Breaking: FDA Approves, Authorizes Updated Monovalent COVID-19 Vaccines
Drug Topics
SEPTEMBER 11, 2023
Bivalent COVID-19 vaccines by both Moderna and Pfizer-BioNTech are no longer authorized for use in the United States.
Drug Topics
SEPTEMBER 11, 2023
Bivalent COVID-19 vaccines by both Moderna and Pfizer-BioNTech are no longer authorized for use in the United States.
Pharmacy Times
SEPTEMBER 11, 2023
Although GLP-1 receptor agonists have shown promise in promoting weight loss, they are prescription medications and should be used under the guidance of health care professionals.
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Fierce Pharma
SEPTEMBER 11, 2023
Out with the old and in with the new: Monday, the U.S. | The FDA has approved Pfizer and Moderna’s separate vaccine formulations that target current variants of the disease. Each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old.
STAT
SEPTEMBER 11, 2023
The Food and Drug Administration announced Monday that it had greenlit two updated Covid-19 booster shots in people as young as 6 months old, triggering a process that could see the Moderna and Pfizer-BioNTech vaccines become available in doctors’ offices, clinics, and pharmacies later this week. The updated approvals relate only to the two messenger RNA vaccines on the U.S. market.
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.
Pharmacy Times
SEPTEMBER 11, 2023
FDA grants updated Moderna and Pfizer-BioNTech COVID-19 vaccines with emergency use authorization to target currently circulating variants of the virus.
STAT
SEPTEMBER 11, 2023
Coronary stenting is, by some measures , the most overused procedure in hospitals. The problem costs the health system millions and unnecessarily exposes patients to risks of blood clots, torn arteries, infections, and other life-threatening injuries. In 2020, Medicare started paying physicians to place stents, balloons, and perform other procedures designed to open clogged coronary arteries outside of hospitals, in less expensive outpatient settings.
Pharmacy Technician Pulse brings together the best content for pharmacy technicians from the widest variety of industry thought leaders.
Drug Topics
SEPTEMBER 11, 2023
The clinical pharmacist will play an important role as a medication expert, filling in for the role that pharmaceutical manufacturers once did in supporting patients and prescribers.
Fierce Healthcare
SEPTEMBER 11, 2023
On the heels of big-ticket acquisitions, Walgreens is ramping up its push into healthcare and is partnering with startup Pearl Health to get a foothold in the ongoing movement to value-based care.< | Walgreens' partnership with Pearl Health builds on the assets that the retail pharmacy giant has recently made investments in as it "moves more aggressively into healthcare," Steve Wogen, chief growth officer, told Fierce Healthcare.
STAT
SEPTEMBER 11, 2023
This story contains descriptions of an invasive medical procedure and mention of sexual assault. It’s been nearly three decades since Shelby Smith underwent a series of invasive procedures as a young child to diagnose the cause of recurring urinary tract infections. But the trauma of the procedure, which required her to be restrained while a physician threaded a catheter up her urinary tract without sedation, still impacts her profoundly.
Fierce Healthcare
SEPTEMBER 11, 2023
Retail giant Walmart is reportedly exploring buying a majority stake in primary care clinic operator ChenMed to expand its healthcare business. | Retail giant Walmart is reportedly exploring buying a majority stake in primary care clinic operator ChenMed to expand its healthcare business.
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
SEPTEMBER 11, 2023
Hypercortisolemia during the late afternoon and early evening is harmful and believed to cause insulin resistance observed with advanced age.
Fierce Pharma
SEPTEMBER 11, 2023
Competing to treat patients with severe eosinophilic asthma (SEA), AstraZeneca has fared well matching its IL-5 inhibitor Fasenra up against GSK’s Nucala. | AstraZeneca's Fasenra has achieved its primary endpoint in a phase 3 trial, demonstrating noninferior rates of remission in a head-to-head battle against GSK's Nucala in patients with eosinophilic granulomatosis with polyangiitis.
Fierce Healthcare
SEPTEMBER 11, 2023
Shareholders in home health company Amedisys have approved its $3.3 billion union with Optum, even as the feds take a closer look at the deal. | Shareholders in home health company Amedisys have approved its $3.3 billion union with Optum, even as the feds take a closer look at the deal.
STAT
SEPTEMBER 11, 2023
The biotech company Acelyrin, which raised more than $500 million in an IPO this year, ran into its first major setback Monday as its investigational anti-inflammatory drug missed the primary goal in a pivotal clinical trial. Acelyrin’s medicine, a subcutaneous treatment called izokibep, is meant to clear up lesions for patients with the common skin disease hidradenitis suppurativa, or HS, an inflammatory disorder that leads to abscesses and scars.
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Fierce Healthcare
SEPTEMBER 11, 2023
L.A. | L.A. Care, which provides coverage for about 2.9 million people in Medicaid, Medicare, and Affordable Care Act plans, was ordered to shore up its data protection systems.
Drug Topics
SEPTEMBER 11, 2023
The Vice President of Industry Relations at IQVIA gave a presentation at the 2023 PBMI Annual National Conference in Orlando, where he discussed everything from healthcare utilization during COVID-19 to spending on specialty drugs.
Fierce Healthcare
SEPTEMBER 11, 2023
Kaiser Permanente has settled with the state of California for $49 million to resolve allegations that it was improperly disposing of hazardous medical waste—including body fluids—and thousands of | California law enforcement said it found "hundreds of items of hazardous and medical waste," such as medical tubing with body fluids, and paper records with thousands of patients' information in landfill-bound dumpsters.
Fierce Pharma
SEPTEMBER 11, 2023
Ahead of an important advisory committee meeting, the FDA has raised serious questions about Alnylam’s bid to expand Onpattro into a much larger group of patients with transthyretin amyloidosis (AT | The FDA has raised questions about Alnylam's Onpattro as the company seeks to expand the drug into a much larger group of patients with transthyretin amyloidosis (ATTR).
Pharmacy Times
SEPTEMBER 11, 2023
Research into the mechanisms of intravenous immunoglobulin is often challenging due to the complexity of polyclonal preparations, including diversity, repertoires, blocking, or anti-idiotypic antibodies.
Fierce Pharma
SEPTEMBER 11, 2023
After plotting a course to grow by leveraging its biosimilar expertise, Sandoz has inked a deal to get involved in one of the industry's next major biosim debuts. | The blockbuster inflammatory med's patents begin to expire this year, leaving biosimilar makers scrambling for a piece of the large market. Versions from Amgen, Teva and Alvotech are expected to launch in early 2025.
Pharmacy Times
SEPTEMBER 11, 2023
Precision medicine in pharmacy has the potential to revolutionize patient care by optimizing drug selection, dosing, and monitoring.
Fierce Healthcare
SEPTEMBER 11, 2023
At a time when inflation seems to be on the nation’s radar, it’s no surprise that Blue Cross and Blue Shield of North Carolina would tout that members in the healthcare plans it offers in the Affor | The rate decrease, approved by the North Carolina Department of Insurance, will lower total premiums by an estimated $130 million for enrollees in the insurer’s ACA plans.
Fierce Pharma
SEPTEMBER 11, 2023
A shortage of attention-deficit/hyperactivity disorder (ADHD) medicines has been ongoing for a year in the U.S. | Supernus is sharing positive results for its nonstimulant ADHD treatment, Qelbree, which was approved for children in 2021. In a poster presented over the weekend at Psych Congress 2023, Qelbree was shown to sharpen the focus of children 6 and older when combined with a stimulant.
Pharmacy Times
SEPTEMBER 11, 2023
The CDK12/13 inhibitor will be tested for efficacy and safety in patients with advanced solid tumors, such as breast, ovarian, and Ewing Sarcoma.
Fierce Healthcare
SEPTEMBER 11, 2023
Members of MedPAC, the Medicare Payment Advisory Commission, reiterated their broad support for simplifying the Medicare Advantage (MA) landscape for consumers during a meeting Sept. | Experts discussed how to best eliminate redundant options between Medicare Advantage plans while not impeding insurers' ability to differentiate its offerings.
Fierce Pharma
SEPTEMBER 11, 2023
After 10 years of stagnation, a new FDA approval could help more cancer patients become eligible for stem cell transplants. | The FDA approved motixafortide—also known as Aphexda—in tandem with the decades-old colony stimulating factor (CSF) filgrastim to mobilize hematopoietic stem cells for collection and autologous stem cell transplantation (ASCT) in patients with multiple myeloma.
Drug Store News
SEPTEMBER 11, 2023
ChenMed, which provides care to seniors, could be valued at several billion dollars in a deal that would be Walmart’s biggest health care foray yet, per a Bloomberg report.
Fierce Healthcare
SEPTEMBER 11, 2023
The FTC alleged 1Health.io failed to protect sensitive genetic and health data of consumers and deceived them about its privacy and security practices.
Drug Store News
SEPTEMBER 11, 2023
HRG reviewed 25 products in the health category, 34 items in the wellness sector and 35 items in the beauty aisle to see which ones stood out as Products to Watch.
Fierce Healthcare
SEPTEMBER 11, 2023
As the Medicare Advantage (MA) market continues to grow, insurers should be thinking about building trust with members to rise to the top of the pack, according to a
Drug Store News
SEPTEMBER 11, 2023
The U.S. healthcare system, including patients, employers and taxpayers, saved $408 billion in 2022 by using FDA-approved generic and biosimilar drugs, per the AAM's report.
The Checkup by Singlecare
SEPTEMBER 11, 2023
Compared to individuals who maintain a healthy weight, people with obesity or who are considered overweight are at an increased risk for several serious health issues, including Type 2 diabetes , hypertension , heart disease , and even stroke. The good news? Even losing a small amount of weight ( 5%-10% of your body weight) comes with health benefits like more energy, improved blood sugar levels, and better sleep.
Hospital Pharmacy Europe
SEPTEMBER 11, 2023
Guidance on how global warming can be addressed in clinical practice has been outlined by the European Respiratory Society (ERS) in its latest consensus statement on climate change and respiratory health. Published in the European Respiratory Journal , the statement describes climate change as ‘an unfolding major planetary and health crisis’ , and a major threat to those with common lung conditions.
Fierce Healthcare
SEPTEMBER 11, 2023
A new $100 million donation will help cancer research and treatment organization City of Hope establish a new evidence-based “integrative oncology” program that blends Eastern and Western medicine, | The largest charitable donation in City of Hope's history will help establish an evidence-based "integrative oncology" program that melds Eastern cultures' healing traditions, such as acupuncture or meditation, with cancer treatments more typical in the West.
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