Thu.Sep 14, 2023

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FDA Grants Tentative Approval to Generic Triumpeq PD for Children With HIV

Drug Topics

Abacavir/dolutegravir/lamivudine is a fixed-dose combination containing two nucleoside reverse transcriptase inhibitors (NRTIs) and integrase strand transfer inhibitor (INSTI).

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Impact of the Inflation Reduction Act on Vaccinations: What Pharmacists Need to Know

Pharmacy Times

By educating their patients on the provisions of the Inflation Reduction Act, pharmacists can have an even greater impact by increasing vaccine uptake in historically underserved groups.

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Video: Majority of Pharmacists Say They Are Being Impacted by Drug Shortages

Drug Topics

Michael Ganio, PharmD, MS, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists (ASHP), sat down with Drug Topics to discuss the current drug shortages and how pharmacists are dealing with them.

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Researchers Assess Connection Between Socioeconomic Status, Cardiovascular Health

Pharmacy Times

Heart disease prevention efforts should acknowledge non-biological factors that can cause issues within cardiovascular health rather than relying on decreasing socioeconomic disparities.

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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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Opinion: Long Covid is a new name for an old syndrome

STAT

Long Covid goes by  many names. Today, it is no longer a new public health enigma, but the outlook for sufferers is no better than when the condition was first recognized in early 2020. Although its prevalence has recently decreased to 6% of the U.S. adult population, there has been no significant progress in understanding its causes, prevention, or treatment.

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SARS-CoV-2, Seasonal Influenza Vaccine Coadministration is Safe, Effective in Protection Against Viruses

Pharmacy Times

Compared with COVID-19 vaccination alone, recent study findings show health care workers who received both a COVID-19 booster and influenza vaccinations did not have lower immune response or more frequent adverse events.

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Cancer Diagnoses Significantly Decreased in First Few Months of COVID-19 Pandemic

Pharmacy Times

Investigators found an approximately 23% decrease in overall cancer incidence in April 2020, specifically for breast, colon, rectal, head and neck cancers, as well as melanoma and endocrine cancer diagnoses.

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Novelist John Green launches attack on Cepheid over the price of its TB test

STAT

John Green, a novelist and high-profile YouTuber, is once again leveraging his star power in the global fight to end tuberculosis. His latest target? The diagnostics company Cepheid and the price of its tuberculosis test, GeneXpert. Cepheid sells individual test cartridges for $9.98 each, which lab technicians can analyze in a speedy machine that is also sold by the company.

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Preserving Patient Access to Compounded Medications Act of 2017

Pharmacy Times

The act would have permitted health care facilities to stock up on compounded medications without forcing the supplying 503A pharmacies to register as outsourcing facilities.

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STAT+: Machine learning biotech raises $273 million in rare successful late-stage round

STAT

Biotech startup Generate Biomedicines, which uses artificial intelligence to find new drugs, raised $273 million in a Series C funding round from investors including pharma company Amgen and the VC arm of AI giant NVIDIA. Generate was founded in 2018 by venture-creation firm Flagship Pioneering to use machine learning algorithms to identify antibodies, peptides, cell therapies, and other medicines.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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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Study Suggests Base-Edited T Cells Could Minimize Immunotherapy Complications in Leukemia Treatment

Pharmacy Times

The use of base editing to generate universal, off-the-shelf CAR T cells is a promising approach for relapsed leukemia, with potential implications for the future of gene therapy.

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STAT+: New study adds to evidence on psychedelic as effective treatment for PTSD

STAT

MDMA is a safe and effective treatment for post-traumatic stress disorder in a racially and ethnically diverse population, according to the results of a study published Thursday in Nature Medicine. The research adds to the growing body of evidence supporting MDMA as a treatment for PTSD, and brings the psychedelic one step closer to potentially becoming the first to obtain Food and Drug Administration approval.

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At least 67,000 Kaiser Permanente workers vote to authorize strike, allege bad faith bargaining

Fierce Healthcare

Tens of thousands of Kaiser Permanente’s workers have voted to authorize a labor strike should no contract deal be in place by Sept. 30, unions announced Thursday. | The total could grow by nearly 20,000 more as other unions tally their votes. The large nonprofit would need to reach a contract deal by Sept. 30 to avoid the walk-off.

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Pig kidney works a record two months in donated body, raising hope for animal-human transplants

STAT

NEW YORK — Dozens of doctors and nurses silently lined the hospital hallway in tribute: For a history-making two months, a pig’s kidney worked normally inside the brain-dead man on the gurney rolling past them. The dramatic experiment came to an end Wednesday as surgeons at NYU Langone Health removed the pig kidney and returned the donated body of Maurice “Mo” Miller to his family for cremation.

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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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Another round of Medicare Part B drugs capped by inflation rebates

Fierce Healthcare

A third set of Medicare Part B prescription drugs will cost up to $618 less per average dose beginning Oct. 1, announced the Centers for Medicare & Medicaid Services (CMS). | 34 additional drugs, with prices rising faster than inflation, will be capped by an Inflation Reduction Act program, lowering out-of-pocket costs for patients.

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Listen: Covid’s latest surge, Alnylam at the FDA, & the end of an era

STAT

What does Covid-19 have in store for the winter? When are good data not good enough? And how many would-be Wegovys are there? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Our colleague Helen Branswell joins us to discuss the state of the Covid-19 pandemic heading into the fall and the rollout of boosters shots aimed at the latest viral variants.

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Designation of Interchangeability (IC) for Biosimilars in the US: To Be IC or Not IC? That Is the Question

Pharmacy Times

The "interchangeable" designation has created confusion around the difference between biosimilars designated as interchangeable and those that are not.

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STAT+: Medicare is urged to monitor how rebates affect Part D drug spending, but agency demurs

STAT

The U.S. government should monitor the effect that rebates have on Medicare Part D plans and whether these discounts ultimately discourage some people from enrolling in the prescription drug program, according to a new report by a federal watchdog. At issue is the opaque pharmaceutical pricing system. To win coveted placement on formularies – the list of medicines covered by insurers – drug companies pay rebates to Medicare Part D and commercial health plans.

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Powerful animal tranquilizer xylazine present in drug tests across the US, analysis finds

Fierce Healthcare

Xylazine, a powerful veterinary tranquilizer, was detected in drug tests in 34 states from every region of the country, according to a new analysis. | Xylazine, also known as “tranq,” is a sedative that prolongs and enhances the euphoric effects of illicit fentanyl. Xylazine-associated deaths are on the rise, and nearly all involve illicit fentanyl or fentanyl analogs.

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STAT+: FTC warns drugmakers they can face legal action over improper patent listings

STAT

The Federal Trade Commission warned pharmaceutical companies they could face legal action if they improperly list patents for brand-name medicines in a Food and Drug Administration registry, the latest effort by the federal government to scrutinize patent moves by drugmakers. In explaining its new policy statement , the FTC noted that some drug companies have failed to follow requirements for listing patents in the so-called Orange Book in hopes of thwarting competition from lower-cost generic m

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Bipartisan bill aims to bolster primary care workforce

Fierce Healthcare

Key Senate panels have reached a bipartisan deal on a bill that aims to bolster primary care. | The package would invest more than $26 billion into primary care programs as well as initiatives to grow the healthcare workforce.

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STAT+: Civica Rx considers moving into chemo drugs as shortages worsen

STAT

WASHINGTON — A nonprofit formed by hospitals to deal with drug shortages is considering a move into chemotherapies. Frustrated by drug shortages and the price spikes that typically ensue, executives from large hospital systems launched the nonprofit Civica Rx to deal with the problem in September 2018. Months later, the publicly traded group purchasing organization Premier created a subsidiary , ProvideGx, with the same aim.

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MorningRX: September 14, 2023

Drug Topics

FDA sends warning letters to 8 companies over unapproved eye drops, healthcare visits delivered by nurse practitioners and physician assistants continue to increase, and WHO agrees on the first-ever patient safety rights charter.

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Fully integrated D-SNP plans aren't improving the member experience, study finds

Fierce Healthcare

A comparison between two different types of dual-eligible special needs plans (D-SNPs) as well as non-dual-eligible special needs Medicare Advantage (MA) plans in a recent

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STAT+: House subcommittee forays into fixing drug shortages

STAT

WASHINGTON — A House subcommittee took a first step Thursday toward legislation to fix drug shortages at hospitals. Don’t expect a new law soon, though. Asked if he expects the House to pass a bill on the subject this year, Energy and Commerce health subcommittee Chair Brett Guthrie (R-Ky.) said drug shortages are an emergency, “but the proposals that have been offered aren’t going to fix it by tomorrow or the next day.

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Diabetes Distress Remains Greater in People with T1D, Impaired Awareness of Hypoglycemia

Drug Topics

Widespread use of continuous glucose monitoring was not found to attenuate the association between impaired awareness of hypoglycemia and diabetes-related distress.

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Biosimilars Could Provide Huge Savings in Future, But Patient Education is Needed

Pharmacy Times

Clinicians raise concerns about immunogenicity, product quality, and reimbursement for biosimilars.

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After Kenvue spinoff, J&J says it's 'uniting' Janssen and medtech segments under one brand

Fierce Pharma

Alongside a new logo reveal Thursday, Johnson & Johnson unveiled some major changes to its corporate persona. | J&J is uniting its medtech and pharmaceutical arms so that they will be “more connected to the Johnson & Johnson brand," the company said. Over time, Janssen is slated to become Johnson & Johnson Innovate Medicine, while the company’s medical technology segment will continue to run with the J&J MedTech moniker.

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Artificial Intelligence Is Revolutionizing Controlled Substance Diversion Detection

Pharmacy Times

AI is able to quickly analyze, identify, and route data for investigation.

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New Senate deal would ban some facility fees, reform hospital contracting

STAT

WASHINGTON — A new, bipartisan deal in the Senate to fund primary care programs also includes new policies to restrain hospital costs, including a ban on some facility fees and restrictions on anticompetitive contracting practices. The package, negotiated between Senate health committee Chair Bernie Sanders (I-Vt.) and Sen. Roger Marshall (R-Kan.), is urgent because it includes funding for community health centers that is set to expire at the end of the month.

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Researchers Rule Out Gefapixant to Help Unexplained Chronic Cough

Pharmacy Times

The use of gefapixant reduces cough frequency but increases adverse events in individuals suffering from a chronic cough.

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FDA, manufacturers make progress in resolving key cancer drug shortages: White House

Fierce Pharma

While there's certainly more work to do, the U.S. | Efforts from regulators and manufacturers have brought the U.S. supply of cisplatin back to nearly 100% of pre-shortage levels, according to the White House. The moves are “greatly alleviating the shortages of carboplatin,” too, the White House said.

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Johnson & Johnson is getting rid of its script logo after more than 130 years

STAT

Johnson & Johnson is signing off on a new logo. The health care giant said Thursday that it will replace the well-known signature script it has used since 1887 with a modern look that reflects its sharpened focus on pharmaceuticals and medical devices.

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FTC, amid biopharma M&A drive, says it will take action against 'sham' patents

Fierce Pharma

Amid the Federal Trade Commission's (FTC's) campaign to bolster scrutiny around large biopharma M&A deals, the agency is now taking a closer look at patent gamesmanship. | The Federal Trade Commission is warning pharmaceutical companies that they could face legal action by making “improper” listings in the FDA’s Orange Book, a registry of patents for approved drugs.