Sat.May 20, 2023 - Fri.May 26, 2023

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Setting the record straight on accelerated approval

PhRMA

As we’ve discussed on this blog before, the U.S. Food and Drug Administration’s (FDA) accelerated approval program has served as a critical lifeline for patients with serious and life-threatening conditions. The program was originally established at the urging of patient advocates during the height of the HIV/AIDS epidemic, in which patients waited years for the FDA to review and approve new treatments.

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Pharmacists are Overworked, Frustrated, and Unintentionally Absent from Patient Care: It’s Time to Rightsize the Role

Pharmacy Times

Specialty pharmacists—those caring for patients with serious, sometimes life-threatening conditions such as cancer or rheumatologic disease—are not immune from the ongoing labor crisis.

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Physicians, Staff Express Negative Attitudes Toward Emergency Department-Initiated Buprenorphine Use

Pharmacy Times

The attitudes of community-based opioid use disorder treatment center staff toward the emergency department as a site of initiation were varied, with some feeling that emergency department-initiated buprenorphine may attract patients who were not experiencing life-threatening emergencies.

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An Interview with Jamila Jorden, Pharmacy Advisor

Pharmacy Is Right For Me

Jamila Jorden, a pharmacist and academic advisor, recently gave an interview discussing the multifaceted role of pharmacists. She also discussed the importance of experiential education in preparing pharmacy students for their careers. Jamila’s experiences in the pharmacy profession provide valuable insight into the varied roles and responsibilities of pharmacists.

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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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Two Lawsuits Allege Iowa Medicaid Did Not Provide Proper Mental Health Care

Drug Topics

Iowa's Department of Health and Human Services, which manages the two health insurers that delivered care to adults and children in the state’s Medicaid program last year, was alleged to provide inadequate mental and behavioral health care to children on Medicaid.

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STAT+: Addiction treatment center founder indicted in sprawling fraud scheme

STAT

Over the last few years, Daniel Cleggett Jr. appeared to be living a charmed life. The founder of a small Boston-area   addiction treatment empire knew he was under scrutiny; the Globe and STAT News  published investigations  in 2017 and 2019 into his questionable business dealings, and the Massachusetts attorney general’s office announced   shortly after that   it was examining alleged scams involving addiction treatment.

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2022 Prescription Trends

PharmExec

The market for prescription medicines in the United States was subject to major shifts in use across therapeutic areas in 2022, reflecting changes in patient health needs, the development, and availability of novel medicines, and complex market dynamics.

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Sulbactam-Durlobactam for Bacterial Pneumonia Gets FDA Approval

Drug Topics

The antibiotic, marketed as Xacduro, is indicated for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii.

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Opinion: Cancer patients shouldn’t be responsible for out-of-pocket costs

STAT

In 2023, just under 2 million Americans will be diagnosed with cancer. Many will endure multiple CT and MRI studies and intensive medical care, including surgery, radiation, chemotherapy, or immunotherapy. Fortunately, advances in treatment and novel therapies have steadily improved survival following a cancer diagnosis. Cancer death rates have declined by 27% over the past 20 years.

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Five Trends Transforming Pharmacies into Wellness Centers of the Future

Pharmacy Times

With so many radical developments in medicine and technology unfolding at once, the role and potential of the pharmacy as we know it is evolving at breakneck speed.

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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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Johnson & Johnson cites rebates and discounts for drug price increases

Fierce Pharma

Johnson & Johnson cites rebates and discounts for drug price increases kdunleavy Fri, 05/26/2023 - 07:36

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FDA Approves First Oral Treatment for Patients With Moderate to Severe Crohn's Disease

Drug Topics

The approval of Rinvoq (upadacitinib) was based on the results of three clinical trials: two induction therapy studies and one maintenance study.

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What does generative AI mean for health care? We asked the experts

STAT

Health care companies are racing to incorporate generative AI tools into their product pipelines and IT systems after the technology displayed an ability to perform many tasks faster, cheaper — and sometimes better — than humans. But the rush to harness the power of so-called large language models, which are trained on vast troves of data, is outpacing efforts to assess their value.

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Sublingual Vaccine Shows Efficacy in Preventing Recurrent UTIs, Helping to Eliminate Need for Antibiotics

Pharmacy Times

Women with recurrent urinary tract infections (UTIs) are often on and off antibiotics for years, and even decades, as the only treatment available in health systems for treating UTIs.

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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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China’s NMPA accepts IND for SinoMab BioScience’s SM17 to treat asthma

Pharmaceutical Technology

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma. SM17 is a humanised IgG4-k monoclonal antibody that targets IL-17RB to treat asthma, idiopathic pulmonary fibrosis (IPF), atopic dermatitis (AD) and other immunological disorders.

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Fourth Dose of COVID Vaccine Produced Milder Symptoms In Patients With IBD

Drug Topics

Data presented at Digestive Disease Week show that patients with IBD had less intense post-vaccination symptoms after a fourth dose.

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Opinion: What if we’re talking about teens’ mental health too much?

STAT

Every day, it seems, is mental health awareness day. In the U.S., there’s Eating Disorders Awareness Week in February. May is National Mental Health Awareness Month, which includes National Children’s Mental Health Awareness Day. September is Suicide Prevention Awareness Month and in October we go global, with  World Mental Health Day.

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SLFN12 Expression is Found in Cells Positive for HIV Transcripts But Negative for HIV Protein

Pharmacy Times

A barrier in effectively treating HIV has been the latency of infected CD4+ T cells, which are often treatment-resistant and contribute to the persistence nature of the virus.

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European biotechs choosing Switzerland as base, research shows

European Pharmaceutical Review

New research by IQVIA and recently published in the 2023 Swiss Biotech Report shows that 20 percent of European biotech companies are now headquartered in Switzerland. Sixty three out of a total of 265 companies settling in Switzerland were biotechs. This makes it the second most important sector after ICT, the research found. 2022 statistics by the Swiss federal government confirm that the trend to base here is continuing.

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A National Drug Shortage Creates Care Challenges in Oncology

Drug Topics

A short supply of cisplatin and carboplatin is forcing health care providers to find less effective alternative treatments.

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Some hoped a new oral vaccine would solve all the polio campaign’s problems. Reality is settling in

STAT

When a new and hoped-to-be safer oral polio vaccine started to make its way into use in March 2021, there was huge optimism that this long-needed tool would help the polio eradication campaign quell a growing problem that was — and is still — complicating efforts to stamp out polio forever. Two years later, expectations surrounding the new vaccine, known as novel oral polio vaccine type 2, or nOPV2 for short, are moderating a bit.

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Incorporating FMT Treatment Into Clinical Practice

Pharmacy Times

Candace Cotto, RN, reviews the process of incorporating fecal microbiota, live-jslm treatment into clinical practice, what patients can expect, and the room sanitation process after the procedure.

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Startup Florence acquires Zipnosis from Bright Health to build out telehealth services

Fierce Healthcare

Startup Florence acquires Zipnosis from Bright Health to build out telehealth services hlandi Wed, 05/24/2023 - 06:15

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What Is The Link Between Antidepressants and Hospital-Acquired Clostridium Difficile Infection?

Drug Topics

Researchers found an increased occurrence of CDI in individuals who were prescribed antidepressants.

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FDA grants priority review for Takeda and HUTCHMED’s fruquintinib NDA

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted priority review for Takeda and HUTCHMED’s new drug application (NDA) for fruquintinib. Fruquintinib is a selective and potent oral VEGFR -1, -2 and -3 receptors inhibitor and is used for the treatment of adults with previously treated metastatic colorectal cancer. Fruquintinib will be the first and only highly selective inhibitor of these receptors approved in the US.

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Probiotic Use Has Increased in Neonatal ICUs, But Further Data Are Still Needed

Pharmacy Times

In neonatal intensive care units, probiotic usage was associated with a decline in necrotizing enterocolitis, but not with sepsis or mortality rates.

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HIV rates decline in U.S., data show, but disparities persist

STAT

The latest accounting of HIV incidence in the United States is a mixed bag. Overall estimated new infections dropped 12% in 2021 compared to 2017, according to data released Tuesday by the Centers for Disease Control and Prevention. But the American South — which has had a longtime HIV problem compared with other areas across the U.S. — was the only region to show a “statistically significant decline.

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First Oral Antiviral Treatment For COVID-19 Gets FDA Approval

Drug Topics

More than 11.6 million treatment courses of the medication have been prescribed in the U.S. to date.

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Immuno-oncology market set to grow in billions, but access concerns remain

Pharmaceutical Technology

The immuno-oncology market continues to evolve as treatments establish their presence across different types of cancer, having seen approvals in multiple indications in the past decade. While the market was worth over $6 billion in 2012, this has now grown to nearly $48 billion only a decade later, said Avigayil Chalk, PhD, GlobalData’s Senior Oncology and Haematology analyst, at an immuno-oncology webinar held on May 23.

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FDA Approves First Gene Therapy for Patients Aged 6 Months and Older with Serious Genetic Skin Disorder

Pharmacy Times

Beremagene geperpavec completely closed severe blistering and wounds in more than half of all patients with dystrophic epidermolysis bullosa with specific mutations.

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STAT+: In early trial, drug appears to reduce harmful protein buildup in heart

STAT

An early-stage drug for a heart disease called ATTR-CM showed potential to reverse disease progression, opening up a new way of attacking the condition as existing drugs have been designed to only slow or stall the disease. In a small Phase 1 trial, the drug, a monoclonal antibody named NI006, appeared to reduce harmful protein buildup in the heart based on imaging, according to the study , published Saturday in the New England Journal of Medicine.

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Exploring the Link Between Low Socioeconomic Status and Risk of Invasive Pneumococcal Disease

Drug Topics

Active tobacco use and BMI were inversely related to the risk of developing IPD.

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Krystal Biotech receives FDA approval for DEB topical gene therapy

Pharmaceutical Technology

Krystal Biotech has received approval from the US Food and Drug Administration for topical gene therapy VYJUVEK to treat dystrophic epidermolysis bullosa (DEB) in adults and in children aged six months and above. VYJUVEK is designed to address the underlying genetic cause of the disease. An excipient gel applied topically is a key component of the therapy, which is supplied by Krystal’s client, Berkshire Sterile Manufacturing (BSM).

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Semaglutide With Lifestyle Interventions Shows Benefits for Adolescents With Obesity

Pharmacy Times

The use of semaglutide for adolescents was included in recent pediatric guidelines, though there are few studies assessing the drug in this patient population.

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