PhRMA

MARCH 30, 2023

At the request of the U.S. Trade Representative, the U.S. International Trade Commission (USITC) is conducting an investigation and will issue an accompanying report concerning the TRIPS Agreement and a variety of issues related to COVID-19 diagnostics and therapeutics. According to USTR, the USITC report will inform future discussions within the United States and at the World Trade Organization (WTO) concerning potential TRIPS waiver expansion.

Vaccines 250

Vaccines 250

Drug Topics

MARCH 30, 2023

The suit alleges that Express Scripts, Prime and Prime customer Humana Pharmacy Solutions are able to share drug pricing and rebate information to increase prices for insulins, biologics and cancer drugs.

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PhRMA

MARCH 30, 2023

Between Congress, the Medicare Payment Advisory Commission (MedPAC) and the Center for Medicare & Medicaid Innovation (CMMI), there have been a number of policy proposals of late that would change reimbursement for medicines covered by Medicare Part B, some of which may harm patient access to important treatments. As we debate these proposals, it’s important to levelset on how reimbursement works in the program today.

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STAT

MARCH 30, 2023

New evidence of the spillover of the avian flu virus, known as H5N1, to some mammals is again raising alarm bells, though for experts familiar with the virus, “ none of them ever stopped worrying about H5N1.” The recent death of a Cambodian girl from bird flu is a reminder that much is at stake. If H5N1 were to cross over to humans and ignite another pandemic, could the United States do it all over again?

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Vaccines FDA 145

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.

Fierce Healthcare

MARCH 30, 2023

Uber Health rolls out same-day prescription delivery with plans to ship healthy food, OTC meds hlandi Thu, 03/30/2023 - 12:54

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Drug Topics

MARCH 30, 2023

However, the researches make clear that their findings should not be construed as an endorsement of irresponsible or liberal opioid use.

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Drug Topics

MARCH 30, 2023

The drug, called Tauramox, is the first generic moxidectin injectable solution to control internal and external parasites.

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FDA 98

STAT

MARCH 30, 2023

The Food and Drug Administration on Thursday released a new plan allowing developers of medical devices that rely on artificial intelligence to automatically update products already being used in the clinic. The agency’s draft guidance outlines a new process in which the makers of AI tools could get approval for modifications in advance by submitting a document describing how the changes will be implemented and tested.

Documentation 102

Documentation FDA 102

Hospital Pharmacy Europe

MARCH 30, 2023

Esketamine nasal spray induced remission from 6 weeks onwards compared to extended-release quetiapine in treatment-resistant depression In data presented at the 31st European Congress of Psychiatry (EPA 2023) researchers found that in treatment-resistant major depressive disorder, esketamine nasal spray achieved significantly higher rates of remission from as early as week 6 compared to the use of extended-release (XR) quetiapine.

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Communication Hospitals 98

STAT

MARCH 30, 2023

Mathai Mammen, who until recently led research at Johnson & Johnson, will become the CEO of a privately held biotech company working to find treatments for diseases deemed undruggable. Mammen, previously a candidate for the top job at Biogen , will take over as chairman, president, and CEO of FogPharma, a Cambridge, Mass., company that spun out of the lab of ​​Harvard University biologist Greg Verdine in 2015.

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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

ISPE

MARCH 30, 2023

Road Mapping Digital Transformation in the Biopharmaceutical Industry Trudy Patterson Thu, 03/30/2023 - 10:38 iSpeak Blog iSpeak Road Mapping Digital Transformation in the Biopharmaceutical Industry Prudence Edwards Stephan Huelber 30 March 2023 The advantages that come with a fully digitalized plant for manufacturing biopharmaceuticals are well documented and showcased throughout the biopharmaceutical industry and will be a featured topic during the 2023 ISPE Biotechnology Conference.

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Documentation 98

STAT

MARCH 30, 2023

The U.S. solicitor general urged the U.S. Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding threatens the availability of lower-cost generic drugs. Skinny labeling refers to a process in which a generic company seeks regulatory approval to market its medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed.

Labelling 101

Labelling 101

Hospital Pharmacy Europe

MARCH 30, 2023

Caffeinated coffee consumption did not increase the level of premature atrial contractions compared to avoidance in a recent randomised trial Drinking caffeinated coffee does not significantly elevate the daily mean level of premature atrial contractions compared to days where the drink is avoided according to a study by researchers from the university of California.

Hospitals 98

Hospitals 98

STAT

MARCH 30, 2023

NEW YORK — For every American killed by gunfire, an estimated two or more more survive, often with terrible injuries — a fact that public health experts say is crucial to understanding the full impact of guns on society. A new government study highlights just how violent the recent past has been in America by showing a surge in people wounded by gunshots during the pandemic, when the number of  people fatally shooting each other — and themselves — also increased.

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Fierce Healthcare

MARCH 30, 2023

Wellth reels in $20M to scale up its 'behavioral economics' approach to tackle chronic conditions hlandi Thu, 03/30/2023 - 07:10

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STAT

MARCH 30, 2023

CHICAGO — When she entered the field of Alzheimer’s research a quarter century ago, Lisa Barnes was deeply disappointed to find few Black people like her family members with dementia were being studied. A rarity herself — as a Black female cognitive neuropsychologist — she’s spent her career quietly pushing back. Since 2004, Barnes has been running the Minority Aging Research Study, one of the nation’s largest studies of Alzheimer’s focused exclus

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Hospital Pharmacy Europe

MARCH 30, 2023

Long-term exposure to higher road traffic noise is linked to a higher incidence of hypertension particularly if there is higher air pollution Chinese and UK researchers have observed that long-term exposure to high levels of road traffic noise (RTN) increases the risk for developing hypertension and that this risk is even greater when levels of air pollution are also increased.

Medical Records 97

Medical Records Hospitals 97

Fierce Pharma

MARCH 30, 2023

As deadly pathogen spreads, GSK throws a lifeline to Scynexis with $90M deal to market antifungal aliu Thu, 03/30/2023 - 10:39

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STAT

MARCH 30, 2023

Rise and shine, another busy day is on the way. We can tell because the official mascot got an early start chasing down cats, squirrels, and other creatures darting about the Pharmalot campus. And then there is the noisy parade of vehicles passing nearby on their way to who knows what? As for us, we are firing up the trusty coffee kettle to brew another cup of stimulation.

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Vaccines FDA 94

PharmExec

MARCH 30, 2023

At Pharma USA 2023, Peter Marks, MD, PhD and director of CBER described FDA and public/private partnerships working toward scalable manufacturing approaches to address commercial viability and global access for cell and gene therapies

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FDA 96

Drug Store News

MARCH 30, 2023

Made with avocado oil, the brand is launching Farmhouse Ranch to its portfolio as well as a Spicy Salsa Verde, an update to its Spicy Tomatillo products.

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European Pharmaceutical Review

MARCH 30, 2023

GSK is set to gain exclusive rights to first-in-class oral antifungal Brexafemme (ibrexafungerp tablets) for vulvovaginal candidiasis (VVC) from SCYNEXIS. The exclusive licence agreement will enable GSK to commercialise Brexafemme for VVC and recurrent VVC (RVVC). Currently, the treatment is in Phase III clinical trials for invasive candidiasis (IC).

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FDA 93

Fierce Healthcare

MARCH 30, 2023

Capital Rx exec to senators: Here's how to fix the PBM industry fdiamond Thu, 03/30/2023 - 15:36

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STAT

MARCH 30, 2023

What happened to the market for monkeys? Are some drugs too cheap? And why are biotech stocks still in the tank? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. We explain how biotech is affected by a bizarre situation involving smuggled monkeys, international intrigue, and a criminal investigation.

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Fierce Healthcare

MARCH 30, 2023

Hint Health, powering cash-only providers, launches new management platform agliadkovskaya Thu, 03/30/2023 - 13:42

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Drug Store News

MARCH 30, 2023

The Sesame Street x wet n wild line consists of cosmetics, tools and accessories featuring Elmo, Big Bird and other classic characters.

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Fierce Healthcare

MARCH 30, 2023

ViVE 2023: Tripledemic, mental health crisis highlight unequal investment in children's health dmuoio Thu, 03/30/2023 - 17:44

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Fierce Pharma

MARCH 30, 2023

Pfizer, BMS' Eliquis tops list of drugs destined for Medicare price negotiations in 2026: Moody's kdunleavy Thu, 03/30/2023 - 07:28

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The People's Pharmacy

MARCH 30, 2023

Americans think of antibiotics as silver bullets. Our reverence for this type of medication is understandable. Before penicillin was developed, people routinely died from pneumonia and other infections. With this miracle of modern medicine, such deaths have become rare. However, the widespread use of quinolone antibiotics has gradually revealed some serious side effects.

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Adverse Reactions Insurance Hospitals 93

European Pharmaceutical Review

MARCH 30, 2023

Intrathecal (IT) (directly into the spinal fluid) and intravenous (IV) nivolumab (anti-PD-1) immunotherapy was found to be safe and improved survival in a subset of melanoma patients with leptomeningeal disease (LMD). The first-in-human, Phase I/Ib study published in Nature Medicine , described the interim analyses of the novel delivery approach. Leptomeningeal disease is a cancer complication that occurs when cancer cells from primary tumours migrate into the cerebrospinal fluid (CSF) and lepto

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Fierce Healthcare

MARCH 30, 2023

Michigan's Covenant Healthcare System, physicians pay $69M to settle whistleblower's False Claims Act allegations dmuoio Thu, 03/30/2023 - 14:14

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Drug Store News

MARCH 30, 2023

The collection of hair removal products, which feature marguerite patterned florals, aims to elevate the in-shower experience, the company said.

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Drug Topics

MARCH 30, 2023

The AVMA is working with lawmakers to help increase the numbers of animal drug approvals.

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Pharmafile

MARCH 30, 2023

After receiving FDA approval in January 2023, Biogen/Eisai’s new Alzheimer’s disease Leqembi is expected to become a blockbuster, with a predicted $12.9bn predicted to be made in sales between 2023 and 2028. The drug is still awaiting approval in the EU and Japan, with these approvals potentially making it the top-selling Alzheimer’s drug.

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FDA 83