Pharmacy Times
JUNE 9, 2023
The study will assess the use of the drug to treat impaired social motivation, or asociality, which is a difficult-to-treat symptom of schizophrenia that can cause significant functional impairment.
Fierce Healthcare
JUNE 9, 2023
Emerging Alzheimer’s disease medications come with high price tags, but researchers with the University of Chicago calculate that in the long run, it’s much less costly to cover these therapies for | Emerging Alzheimer’s medications come with high price tags, but researchers with the University of Chicago calculate that in the long run, it’s much less costly to cover these therapies for Medicare beneficiaries.
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Fierce Pharma
JUNE 9, 2023
After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen's Leqembi is heading into the final stretch of its regulatory review on strong footing. | After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen's Leqembi is heading into the final stretch of its regulatory review on strong footing.
STAT
JUNE 9, 2023
Expert advisers to the Food and Drug Administration on Friday voted unanimously in favor of expanding the approval of Leqembi, an Alzheimer’s disease treatment from Eisai and Biogen, further clearing the way for what could be the first widely available medicine that delays the disease’s progress. The group voted 6-0 that an 1,800-patient study of Leqembi confirmed its benefits for patients in the early stages of Alzheimer’s, recommending the FDA widen the drug’s
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.
Fierce Healthcare
JUNE 9, 2023
The Federal Trade Commission is building out its deep dive into the pharmacy benefit management industry yet again. | The Federal Trade Commission is building out its deep dive into the pharmacy benefit management industry yet again.
STAT
JUNE 9, 2023
Heart monitoring company iRhythm is in hot water with the Food and Drug Administration, which issued a stern warning letter to the device maker this week for marketing its product for “high risk” patients and changing its algorithm without seeking the FDA’s permission. The letter highlights FDA’s growing scrutiny of digital health and patient monitoring tools — as well as the grave impacts even small device glitches can have on patients.
Pharmacy Technician Pulse brings together the best content for pharmacy technicians from the widest variety of industry thought leaders.
Drug Topics
JUNE 9, 2023
Advisers with the FDA endorse a monoclonal antibody treatment for RSV in children, AstraZeneca and Quell sign a $2 billion agreement, and HSS hopes to strengthen the pediatric workforce.
Pharmacy Times
JUNE 9, 2023
The CDC has recommended a follow-up nucleic acid amplification test to be used for patients clinically suspected to have influenza, despite a negative POC test.
Fierce Healthcare
JUNE 9, 2023
Walgreens Boots Alliance sold its remaining stake in post-acute care and infusion services company Option Care Health for $330 million. | Walgreens Boots Alliance sold its remaining stake in post-acute care and infusion services company Option Care Health for $330 million.
Drug Topics
JUNE 9, 2023
Welcome back to RPHCast! This week, our hosts dive into the profitability of A1C testing, and how quick and easy these tests can help maximize your pharmacy's capabilities.
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.
Pharmacy Times
JUNE 9, 2023
April Gill, chief commercial officer at Tabula Rasa HealthCare, discusses how to identify underserved patients and address social determinants of health.
STAT
JUNE 9, 2023
The scientific paper inspired international headlines with its bold claim that the combination of brain scans and machine learning algorithms could identify people at risk for suicide with 91% accuracy. The promise of the work garnered lead author Marcel Adam Just of Carnegie Mellon University in Pittsburgh and co-author David Brent of the University of Pittsburgh a five-year, $3.8 million grant from the National Institute of Mental Health to conduct a larger follow-up study.
Fierce Healthcare
JUNE 9, 2023
The Department of Health and Human Services (HHS) has released a 43-drug list of the Medicare Part B prescription treatments that must repay the program for raising prices above the rate of inflati | The non-final list of 43 prescription drugs and biological products could save Medicare beneficiaries anywhere from $1 to $449 per average dose in out-of-pocket costs from July 1 to Sept. 30.
STAT
JUNE 9, 2023
Two large drugmakers and two of the biggest pharmacy chains finalized a $17.3 billion deal to settle accusations by state governments that they contributed to the opioid crisis that swept across the U.S. for more than a decade and contributed to thousands of overdose deaths. The agreement —which involves Teva Pharmaceuticals; Allergan, a unit of AbbVie; CVS; and Walgreens — is the latest involving several major players blamed for the crisis.
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Pharmacy Times
JUNE 9, 2023
Study highlights the importance of interprofessional decision-making between pharmacists and emergency department medical officers.
STAT
JUNE 9, 2023
In 2017, the Massachusetts state Legislature passed a law to ensure ease of access to birth control. It says there should be no copay for hormonal birth control prescriptions. It also allows women to fill a 12-month prescription at once. Infertility care has similar protections. The state mandates that plans cover “ medically necessary expenses of diagnosis and treatment of infertility ” if the insurance provides other pregnancy-related benefits.
Pharmaceutical Technology
JUNE 9, 2023
WestVac Biopharma has announced that the Chinese authorities have granted emergency use authorisation (EUA) for coviccine trivalent XBB.1.5-recombinant Covid-19 trivalent (XBB.1.5+BA.5+delta) protein vaccine (Sf9 cell). This marks the world’s first Covid-19 vaccine approved for emergency use against XBB descendent lineages of SARS-CoV-2. The vaccine has been developed by WestVac Biopharma along with the West China Medical Center and Sichuan University.
STAT
JUNE 9, 2023
FRANKFURT — Updated results released Friday highlighted the lasting benefits of a CRISPR-based medicine for blood disorders developed by Vertex Pharmaceuticals and CRISPR Therapeutics, as the treatment awaits regulatory decisions in the United States and Europe. The treatment, a one-time infusion known as exa-cel, uses CRISPR to fix the genetic faults at the root of sickle cell disease and beta thalassemia.
Fierce Pharma
JUNE 9, 2023
After overhauling Amarin’s board earlier this year, activist investor Sarissa Capital has set its sights on Alkermes. | Activist investor Sarissa Capital believes Alkermes' long-time CEO Richard Pops has "far too much control" of the board. It's asking for representation after years of rejections.
STAT
JUNE 9, 2023
WASHINGTON — After getting burned by the high-profile implosion of a digital health company, a senior official at Oklahoma’s Medicaid program said the state would be hesitant to buy into similar products again. “I don’t want to say we’re not receptive,” Terry Cothran, the senior pharmacy director at Oklahoma Health Care Authority said at the Digital Therapeutics Alliance’s summit this week.
Fierce Healthcare
JUNE 9, 2023
Many retail pharmacies do not have buprenorphine in stock, posing a problem for opioid use disorder (OUD) patients, a new study shows. | Pharmacies don’t keep every medication in stock. But that should be the case for buprenorphine, which is time-sensitive for opioid use disorder patients, the study's author argues.
Drug Topics
JUNE 9, 2023
Nivolumab plus relatlimab showed a clear benefit in progression-free survival, overall survival and objective response rate.
STAT
JUNE 9, 2023
The Food and Drug Administration is convening a meeting of outside experts on Friday to consider full approval for Leqembi, the Alzheimer’s treatment made by Eisai and Biogen. Leqembi was granted conditional approval in January based on preliminary evidence showing it could eliminate toxic brain plaques from people diagnosed with early-stage Alzheimer’s.
Hospital Pharmacy Europe
JUNE 9, 2023
The combination of ribociclib and standard endocrine therapy improves invasive disease-free survival rates more than endocrine therapy alone in patients with early stage, hormone receptor–positive, HER2-negative (HR+/HER2-) breast cancer, according to recent data presented at ASCO 2023. The standard treatment for HR+/HER2- advanced or metastatic breast cancer involves the use of endocrine therapies such as aromatase inhibitors, selective oestrogen receptor (ER) modulators, and selective ER down-
STAT
JUNE 9, 2023
In May, a National Public Radio story asked , “Can a chatbot help people with eating disorders as well as another human?” It focused on a chatbot that we developed to prevent eating disorders and help people with body image concerns and who are otherwise not likely to have access to other resources. We’ve committed our careers to increasing detection of eating disorders and access to care, and we received research funding from the National Eating Disorders Association (NEDA)
Hospital Pharmacy Europe
JUNE 9, 2023
Many medicines optimisation teams lack the capacity to build relationships across integrated care systems (ICSs) and drive transformation for this ‘golden thread of healthcare while also focusing on operational work, the NHS Confederation has warned. These teams should be involved in projects and service redesigns from the start, the NHS Confederation recommended in its recent ‘ Taking Stock: the experience of medicines optimisation in ICSs ’ report.
Pharmaceutical Technology
JUNE 9, 2023
Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% to treat the signs and symptoms of dry eye disease. VEVYE, the development name of which is CyclASol, is a cyclosporine, solubilised solution in a new, water-free excipient. It has been designed to address the unmet needs of patients and to provide quick action and well-tolerated dry eye drug therapy.
Hospital Pharmacy Europe
JUNE 9, 2023
SGLT2 inhibitor drug use in patients with diabetes appears to reduce cancer risk, according to a retrospective analysis by Taiwanese researchers. Epidemiological evidence suggests that diabetes increases the risk of cancer. It is thought the combination of hyper-insulinaemia, chronic inflammation and hyperglycaemia could increase the growth of tumours.
PharmExec
JUNE 9, 2023
The new era of generative AI is poised to impact pharma marketing and engagement in powerful and lasting ways. But amid all the technological praise, what are the key considerations brand teams must navigate?
Hospital Pharmacy Europe
JUNE 9, 2023
In an exploratory analysis of low-dose colchicine use to reduce the occurrence of cardiovascular events, researchers have found that the drug lowers the incidence of hip and knee replacements for osteoarthritis (OA). Published in the Annals of Internal Medicine , researchers examined the effect of colchicine on the incidence of hip and knee replacements in participants within the LoDoCo2 trial.
STAT
JUNE 9, 2023
Editor’s Note: A livestream of the event will be embedded below on Monday, June 12 at 1 p.m. ET Running a successful clinical trial is as much about execution as science, as companies and researchers must nail operational details from picking the right trial sites to ensuring patients remain in the study. How can you tell which studies are best positioned to end on time with high-quality data?
European Pharmaceutical Review
JUNE 9, 2023
Samsung Biologics, the South Korean contract development and manufacturing organisation (CDMO), has entered into a strategic partnership for the long-term commercial manufacturing of Pfizer’s multi-product biosimilars portfolio. Under the deal, Samsung Biologics said it will provide Pfizer with “additional capacity for large-scale manufacturing of a multi-product biosimilars portfolio covering oncology, inflammation, and immunology.
STAT
JUNE 9, 2023
FRANKFURT, Germany — Even as other cutting-edge genetic therapies for sickle cell disease move closer to approval, the CRISPR company Editas Medicine believes there is still a need and a commercial opportunity for its treatment, which remains further behind in development. On Friday, Editas offered a preliminary update on the handful of patients who’ve received its gene-editing-based therapy for sickle cell, which is also being tested for another blood disorder, beta thalassemia.
PharmExec
JUNE 9, 2023
The core building blocks of trust must be operationalized for pharma companies to strengthen their social contract, deliver business value, and improve patients’ quality of life.
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