Fri.May 19, 2023

article thumbnail

Are We Close To A Universal Flu Vaccine?

Drug Topics

Seasonal influenza kills hundreds of thousands of people every year due to a constantly changing virus and highly inefficient vaccine production. A universal flu vaccine could deal with the first problem, and mRNA technology with the second.

Vaccines 180
article thumbnail

Lipid Nanoparticles Could Be Effective Carriers for mRNA Vaccines for Viral Lung Infections

Pharmacy Times

Nanoparticles could improve the solubility of drugs, aid in treatment escape from the immune system, and increase the half-life of drugs in the circulatory system against viral lung infections such as influenza, coronavirus, and respiratory syncytial virus.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

STAT+: In its first tough test, CRISPR epigenome editing cuts cholesterol levels in monkeys

STAT

A defanged form of CRISPR, which doesn’t slice or nick DNA, but rather alters the epigenome — the layers of chemical coding that sit on top of DNA and control the activity of genes — has aced its first substantive test. When researchers used CRISPR “ epigenome editing ” to dial down a cholesterol-associated gene in monkeys, the animals’ blood levels of heart-disease-causing LDL, or “bad” cholesterol, plummeted by more than 50%, Jennifer Kwo

142
142
article thumbnail

US FDA approves Bausch + Lomb and Novaliq’s DED treatment Miebo

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval to Bausch + Lomb and Novaliq’s Miebo (perfluorohexyloctane ophthalmic solution) to treat the signs and symptoms of dry eye disease (DED). Formerly known as NOV03, Miebo is a first-in-class eye drop designed for preventing the evaporation of excessive tears and restoring tear balance in evaporative DED patients.

FDA 133
article thumbnail

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.

article thumbnail

After decades of neglecting women athletes, sport and exercise medicine is finally catching up

STAT

When cyclist Alison Tetrick joined the sport’s professional ranks, she received the perks that come with the job — new bikes and clothing included. But she could never get comfortable on the bike saddles. After several years, Tetrick suffered so much damage to her genital area that she eventually resorted to surgery to trim excess skin from her labia.

140
140
article thumbnail

Role of Live-JSLM in Treating Recurrent CDI

Pharmacy Times

Joseph Reilly, BS, PharmD, BCGP, and Andrew Skinner, MD, discuss the potential benefits of using live-jslm early on to treat CDI, as well as the implications of this new treatment.

122
122

More Trending

article thumbnail

News Roundup: May 15 to May 19

Drug Topics

Your weekly roundup of the latest news from Drug Topics®.

184
184
article thumbnail

STAT+: One in five primary endpoints changed in late-stage trials of cancer drugs already underway, study finds

STAT

Amid increased concerns over a lack of transparency in clinical trials, a new study found that one in five primary endpoints were changed after a late-stage study had begun, and 70% of the trials examined did not include information about primary endpoint changes in articles published in medical journals. Specifically, 145 of 755 randomized controlled trials for cancer medications — or 19% — had changes to the primary endpoints when using at least one of three different methods to

125
125
article thumbnail

Challenges in Reimbursement for Pharmacy Services, DIR Fees, and the Evolving PBM Model

Pharmacy Times

Amid various obstacles, health care providers and pharmacists can initiate measures to enhance compensation for pharmacy services in managed care.

132
132
article thumbnail

Dual Steroid Treatment Could Be Helpful For Septic Shock

Drug Topics

Researchers found a significant decrease in mortality or discharge to hospice with the hydrocortisone-fludrocortisone combination versus hydrocortisone alone in septic shock cases.

98
article thumbnail

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.

article thumbnail

Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease

Fierce Pharma

Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease zbecker Fri, 05/19/2023 - 16:25

FDA 145
article thumbnail

Pharmacy Focus: Psychedelic Pharmacy - Managing Potential Adverse Effects With Psychedelic Medicines

Pharmacy Times

Rick Strassman, MD, a clinical researcher, author, and expert in psychedelic medicines, sat down to discuss pharmacists' role in adverse event management.

123
123
article thumbnail

Cybersecurity attack against Amazon-owned online pharmacy PillPack exposed user health data

Fierce Healthcare

Cybersecurity attack against Amazon-owned online pharmacy PillPack exposed user health data aburky Fri, 05/19/2023 - 16:16

137
137
article thumbnail

FDA Approves Epcoritamab-bysp for Relapsed, Refractory Diffuse Large B-Cell Lymphoma

Pharmacy Times

Treatment with epcoritamab-bysp showed a 61% overall response rate and a 38% complete response rate in heavily pretreated patients with R/R DLBCL.

FDA 126
article thumbnail

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.

article thumbnail

How Much Are Social Factors Impacting Asthma In Young Patients?

Drug Topics

Relocation led to a reduction in asthma exacerbations, exceeding the effect of inhaled corticosteroids, and was similar to biologic agents.

98
article thumbnail

FDA Approves Perfluorohexyloctane Ophthalmic Solution for Dry Eye Disease

Pharmacy Times

The approval marks the first and only FDA-approved treatment for dry eye disease that directly targets tear evaporation.

FDA 132
article thumbnail

Commercial payers frequently delayed paying out providers' claims in Q1, report finds

Fierce Healthcare

Commercial payers frequently delayed paying out providers' claims in Q1, report finds dmuoio Fri, 05/19/2023 - 15:44

133
133
article thumbnail

STAT+: Novo Nordisk pauses ads for weight loss drug Wegovy as it struggles to meet demand

STAT

Novo Nordisk is pausing ads for its obesity drug Wegovy as it struggles to keep up with surging demand, the latest hurdle in its rollout of the weight loss drug. “To avoid stimulating further demand for this medicine, we’re pausing some key Wegovy promotional efforts,” the Danish drugmaker said in an emailed statement. “We are pausing all local television advertising and postponing planned national television advertising for Wegovy.

105
105
article thumbnail

Treatment options for Crohn’s disease expand after Rinvoq approval

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. Whilst there is a range of FDA-approved biologics for Crohn’s disease, Rinvoq is the first approved oral product for the moderate to severe type of the disease.

article thumbnail

Study: Pneumococcal Carriage Declines With Higher Uptake of 10-Valent Pneumococcal Conjugate Vaccine

Pharmacy Times

PCV10 protection is likely to have reduced the incidence of pneumococcal disease among all ages by between 48% and 66%.

Vaccines 123
article thumbnail

STAT+: FDA approves first treatment for skin condition that causes persistent wounds, a redosable gene therapy

STAT

The Food and Drug Administration on Friday approved the first treatment for a devastating condition that causes the skin to be so fragile that even a touch can cause it to splinter, bringing another gene therapy onto the market. The therapy, known as Vyjuvek and made by Krystal Biotech, will soon be available for patients with dystrophic epidermolysis bullosa, a genetic disease that causes painful blisters and persistent wounds.

FDA 103
article thumbnail

Bulevirtide Shows Promise for Hepatitis D, Despite No FDA Approval

Pharmacy Times

Delivery, manufacturing concerns hinder green light from US Agency, but European Medicines Agency approves treatment.

FDA 123
article thumbnail

Intercept's NASH dreams may be dashed after FDA panel votes against Ocaliva's approval bid

Fierce Pharma

Intercept's NASH dreams may be dashed after FDA panel votes against Ocaliva's approval bid fkansteiner Fri, 05/19/2023 - 17:30

FDA 122
article thumbnail

STAT+: FDA official offers insights into whether gene therapy makers could use common manufacturing process

STAT

WASHINGTON — A Food and Drug Administration official provided some insights this week into the FDA’s thinking about a groundbreaking approach to making gene therapies that could help make the products more profitable and attractive to investors. At issue is whether makers of gene therapies may one day use a common manufacturing platform.

FDA 101
article thumbnail

Follow-up Evaluations Are Essential

Pharmacy Times

These appointments help identify medication-related problems and serve as a platform for additional education.

123
123
article thumbnail

STAT+: FDA advisers vote against approving Intercept’s NASH drug

STAT

A panel of expert advisers to the Food and Drug Administration voted Friday against approving Intercept Pharmaceuticals’ investigational treatment for NASH, a prevalent liver disease with no available medicines. The group voted 12-2, with two abstentions, that the benefits of Intercept’s medicine did not outweigh its risks, citing serious concerns about fatal drug-related liver damage and uncertainty over whether the drug’s modest effects will ultimately improve the lives of

FDA 100
article thumbnail

Could FDA recommend new antibiotic for hospital-acquired pneumonia?

European Pharmaceutical Review

A Phase III trial has found that the novel combination antibiotic sulbactam-durlobactam prevents at least as many fatalities of hospital-acquired pneumonia as colistin, the best currently approved treatment. This finding alongside the other data from the trial led the US Food and Drug Administration (FDA)’s Antimicrobial Drugs Advisory Committee to recommend the FDA approve the combination antibiotic for often-fatal pneumonia strain carbapenem-resistant Acinetobacter baumannii–calcoaceticus co

Hospitals 103
article thumbnail

Opinion: Chelsea Clinton: How to eliminate viral hepatitis by 2030

STAT

Viral hepatitis affects almost 400 million people and kills more than 1 million each year. Yet it was left off the agenda of the Millennium Development Goals. Now, 20 years later, we have a cure for hepatitis C and a highly effective vaccine and treatment for hepatitis B — but annual deaths from the two are projected to outnumber deaths from HIV, tuberculosis, and malaria combined by 2040.

Vaccines 100
article thumbnail

Myeloid raises funds to support lead cell therapy programme

Pharmaceutical Technology

Myeloid Therapeutics has raised $73m to support the continued clinical development of its lead cell therapy programme, MT-101, in Phase I/II trials for T cell lymphoma. Led by Hatteras Investment Partners, the financing round has seen participation from existing investors, including 8VC, Alexandria Venture Investments and Newpath Partners, along with new investors Moore Strategic Ventures and ARCH Venture Partners.

article thumbnail

First NICE-recommended treatment for chronic heart failure

European Pharmaceutical Review

Final draft guidance has been published for the first National Institute for Health and Care Excellence (NICE)-recommended treatment for symptomatic chronic heart failure with preserved or mildly reduced ejection fraction. The regulatory body’s decision means up to 150,000 patients would be eligible for AstraZeneca-made dapagliflozin (Forxiga).

Hospitals 102
article thumbnail

Cost of disease-modifying therapies for multiple sclerosis continues to rise in US

Pharmaceutical Technology

Multiple sclerosis (MS) is a primary autoimmune disease in which inflammation is a core contributor to the degeneration of the central nervous system (CNS), leading to neurological disability and affecting sensory, visual, motor, and autonomic systems. While MS is not a terminal diagnosis, the effect of the disease on the CNS can significantly impact patients’ independence and disturb their daily lives.

98
article thumbnail

AbbVie, Genmab's lymphoma drug Epkinly snags FDA approval in heated blood cancer race

Fierce Pharma

AbbVie, Genmab's lymphoma drug Epkinly snags FDA approval in heated blood cancer race aliu Fri, 05/19/2023 - 11:21

FDA 122
article thumbnail

STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them.  Don’t be shy. Everyone wants to know who is coming and going.

94
article thumbnail

Bausch + Lomb bags FDA approval for dry eye disease treatment Miebo

Fierce Pharma

Bausch + Lomb bags FDA approval for dry eye disease treatment Miebo zbecker Fri, 05/19/2023 - 09:39

FDA 130