Drug Topics

OCTOBER 6, 2023

Through her work at the Centre Volunteers in Medicine, my wife—now retired—has made an impact on more people than I ever will.

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Pharmacy Times

OCTOBER 6, 2023

Ketamine topical cream may alleviate symptoms of PTSD without causing the adverse effects and abuse potential often associated with other forms of ketamine administration.

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Drug Topics

OCTOBER 6, 2023

Two possibly curative gene therapies for the disease, which disproportionately affects Black people, are under consideration by the FDA.

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FDA 186

Pharmacy Times

OCTOBER 6, 2023

With World Standards Week on October 10 to 12, 2023, it is a key time to assess preparation for the official date for revised USP General Chapters and on compounding, as well as the associated USP General Chapter on the handling of hazardous drugs in healthcare settings.

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Compounding 142

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.

Drug Topics

OCTOBER 6, 2023

Moderna plans to begin a phase 3 trial of the combination vaccine this year.

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Vaccines 200

STAT

OCTOBER 6, 2023

In a fall in which new tools to fight old diseases — updated Covid-19 vaccines, new products to protect older adults and babies from RSV — have been introduced with fanfare but rolled out in a particularly rocky manner, frustration may be about to go next level. Parents of young babies are anxiously waiting to find out how and where they’ll be able to get their children shots of Sanofi’s new monoclonal antibody that protects against RSV, or respiratory syncytial virus

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Vaccines 143

STAT

OCTOBER 6, 2023

If the Covid-19 pandemic has shown us one thing, it is how little we really know about how the human immune system works. Despite the remarkable success in development of vaccines to prevent severe disease from SARS-CoV-2, it remains unclear how SARS-CoV-2, a newly emerging virus, causes such a broad spectrum of disease , ranging from asymptomatic and mild cases to severe disease and death.

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Immunization Vaccines 137

Fierce Healthcare

OCTOBER 6, 2023

The Drug Enforcement Administration (DEA) said Friday it will extend telehealth flexibilities that enable clinicians to virtually prescribe controlled medications to their patients through 2024 as | The DEA announced Friday that it is extending pandemic rules for prescribing controlled substances via telemedicine through the end of next year.

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Controlled Substances 135

Pharmacy Times

OCTOBER 6, 2023

Harmful LDL functionality contributes to an increase of cardiovascular disease in those with obesity but could decrease within weight loss.

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Fierce Pharma

OCTOBER 6, 2023

While the White House recently touted the FDA’s efforts to mitigate the ongoin | The National Comprehensive Cancer Network found that 72% of centers are still experiencing a carboplatin shortage, while 59% remain low on cisplatin. The survey follows a June report which found that nearly all centers had short supply of the chemotherapies.

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Chemotherapy FDA 129

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.

FDA

Pharmacy Times

OCTOBER 6, 2023

Roflumilast is the first topical agent indicated to treat psoriasis in sensitive intertriginous areas of the skin.

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FDA 149

Fierce Pharma

OCTOBER 6, 2023

Amgen has completed its $27.8 billion acquisition of Horizon Therapeutics after fending off a legal challenge by the U.S. antitrust watchdog. | Amgen has completed its $27.8 billion acquisition of Horizon Therapeutics after fending off a legal challenge by the U.S. antitrust watchdog.

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OCTOBER 6, 2023

CHICAGO — At what point does inflammation, a key component of the body’s immune defense system, swerve out of control and start to drive disease? That’s the key question that a new research center, the Chan Zuckerberg Biohub Chicago, has been created to try to answer. The Chicago hub is the second one started by the Chan Zuckerberg Initiative, the philanthropic organization of Facebook founder Mark Zuckerberg and his wife, Priscilla Chan.

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Immunization 119

Fierce Pharma

OCTOBER 6, 2023

People who use Novo Nordisk’s popular weight-loss drugs are taking on a small risk of developing severe stomach problems, according to research conducted by the University of British Columbia and < | People who use Novo Nordisk’s popular weight-loss drugs are taking on a small risk of developing severe stomach problems, according to research conducted by the University of British Columbia.

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Pharmacy Times

OCTOBER 6, 2023

Expert discuss access barriers for the COVID-19, respiratory syncytial virus, and influenza vaccines, and ways to facilitate uptake.

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Vaccines 132

STAT

OCTOBER 6, 2023

In a setback for Novo Nordisk, a U.S. judge dismissed its lawsuit accusing a compound pharmacy of selling versions of its Wegovy and Ozempic medicines, which are widely prescribed for weight loss and have become franchise products for the drug company. The decision, which was conveyed in a one-page filing in the court docket, comes after Novo Nordisk filed lawsuits last July against Brooksville Pharmaceuticals and three other compound pharmacies for allegedly violating laws in different states.

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Compounding Compounding Pharmacies 116

Fierce Pharma

OCTOBER 6, 2023

Aiming to hit a corporate value of around $15 billion by the end of the decade, Korean CDMO Lotte Biologics has laid out plans to stand up three new manufacturing facilities in the same time frame. | Lotte this week unveiled a land purchase agreement with the Incheon Free Economic Zone Authority in Incheon, Korea. With the new real estate, Lotte plans to build out three separate bio plants by 2030.

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Fierce Healthcare

OCTOBER 6, 2023

Thirteen major health systems have signed on to a pledge agreeing to work toward sharing patient care data with the Department of Veterans Affairs (VA) in a bid to improve veterans’ cross-organizat | By working toward seamless, secure data exchange, the organizations hope to better coordinate the care veterans seek from community providers and ensure they benefit from cost-saving VA policies.

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Department of Veterans Affairs Patient Care 110

STAT

OCTOBER 6, 2023

Within the linings of our guts, immune cells patrol like sentries on a castle wall. These cells, called intraepithelial T lymphocytes, are constantly probing the cells of the gut barrier for signs of disease, killing any cells that appear suspect due to infections or cancer mutations. A new paper published in Science Immunology on Friday suggests that a subtype of T cells called gamma-delta T cells may be key to that process — and that a protein known as TCF-1 is central to controlling th

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Immunization 110

Drug Topics

OCTOBER 6, 2023

A recent study found that vitamin E, with or without vitamin C, improved symptoms in patients with chronic pelvic pain.

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OCTOBER 6, 2023

Earlier this year, Food and Drug Administration Commissioner Robert M. Califf proposed something radical: that private health care insurance companies (payers) should participate in clinical research on FDA-approved drugs. This challenges the prevailing convention that only drug developers conduct such studies — and it’s an idea worth considering.

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FDA Insurance 107

The Checkup by Singlecare

OCTOBER 6, 2023

Chances are, you or someone you know has taken the prescription medication amoxicillin for an infection. The penicillin antibiotic is one of the best-known and commonly used remedies for human infections, whether caused by injuries, illnesses, or other germs. But what about our four-legged friends? Pets, including dogs, are also prone to infection from various sources—but can dogs take amoxicillin?

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Dosage Adverse Reactions Hospitals 105

Pharmafile

OCTOBER 6, 2023

Sanofi has shared new data for the long-term efficacy of Nexviazyme (avalglucosidease alfa) for the treatment of Pompe disease at the 28th Annual Congress of the World Muscle Society (WMS) in Charleston, South Carolina, US. Nexviazyme is approved in the US and elsewhere as a monotherqapy for the treatment of late-onset Pompe disease, and is […] The post Sanofi shares new data for long-term efficacy of Nexviazyme for Pompe disease treatment appeared first on Pharmafile.

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Digital Pharmacist

OCTOBER 6, 2023

ConclusionI n July 2023, Florida passed the Prescription Drug Reform Act (Chapter 2023-29). Now, what is this act? The Prescription Drug Reform Act aims to regulate pharmacy benefit managers (PBMs) and pharmaceutical manufacturers in the state. The primary focus of this act is to bring transparency, accountability, and fairness to the outpatient pharmaceutical system in Florida, especially in relation to PBMs.

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Insurance 105

Fierce Healthcare

OCTOBER 6, 2023

Commercial health insurers should utilize telehealth to address the dearth of pediatric mental health providers, according to a research letter.

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Insurance 118

STAT

OCTOBER 6, 2023

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still taking shape, but we expect to hang with our shortest person, who returns for a quick break from an institution of higher learning, catch up on sundry chores and, if possible, hold another listening party.

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FDA 102

European Pharmaceutical Review

OCTOBER 6, 2023

Positive interim results from Moderna’s Phase I/II trial of mRNA-1083 , an investigational vaccine designed to immunise against both influenza and COVID-19, have been released. There are several benefits of the combination vaccine as a preventative measure against these respiratory conditions, according to the pharmaceutical company. For example: higher patient compliance, easier administration and greater convenience.

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Vaccines Pharmaceutical Companies Pharmaceutical Companies 101

Drug Store News

OCTOBER 6, 2023

Using manufacturer-sponsored savings cards, eligible patients can get a 28-day supply of insulin for as low as $35 per month at their local Hy-Vee Pharmacy.

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Insurance 105

Drug Topics

OCTOBER 6, 2023

Overall median survival was higher in participants taking quizartinib, according to results from QuANTUM-First trial.

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European Pharmaceutical Review

OCTOBER 6, 2023

The Indian Pharmacopoeia Commission (IPC) is now a member the Pharmacopoeial Discussion Group (PDG). As the Indian pharmaceutical industry is “a major manufacturer of the world’s medicines,” Jaap Venema, PhD, Executive Vice President and Chief Science Officer for USP declared, inclusion of the IPC in the discussion group is a “milestone” in expanding recognition of harmonised pharmacopoeial standards, Cathie Vielle, Secretary to the European Pharmacopoeia Commission added.

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OCTOBER 6, 2023

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.

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Pharmaceutical Commerce

OCTOBER 6, 2023

Sr. Director of Community Engagement for Pharmaceuticals at GS1 US explains what the implementation guidelines are meant to accomplish.

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Outsourcing Pharma

OCTOBER 6, 2023

EDETEK and Pfizer are in collaboration to speed access to clinical data, promote interoperability and enable data visualization to drive faster decision-making capabilities in clinical operations.

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OCTOBER 6, 2023

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hi! Today, we discuss why an advisory committee was not thrilled with Amgen’s data for Lumakras, and Neurocrine Biosciences has a potential blockbuster up its sleeve. Oh, and we’ll be off for Indigenous Peoples’ Day next week and will be back in your inbox Tuesday!

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Vaccines 81