Fri.Apr 28, 2023

article thumbnail

Policies need to address the growing threat of antimicrobial resistance

PhRMA

Today, the House Energy & Commerce Subcommittee on Oversight and Investigations will be holding a hearing on the growing public health threat of antimicrobial resistance (AMR). AMR occurs when microorganisms such as bacteria, viruses, fungi and parasites develop the ability to survive against the drugs designed to kill them. Recognized by the World Health Organization (WHO) as “one of the biggest threats to global health, food security and development today,” AMR is a growing crisis that has

211
211
article thumbnail

FDA Approves Qalsody, First-of-its-Kind Treatment for Rare Form of ALS

Drug Topics

The drug treats amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene (SOD1-ALS).

FDA 187
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

DEA’s Proposed Rules on Controlled Substances Prescribing via Telemedicine and Their Uncertain Impact on the Pharmacy Community

Pharmacy Times

Proposed rules would permit a telehealth provider to prescribe only up to a 30-day supply of a Schedule III-V non-narcotic controlled substance or buprenorphine through telehealth without the patient first being evaluated in person by a provider.

article thumbnail

FDA Clears Pfizer’s Pneumococcal Conjugate Vaccine for Infants and Children

Drug Topics

Prevnar 20 contains 20 serotypes and grants the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine.

Vaccines 186
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

FDA Approves Prevnar 20 Vaccine to Prevent Invasive Pneumococcal Disease in Children 6 Weeks Through 17 Years

Pharmacy Times

Prevnar 20 is a next-generation pneumococcal conjugate vaccine that includes capsular polysaccharide conjugates for the 13 serotypes already included in Prevnar 13.

Vaccines 132
article thumbnail

STAT+: Once bullish on digital health, Orexo hits a wall on reimbursement

STAT

After several quarters of promising to deliver concrete progress on key digital therapeutics projects, Swedish pharmaceutical company Orexo on Thursday reported the somber news that its efforts remained stalled. Orexo, which made almost all of its $60 million in 2022 revenues from U.S. sales of Zubsolv, a drug used to treat opioid use disorder, earned negligible income from its three software-based treatments in the first quarter of the year.

More Trending

article thumbnail

STAT Wunderkinds discuss high-impact research, resilience, and social justice

STAT

Elenoe “Crew” Smith used to faint at the sight of blood. Still, she knew from a very young age that she wanted to help people living with sickle cell disease. Now, as a research director at Vertex Pharmaceuticals, she is working on potential sickle cell medicines. Smith was in STAT’s 2017 class of Wunderkinds , an annual selection of standout researchers who are launching their careers.

article thumbnail

Report Finds Health-System Workforce Challenges Influence Work of Pharmacists, Technicians

Pharmacy Times

Nearly 84% of hospitals are working to prevent and mitigate burnout, with increased support and programs for individual wellness and resilience practices.

Hospitals 123
article thumbnail

How Can Improving Provider-Patient Relationships Help Reverse Chronic Disease?

Drug Topics

The existing approach to disease management may be ill-suited to address the dynamic and diverse factors at play when it comes to chronic illness.

98
article thumbnail

Changing the Game: Pharmacy Students' Perspective on Naloxone OTC Approval

Pharmacy Times

To eliminate the existing stigma in the community, addiction must be recognized as a treatable condition rather than an immoral act.

123
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

Editas grabs orphan drug status for sickle cell disease CRISPR therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022. The company is studying EDT-301 in sickle cell disease in a Phase I/II RUBY study (NCT04853576), and is on track to provide a clinical update by mid-2023.

FDA 105
article thumbnail

STAT+: Bright Health looks to get out of health insurance entirely

STAT

Bright Health Group started as a health insurance company. But it will no longer be one. Bright is looking to sell off the Medicare Advantage plans it manages in California, the company said Friday. That is the last component of its health insurance business, after the company said this past October it was fully exiting all Affordable Care Act marketplaces.

Insurance 111
article thumbnail

The Challenges Of Keeping Proper Inventory in Pharmacy

Drug Topics

Keeping inventory in pharmacy is already difficult. And keeping stock of dangerous substances like opioids requires even more caution.

98
article thumbnail

Opinion: There’s a surprisingly easy way to avoid a huge number of major amputations

STAT

More than 400 Americans undergo major amputation of a leg , either above or below the knee, every day. Many of them suffer from what’s known as chronic limb-threatening ischemia (CLTI), a form of peripheral artery disease that narrows people’s arteries. At my health system, we perform about 70 major amputations every year for CLTI. Amputation can save the lives of patients with CLTI, but it brings with it a lifetime of disability , emotional distress, social burden, and increased h

Hospitals 103
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

Should I see an ENT or allergist?

The Checkup by Singlecare

If you’re experiencing seasonal allergies , you might consider seeing an otolaryngologist (ENT) for treatment. Or maybe you’re wondering if an allergist would be a better choice. Because there is some overlap in the conditions these two types of healthcare providers treat, deciding which one to visit can be confusing. While allergists are trained in allergy diagnosis, treatment, and prevention, ENTs are trained to treat medical issues occurring in the head, throat, ear, nose, and neck—and may or

article thumbnail

‘We went from almost no lockdowns to daily lockdowns’: The mental health crisis inside California women’s prisons

STAT

Liz Lozano has been incarcerated since 1995. Having spent over 20 years at the Central California Women’s Facility, the largest women’s prison in the world, she’s a big believer in the importance of mental health for rehabilitation. She also knows what works for her. In addition to talking to a therapist once a month, she jogs in the yard whenever she can.

103
103
article thumbnail

FAQs about the ABP Pediatrics Certifying Exam 

Board Vitals - Pharmacist

The American Board of Pediatrics (ABP) General Pediatrics Certifying Exam is the final step on your journey towards becoming a pediatrician. This exam tests you on the knowledge you’ll need to practice as a general pediatrician. What do you need to know about the ABP exam, and how can you best prepare to pass? What requirements are there for certification?

article thumbnail

Putting radiation to the test to heal irregular heartbeat

STAT

ST. LOUIS — Doctors are zapping the heart with radiation normally reserved for cancer, a bid to better treat people with life-threatening irregular heartbeats who’ve exhausted other options. While it’s highly experimental, surprising early research suggests it may reprogram misfiring heart cells to control heartbeats more like younger, healthier cells do.

103
103
article thumbnail

With bankruptcy looming, Bright Health is fully ditching its insurance business

Fierce Healthcare

With bankruptcy looming, Bright Health is fully ditching its insurance business pminemyer Fri, 04/28/2023 - 14:06

Insurance 123
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. And here is our regular feature in which we highlight a different person each week.

102
102
article thumbnail

One in 5 adults without cars, transit access defer care, survey finds

Fierce Healthcare

One in 5 adults without cars, transit access defer care, survey finds dmuoio Fri, 04/28/2023 - 14:23

128
128
article thumbnail

STAT+: Pharmalittle: Amgen ends two lupus programs; Illumina sequencers have security vulnerability

STAT

Hello and happy Friday, with STAT reporter Andrew Joseph here steering the ship in place of Ed for the day. We’re treating ourselves to a cappuccino at the moment, which will perhaps inspire some of you to get yourself your own Friday reward. Or maybe the promise of a weekend is all that you need to get you through today. In the meantime, a few headlines for you.

98
article thumbnail

Walmart Health moves into Oklahoma as part of expansion plans in 2024

Fierce Healthcare

Walmart Health moves into Oklahoma as part of expansion plans in 2024 hlandi Fri, 04/28/2023 - 07:30

128
128
article thumbnail

SARS-CoV-2 Associated With Higher Risk of Diabetes

Pharmacy Times

Risk of incident diabetes was markedly higher among males and in those with more severe COVID-19.

123
123
article thumbnail

STAT+: Covid-19 burnished pharma’s reputation among patient groups, but access to medicines is now an issue

STAT

In the wake of the Covid-19 pandemic, the pharmaceutical industry enjoyed something of an afterglow, as far as patient advocacy groups were concerned. Not anymore.

98
article thumbnail

As retailers push into clinical trials, COTA's Miruna Sasu sees big opportunities for real-world, genomics data

Fierce Healthcare

As retailers push into clinical trials, COTA's Miruna Sasu sees big opportunities for real-world, genomics data hlandi Fri, 04/28/2023 - 13:15

104
104
article thumbnail

Muscle Wasting and Hashimoto’s

The Thyroid Pharmacist

Years ago, I struggled just to get through each day. I had so many frustrating symptoms, including anxiety, irritable bowel syndrome (IBS) and acid reflux. I also had other seemingly odd symptoms for someone my age, like frequent muscle cramps, stiffness, carpal tunnel in both arms, and pain. (I’ve shared articles on pain and will be sharing one on carpal tunnel soon as well.

article thumbnail

Pharmacy Times Interactive Case Studies: April 2023

Pharmacy Times

Pharmacists answer questions about blood pressure and antidepressant use during pregnancy.

122
122
article thumbnail

Innovating pharma at the edge

European Pharmaceutical Review

NEW, FLEXIBLE, data-driven manufacturing models are emerging to address the pharmaceutical industry’s need for greater operational efficiency. While new approaches aim to solve the unique challenges of the sector, like adhering to strict compliance regulations, digitalisation has quickly developed into a pathway for achieving information technology (IT)/operational technology (OT) integration, edge-to-enterprise connectivity, and overall operational excellence.

94
article thumbnail

EU plots major pharma reforms—but industry is already pushing back

Fierce Pharma

EU plots major pharma reforms—but industry is already pushing back zbecker Fri, 04/28/2023 - 18:04

116
116
article thumbnail

Global research consortium to help address antimicrobial resistance

European Pharmaceutical Review

A new global research consortium is being established to address the global impact of antimicrobial resistance (AMR). Centres for Antimicrobial Optimisation Network (CAMO-Net) , brings together research teams from the University of Liverpool and Imperial College London in the UK, the University of Cape Town in South Africa, the Infectious Diseases Institute in Uganda and the Faculty of Medicine at the University of São Paulo in Brazil. ”… this network… represents a major commitment t

94
article thumbnail

Milani launches new eyeshadow sticks

Drug Store News

The gilded eyeshadow sticks can be smudged, blended or applied for an all-over shadow or liner look, the company said.

103
103
article thumbnail

Pharma responds to proposed EU pharmaceutical legislation reform

European Pharmaceutical Review

The European Commission ’s (EC’s) reform of the EU pharmaceutical legislation published on 26 April 2023, adopted a proposal for a new Directive and a new Regulation. These amend and replace the existing general pharmaceutical legislation. According to the EC, the revision is intended to: Ensure all EU patients can access safe, effective, and affordable medicines Enhance the security of medicine supply and availability, regardless of where patients live in the EU Continue to make Europe an attra

article thumbnail

Eleos Outreach brings AI-enabled click-to-text functionality to field-based clinicians' EHRs

Fierce Healthcare

Eleos Outreach brings AI-enabled click-to-text functionality to field-based clinicians' EHRs aburky Fri, 04/28/2023 - 13:30

98