Sat.Apr 22, 2023 - Fri.Apr 28, 2023

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FDA Now Requiring New Warnings For Prescription Opioids

Drug Topics

The FDA is hoping these warnings are a positive step in what will be an extremely long process of ending opioid related deaths.

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How Understanding Risk Factors Can Help Patients With Chronic Diseases Quit Smoking

Drug Topics

How much does education about the specific risks of smoking assist in smoking cessation?

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Opinion: Why involuntary treatment for addiction is a dangerous idea

STAT

As the overdose crisis rages on and the pandemic-fatigued public runs low on empathy, there have been increasing calls for expanded involuntary commitment for people with substance use disorder. Some of the advocacy for more coercive treatment seems rooted in a disdain for people who use drugs, most especially when their drug use occurs visibly and in close geographic proximity to affluence, for example in San Francisco or in the Massachusetts Avenue and Melnea Cass area of Boston which borders

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World IP Day 2023: Celebrating women leaders in innovation

PhRMA

Today PhRMA joins with innovators around the globe to recognize World IP Day and celebrate biopharmaceutical innovators who dedicate their lives to bringing new treatments and cures to patients. It’s also a day to reflect on the role Intellectual Property (IP) protections, such as patents, play in supporting the development of cutting-edge technologies.

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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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Limitations on Reproductive Rights Makes Agonizing Decisions Even Harder for Pregnant Women With Cancer

Pharmacy Times

Even before the Dobbs ruling overturned country-wide reproductive rights, the oncology field was already facing a dearth of maternal care access challenges.

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PBMs Are in the Hotseat in Washington DC

Drug Topics

The Senate Finance Committee recently released a framework for legislation, and the leaders of the “big three” PBMs are scheduled to be witnesses at another committee's hearing regarding insulin prices on May 10.

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More Trending

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Three facts about health care spending

PhRMA

There is increasing talk about making changes to our health care system to lower costs for patients and address misaligned incentives. These are important conversations that could lead to meaningful improvements, but only if policymakers take a holistic approach to address all the health care drivers. Far too often, there is a singular focus on prescription medicines, ignoring the other parts of the supply chain that are key drivers of U.S. health care spending.

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DEA’s Proposed Rules on Controlled Substances Prescribing via Telemedicine and Their Uncertain Impact on the Pharmacy Community

Pharmacy Times

Proposed rules would permit a telehealth provider to prescribe only up to a 30-day supply of a Schedule III-V non-narcotic controlled substance or buprenorphine through telehealth without the patient first being evaluated in person by a provider.

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Health Care Spending Has Shot Back Up to Pre-Pandemic Levels

Drug Topics

The average annual healthcare spending for people with employer-sponsored insurance spending increased from $5,630 in 2020 to $6,467 in 2021. After decreasing in 2020, per person healthcare spending increased 15%.

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STAT+: Once bullish on digital health, Orexo hits a wall on reimbursement

STAT

After several quarters of promising to deliver concrete progress on key digital therapeutics projects, Swedish pharmaceutical company Orexo on Thursday reported the somber news that its efforts remained stalled. Orexo, which made almost all of its $60 million in 2022 revenues from U.S. sales of Zubsolv, a drug used to treat opioid use disorder, earned negligible income from its three software-based treatments in the first quarter of the year.

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Policies need to address the growing threat of antimicrobial resistance

PhRMA

Today, the House Energy & Commerce Subcommittee on Oversight and Investigations will be holding a hearing on the growing public health threat of antimicrobial resistance (AMR). AMR occurs when microorganisms such as bacteria, viruses, fungi and parasites develop the ability to survive against the drugs designed to kill them. Recognized by the World Health Organization (WHO) as “one of the biggest threats to global health, food security and development today,” AMR is a growing crisis that has

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Despite Lack of Consensus on Definition and Regulations, Digital Therapeutics Are Becoming General Medical Practice

Pharmacy Times

The market for digital therapeutics products is expected to grow given increasing global access to smart technologies, their cost-effectiveness, and the need for patient-specific treatments.

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FDA Approves Broad Spectrum Parasite Protection for Cats

Drug Topics

The NexGard COMBO topical solution from Boehringer Ingelheim helps protect cats from tapeworms and other intestinal parasites like fleas, ticks, and heartworms.

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Led by students, a nascent climate movement is taking hold in medical education

STAT

When Cecilia Sorensen was an emergency medicine resident practicing at Denver Health in Colorado a few years ago, summer was known as “trauma season.” Gunshot and motor vehicle accident victims, people with heart attacks and COPD would stream into the ER. Later, on a fellowship, she witnessed the health impacts of drought in Syria. The common driver, she realized, was climate change and its impact, both locally and globally.

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AHIP’s latest misinformation campaign & what it’s trying to hide

PhRMA

If we needed any more proof that the health insurance and pharmacy benefit manager (PBM) industries are one and the same, look no further than a new ad campaign by America’s Health Insurance Plans (AHIP). With PBMs facing increasing scrutiny on Capitol Hill, AHIP is hitting the airwaves to deflect any responsibility for the high cost of medicine many people face.

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FDA Approves Prevnar 20 Vaccine to Prevent Invasive Pneumococcal Disease in Children 6 Weeks Through 17 Years

Pharmacy Times

Prevnar 20 is a next-generation pneumococcal conjugate vaccine that includes capsular polysaccharide conjugates for the 13 serotypes already included in Prevnar 13.

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The Prevalence Of Long COVID in Vaccinated vs. Unvaccinated Children

Drug Topics

Post-COVID-19 conditions were more common in unvaccinated children than in children who had received at least 1 dose of a COVID-19 vaccine.

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STAT Wunderkinds discuss high-impact research, resilience, and social justice

STAT

Elenoe “Crew” Smith used to faint at the sight of blood. Still, she knew from a very young age that she wanted to help people living with sickle cell disease. Now, as a research director at Vertex Pharmaceuticals, she is working on potential sickle cell medicines. Smith was in STAT’s 2017 class of Wunderkinds , an annual selection of standout researchers who are launching their careers.

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Nonprofit hospitals fall short on community benefit, studies show

PhRMA

Nonprofit hospitals are supposed to help provide access to crucial treatment and services in our most vulnerable communities. But recent research adds to the mountain of evidence showing nonprofit hospitals continue to fall short in their community benefit. For example, many nonprofit hospitals participate in the federal 340B Drug Pricing Program, where eligible large nonprofit hospitals can buy deeply discounted 340B medicines and then turn around and charge both uninsured patients and insuranc

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Study Finds Novel CAR T-cell Therapy Feasible, Safe in High-Risk Neuroblastoma

Pharmacy Times

Six weeks after infusion of GD2-CART01, 9 of 27 patients (33%) with relapsed or refractory high-risk neuroblastoma had a complete response or maintained a complete response.

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FDA Approves Qalsody, First-of-its-Kind Treatment for Rare Form of ALS

Drug Topics

The drug treats amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene (SOD1-ALS).

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Pennsylvania set to ban supervised drug use sites, in setback for harm reduction

STAT

Pennsylvania lawmakers are set to pass a new ban on supervised drug consumption, effectively ending a Philadelphia nonprofit’s long-running effort to offer a sanctioned substance-use site meant to prevent overdose and death. A bill outlawing sites that “knowingly” provide a space for drug consumption passed a committee vote by a wide margin on Tuesday.

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Breathing easy: How digital inhalers are changing asthma treatment

Pharmaceutical Technology

AstraZeneca , Teva Pharmaceuticals , and Novartis , and other companies, are expanding their reach in the asthma space by capitalizing on digital technologies to enhance the patient experience. But experts say the complete integration of these devices and platforms into the healthcare system remains to be seen. Dr. Amy Chan, senior clinical research fellow at the School of Pharmacy, University of Auckland, says digital inhalers have existed for almost 30 years.

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Study: New Novel Treatment Increases Frequency of Vaccine Responder for HIV

Pharmacy Times

The analysis, published in Nature Communications, demonstrates glycan trimming also keeps the antibody response away from immunodominant glucan holes and patches.

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FDA Clears Pfizer’s Pneumococcal Conjugate Vaccine for Infants and Children

Drug Topics

Prevnar 20 contains 20 serotypes and grants the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine.

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To prevent preeclampsia, experts push for broader blood pressure testing at home

STAT

Eleni Tsigas likens her first experience with preeclampsia to a plane crash. She was in the midst of what she thought was a healthy first pregnancy, with low risk for complications. But at 29 weeks, she was rushed to the emergency room with what she now knows are classic signs of preeclampsia: very high blood pressure, a pounding headache, nausea, blurred vision.

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Show 1339: Harnessing the Power of the Vagus Nerve

The People's Pharmacy

We have multiple nervous systems. You are probably aware of the nerves that help move your arms to throw a ball or move your legs to jump. No doubt you also know about the fight-or-flight response triggered by a fright. The oddly named sympathetic nervous system is in charge of that. Many of us don’t pay much attention to the parasympathetic nervous system.

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Study: Fecal Microbiota Transplantation Likely Leads to Large Increase in Resolution of Recurrent C. Difficile

Pharmacy Times

Fecal microbiota transplantation may result in a slight reduction in serious adverse events, but the confidence intervals around the summary estimate were wide in immunocompetent adults with recurrent C. difficile infection.

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FDA Clears Wearable Insulin Delivery Device Omnipod GO for Type-2 Diabetes

Drug Topics

Insulet plans to commercialize the new product in the United States starting in 2024.

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Dying patients protest looming telehealth crackdown

STAT

At age 93, struggling with the effects of a stroke, heart failure and recurrent cancer, Teri Sheridan was ready to end her life using New Jersey’s law that allows medically assisted suicide — but she was bedbound, too sick to travel. So last Nov. 17, surrounded by three of her children, Sheridan drank a lethal dose of drugs prescribed by a doctor she had never met in person, only online.

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New AI-driven long COVID app coming soon to individual, enterprise customers

Fierce Healthcare

New AI-driven long COVID app coming soon to individual, enterprise customers agliadkovskaya Wed, 04/26/2023 - 14:04

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Sotatercept Improves Exercise Capacity in Individuals With Pulmonary Arterial Hypertension

Pharmacy Times

The median change from baseline at week 24 in the 6-minute walk distance was 34.4 m in the sotatercept group and 1 m in the placebo group among patients with pulmonary arterial hypertension.

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Eli Lilly's weight-loss drug passes 2nd trial with flying colors, setting up likely approval

Fierce Pharma

Eli Lilly's weight-loss drug passes 2nd trial with flying colors, setting up likely approval aliu Wed, 04/26/2023 - 22:30

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STAT+: Bright Health looks to get out of health insurance entirely

STAT

Bright Health Group started as a health insurance company. But it will no longer be one. Bright is looking to sell off the Medicare Advantage plans it manages in California, the company said Friday. That is the last component of its health insurance business, after the company said this past October it was fully exiting all Affordable Care Act marketplaces.

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Kaiser Permanente to acquire Geisinger Health in bid to launch multi-system VBC platform

Fierce Healthcare

Kaiser Permanente to acquire Geisinger Health in bid to launch multi-system VBC platform dmuoio Wed, 04/26/2023 - 12:49

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Tislelizumab Demonstrates Superior Overall Survival Compared With Chemotherapy

Pharmacy Times

Efficacy and safety data for BeiGene’s therapy shows positive results for individuals with advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.