Mon.Dec 11, 2023

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Benralizumab May Be Significant in Helping Patients With Severe Asthma Reduce Regular, Inhaled Steroids

Pharmacy Times

The study results demonstrated that 92% of patients treated with benralizumab were able to safely reduce inhaled steroid dose, and more than 60% could stop use entirely.

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House passes site-neutral policy, transparency, PBM reform package

STAT

WASHINGTON — The House passed a relatively major health care package late Monday, an end-of-year victory after the same policies had to be yanked from consideration in September because they lacked bipartisan support. Though the package is unlikely to pass the Senate and become law as-is, its advancing through the House does make each included policy more attractive for a potential government funding deal, as lawmakers draw closer to the Jan. 19 deadline to fund the government and extend

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High-Risk Pediatric Patients With Antiphospholipid Syndrome Present Risk of Severe Health Issues

Pharmacy Times

The results found that 93% of individuals in the high-risk group presented persistently positive antiphospholipid antibodies, compared with 47% of individuals in the lower-risk group.

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Opinion: U.S. medical schools aren’t teaching future doctors about 7.4 million of their patients

STAT

Oliver McGowan was 18 years old when he was hospitalized in England with recurrent seizures and pneumonia. He was autistic, and he and his parents had one specific request for the medical team: no antipsychotic medications. When he had taken them in the past, they made his seizures worse and had devastating effects on his mood. Despite the family’s vehement protests, doctors gave him an antipsychotic.

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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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House price transparency legislation passes with bipartisan support

Fierce Healthcare

The Lower Costs, More Transparency Act, which advances policies to force pharmacy benefit managers and hospitals to meet price transparency standards, passed on the House floor Monday by a vote of | Members on both sides of the aisle are celebrating successful efforts to codify price transparency requirements and establish site-neutral payments in the Lower Costs, More Transparency Act passed by the House of Representatives on Monday.

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STAT+: Inside Vertex’s decades-long quest to develop a new class of non-opioid painkillers

STAT

SAN DIEGO — For decades, the biotech industry has tried — and repeatedly failed — to develop new and effective painkillers without the addictive potential of opioids. But there’s reason to think that could begin to change soon. Vertex Pharmaceuticals is on the cusp of announcing results from late-stage trials of a drug that precisely blocks pain-sensing neurons from signaling the brain.

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STAT+: The prices of 8 drugs were hiked without proof of new benefits, costing the U.S. $1.2 billion in 2022, report finds

STAT

During 2022, drugmakers substantially raised prices on eight widely used medicines without any new clinical evidence to justify the increases, leading patients and health insurers in the U.S. to spend an additional $1.2 billion last year, according to a new report. The drug for which spending increased the most due to a price increase was Humira, which is used to treat rheumatoid arthritis, plaque psoriasis, and other disorders.

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Psychedelic-Assisted Therapy: A Novel, Yet Effective Approach to Treating Mental Health Disorders

Pharmacy Times

By combining the administration of psychedelic compounds with therapeutic support, ketamine-assisted therapy is proving remarkable efficacy in treating mental health conditions.

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STAT+: After sickle-cell screwups, Bluebird Bio’s only option might be a company sale

STAT

The approval Friday of Bluebird Bio’s gene therapy for sickle cell disease should have been a momentum-swinging achievement for the long-struggling biotech. Instead, the company mispriced its new drug and fumbled a pivotal financial lifeline. The consequences of these strategic blunders — arguably, self-inflicted — could imperil Bluebird’s independence, perhaps even its survival.

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Medefy Health lands $10M series A to help employees navigate complex health benefits

Fierce Healthcare

Navigating healthcare benefits can be a frustrating and confusing experience for most health plan members and employees. | Medefy Health developed a mobile-first healthcare benefits navigation platform that offers real-time guidance from actual people, not AI-based chatbots. The company has seen rapid growth and landed $10 million in series A funding to build out its tech platform.

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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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STAT+: NEJM aims to hold AI to account with new publication

STAT

One of the most prestigious names in medical publishing is going all in on artificial intelligence. The New England Journal of Medicine on Monday will launch NEJM AI , a monthly, online-only publication that will focus on evaluating applications of artificial intelligence in clinical medicine. The journal will also publish review articles, policy perspectives, and educational materials for physicians and computer scientists.

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Floreo nabs FDA breakthrough label for its VR software

Fierce Healthcare

Floreo, maker of virtaul reality (VR) behavioral therapy content, has received the Food and Drug Administration’s breakthrough device designation. | Floreo says it seeks full market authorization to further recognize its effectiveness and to open up reimbursement pathways for its tech to reach more families.

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STAT+: A Q&A with Vertex founder Joshua Boger on Casgevy, the biotech industry, and Elon Musk

STAT

Vertex Pharmaceuticals made history Friday when it received regulatory approval for a medicine that could alter people’s DNA. While the company celebrated, its founder, Joshua Boger, looked on like a proud parent. Boger, 72, founded Vertex in 1989 and served in various roles until 2017. To this day, he lives next door to the company’s headquarters in Boston’s Seaport District, in a high-rise penthouse where he can quite literally look in on the biotech’s offices.

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Examining the Impacts of Antimicrobial Stewardship Programs

Drug Topics

Three posters presented at ASHP Midyear 2023 delved deeper into the topic of antimicrobial stewardship programs and their impact on antibiotic resistance.

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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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AI Model Can Differentiate Prefibrotic Primary Myelofibrosis From Essential Thrombocythemia With High Accuracy

Pharmacy Times

The model may help clinicians identify patients who would benefit from disease-specific therapies or enrollment into clinical trials.

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STAT+: Sanofi ends deal for a rare disease drug after FTC voices monopoly concerns

STAT

In its latest bid to police the pharmaceutical industry, the U.S. Federal Trade Commission sought to block Sanofi from licensing a Pompe disease treatment made by another drug company. And in response, Sanofi is ending the deal. Sanofi sought the rights to the medication from Maze Therapeutics, but the regulator argued the deal — valued at $775 million — would eliminate a “nascent competitor” that could, otherwise, challenge the monopoly Sanofi has in the market for P

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Trusting the process

Drug Store News

With a mantra of “whatever goes on your body should be good enough to go in it,” beauty brand Camille Rose has grown from offering homemade eczema cream to a multi-million-dollar company.

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STAT+: Amid fears of superbugs, sales of antibiotics used in food-producing livestock rose last year

STAT

Amid fears of superbugs, the sale of medically important antibiotics given to food-producing livestock rose by 4% overall in the U.S. in 2022, an increase that prompted advocates to complain that not enough is being done to thwart antibiotic resistance. In particular, the sale and distribution of tetracycline, which accounted for 65% of the medically important antibiotics given the livestock, increased by 4%, according to the latest annual report from the U.S.

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ASH 2023: microbiome-based therapy shows potential in graft-versus-host disease

European Pharmaceutical Review

Results from MaaT Pharma’s Early Access Program (EAP) for its microbiome-based therapy MaaT013, have demonstrated positive overall response and overall survival rates in European patients with graft-versus-host disease (GvHD). The findings were presented at the 2023 American Society of Hematology (ASH) Annual Meeting. MaaT013 is an off-the-shelf, pooled-donor, enema Microbiome Ecosystem Therapy TM.

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Mitigating Financial Toxicity for Patients and Providers

Drug Topics

Safiya Tisdell details the available assistance options designed to ease the financial burden associated with accessing care for both patients and providers.

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STAT+: GE HealthCare CEO named chair of medical device lobby AdvaMed’s new imaging division

STAT

AdvaMed named Peter Arduini, CEO of GE HealthCare, chair of its board of directors on Monday. The medical device lobby also announced the creation of a new division focused on policy issues for medical imaging technology. Arduini has been acting chair over the past few weeks, after former Johnson & Johnson MedTech CEO Ashley McEvoy stepped down.

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Assessing Impact of Community Clinic, Updated Care Guidelines, on Patients With Diabetes

Drug Topics

Two posters presented at ASHP Midyear 2023 explored the impact of diabetes management interventions among patients with diabetes.

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WTW: Global insurers brace for healthcare cost hikes over next several years

Fierce Healthcare

More than half of global health insurers are expecting significant increases in healthcare costs over the next several years, according to a new report. | More than half of global health insurers are expecting significant increases in healthcare costs over the next several years, according to a new report.

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As ICER places a spotlight on pharma's price hikes, J&J, Roche and more hit back

Fierce Pharma

After many years of tracking the pharmaceutical industry’s pricing tactics, the Institute for Clinical and Economic Review (ICER) is once again placing a spotlight on the price increases that end u | The Institute for Clinical and Economic Review (ICER)’s fifth annual report on unsupported price increases (UPI) puts Humira in the top spot of offenders.

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Opinion: STAT+: Dana-Farber CEO Laurie Glimcher has always been a trailblazer and a risk taker

STAT

Dr. Laurie Glimcher learned early on from her father, a prominent physician-researcher, that success in science was built on a basic principle: Big discoveries require big risks. The younger Glimcher took that advice to heart. In the late 1990s at her Harvard immunology lab, Glimcher and her postdoctoral student began a series of experiments that colleagues deemed “crazy.

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Cigna reportedly ends negotiations to acquire Humana, plans major stock buyback

Drug Store News

Cigna on Sunday announced plans to do an additional $10 billion in share repurchases, bringing total repurchases to $11.3 billion, per a Reuters report.

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What does a headache in the back of the head mean?

The Checkup by Singlecare

If you have pain anywhere in your head, your first question is likely, “How do I make it stop?” Headaches can be uncomfortable and make it difficult to function at your best. To get relief, you’ll need to figure out why your head hurts in that particular spot—and what’s causing the throbbing. And if the pain is in the back of your head, you may worry it’s cause for concern.

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Quality and sustainability: The balancing act for pharma manufacturing  

Pharmaceutical Technology

Trends in sustainability and quality assurance were key themes discussed at the recent CPHI Europe 2023 meeting, although the data reveals a lack of implementation of sustainable solutions.

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Merck and Moderna to Launch Trial of mRNA-4157 Plus Keytruda in Non-Small Cell Lung Cancer

PharmExec

Phase III trial to investigate novel individualized neoantigen therapy V940 (mRNA-4157) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer.

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Align joins forces with Jodie Sweetin, Andrea Barber on latest probiotic launch

Drug Store News

To kick off the launch of its new Bloating Relief + Food Digestion Probiotic, the brand is debuting a campaign featuring “Fuller House” stars Jodie Sweetin and Andrea Barber.

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STAT+: UnitedHealth executive to head health insurance group AHIP

STAT

WASHINGTON — An executive at insurance giant UnitedHealth Group is slated to be the next leader of the health insurance industry’s largest lobbying group, the group announced Monday. AHIP has selected Mike Tuffin, who’s currently UnitedHealth’s senior vice president for external affairs and head of U.S. government affairs, to be its next leader, after Matt Eyles announced his retirement from the group earlier this year after a five-year tenure.

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Shorter Sleep Duration May be Linked to Worse Mental Well-being in Women Newly Diagnosed with Breast Cancer

Pharmacy Times

Only 20% of the patient population were reported as being “very good” sleepers when it comes to sleep disturbances.

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STAT+: Pharmalittle: Bluebird’s sickle-cell screwups may prompt a sale; drugmakers raised prices on widely used meds without new clinical evidence

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because the usual routine of online meetings and deadlines has predictably returned. But what can you do? The world, such as it is, continues to spin. So time to give it a nudge in a better direction with a cup or three of stimulation.

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Community Oncology Pharmacists Should Learn How to Manage Adverse Events Related to New Therapies for Acute Myeloid Leukemia

Pharmacy Times

The pharmacist can help patients to manage symptoms throughout the entire treatment journey.

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