Tue.Aug 23, 2022

article thumbnail

Combination Flu, COVID-19, RSV mRNA Vaccine Could Change Immunizations Landscape

Pharmacy Times

Francesca Ceddia, MD, senior vice president of respiratory vaccines at Moderna, said the company is in early stages of development for a combined mRNA vaccine for influenza, COVID-19, and RSV.

Vaccines 177
article thumbnail

Gilead’s Sunlenca receives EC approval to treat HIV

Pharmaceutical Technology

Gilead Sciences has obtained the European Commission (EC) marketing authorisation for Sunlenca (lenacapavir) injection and tablets to treat human immunodeficiency virus (HIV) infection. The twice-yearly treatment is indicated to be administered along with other antiretroviral(s) in adult patients with multi-drug resistant HIV infection who otherwise cannot have a suppressive anti-viral regimen.

FDA 119
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

Expert Discusses How Pharmacists Can Help Prevent Drug Diversion

Pharmacy Times

Jake Nichols, PharmD, CEO, president, and co-founder of Renovo Health, discusses the stigma around drug diversion and the best ways to address and fight that stigma.

123
123
article thumbnail

Takeda gets first approval for its dengue vaccine

pharmaphorum

Japan’s Takeda has secured its first regulatory approval – in Indonesia – for its dengue fever vaccine TAK-003, which has been tipped as a potential blockbuster product. Indonesia’s National Agency for Drug and Food Control (BPOM) has approved the vaccine as Qdenga to protect against the virus in people aged six to 45, on the back of data showing that it can cut dengue-related hospitalisations by 84%, with 61% protective efficacy against symptomatic illness seen up to three years aft

Vaccines 104
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

CVS Health Plans Next Steps to Expand Primary Care by End-of-Year

Pharmacy Times

Executives from CVS Health said they have multiple pathways in achieving a push to establish primary care services, provider enablement, and home health.

123
123
article thumbnail

Outsourcing strategists thinking farther ahead than ever: CPHI

Outsourcing Pharma

The groupâs latest report glimpses inside the minds of pharma leaders, who are looking at a productâs full life-cycle development at the preclinical stage.

114
114

More Trending

article thumbnail

Bayer unit BrainVectis cleared to start Huntington gene therapy trial

pharmaphorum

France’s BrainVectis, a subsidiary of Bayer’s Asklepios BioPharma (AskBio) unit, has been given the green light by regulators in France to start dosing patients with its gene therapy candidate for devastating neurodegenerative disorder Huntington’s disease. The phase 1/2 study is due to get underway before the end of the year and will test BrainVectis’ one-shot BV-101 gene therapy, which will be delivered using an adeno-associated virus (AAV) vector directly to areas of

Labelling 105
article thumbnail

Study: Medical Cannabis Patients Prefer High-THC Products

Pharmacy Times

In New York’s medical cannabis program, research showed that patients’ preference around potency differed among users, regardless of their health conditions.

149
149
article thumbnail

Overcoming mental health’s drug development challenges with AI

PharmaVoice

PsychoGenics is leveraging AI-driven drug discovery platforms to advance mental health treatments for schizophrenia, bipolar disorder and treatment-resistant depression.

105
105
article thumbnail

Pfizer, BioNTech Apply to FDA for Emergency Use Authorization of Omicron-Adapted COVID-19 Booster Vaccine

Pharmacy Times

The companies are prepared to deliver doses of the Omicron-adapted bivalent vaccine for September, pending authorization.

Vaccines 123
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

Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations. Of the cGMP letters, three major types of violations – deficiencies in process validation, documentation practices (data integrity) and quality control – account

FDA 102
article thumbnail

COVID At-Home Antigen Tests: If at First You Don’t Succeed Try, Try and Try Again

The FDA Law Blog

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Richard A. Lewis, Senior Regulatory Device & Biologics Expert — We are almost three years into the public health emergency as a result of the COVID-19 pandemic, and still only have 19 rapid antigen tests authorized for at-home use in the United States. The primary barrier to bringing new antigen tests to market has been FDA’s minimum requirement of 80% sensitivity for authorization.

article thumbnail

The EU HTA regulation: a new frontier for access to innovative technologies

European Pharmaceutical Review

ON 11 JANUARY 2022, Regulation (EU) 2021/2282 on health technology assessment (HTA) came into force. 1 The regulation is the culmination of a long debate between European Union (EU) Member States and health sector stakeholders, triggered by joint actions such as European Network for Health Technology Assessment (EUnetHTA) and formalised through the European Commission (EC)’s proposal in January 2018. 2.

98
article thumbnail

The story behind the PharmaVoice 100

PharmaVoice

Taren Grom, our editor-in-chief emeritus, explains how the coveted PharmaVoice 100 awards got its start and what makes it stand out in the industry.

105
105
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

Securing every dose with an edible security technology for safe medicines

European Pharmaceutical Review

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. The prevalence of fake drugs is a continually growing problem worldwide. Fake drugs can be categorised as substandard, falsified, counterfeit and diverted drugs, and the World Health Organization (WHO) broadly defines a counterfeit medicine as “one which is deliberately and fraudulently mislabelled with respect to identity and/or source.” 1

Dosage 97
article thumbnail

Illinois Business Partners With Hospital to Reduce Readmissions

Pharmacy Times

Dundee Pharmacy’s compliance packaging encourages patients to stay adherent to their medications.

Hospitals 123
article thumbnail

Innovation Leads to Transformation | Avant Pharmacy and Wellness Center

PioneerRx

In the world of independent pharmacy, Amina Abubakar is something like a celebrity. For over a decade, Amina has promoted the profession and practiced at the top.

article thumbnail

Study Results Show COVID-19 Becomes Infectious When Symptoms are Present

Pharmacy Times

Investigators report that while lateral flow tests do not detect the start of infectiousness well, they can identify individuals who will not infect others and can safely leave isolation.

123
123
article thumbnail

Fighting for a Place at the Table

PioneerRx

Jordan Ballou shares her professional journey, shows the power of connection, and proves just how valuable women in pharmacy really are. Tuesday, March 8 is the.

98
article thumbnail

Pfizer, BioNTech seek US okay for Omicron BA.4/BA.5 booster

pharmaphorum

Pfizer and BioNTech have asked the FDA for emergency authorisation of an Omicron-targeted COVID-19 booster vaccine ahead of the planned autumn immunisation campaign in the US. The new version of their Comirnaty vaccine includes mRNA for the spike protein of the wild-type SARS-CoV-2 that first emerged in late 2019, as well as for the BA.4 and BA.5 subvariants of the now-dominant Omicron variant.

article thumbnail

Get Your Business On the Go | Table Rock Pharmacy

PioneerRx

Michael Stout is a designer by trade and a pharmacy aficionado by chance. When he started his career, full of fervor and plenty of artistic potential, Michael.

98
article thumbnail

$6mn grant to advance purification membranes for viral vectors

European Pharmaceutical Review

Researchers from the University of Arkansas (U of A) and two partner institutions have been awarded a $6 million grant by the US’s National Science Foundation (NSF) to develop purification membranes for future large-scale manufacturing of viral vectors and virus-like particles. According to the team, the successful development of commercial-grade purification membranes will increase access to new treatments for genetic and chronic diseases, especially for middle- and low-income people.

article thumbnail

How to Win at Relationships

PioneerRx

It’s the season of red roses, romance, and celebrating those who mean the most. For you, February 14 may mean a night out with your spouse, a sweet treat for.

98
article thumbnail

Long-Term Review Supports Pembrolizumab with Etoposide/Platinum for First-Line Small Cell Lung Cancer

Pharmacy Times

Long-term follow up on the KEYNOTE-604 study suggests pembrolizumab plus etoposide/platinum is a superior first-line therapy for small cell lung cancer vs placebo.

123
123
article thumbnail

They’re More Than Just Supplements | North Century Pharmacy

PioneerRx

Easton Bryant had always dreamed of breaking the mold. A Columbia, KY native with a passion for serving patients, Easton took to North Century Pharmacy with big.

96
article thumbnail

Take a look inside drug delivery devices

European Pharmaceutical Review

While combing for our typical insights into the pharmaceutical industry, we came across Scan of the Month and could not help but share their drug delivery device edition – a fascinating insight into the complexities of drug delivery devices many may take for granted. Using computerised tomography (CT) scanning, we can see beyond the consumer friendly design to the inner workings of two common drug delivery devices: the powder asthma inhaler and Mylan’s well-known EpiPen ®.

90
article thumbnail

Get to Know Nashville

PioneerRx

It’s the home of honky-tonks, hoedowns, and old-fashioned Southern hospitality — and now it’s the home of Connect 2022. This summer, we’re packing our bags.

article thumbnail

Include patient voice at every stage of clinical processes: Within3

Outsourcing Pharma

A leader suggests considering patient views and needs all along the clinical development path reaps a number of benefits, including time and cost savings.

92
article thumbnail

When Disaster Strikes | Phipps Pharmacy

PioneerRx

August 21, 2021 seemed like another normal day — until it wasn’t. What started off as a summer shower in Western Tennessee turned into a steady downpour, and then.

94
article thumbnail

Can Hepatitis C drugs reduce symptoms of PTSD?

European Pharmaceutical Review

A study led by Boston University School of Public Health (BUSPH) and the White River Junction Veterans Affairs Medical Center in Vermont has completed a rigorous analysis to compare the effectiveness of direct acting antivirals on improving symptoms of posttraumatic stress disorder (PTSD). . The researchers studied 254 VA patients who were diagnosed with PTSD and hepatitis C between October 1999 and September 2019.

article thumbnail

Dogs & Cats & Birds, Oh My! | Sand Run Pharmacy

PioneerRx

From furry paws to feathered friends, Sand Run Pharmacy sees them all. A staple in the Akron, OH community, Sand Run has been serving families since back in.

95
article thumbnail

Phase 3 Trial Investigating Onivyde for Small Cell Lung Cancer Fails to Meet Primary End Point

Pharmacy Times

Irinotecan liposomal injection (Onivyde) used as second-line therapy for patients with small cell lung cancer did not meet the primary end point of overall survival compared to topotecan.

65
article thumbnail

Are You Ready to ReConnect?

PioneerRx

Cold winds whip around and snowflakes stream down, but we’re still dreaming of June. Amidst the winter weather, we’re prepping for warm days, sunny rays, and an.

89
article thumbnail

Samidorphan/Olanzapine Combination Proves Effective in Treatment of Schizophrenia

Pharmacy Times

Investigators also report that the therapy could mimic the efficacy of olanzapine but cancelled out the medication-induced weight gain, improving symptoms and outcomes.

65