PhRMA

MARCH 29, 2023

The Patient Experience Survey (PES) series continues to reveal how health insurance is not working as it should for too many Americans — especially vulnerable groups. This series – including surveys of 5,000 Americans conducted with Ipsos, a leading research company in the United States — documents a consistent trend in reports of insurer- and middlemen-imposed practices that can keep patients from the medicines and treatments that they need.

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Insurance Documentation 288

Drug Topics

MARCH 29, 2023

Though unlikely to pass this year, opponents say the proposal is nonetheless amplifying the spread of false claims and sowing distrust of medical professionals.

Vaccines 186

Vaccines 186

STAT

MARCH 29, 2023

The Marburg outbreak in Equatorial Guinea continues to grow, the World Health Organization said Wednesday, as the global health agency stated that it knows of confirmed cases that the country has not yet reported. To date Equatorial Guinea has acknowledged nine laboratory-confirmed cases, seven of whom have died. In addition, 20 other people with links to the confirmed cases died without being tested; they are considered probable cases.

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Drug Topics

MARCH 29, 2023

Naloxone hydrochloride nasal spray (Narcan) 4 mg is expected to be available over the counter in late summer 2023.

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FDA 184

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.

STAT

MARCH 29, 2023

A growing shortage of monkeys used for early-stage pharmaceutical research is causing concern that many companies will soon face costly delays starting clinical trials — leading to a slowdown in drug development. In recent weeks, the U.S Fish & Wildlife Service began denying company requests to import long-tailed macaques from Cambodia in the wake of a federal investigation into a smuggling ring.

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Drug Topics

MARCH 29, 2023

Pharmacists can provide support and guidance to patients during their month of fasting.

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Drug Topics

MARCH 29, 2023

If approved, Perrigo’s Opill would be the first nonprescription birth control pill ever.

FDA 184

FDA 184

STAT

MARCH 29, 2023

As the health impacts of climate change become harder to ignore, biotechnology and pharmaceutical companies are facing increasing pressure from investors, employees, and government regulators to reduce their carbon emissions, and to make environmental sustainability a core part of their business. Globally, large public biotech and pharmaceutical companies are responsible for more than 200 million metric tons of carbon dioxide and equivalent emissions, according to estimates from one 2022 report.

Pharmaceutical Companies 107

Pharmaceutical Companies Pharmaceutical Companies 107

Drug Topics

MARCH 29, 2023

Sponsored by Provetica, Modulis for Cats contains the same active ingredient, concentration and dosage form as the Atopica for Cats brand product.

Dosage 98

Dosage FDA 98

The FDA Law Blog

MARCH 29, 2023

By Kalie E. Richardson — Early on March 29, 2023, FDA announced the landmark approval of Narcan (naloxone hydrochloride) Nasal Spray for use as a nonprescription opioid overdose reversal agent. I previously blogged on the February 15, 2023 Joint Meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) which unanimously agreed that the benefit-risk profile of Narcan Nasal Spray (NNS) is “supportive of its use as a n

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Insurance FDA Labelling 105

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

Pharmaceutical Technology

MARCH 29, 2023

Viking Therapeutics has announced the start of a Phase I clinical study to evaluate its dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist VK2735. The trial, which is investigating healthy adults with a minimum body mass index of 30 kg/m2, will see VK2735 administered as an oral tablet once daily for 28 days.

Dosage 105

Dosage Labelling FDA 105

STAT

MARCH 29, 2023

British Columbia plans to limit sales of the popular diabetes drug Ozempic to Canadian residents in response to a wave of Americans flocking to local pharmacies in search of the drug, potentially straining supplies in the province. Ozempic, made by Novo Nordisk, is experiencing surging demand because it not only helps regulate blood sugar in people with diabetes, but can also help people lose weight.

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Drug Store News

MARCH 29, 2023

Amazon is working with GSK, Kaléo, Novo Nordisk and Dexcom to integrate coupons for their brand-name medications directly into the checkout experience on the Amazon Pharmacy website and app.

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STAT

MARCH 29, 2023

Lupus is a disease long-plagued by failed clinical trials. And hopeful patients, many of them young women of color, are waiting — just three lupus drugs have been approved by the Food and Drug Administration in six decades. A key partnership is looking to change that.   On Wednesday, the nonprofit Lupus Research Alliance announced it was entering into a public-private partnership with the FDA.

FDA 105

FDA 105

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The Checkup by Singlecare

MARCH 29, 2023

This March, we may have changed our clocks for the last time. Whether or not you’re excited that daylight saving time might come to an end, there’s something we can all celebrate–it’s officially spring! And that, of course, means warmer weather and longer days. But if you’re one of the 81 million adults in the United States with seasonal allergies, you may be experiencing uncomfortable symptoms from all that pollen.

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Customer Service Dosage 98

STAT

MARCH 29, 2023

The U.S. Food and Drug Administration on Wednesday approved selling naloxone without a prescription, setting the overdose-reversing drug on course to become the first opioid treatment drug to be sold over the counter. It’s a move that some advocates have long sought as a way to improve access to a lifesaving drug, though the exact impact will not be clear immediately.

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FDA 103

Drug Store News

MARCH 29, 2023

Under the terms of the transaction, each outstanding share of Signify Health common stock is being exchanged for $30.50 in cash, representing a total transaction value of approximately $8 billion.

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STAT

MARCH 29, 2023

Mark Hurst just wanted to kill some bugs. A newly credentialed bacteriologist working for the New Zealand government in the early 2000s, his job was to invent new and exciting weapons in the war against grass grubs, the squishy, ectoplasmic beetle larvae that had long bedeviled the islands’ farmers. Fortunately, there were already multiple strains of bacteria that infected and killed these insects.

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Pharmaceutical Technology

MARCH 29, 2023

Regeneron Pharmaceuticals has collaborated with Sonoma Biotherapeutics to discover, develop and commercialise new regulatory T cell (Treg) therapies for autoimmune diseases. The partnership will combine the VelociSuite technologies of Regeneron with Sonoma Biotherapeutics’ pioneering approach to develop and produce gene modified Treg cell therapies.

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STAT

MARCH 29, 2023

In a rare move, the Dutch health ministry refused to provide coverage for a Gilead Sciences breast cancer treatment in a dispute over cost, one of the few times the government agency has taken such a step in recent years. In explaining the decision, Health Minister Ernst Kuipers maintained that the price Gilead sought to charge for its medication, known as Trodelvy, did not justify the health benefits.

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Hospital Pharmacy Europe

MARCH 29, 2023

Lebrikizumab monotherapy every two weeks but without concomitant topical steroid use is effective for moderate to severe atopic eczema In two identical randomised, double-blind, placebo-controlled trials, it has been found that lebrikizumab used alone in patients 12 years of age and older with moderate to severe atopic eczema, gave rise to significant improvements in disease severity.

Hospitals 96

Hospitals 96

STAT

MARCH 29, 2023

Twenty years ago, virtually all people seeking genetic testing were individuals diagnosed with diseases possibly linked to their genetic makeup. Today, millions of people order genetic tests to learn about their ancestry, as well as to understand what their genes say about their future health. This rapid growth has created what some might see as a big problem and others might see as an opportunity.

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Fierce Healthcare

MARCH 29, 2023

Signify Health CEO says CVS deal will 'turbocharge' home health provider's roadmap hlandi Wed, 03/29/2023 - 19:57

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STAT

MARCH 29, 2023

In response to mounting criticism, the National Institutes of Health published data that shows an improvement in the reporting of results from clinical trials sponsored by the agency. In fiscal year 2022, 41% of trial results were submitted to the federal database ClinicalTrials.gov, compared with 34% in the previous year and just 29% in fiscal year 2020.

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Fierce Healthcare

MARCH 29, 2023

UnitedHealthcare to begin reducing prior authorizations this summer pminemyer Wed, 03/29/2023 - 17:02

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STAT

MARCH 29, 2023

Good morning, everyone, and how are you today? We are doing just fine, thank you. After all, the birds are still chirping and a cool breeze is wafting by the placid Pharmalot campus. Moreover, this marks the middle of the week, which means we have managed to survive this far. And this calls for celebration, yes? So please join us as we hoist another cup of delicious stimulation.

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ISPE

MARCH 29, 2023

The Culture Club: Wrapping it up - Part 4 of 4 Trudy Patterson Wed, 03/29/2023 - 10:55 iSpeak Blog iSpeak The Culture Club: Wrapping it up - Part 4 of 4 Michelle Vuolo Levi Schenk Andre L. Walker, CPIP Brandi M. Stockton 29 March 2023 We are The Culture Club, a self-formed cross-CoP group of individuals who came together to discuss challenges encountered as we transition quality and validation into the digital world and identify ways to influence cultural changes needed within our industry to be

Documentation 96

Documentation 96

European Pharmaceutical Review

MARCH 29, 2023

Pembrolizumab (Keytruda) has been recommended in National Institute for Health and Care Excellence (NICE) final draft guidance for advanced cervical cancer. A promising immunotherapy “Pembrolizumab shows promise as the first effective immunotherapy [for advanced cervical cancer]” “Pembrolizumab shows promise as the first effective immunotherapy” for the condition, stated Helen Knight, Director of Medicines Evaluation at NICE.

Chemotherapy 94

Chemotherapy 94

Fierce Healthcare

MARCH 29, 2023

Survey Shows the Terrifying Truth About America’s Healthcare Affordability Crisis: Patients Put off Care for Years due to Costs mteefey Wed, 03/29/2023 - 19:41

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Drug Store News

MARCH 29, 2023

Amazon is working with GSK, Kaléo, Novo Nordisk and Dexcom to integrate coupons for their brand-name medications directly into the checkout experience.

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Fierce Healthcare

MARCH 29, 2023

Bipartisan Senate bill aims to take on Medicare Advantage up-coding practices rking Wed, 03/29/2023 - 17:02

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Fierce Pharma

MARCH 29, 2023

After drug rejection, Vanda scores courtroom win over FDA in records case zbecker Wed, 03/29/2023 - 11:23

FDA 100

FDA 100

Drug Store News

MARCH 29, 2023

New launches from the brand include the Color Haul Eyeshadow Palette, Simplifeyed Power Quad and Super Sidekick Eyeshadow Primer.

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PharmaVoice

MARCH 29, 2023

Psilera founder’s “third eye” approach to psychedelics ushers them into the therapeutic realm.

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