Tue.Feb 13, 2024

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How Will the Extinction of B/Yamagata Impact Global Flu Vaccination Strategies?

Drug Topics

Drug Topics talked with Gregg Sylvester, MD, chief health officer and vice president of medical affairs at CSL Seqirus, about what can we learn from this unique situation to improve future vaccine development and distribution.

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FDA Accepts New Drug Application for MDMA-Assisted Therapy for PTSD

Pharmacy Times

If approved, this would mark the first MDMA-assisted therapy and psychedelic-assisted therapy approved, calling for a reschedule of MDMA from Schedule I. A PDUFA was set for this summer.

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Trending Sources

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Patients With Type 1 Diabetes Not Achieving Glycemic Targets Despite Use of New Technology

Drug Topics

Many patients with the condition continue to experience severe hypoglycemic events even with the use of continuous glucose monitors and other disease management tools.

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Seeing Through the Fog of ‘Pharmageddon’

Pharmacy Times

Pharmacists are uniquely positioned to play a frontline role in advancing health equity. This will require, however, that we build the pipeline of future pharmacists and preserve vital community touchpoints.

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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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Biogen CEO plots long-term turnaround after analysts brand company's recent results as 'weak'

Fierce Pharma

While Biogen’s financials are in rough shape now, the company’s CEO, Chris Viebacher, sees reason to be optimistic about the future. | With four new drug launches rolling and the majority of the company’s losses of exclusivity in the rearview, Biogen figures it could chart continued revenue growth over the next 10 years, CEO Chris Viehbacher said Tuesday.

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Hospital violence isn't confined to EDs, often rising during COVID-19 surges, full moons, data show

Fierce Healthcare

Most alarms triggered by hospital staff’s wearable safety alert systems occurred outside of the emergency department and more often during weekdays, non-holidays, surges of COVID-19 and even during | Aggregate data from 200,000 workers' wearable duress systems suggest emerging or active violent incidents occur "throughout every part of the hospital," and are more frequent during weekdays, COVID-19 surges and full moons.

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More Trending

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Redesign Health reduces workforce as it slows down pace of new company launches in 2024

Fierce Healthcare

Redesign Health, a healthcare startup creator, is reducing its workforce, cutting 77 staff positions, as it slows the pace of new company launches this year, Fierce Healthcare has learned. | Redesign Health, a healthcare startup creator, is reducing its workforce, cutting 77 staff positions, as it slows the pace of new company launches this year, Fierce Healthcare has learned.

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STAT+: Lawmakers eye partial increase for Medicare doctor pay

STAT

WASHINGTON — Lawmakers are considering increasing doctors’ Medicare pay in an upcoming government funding package, but their policy would only partially offset cuts providers saw earlier this year, three lobbyists and two sources familiar with the talks told STAT. Physicians’ groups have agitated for Congress to undo a roughly 3.4% Medicare pay cut this year, resulting from the expiration of pandemic-era bonuses lawmakers chose to give the industry.

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With FDA nod for Onivyde combo, Ipsen ends 10-year drought in newly diagnosed pancreatic cancer

Fierce Pharma

It’s the approval Ipsen has been waiting for since buying up Onivyde in 2017. | It’s the approval Ipsen has been waiting for since buying up Onivyde in 2017. The FDA has approved Onivyde as part of a combination dubbed Nalirifox to treat patients with newly diagnosed metastatic pancreatic cancer.

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STAT+: FDA advisory panel votes in favor of Abbott’s new heart device

STAT

An advisory panel to the Food and Drug Administration voted in favor of a new device from Abbott meant to treat patients with tricuspid heart valve disease. All but one of the 14 panelists said the treatment’s benefits outweighed its risks. The FDA tends to follow advisory panel recommendations. “If we can help symptoms with this at a low cost in terms of risk, I think it makes a lot of sense,” said James Blankenship, a panelist and cardiologist at the University of New Mexi

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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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Lawmakers urge White House officials to enforce sanctions on China's WuXi AppTec, WuXi Biologics: Reuters

Fierce Pharma

After introducing legislation targeting certain Chinese biopharma companies, a group of bipartisan lawmakers are taking their concerns to the White House—and upping the stakes. | After proposing a bill to revoke funding from certain Chinese biopharmas, a group of bipartisan legislators penned a letter to certain White House officials pressing for sanctions on the two companies based on alleged links to China's Communist Party and its military.

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Omada GLP-1 program to prioritize muscle mass restoration through expanded care track

Fierce Healthcare

Chronic care provider Omada Health is expanding its GLP-1 program to better care for patients interested in maintaining weight loss progress while discontinuing usage of the drugs. | Omada executives shared they are expanding upon its GLP-1 Care Track, pushed by the belief that helping patients regain muscle mass is a critical to weight maintenance after tapering off utilization.

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Biogen’s Skyclarys is first EU drug for Friedreich’s ataxia

pharmaphorum

Biogen’s Skyclarys is the first approved medicine for the inherited neurological disease Friedreich’s ataxia (FA) in the EU, after getting a green light from the European Commission.

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IRd Regimen Shows No Significant Advantage in Frail Patients With NDMM Compared With IDd Regimen

Pharmacy Times

Progression-free survival in the ixazomib/pegylated liposomal doxorubicin/dexamethasone group was shorter than in the ixazomib/lenalidomide/dexamethasone group.

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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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Incyte crosses $1B in quarterly revenue for the 1st time, even as Jakafi faces off against GSK rival

Fierce Pharma

Buoyed by JAK inhibitor market-leader Jakafi and its cream counterpart Opzelura, Incyte crossed the $1 billion threshold in quarterly revenues for the first time. | Buoyed by JAK inhibitor market-leader Jakafi and its cream counterpart Opzelura, Incyte crossed the $1 billion threshold in quarterly revenues for the first time. But only one of the drugs met Wall Street’s expectations.

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Opinion: STAT+: A California court is setting a dangerous precedent over drug development (or lack thereof) liability

STAT

The assault on the development of new lifesaving therapies continues apace. Recently, the First Appellate Division of California Appeals held that companies not only have to defend products they have developed and marketed, but also those they have not. In 2001, Gilead secured FDA approval of tenofovir disoproxil fumarate (TDF), one of first medicines to treat HIV — a product still on the market, despite the potential side effect of causing skeletal and kidney damage.

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Precision medicine in mental health - one size really doesn’t fit all

pharmaphorum

In this episode of the pharmaphorum podcast, web editor Nicole Raleigh welcomed Dr Hans Eriksson, chief medical officer at HMNC Brain Health, a precision psychiatry biopharma company, to discuss his work exploring current studies into the use of ketamine in mental health, HMNC Brain Health having last year announced topline results from a Phase 2 study looking at a take-at-home, oral ketamine option for Treatment Resistant Depression (or TRD).

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Gargling With Mouthwash Can Improve Oral Environment, Reduce HbA1c in Adults with Type 2 Diabetes

Pharmacy Times

Mouthwash that contains chlorhexidine gluconate was especially effective at improving hyperglycemic status in younger patients with diabetes.

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The innovative future of CRISPR tech

pharmaphorum

CRISPR technology is revolutionising gene editing and paving the way for innovative advancements in various fields. Explore the exciting potential and future possibilities of this cutting-edge technology.

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Researchers Announce Results of New COVID-19 sa-mRNA Vaccine

Pharmacy Times

The findings suggest that 6 months after vaccination with ARCT-154, individuals had a longer immune response.

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STAT+: KalVista pill reduces swelling symptoms caused by genetic disease, achieving goal of late-stage study

STAT

KalVista Pharmaceuticals said Tuesday that its oral, on-demand treatment for the swelling “attacks” commonly experienced by patients with a genetic condition called hereditary angioedema achieved the goals of a Phase 3 clinical trial. Based on the study results, the company plans to submit a marketing application to the Food and Drug Administration by the middle of the year.

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Biomarkers ‘may predict dementia 15 years before diagnosis’

pharmaphorum

Researchers have used proteomics data from the UK Biobank to identify protein biomarkers in blood that could give warning of dementia years before diagnosis

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STAT+: Startup BioAge raises $170 million Series D for Zepbound combination therapy

STAT

A California biotech developing a combination therapy with the obesity drug Zepbound has raised a $170 million Series D round. The company, BioAge, raised money from more than a dozen investors. Sofinnova Investments led the round, which also included Eli Lilly and Amgen’s venture arms and previous investor Andreessen Horowitz. BioAge’s primary focus is in developing medications that boost a person’s healthspan, or the number of healthy years a person lives.

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NACDS regional conference’s 2nd day focuses on health, wellness trends

Drug Store News

Panelists discussed health and wellness innovation, the Nourish My Health public education campaign and pharmacy’s role in value-based care, among other topics.

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Private equity deals in MA are declining, but experts say regulators should keep an eye on this space

Fierce Healthcare

Private equity firms have seen plenty of potential in the rapidly growing Medicare Advantage space, but deal volumes are slowing, according to a new report. | Private equity firms have seen plenty of potential in the rapidly growing Medicare Advantage space, but deal volumes are slowing, according to a new report.

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Kroger to lower prices following merger with Albertsons

Drug Store News

The retailer said it will invest $500 million to lower prices following the merger with Albertsons starting day one following the transaction close.

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STAT+: Biogen Alzheimer’s drug launch off to slow start

STAT

Seven months after US drug regulators fully approved Biogen’s treatment for Alzheimer’s disease, only about 2,000 patients are taking the medicine nationwide, the company said Tuesday. Biogen’s chief executive, Christopher A. Viehbacher, said as the firm released fourth-quarter earnings that he had expected the slow uptake and sees considerable demand for the medication.

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Target revamps up&up line of everyday essentials

Drug Store News

The up&up line of everyday essentials is getting new packaging, and hundreds of new items and will see the reformulation of 40% of existing products to meet higher quality standards.

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The need to know biotech news stories today

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hi! It’s Meghana. Today, some amazing intel on Merck’s Ebola vaccine: Turns out, it can reduce risk of death, even after a person has been infected. Also, investors bet on another obesity drug — this time from BioAge, which is combining Zepbound with a pill that keeps muscle wasting at bay.

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NACDS regional conference’s 2nd day focuses on health, wellness trends

Drug Store News

Several topics were discussed including health and wellness innovation, the Nourish My Health public education campaign and pharmacy’s role in value-based care, among others.

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White House wins in first Medicare negotiation legal ruling

pharmaphorum

Texas judge has thrown out the first lawsuit brought by PhRMA claiming Medicare negotiation of drug pricing is unconstitutional

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Vertex secures European approval for CRISPR cell therapy

European Pharmaceutical Review

The first CRISPR/Cas9 gene-edited therapy has been granted a marketing authorisation by the European Commission (EC). Vertex Pharmaceuticals’ CASGEVY ( exagamglogene autotemcel [exa-cel]) is conditionally approved individuals 12 years and over with severe sickle cell disease characterised by recurrent vaso-occlusive crises or transfusion-dependent beta thalassemia.

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UK Agency targets blood thinners in personalised medicine pursuit

Pharmaceutical Technology

The MHRA kicks off phase two of the Yellow Card biobank to explore the genetic link to side effects of direct oral anticoagulants.

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USP recommends revisions to proposed RMM chapters

European Pharmaceutical Review

In January, United States Pharmacopeia (USP) published revisions to previous drafts of chapters about using rapid microbiological methods (RMM), with a specific focus on short-life products. <72> Respiration-Based Microbiological Methods for the Detection of Contamination in Short-Life Products The changes for the proposed chapter the detection of contaminants in short-life products.

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