Drug Topics

AUGUST 25, 2023

A 2022 survey conducted by the National Community Pharmacists Association reported that more than 70% of pharmacies were struggling to fill staff positions.

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Patient Care 187

Pharmacy Times

AUGUST 25, 2023

Investigators determined that there needs to be an evaluation of harm caused by pharmacy professionals who are in unique positions on social media, propagating misinformation about COVID-19, vaccines, treatment, masks, and other conspiracy theories.

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Drug Topics

AUGUST 25, 2023

The new deadline to be in compliance with the requirements will be November 27, 2024.

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FDA 187

Pharmacy Times

AUGUST 25, 2023

There is lots of information about matters of women's health online, both true and untrue, but pharmacists remain a credible source for educating women about health matters.

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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

AUGUST 25, 2023

HHS awards money for mental health awareness training, UnitedHealthcare pays $80,000 over potential HIPPA violation, and the FDA issues a recall for sub-acute care ventilators.

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Pharmacy Times

AUGUST 25, 2023

Tailor pharmacy roles based on skill sets, although every technician must be capable of basic professional communication.

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Communication 123

Pharmacy Times

AUGUST 25, 2023

The recent discovery could aid further research on the cause of Huntington’s disease and other inherited conditions.

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STAT

AUGUST 25, 2023

A group of Nigerian, British, and U.S. doctors have discovered a genetic variant that increases the risk of Parkinson’s disease in people of African and mixed-African descent and is not seen in those with European ancestry, a finding that could improve treatment of the movement disorder in a vastly underserved population. “It could be a major mechanistic basis of Parkinson’s disease in African populations,” the researchers said in their paper , published this week in

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Pharmacy Times

AUGUST 25, 2023

The digital cessation platform is the first FDA-cleared OTC device to help individuals quit smoking tobacco.

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FDA 123

STAT

AUGUST 25, 2023

With last fall’s chaotic early start to the respiratory virus season still fresh in the public memory, federal health authorities are trying to move quickly to convey the impression that this year will be different. In a briefing for reporters Thursday, senior officials of the Centers for Disease Control and Prevention and the Food and Drug Administration detailed the various countermeasures available to combat Covid-19, RSV, and influenza, and discussed the expected timing on the rollout

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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.

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Pharmacy Times

AUGUST 25, 2023

The FDA is the first regulatory agency globally to approve natalizumab-sztn as a biosimilar for natalizumab.

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FDA 123

STAT

AUGUST 25, 2023

Just weeks after Novo Nordisk announced that its obesity drug Wegovy cut the risk of heart complications in a major trial, the company now has results from a different study showing the treatment can also benefit people with a common type of heart failure. The results, published Friday in the New England Journal of Medicine, found that among people with obesity and heart failure with preserved ejection fraction, or HFpEF, those taking Wegovy experienced greater improvements in symptoms and physi

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Fierce Pharma

AUGUST 25, 2023

With one week to go until the Centers for Medicare and Medicaid Services (CMS) releases its list of ten drugs up for the first round of pricing negotiations, AstraZeneca is jumping into the legal b | The company cited concerns with the law's consequences for orphan drug development. AstraZeneca becomes the sixth drugmaker to file suit against the IRA.

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STAT

AUGUST 25, 2023

In 1972, as Congress promised dialysis and rehabilitation for all kidney failure patients in America, Australia was passing its own law to guarantee universal dialysis coverage. Since then, Australia and America have traveled very different paths, in dialysis and in health care as a whole. Most leading nephrologists worldwide agree that dialysis should ideally be delivered in long, frequent sessions at low ultrafiltration rates, and be carefully tailored to each patient’s physiology.

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Clinic Management 98

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Fierce Pharma

AUGUST 25, 2023

Add another failed trial to the list of setbacks for Merck and Eisai’s combination of Keytruda and Lenvima. | Add another failed trial to the list of setbacks for Merck and Eisai’s combination of Keytruda and Lenvima. The companies have decided to shut down a phase 3 study testing the PD-1/TKI combo in first-line head and neck cancer.

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STAT

AUGUST 25, 2023

NEW YORK — A fourth-year medical student, a music therapist, a child psychiatrist, and a physician-researcher stared at their laptops, puzzling over the combination of words that would make a supposedly intelligent system — NYU Langone’s customized version of ChatGPT — think about health care problems in a way that was useful to them.

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Pharmaceutical Technology

AUGUST 25, 2023

The US Food and Drug Administration's recent accelerated approval of Pfizer's Elrexfio for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) has made a significant impact in the oncology community.

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STAT

AUGUST 25, 2023

Neumora, a neuroscience startup founded by VC Arch Venture Partners, hopes to become one of the few biotechs to go public this year. The company filed paperwork for an IPO with the Securities and Exchange Commission on Friday. It did not state how many shares it plans to sell or at what price. The biotech had begun planning for an IPO last year, STAT reported in June 2022.

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PharmExec

AUGUST 25, 2023

The Generic Drug User Fee Amendments, designed to facilitate the delivery of safe and effective generic drugs to the public and improve the predictability of the ANDA assessment process, has undergone changes that will impact the pre-ANDA and ANDA approval process—and ultimately the path for generic drugs to approval.

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STAT

AUGUST 25, 2023

When the American Academy of Pediatrics reaffirmed its support for gender-affirming care earlier this month, and called for a systematic review of the evidence, some swaths of the public saw the move as casting doubt on the benefits of such care. But the AAP and other experts say the systematic review only indicates their confidence in the current standards of care, and their awareness of a need to stay on top of the evidence amid a changing political landscape in which anti-trans legislation &#

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Fierce Pharma

AUGUST 25, 2023

Two months after a federal court in Delaware rejected Biogen’s patent infringement c | The FDA has endorsed Novartis' Tyruco as the first U.S. biosimilar to treat multiple sclerosis. The copycat will compete with Biogen's Tysabri, covering all of the original drug's indications for relapsing MS in addition to Crohn’s disease.

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STAT

AUGUST 25, 2023

Advancements in LLMs such as ChatGPT and GPT-4 have generated substantial excitement. Many see these models as assistants or even potential replacements for time-intensive tasks, like patient-physician communication through the electronic health record. Designed to serve numerous downstream applications, these models convert data into representations that are useful for multiple tasks.

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Fierce Healthcare

AUGUST 25, 2023

Cigna is cutting down its Affordable Care Act exchange footprint down to 14 states, the company said Monday. | Cigna is cutting down its Affordable Care Act exchange footprint down to 14 states, the company said Monday.

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Fierce Pharma

AUGUST 25, 2023

Every year, the teams at Fierce Pharma, Fierce Biotech and Fierce Medtech compile lists of the highest-paid executives in their respective fields, and every year, those lists remain woefully low on | Nominations are now open for this year’s list of the fiercest women in pharma, biotech and medtech.

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European Pharmaceutical Review

AUGUST 25, 2023

A paper published in Molecules has detailed a strategy and evaluation approach for acceptable classification of species usually detected in migration studies. This can therefore support extractable and leachable (E&L) studies. Migration studies are one of the few domains of QA/QC pharmaceutical analysis employing wide-scope screening methodologies, the paper noted.

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STAT

AUGUST 25, 2023

Good morning Pharmalittle students. This is Allison DeAngelis, filling in for Ed Silverman while he’s away from the Pharmalot campus. I debated assigning you a “What I did on my summer vacation” essay to write over the weekend. Instead, we’re going to discuss the latest healthcare news! Here are the major headlines of the day.

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Vaccines FDA 91

European Pharmaceutical Review

AUGUST 25, 2023

The European Commission (EC)’s revised Annex 1 – Manufacture of Sterile Medicinal Products is now effective in the EU. As of 25 August 2023, pharmaceutical manufacturers are required to implement the GMP regulation into cleaning and bio-decontamination procedures for these products. What is included in the new revision? According to the EC, revision to the document has been made to reflect changes in regulatory and manufacturing environments.

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Documentation 96

Pharmacy Times

AUGUST 25, 2023

The drug can now be tested for safety, tolerability, and efficacy in a phase 1 study.

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FDA 123

Drug Store News

AUGUST 25, 2023

The full Rabanne Beauty collection will be available exclusively at Ulta Beauty within its prestige cosmetics assortment, with prices ranging from $20-$40.

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PharmaVoice

AUGUST 25, 2023

FDA Commissioner Robert Califf suggested larger reforms are needed to bolster the generic drug industry and prevent future medication shortages.

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FDA 97

Drug Store News

AUGUST 25, 2023

Abrysvo is the first vaccine approved for use in pregnant women to prevent lower respiratory tract disease and severe LRTD.

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Fierce Healthcare

AUGUST 25, 2023

Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry.

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Drug Store News

AUGUST 25, 2023

The powdered drink mixes—available in Lemonade and Berry Medley flavors—are infused with 25 mg of 100% CBD per serving.

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Pharmaceutical Technology

AUGUST 25, 2023

Soliris is already approved to treat refractory generalised myasthenia gravis in adults in different regions.

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