Sat.Sep 07, 2024 - Fri.Sep 13, 2024

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From Opioids to Cannabis: The Impact of Cannabis Rescheduling on Pharmacy Revenue Streams

Pharmacy Times

The DEA will have a hearing in December 2024 regarding the potential reclassification of cannabis to Schedule III, which could significantly impact the regulatory environment for pharmacies and their involvement in the cannabis market.

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Chronic Hand Eczema Studies Show Condition is Common, Burdensome

Drug Topics

LEO Pharma presented data from 2 of the largest multinational real-world studies on the prevalence, severity and treatment of chronic hand eczema at the European Society of Contact Dermatitis congress.

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Inquiry into unexplained bird flu case in Missouri broadens to a close contact

STAT

A close contact of the person in Missouri who had an unexplained H5N1 bird flu infection last month was also sick around the same time, but was not tested for influenza, the Centers for Disease Control and Prevention reported on Friday.  The CDC revealed the previously undisclosed information in FluView , its weekly report on influenza activity.

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UTHealth Houston collaborates with OpenAI to offer clinicians HIPAA-compliant ChatGPT solutions

Fierce Healthcare

UTHealth Houston unveiled a partnership with OpenAI on Friday to build and deploy algorithms for use in medical training and at the patient’s bedside. | UTHealth Houston, an academic medical center in Texas, is partnering with OpenAI to give clinicians, faculty and students access to ChatGPT tools to build custom, HIPAA-compliant AI solutions.

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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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FDA Approves Guselkumab for Treatment of Ulcerative Colitis

Pharmacy Times

Guselkumab (Tremfya; Johnson & Johnson) is the first and only approved fully human and dual-acting monoclonal antibody blocking interleukin-23 and binding to CD64 receptors.

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Community Pharmacist Education to Combat Vaccine Hesitancy

Drug Topics

Researchers explored an alternative pharmacist education intervention as a way of improving pharmacist-patient conversations and decreasing vaccine hesitancy among patients.

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Akeso, Summit's PD-1 bispecific crushes Merck's Keytruda in study, signaling potential new standard in lung cancer

Fierce Pharma

The Keytruda-beating data from Akeso and Summit’s ivonescimab that oncology industry watchers had been awaiting are here. | The Keytruda-beating data from Akeso and Summit’s ivonescimab that oncology industry watchers had been awaiting are here. The China-only data are impressive, signaling the PD-1/VEGF bispecific antibody’s potential as a new standard of care in non-small cell lung cancer.

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The Future of Bispecific Antibodies in Aggressive B-Cell Lymphomas

Pharmacy Times

Presenter Krish Patel, MD, discusses the use of epcoritamab (Epkinly; AbbVie) and glofitamab (Columvi; Genentech) in aggressive B-cell lymphomas as monotherapies and in combination regimens.

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Lenacapavir for PrEP Demonstrates Strong Efficacy in Second Phase 3 Trial

Drug Topics

Gilead said data from the study will support global regulatory filings that the company plans to begin by the end of the year.

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Cause of Missouri H5 bird flu case remains a mystery, CDC says

STAT

Disease investigators have not been able to determine how a person in Missouri with no known exposures to animals or poultry became infected with an H5 bird flu virus, the principal deputy director of the Centers for Disease Control and Prevention said Thursday. But Nirav Shah said the ongoing investigation has turned up no evidence of onward spread of the virus, suggesting this case may turn out to be a one-off infection that defies explanation.

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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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After delay, Roche's Tecentriq Hybreza wins first FDA approval for a subcutaneous PD-L1 drug

Fierce Pharma

It’s better late than never for an FDA approval for the first subcutaneous PD-L1 inhibitor, which was doled out to Roche’s Tecentriq Hybreza after manufacturing delays derailed the company's initia | The under-the-skin formulation trims administration time down to seven minutes compared to the 30 to 60 minutes needed for intravenous Tecentriq.

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FDA Grants Orphan Drug Designation to AISA-021 for Systemic Sclerosis

Pharmacy Times

The company also submitted data from the ongoing phase 2 study, demonstrating the improvements of the investigational drug for symptoms of overall disease severity.

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New Study Examines Potential of Oxytocin as Pain Management Adjunctive, Addiction Treatment

Drug Topics

The “cuddle hormone” plays a powerful role in human behavior and may be an additional option to treat pain and manage opioid addiction.

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STAT+: A rare disease program, portrayed as both lifeline and pharma handout, is set to expire

STAT

After his son Michael was diagnosed with a devastating, ultra-rare disease in 2019, Terry Pirovolakis dedicated himself to eradicating it.  Pirovolakis, a Canadian IT director, recruited academics and raised $3 million to design a gene therapy. He got Michael treated, an intervention that seems to have helped the 6-year-old stand on his heels for the first time and slow the course of a disease that can be severely cognitively and physically disabling.

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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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With another phase 3 win, Gilead races toward 2025 launch for long-acting PrEP drug

Fierce Pharma

Gilead Sciences is no stranger to making history in HIV. | In a study of more than 3,000 participants, Gilead's twice-yearly lenacapavir delivered a 96% reduction in HIV infections compared with background HIV incidence.

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HIV Infections Significantly Reduced With Twice-Yearly Lenacapavir in Cisgender Men, Gender-Diverse Participants

Pharmacy Times

These results build off the PURPOSE 1 trial, contributing to the wealth of evidence surrounding lenacapavir’s positive effects in patients with HIV.

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Education Is Crucial to Close Gaps in Colorectal Cancer Risk Awareness

Drug Topics

The #MyCRChistory campaign encourages the public to share their family history of colorectal cancer.

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How a government scientist is pushing to supersize research into ultra-processed foods

STAT

CHICAGO — The last place you might have expected Kevin Hall to make a plea for help was at a conference of scientists who work for global food conglomerates. After all, the government researcher is the leading scientific voice in the United States warning that a steady diet of these engineered products might be a crucial driver of the nation’s epidemic of overeating.

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Half of women skip or delay care due to 'triple threat' of factors, report finds

Fierce Healthcare

Half of women in the U.S. skip or delay medical care due to the “triple threat” of affordability, access challenges and past negative experiences, a new Deloitte report finds. | The Deloitte report, based on a survey of more than 2,000 consumers, found that 50% of women report skipping or delaying medical care and are 35% more likely to skip care than men.

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Experts Develop Multimodal Approach for Treating Long COVID, Other Post-Acute Infectious Syndromes

Pharmacy Times

In the absence of a common treatment for long COVID, researchers from around the world documented the best currently available therapies.

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Small Doses: September 2 to September 6

Drug Topics

Check out a recap of important pharmacy news you might have missed this week, dispensed in small doses.

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STAT+: How hospitals could make money off of Kamala Harris’ medical debt relief plan

STAT

WASHINGTON — The largest health system in North Carolina simply wasn’t interested in canceling its patients’ medical debt. That is, until the state government dangled billions of dollars in incentive payments.  Other health systems have gotten just cents on the dollar to cancel unpaid bills they probably couldn’t collect on anyhow — take Cook County, Ill., which aims to pay about a penny per dollar to cancel an estimated $1 billion of medical debt.

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Nationwide hospital mortality risk fell as acuity, volumes rose, report finds

Fierce Healthcare

Hospital patients’ risk of death has fallen substantially since the COVID-19 pandemic and the months preceding it, even as hospitals are treating more and sicker patients, according to a new report | An analysis of 715 hospitals' patient safety metrics showed that patients hospitalized in Q1 2024 were about 22% more likely to survive as compared to Q4 2019, after adjusting for illness severity.

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Non-Medical Switch to Infliximab Biosimilar Demonstrates Similar Outcomes for IBD

Pharmacy Times

Investigators obtained real-world evidence to evaluate the clinical outcomes of non-medical switching from the infliximab (Remicade; Janssen Immunology) to a biosimilar.

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FDA Approves First-Ever OTC Hearing Aid Software

Drug Topics

Over 30 million American adults experience some hearing loss, yet only one-fifth benefit from hearing aids; the FDA’s approval will expand access to the technology for the patient population.

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STAT+: Apple will offer millions of AirPod users a hearing aid. Can it convince them to use it?

STAT

After years of dabbling in hearing health, Apple earlier this week went all-in, announcing that AirPods Pro, the tech giant’s top wireless earbuds, will soon double as hearing aids for people with milder forms of hearing loss. Apple’s redoubled effort on hearing also includes software to test a person’s hearing and to customize the output of the hearing aid.

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Roche doubles down with another subcutaneous FDA nod, this one for MS star Ocrevus

Fierce Pharma

When Roche's Genentech gained approval for Ocrevus in 2017, the first-in- | The day after Roche gained an FDA approval for its subcutaneous version of cancer drug Tecentriq, the company also scored with a U.S. nod for its under-the-skin formulation of mega-blockbuster multiple sclerosis drug Ocrevus. The approval gives patients a more convenient injected way to receive Ocrevus as opposed to the infused formulation.

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Patients With Difficult-To-Treat Asthma Require Different Intervention Methods Based on Comorbidities

Pharmacy Times

To help with treatment response and compliance as well as optimize treatment, communication between patients and health care providers is necessary.

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Tonix Pharmaceuticals Launches Campaign Promoting Non-Oral Medications for Gastroparesis, Migraine

Drug Topics

Whereby gastroparesis can hinder the absorption of oral medications in the stomach, Tonix Pharmaceuticals is promoting alternative migraine treatments that bypass the digestive system.

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STAT+: Lung cancer drug from iTeos, GSK shows response, boosting TIGIT as a viable target

STAT

BARCELONA, Spain — A targeted immunotherapy being developed by the biotech iTeos Therapeutics and GSK delivered promising response rates in patients with a type of lung cancer, propelling the treatment into a pivotal Phase 3 trial and adding fuel to a broader debate about the validity of the target. The companies reported on Saturday that their combination of a TIGIT-targeting antibody and GSK’s Jemperli increased the percentage of patients who saw their tumors shrink versus those

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Biden admin mandates mental health parity in final rule

Fierce Healthcare

The Biden administration is strengthening private health coverage for individuals seeking mental health and substance use disorder (SUD) care in a final rule unveiled Monday. | The feds are attempting to better regulate mental health coverage by bolstering protections around prior authorization, step therapy and provider networks.

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FDA Authorizes OTC Hearing Aid Software Compatible With Apple AirPods

Pharmacy Times

The Hearing Aid Feature can be customized to the user’s needs by amplifying sounds for individuals 18 years or older who have perceived mild to moderate hearing impairments.

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ESMO: AZ, Daiichi build case for Enhertu in breast cancer patients with brain metastases

Fierce Pharma

Daiichi Sankyo and AstraZeneca are padding the case for their antibody-drug conjugate Enhertu with new data demonstrating the medicine’s worth in patients whose cancer has spread to the b | To bolster Enhertu's case in HER2-positive breast cancer, AstraZeneca and Daiichi Sankyo have rolled out positive data for the antibody-drug conjugate in patients who have brain metastases.

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STAT+: FDA commissioner: Health systems have to ‘step up’ on AI regulation or will ‘end up holding the bag’

STAT

WELLESLEY, Mass. — Amid heated discussions on how artificial intelligence should be regulated and who should be involved in health care AI governance, the U.S. Food and Drug Administration commissioner said that health systems need to take a leading role. “I think there’s a lot of good reason for health systems to be concerned that if they don’t step up, they’re going to end up holding the bag on liability when these algorithms go wrong,” said Robert Cal

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