Sun.Jun 23, 2024

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Opinion: The FDA needs to embrace phage therapy to help fight antimicrobial resistance

STAT

My daughter, Mallory, died in 2017 at the age of 25 from a multiply resistant bacterial lung infection that followed a double-lung transplant necessitated by cystic fibrosis. In the weeks before her death, my wife, Diane Shader Smith, and I sought out and obtained an innovative yet underused treatment for antibiotic-resistant bacteria known as phage therapy.

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FDA clears Argenx’ Vyvgart Hytrulo for rare disease CIDP

pharmaphorum

Netherlands biotech Argenx has a second FDA approval for its FcRn inhibitor Vyvgart Hytrulo, adding a new indication in chronic inflammatory demyelinating polyneuropathy (CIDP) for a drug that it hopes could find a use in more than a dozen diseases.

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20 years of X20

Express Pharma

The X20 system has been an essential component of countless industrial applications for the last 20 years, providing dependable performance and pushing productivity to unprecedented levels. The X20 has transformed industrial automation with its small size and potent features, enabling machines all around the world to function accurately and effectively.

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Vertex islet cell therapy gets type 1 diabetics off insulin

pharmaphorum

Three people with type 1 diabetes who received Vertex Pharma’s islet cell therapy VX-880 were able to come off insulin within a year

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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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Episode 933: Can tenecteplase be used for acute ischemic stroke beyond 4.5 hours from time last know well?

Pharmacy Joe

In this episode, I’ll discuss tenecteplase for stroke from 4.5 to 24 hours after the time last know well. Episode 933: Can tenecteplase be used for acute ischemic stroke beyond 4.5 hours from time last know well? Subscribe on iTunes , Android , or Stitcher While the use of thrombolytics for patients with acute ischemic stroke is usually done if the patient presents within 4.5 hours of the time last know well, data specifically with tenecteplase beyond the 4.5 hour window is sparse.

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EMA approves Biocon’s new mAbs facility in India

Express Pharma

Biocon Biologics a subsidiary of Biocon, has received approval from the European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab at its new, multi-product monoclonal antibodies (mAbs) drug substance facility at Bengaluru. The facility was previously approved to manufacture biosimilar Trastuzumab in September 2022. The company also announced that EMA has renewed its Good Manufacturing Practice (GMP) Certificates of Compliance for its biosimilar manufacturing facility in Bengaluru a

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New tentative approval for Alembic drug dabigatran etexilate mesylate

Drug Patent Watch

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five NDAs. There are three patents protecting this compound. Drug patent litigation for DABIGATRAN ETEXILATE MESYLATE. Nine suppliers are listed for this compound.

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The PCAT Is Going Away, Will NAPLEX Pass Rates Fall?

Med Ed 101

How do you get better at something? Practice. At least that’s what I tell my kids. The (Pharmacy College Admissions Test) PCAT has gone away in 2024 and I can’t help but think that this will be another nail in the coffin of future high NAPLEX pass rates. The PCAT was a good avenue for […] The post The PCAT Is Going Away, Will NAPLEX Pass Rates Fall?

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Drug Patent Expirations for the Week of June 23, 2024

Drug Patent Watch

MOVANTIK (naloxegol oxalate) Valinor Patent: 7,056,500 Expiration: Jun 29, 2024 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or visit www.DrugPatentWatch.

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A throughput benchmarking study of Supor™ Prime filters

PharmaTech

See how Supor Prime filters performed against two comparable products in filtering fluids with antibody concentrations of 70 g/L to 220 g/L. And be sure to request a sample!

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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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Educational Nutrition Programs Targeted at Communities Improve Diabetes Outcomes

Pharmacy Times

Food is medicine is a framework of policy and behavioral interventions, improving population health through access to healthy foods to increase food and nutrition security.

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Which pharmaceutical companies have the most SPCs in Italy?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Italy. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating for the long time needed to obtain regulatory approval for drugs.

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Managing Diabetes and Cardiovascular Risk Through Collaborative Care

Pharmacy Times

Jennifer Goldman discusses the importance of collaborative care between providers like endocrinologists, cardiologists, primary care physicians, and pharmacists to manage diabetes and prevent cardiovascular events.

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DEA’s Expected Guidance: It Should Reduce Current “Pain” at the (Intrathecal Pain) Pump Dispensing Process and Improve Therapeutic Outcomes

FDA Law Blog: Biosimilars

By John A. Gilbert & Karla L. Palmer — For more than 50 years, the Drug Enforcement Administration (DEA) has enforced the central mandate of the Controlled Substances Act (CSA) to maintain a closed chain of distribution for drugs with a potential for abuse and diversion. The CSA and regulations promulgated by DEA are intended to reduce the potential for diversion and abuse and ensure that controlled substances are dispensed and delivered to patients for a legitimate medical purpose.

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Physician Calls for National Dialogue on Inequitable Access to Lifesaving GLP-1 Medications

Pharmacy Times

W. Timothy Garvey expressed concern over limited access to effective obesity medications like Ozempic due to shortages and high costs, urging stakeholders to work together on developing solutions.

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Experts Discuss Serious Adverse Events for GLP-1 Medications

Pharmacy Times

Potential concerns surrounding GLP-include pancreatitis, pancreatic cancer, colorectal cancer, suicide and other phycological effects, and thyroid cancer.

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Expert: Supporting Health Equity and Access to Care Through Community Pharmacies

Pharmacy Times

Niki Shah Vice President of Impact Innovation and Activation at McKesson, discusses efforts to advance health equity and access through community pharmacy initiatives.

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Implementing Community Health Workers into Pharmacy Reduces Health Equities, SDOH

Pharmacy Times

Adding a community health worker can improve the overall health equity for your patients.

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Expert: Semaglutide's Benefits in Obesity-Related Heart Failure, the Role of Pharmacists in Diabetes Care

Pharmacy Times

Semaglutide significantly improved heart failure symptoms and quality of life through weight loss and direct effects on heart tissue.