Sat.Jun 17, 2023 - Fri.Jun 23, 2023

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Sandoz Launches Action Plan to Increase Global Biosimilar Access

Drug Topics

The Act4Biosimilars Action Plan aims to highlight key challenges preventing patient access to biosimilars and outline steps to help overcome them.

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WHO grants emergency use listing to SK bioscience’s SKYCovione

Pharmaceutical Technology

The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. Developed using pharmaceutical company GSK’s pandemic adjuvant, the vaccine targets the receptor-binding domain of the SARS-CoV-2 spike protein.

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How FDA’s modernization strategy could improve drug development

PhRMA

As technology continues to rapidly advance, it’s important for regulatory agencies like the U.S. Food and Drug Administration (FDA) to keep pace and adopt new technologies and approaches to support its public health mission and ultimately, better serve patients.

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What’s New in Next-Generation Vaccines for Respiratory Viruses?

Drug Topics

A recent review evaluated possible approaches for new vaccines targeting respiratory viruses.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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New report shows how the Inflation Reduction Act stifles innovation for small molecule medicines

PhRMA

Research doesn’t end once a medicine is first approved by the U.S. Food and Drug Administration (FDA). Researchers often spend years after an initial approval exploring and obtaining approval of new indications for medicines to treat other patient populations desperate for new treatment options. Patients with cancer or rare diseases often depend on this post-approval research.

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HCA Healthcare accused of pushing patients toward end-of-life care to boost performance metrics

Fierce Healthcare

A pair of new reports released this week allege that HCA Healthcare policies are encouraging staff to transition more patients to palliative and end-of-life care, thereby increasing churn and boost | Two reports, one based on dozens of employee interviews and the other on policies and discharge statistics, paint a picture of internal policies encouraging transfers to boost quality metrics and free up hospital beds.

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Improving Pharmacists’ Knowledge of Biosimilars Can Help Stop Misinformation

Drug Topics

A study found that pharmacists possessed moderate to low knowledge scores when it came to statements tackling biosimilars.

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Deprescribing, Medication Therapy Management Go Hand in Hand

Pharmacy Times

Pharmacists play key roles in performing comprehensive patient reviews, reducing polypharmacy.

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The spotlight is on accelerated approvals — now FDA could run a tighter ship

PharmaVoice

As the fallout of the Aduhelm approval continues, scrutiny of the speedier pathway has increased and the pressure is on to close a key gap in the regulation.

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FDA, Novo Nordisk Warn of Counterfeit Semaglutide Injection Pens

Pharmacy Times

A counterfeit medication was reportedly purchased at a retail pharmacy, appearing to have contained another type of diabetes medication that led to an adverse reaction.

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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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Spotlight On The Infectious Diseases Podcast Over 15 Years Old That Just Added New Mobile Streaming Options

IDStewardship

In this article the story of an infectious diseases podcasts is discussed – IDpodcasts. Authored By: Richard L Oehler, MD Co-founder and Webmaster of ID Podcasts Platforms University of South Florida Morsani College of Medicine, Tampa, FL, USA Article Posted 19 June 2023 In 2007, the University of South Florida Division of Infectious Diseases (ID) was looking for a way to archive and webcast live medical presentations given by its ID faculty.

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Senate Introduces Bill to Combat High Pharmacy DIR Fees

Drug Topics

The Protect Patient Access to Pharmacies Act will help to secure Medicare patients’ freedom to receive medications and care from the pharmacy of their choice.

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Opinion: Peter Hotez is not alone: Online harassment of doctors is a public health issue

STAT

Father’s Day weekend was anything but calm on Twitter, which erupted as vaccine expert Peter Hotez was challenged online to a debate by podcaster and former reality TV host Joe Rogan. Rogan’s challenge began when Hotez, a professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine and vaccine expert, tweeted his  concern about Rogan’s three-hour interview with longtime anti-vaccine activist  and presidential candidate Robert F.

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Physician-owned hospitals' negotiated, cash prices lower than nearby facilities, study finds

Fierce Healthcare

Physician-owned general acute care hospitals charge less than other non-physician-owned facilities in their region for several common shoppable care services, according to a new analysis published | A new analysis of competing hospitals' published prices adds fuel to the debate over whether Congress should lift the Affordable Care Act's ban on new physician-owned hospitals.

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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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Innovation is Necessary to Preserve Independent, Community Pharmacy

Pharmacy Times

Pharmacists can recognize evidence of successful interventions and learn how to integrate them into their own practice.

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Breaking: CDC ACIP Recommends RSV Vaccination for Older Adults

Drug Topics

The first RSV vaccines were approved by the FDA earlier this year.

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STAT+: Two type 1 diabetes patients now freed from insulin shots with cell therapy, Vertex reports

STAT

Vertex Pharmaceuticals said Friday that, over a year after receiving the company’s stem-cell therapy, two type 1 diabetes patients no longer need to take insulin injections and saw stark reductions in a biological marker of disease.  The results, presented at the American Diabetes Association conference in San Diego, bolstered experts’ hopes that the treatment could provide a functional cure for some patients.

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Intercept restructures as Ocaliva's NASH hopes dashed again with FDA rejection

Fierce Pharma

Even after second application attempt, Intercept’s Ocaliva wasn’t the fatty liver disease breakthrough that the company had hoped it would be. | Even after second application attempt, Intercept’s Ocaliva wasn’t the fatty liver disease breakthrough that the company had hoped it would be. Intercept is now swinging into restructuring mode, and the NASH baton passes on to Madrigal Pharma.

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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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Liso-Cel Produces Deep, Durable Responses in Patients with Hard-to-Treat Lymphomas

Pharmacy Times

Treatment with lisocabtagene maraleucel led to strong and durable response rates with little serious adverse effects in patients with relapsed or refractory follicular lymphoma and mantle cell lymphoma.

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Insurance Coverage is Lagging in a Golden Age of Obesity Treatment

Drug Topics

Antiobesity medications are considered to be 'vanity drugs' by many private insurers, and the refusal to cover obesity treatment is counterproductive because of obesity's many health consequences.

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Xylazine, or ‘tranq,’ is making opioid overdoses harder to reverse

STAT

For years, public health guidance about opioid overdoses has been relatively simple: Administer naloxone , then call 911. But the days of simply spraying naloxone into an overdose victim’s nose, then watching that person resume breathing and wake up within minutes, are over.

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Novo Nordisk, Eli Lilly face scrutiny from EU's drug regulator over GLP-1 safety

Fierce Pharma

The EMA is scrutinizing GLP-1s, raising a safety signal about the risk that drugs from Novo Nordisk, Eli Lilly and other companies could cause cancer.

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Common Antibiotics Associated with C. difficile Infection Include Piperacillin, Meropenem

Pharmacy Times

Antibiotics that were found to be most commonly associated with clostridium difficile infection are piperacillin/tazobactam, meropenem, vancomycin, ciprofloxacin, ceftriaxone, and levofloxacin, according to a recent study.

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Front-End Strategies for Consumer Convenience

Drug Topics

Beauty and household items topped the list of what customers want to buy in the pharmacy.

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Opinion: The FDA’s approval of a new gene therapy for Duchenne muscular dystrophy won’t help me — but it gives me hope

STAT

When I was diagnosed with Duchenne muscular dystrophy 20 years ago, there was no hope. The guidance the diagnosing doctor gave my parents was simple: Love your child as much as you can now because he won’t be here very long. That was the inspiration that my mom needed to start CureDuchenne. Her intention — our whole family’s intention — was to cure this disease so no other parents would have to go through the same traumatic prognosis.

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Agepha Pharma gets ancient gout remedy colchicine across FDA finish line for heart disease

Fierce Pharma

Used by Egyptians 35 centuries ago as a remedy for inflammation, colchicine was found over the ages to be effective against a variety of maladies including gout, dropsy and familial Mediterranean f | Agepha Pharma, a family-owned company based in Slovakia, has gained an FDA approval for Lodoco, which becomes the first drug to target cardiovascular inflammation.

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AI Plus Mobile App May Help With Smoking Cessation

Pharmacy Times

More than 4 times as many people who used the app quit smoking compared to a traditional support service.

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Healthcare dealmaking 'resilient' despite regulatory, economic headwinds: PwC

Fierce Healthcare

Even in the face of substantial headwinds, dealmaking in the healthcare industry hasn't fallen off, according to a new analysis from PwC. | Even in the face of substantial headwinds, dealmaking in the healthcare industry hasn't fallen off, according to a new analysis from PwC.

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STAT+: After promising early data, gene therapy trial for Huntington’s takes puzzling turn

STAT

Last year, after a string of high-profile trial failures , the Huntington’s disease community got positive news in the form of very early data from an experimental gene therapy for the rare neurodegenerative condition. On Wednesday, however, the company behind the drug released updated figures that were more mixed — even befuddling. The study from Uniqure, a Dutch biotech, randomized early stage Huntington’s patients to receive low-dose treatment, a high-dose treatment, or a

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Generative Health: A new standard of care

pharmaphorum

Generative Health: A new standard of care Mike.

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Current Dementia Risk Assessment Models Limited in Ability to Predict Disease

Pharmacy Times

Standard prediction models that assess an individual’s risk of developing dementia and how to prevent it are limited in their ability to do so, showing high error rates and a higher chance of receiving a false-positive result, according to a recent study.

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New Ochsner Health, MD Anderson partnership brings integrated cancer care to Louisiana

Fierce Healthcare

Ochsner Health and The University of Texas MD Anderson Cancer Center are partnering to build an integrated cancer care program in southeastern Louisiana, the organizations announced Thursday. | The first phase of the new collaboration will see cancer patients at seven of Ochsner's southeast Louisiana facilities become eligible for breaking clinical trials.

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Bristol Myers follows Merck's lead with its own ?lawsuit blasting IRA's Medicare negotiations

Fierce Pharma

After Merck filed a bombshell lawsuit challenging some measures in the Inflation Reduction Act (IRA), Bristol Myers Squibb has followed on with a case of its own. | After Merck took the first legal stab at the Inflation Reduction Act with a lawsuit against the Department of Health and Human Services (HHS), Bristol Myers Squibb is the latest drugmaker to allege Constitutional violations.

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