STAT

JULY 20, 2023

The tornado that struck parts of North Carolina on Wednesday not only damaged the immediate area, but could soon make it much harder for countless people across the U.S. and around the world to obtain needed medicines the next time they visit a hospital. Among the damaged buildings was a Pfizer plant in Rocky Mountain, N.C. that produces nearly 30% of all sterile injectable medicines that the company sells to U.S. hospitals.

Compounding 241

Compounding Hospitals 241

PharmaVoice

JULY 20, 2023

Peter Benton, co-CEO of Worldwide Clinical Trials, explains how the rise of the mid-sized pharma company has changed drug R&D.

246

246

STAT

JULY 20, 2023

Private equity firms are rapidly buying their way into the U.S. health care system, and as they do, new research finds they tend to increase costs and may also harm quality. A new BMJ systematic review rounded up 55 studies on the effects of private equity buyouts in health care globally to flesh out an overarching conclusion. The team of researchers found that private equity ownership generally means higher costs for patients, insurance companies, and government programs.

Nursing Homes 233

Nursing Homes Hospitals 233

ALiEM - Pharm Pearls

JULY 20, 2023

Welcome to the AIR Infectious Disease Module! After carefully reviewing all relevant posts in the past 12 months from the top 50 sites of the Social Media Index, the ALiEM AIR Team is proud to present the highest quality online content related to related to infectious diseases in the Emergency Department. 6 blog posts met our standard of online excellence and were approved for residency training by the AIR Series Board.

Labelling 188

Labelling 188

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.

STAT

JULY 20, 2023

After Stanford University president and prominent neuroscientist Marc Tessier-Lavigne announced he would resign following an investigation into his research, the scientific community did what it always does with new results: engage in a robust internal debate, marked by a variety of opinions. For some, the investigation , which found Tessier-Lavigne failed to “decisively and forthrightly” correct past papers that contained data manipulation, was a positive example of scientific acc

232

232

Safe Biologics

JULY 20, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). The webinars will focus on unintended consequences for patient access that may result from the implementation of IRA provisions.

Biosimilars 130

Biosimilars Drug Pricing Drug Development 130

Safe Biologics

JULY 20, 2023

On June 26th, ASBM Chairman Ralph McKibbin presented a poster at the DIA Global Annual Meeting in Boston, MA. The poster was based on the findings from ASBM’s Canadian ophthalmologist survey and compared the findings with those of other physicians surveyed in recent years. The surveys examined physician attitudes toward biosimilar substitution practices, pharmacovigilance and nomenclature standards, and different biosimilar access scenarios.

Biosimilars 130

Biosimilars 130

STAT

JULY 20, 2023

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences.  Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday.

188

188

Safe Biologics

JULY 20, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). The webinars will focus on unintended consequences for patient access that may result from the implementation of IRA provisions.

Biosimilars 130

Biosimilars Drug Pricing Drug Development 130

STAT

JULY 20, 2023

Thirty-five years ago, I was proud to introduce the Americans with Disabilities Act in the House of Representatives, because I know firsthand what it is like to be devalued due to a disability — by society, potential employers, even my parents and my church. My epilepsy came with the added stigma of old Catholic doctrine that I must be possessed.

185

185

Advertisement

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.

Pharmacy Management

Safe Biologics

JULY 20, 2023

On June 26th, ASBM Chairman Ralph McKibbin presented a poster at the DIA Global Annual Meeting in Boston, MA. The poster was based on the findings from ASBM’s Canadian ophthalmologist survey and compared the findings with those of other physicians surveyed in recent years. The surveys examined physician attitudes toward biosimilar substitution practices, pharmacovigilance and nomenclature standards, and different biosimilar access scenarios.

Biosimilars 130

Biosimilars 130

STAT

JULY 20, 2023

Seth Berkley, the soon-to-be former CEO of Gavi, the Vaccine Alliance, apologized for being a few minutes late jumping on a Zoom call. Berkley — one of the highest-profile proponents of vaccination on the planet — was under a denial-of-service attack. It was not his first, likely the handiwork of people who object to Gavi’s efforts to help lower-income countries purchase vaccines at affordable prices.

Vaccines 185

Vaccines 185

PharmaVoice

JULY 20, 2023

Efforts to tackle drug pricing, shortages, the speed of FDA approvals and more have been mixed into Congress’ efforts to reauthorize the Pandemic and All Hazards Preparedness Act.

Drug Pricing 100

Drug Pricing 100

STAT

JULY 20, 2023

Vir Biotechnology said Thursday that a long-acting antibody drug designed to protect healthy individuals from influenza A failed to do so in a nearly 3,000-person clinical trial. Volunteers who received the highest dose of the drug, known as VIR-2482, were only 16% less likely than the placebo group to develop symptomatic influenza A infections, as defined by trial criteria, over a seven-month period.

Vaccines 158

Vaccines 158

PharmaVoice

JULY 20, 2023

Genomenon’s acquisition of their contract scientific partner Boston Genetics will help them unlock the potential of genetic knowledge.

100

100

STAT

JULY 20, 2023

WASHINGTON — Hospitals for years have complained that Medicare pays so little for CAR-T cancer treatments that they sometimes lose money administering the incredibly expensive treatments. But that could soon change: if drug companies succeed in making the cancer treatments safer, hospitals could provide them more often in outpatient departments, where payment is higher.

Hospitals 157

Hospitals Immunity Immunization 157

Putting Patients First Blog

JULY 20, 2023

Why is mental health awareness foundational for diverse communities? July 20, 2023 By: Karen Mancera-Cuevas, DrPH, MPH, Senior Director, Health Equity Mental health impacts a variety of aspects of our growing representative landscape in the United States. This intersectional experience represents everything from seeking timely services to care (social service, community-based organizations, mental health centers) to tapping into support systems (family, friends, religious leaders) to training an

Department of Veterans Affairs 91

Department of Veterans Affairs 91

STAT

JULY 20, 2023

The U.S. Federal Trade Commission is reversing years of prior advocacy in support of pharmacy benefit managers amid increased scrutiny of the controversial role these companies play in the U.S. pharmaceutical supply chain. During a Thursday meeting , the agency plans to issue a statement “cautioning against reliance” on previous advocacy statements and studies that “no longer reflect current market realities” about pharmacy benefit managers.

Mail-Order Pharmacies 155

Mail-Order Pharmacies 155

EMCrit Project

JULY 20, 2023

So we used a mean guy on twitter to spur a discussion on Oxygenation Physiology and talk about when PaO2s are necessary and you can't use the pulse ox (hint: not often). My discussant is Alex Yartsev. EMCrit Project by Scott Weingart, MD FCCM.

87

87

STAT

JULY 20, 2023

Americans who live in neighborhoods with less socioeconomic advantage may have a higher risk of dementia, according to a new study published Wednesday in JAMA Neurology. This can be true regardless of an individual’s background, according to the study, which found that people living in areas of the U.S. with the lowest levels of income, education, employment, and housing quality had a 1.17 times higher risk of developing dementia compared to residents of the least disadvantaged areas.

143

143

The Pharmacist

JULY 20, 2023

An influential committee of MPs has urged the government to consider bringing restrictions on packaging and marketing of vapes in line with those that apply to tobacco products, amid concerns over the rise in use among children. The Health and Social Care Committee has written a letter to health and social care secretary Steve Barclay […] The post Government urged to consider restrictions for vapes ‘similar to tobacco products’ appeared first on The Pharmacist.

Packaging 75

Packaging 75

STAT

JULY 20, 2023

This past winter, one of us, Alister, was speaking with the daughter of an elderly patient at a community health center in Boston. Her mother had recently been admitted to a local hospital for pneumonia, and doctors believed that she was an ideal candidate for an innovative “ home hospital ” program, which leverages remote care through the use of internet-enabled devices, video conferencing, and in-person home visits so the patient can receive care in the comfort of her own home.

Hospitals 131

Hospitals 131

The Pharmacist

JULY 20, 2023

A UK company was named as the manufacturer of a cold and flu syrup found to contain toxic levels of diethylene glycol in Cameroon, but the Medicines and Healthcare Regulation Authority (MHRA) has confirmed that no such company exists. A contaminated batch of NATURCOLD Syrup, which lists paracetamol, phenylephrine hydrochloride and chlorpheniramine maleate as its […] The post UK company named as manufacturer of contaminated medicine ‘doesn’t exist’ appeared first on The Pharmacist.

72

72

STAT

JULY 20, 2023

Top of the morning to you. And a steamy one, it is. In fact, there is more steam rising from the grounds of the Pharmalot campus than from our ritual cup of stimulation (our choice today is glazed doughnut). But this is to be expected at this time of year, yes? In any event, there is work to be done, so as always, we have assembled a few items of interest for you.

Pharmaceutical Companies 125

Pharmaceutical Companies Pharmaceutical Companies Hospitals Vaccines 125

The Pharmacist

JULY 20, 2023

Health and care regulators including the General Pharmaceutical Council (GPhC) have issued a joint statement on meeting regulatory standards during GLP-1 receptor agonists (GLP-1 RAs) shortages. They said that they were ‘concerned’ to hear that people with type 2 diabetes were experiencing problems accessing GLP-1 Ras, amid widespread prescribing for weight loss purposes, in some […] The post Regulators issue statement on GLP-1 RA prescribing appeared first on The Pharmacist.

Diabetes 70

Diabetes 70

Pharmaceutical Technology

JULY 20, 2023

Ahead of APEC’s "Rare disease vision 2025" deadline, Asian countries are working at different speeds towards improving drug market access.

75

75

The Pharmacist

JULY 20, 2023

The National Pharmacy Association (NPA) is set to discuss supervision legislation with its members in a closed conversation tonight. This follows ongoing conversations within a sector-wide working group about what the future of pharmacy supervision will look like. And it comes after the health and social care secretary appeared to hint at changes to supervision […] The post NPA to discuss what community pharmacy supervision 'should look and feel like' appeared first on The Pharma

Community Pharmacies 66

Community Pharmacies 66

Pharma Times

JULY 20, 2023

Therapy has the potential to decrease mortality rates in patients with decompensated cirrhosis - News - PharmaTimes

78

78

Pharmaceutical Technology

JULY 20, 2023

The National Cancer Institute funded Enspectra Health to develop deep learning algorithms to predict which skin lesions are cancerous.

75

75

Outsourcing Pharma

JULY 20, 2023

An experimental antidepressant developed by Neumora Therapeutics has shown promising results in a phase 2 trial, leading the company to plan its pathway to phase 3 testing.

75

75

European Pharmaceutical Review

JULY 20, 2023

Late-breaking post-hoc data on Vabysmo ® (faricimab-svoa), the first bispecific antibody (bsAb) approved for treating the eye, is set to be revealed at the 2023 American Society of Retina Specialists (ASRS) Annual Meeting. The bsAb biologic is being assessed as a treatment for wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME).

Diabetes 63

Diabetes 63

PharmaTech

JULY 20, 2023

The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.

98

98

Pharma Times

JULY 20, 2023

In two studies the therapy demonstrated improvements when compared with the placebo - News - PharmaTimes

77

77

European Pharmaceutical Review

JULY 20, 2023

Research published in Processes has reported the first successful establishment, validation and integration of a digital twin with process analytical technology (PAT) operated autonomously for biologics manufacturing. In the study, this was illustrated on alkaline pDNA lysis of Escherichia coli ( E. coli ) using aqueous two-phase extraction (ATPE) with and without cell debris separation.

61

61

World Pharma News

JULY 20, 2023

In February 2023, the IciStem consortium, which includes Asier Sáez-Cirión's team at the Institut Pasteur, published details in Nature Medicine of a third case of HIV remission after a bone marrow transplant, involving the Düsseldorf patient. A total of 5 individuals (the Berlin, London, Düsseldorf, New York and City of Hope patients) are now considered as having probably been cured of HIV infection after receiving a bone marrow transplant.

61

61