcal vaccination for those 50 years and older, especially in communities of color.

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Q&A: Advantages of NADAC for Stakeholders in the Drug Supply Chain

Drug Topics

A conversation with AJ Loiacono, co-founder and CEO of Capital RX, at NCPA 2024.

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Study: Low Number of Patients With Chronic Respiratory Diseases Received Annual Flu Vaccination

Pharmacy Times

In the analysis, 34.7% of commercially insured patients with chronic obstructive pulmonary disease or asthma received an influenza vaccination.

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The 2024 USP 800 Assessment Quiz

OctariusRx

The 2024 version of the OctariusRx USP 800 assessment quiz is about to be released! With the enforcement of USP Chapter 800 beginning last year on November 1, 2023, facilities will be required to assess staff competency on an annual basis. Ongoing education and assessments of staff in the handling of hazardous medications is not only a regulatory requirement, but also a standard of good practice.

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Pfizer considers divestiture of hospital drugs business

Pharmaceutical Technology

Pfizer is currently assessing the potential divestiture of its hospital drugs unit, a division mainly focused on antibiotics and sterile injectables used in hospitals and clinics, Reuters reported.

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Medable and Google Cloud partner to deliver digital clinical trials technology

Outsourcing Pharma

The partners will work together to make Medableâs digital and decentralized clinical trial platform available on Google Cloud Marketplace.

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Fierce Health Payer Summit, Day 1: Opportunities and challenges for insurers in 2025

Fierce Healthcare

AUSTIN, Texas—The second annual Fierce Health Payer Summit kicked off Wednesday to tackle the most pressing issues facing health plan leaders. | AUSTIN, Texas—On Day 1 of the Fierce Health Payer Summit, panelists discussed the role of technology to retain members, trends in Medicare Advantage and changes to Medicare Part D.

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Spinal cord stimulator with AI technology receives CE Mark certification

Pharmafile

The HFC iQ, a personalised spinal cord stimulation (SCS) system developed by Nevro that leverages AI technology to manage chronic pain , has received CE Mark certification in Europe. Following on from US Food and Drug Administration (FDA) in 2022, the HFX iQ has received CE mark certification. The CE mark signifies that the product […] The post Spinal cord stimulator with AI technology receives CE Mark certification appeared first on Pharmafile.

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Debates Continue About Pharmacists’ Provider Status

Pharmacy Times

Despite their proven abilities, organizations such as the American Medical Association still oppose so-called “scope creep.

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Marinus cuts 45% of staff as seizure med Ztalmy remains in limbo following phase 3 misses

Fierce Pharma

Last month, a second phase 3 blow for Marinus Pharmaceuticals prompted the Pennsylvania-based drugmaker to turn an eye toward layoffs and scrap further development of its seizure med Ztalmy. | The company last month opted to end development of its flagship seizure drug while exploring "strategic alternatives" to maximize shareholder value ahead of a planned FDA meeting.

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FDA Grants Rare Pediatric Disease Designation to Elraglusib for Ewing Sarcoma

Pharmacy Times

The designation follows 2 previous orphan drug designations for pancreatic cancer and soft tissue sarcoma.

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Lilly unwraps detailed data showing tirzepatide kept nearly 99% of prediabetic patients diabetes-free over 3 years

Fierce Pharma

Lilly unwraps detailed data showing tirzepatide kept nearly 99% of prediabetic patients diabetes-free over 3 years fkansteiner Wed, 11/13/2024 - 14:37

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London "is number one European city in life sciences"

pharmaphorum

London is the top city in Europe for the life sciences industry, and ranks third worldwide after Boston and New York in the US, says MedCity report

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Gilead data lends insight into transforming HIV prevention landscape

European Pharmaceutical Review

New clinical trial findings show that twice-yearly lenacapavir for HIV pre-exposure prophylaxis (PrEP) had high efficacy and safety in a diverse group of participants. This data provides the first in-depth insight into full results of Gilead Sciences pivotal Phase III PURPOSE 2 trial. In the oral PrEP study group, adherence to the small molecule injectable HIV-1 capsid inhibitor and placebo injections was 91.0 percent with on-time injections at week 26, the results showed.