FDA Roundup: Novavax COVID-19 Vaccine, First Digital Therapeutic for GAD
Drug Topics
SEPTEMBER 6, 2024
Check out important updates from the FDA for the week of September 2.
Drug Topics
SEPTEMBER 6, 2024
Check out important updates from the FDA for the week of September 2.
STAT
SEPTEMBER 6, 2024
This is a developing story and will be updated. A person in Missouri who didn’t report any contact with animals has tested positive for H5 bird flu, the state’s Department of Health and Senior Services and the Centers for Disease Control and Prevention said Friday. It’s not yet clear if the person was infected with the same virus strain that’s causing the ongoing outbreak among dairy cattle.
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Drug Topics
SEPTEMBER 6, 2024
Lingo offers users a real-time glucose graph, a metric to track glucose spikes, food and activity logging, personal recommendations, and challenges to motivate healthy behaviors.
Pharmacy Times
SEPTEMBER 6, 2024
Full traditional approval follows accelerated approval of the medication last year.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Drug Topics
SEPTEMBER 6, 2024
Researchers analyzed a co-developed pharmacy-based intervention for individuals who have experienced domestic abuse or suicidal ideation.
Pharmacy Times
SEPTEMBER 6, 2024
Individuals with a history of shingles was significantly and independently connected with a 20% higher risk of for subjective cognitive decline.
Pharmacy Technician Pulse brings together the best content for pharmacy technicians from the widest variety of industry thought leaders.
Pharmacy Times
SEPTEMBER 6, 2024
The evolving treatment landscape for multiple myeloma includes debates on the timing and effectiveness of CAR T-cell therapy and quadruple immunotherapy regimens.
STAT
SEPTEMBER 6, 2024
As the mom of three young adults, I am worried about their economic future — their ability to get jobs and afford homes. But I am equally concerned about their mental health and well-being. A 2022 national survey found that approximately half of young people ages 18-25 have a mental illness, substance use disorder, or both. Suicide and overdose rates remain persistently high: As Nicholas Kristof has written, “every three or four days we lose as many Americans to drugs, alcohol and
Pharmacy Times
SEPTEMBER 6, 2024
New transparency initiatives will go into effect on January 1, 2025, building off previous actions by the Centers of Medicare and Medicaid Services.
Fierce Healthcare
SEPTEMBER 6, 2024
BOSTON—There’s no shortage of providers and vendors working to develop and deploy artificial intelligence in healthcare—but not all who are delivering care are in a position to make use of these no | Healthcare AI has a tough battle on adoption, trust and responsible use, particularly among organizations lacking in-house tech expertise. Whether it's a vendor or another health system, stakeholders must be prepared to help their peers along the way, experts say.
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.
Pharmaceutical Technology
SEPTEMBER 6, 2024
The US FDA has granted orphan drug designation (ODD) to Abdera Therapeutics’ ABD-147 aimed at neuroendocrine carcinoma.
Fierce Healthcare
SEPTEMBER 6, 2024
Thatch wants to turn the traditional approach to health insurance on its head. | Thatch wants to turn the traditional approach to health insurance on its head. The company secured $38 million, backed by a16z and General Catalyst, to scale up its technology and fuel its growth.
Pharmacy Times
SEPTEMBER 6, 2024
Surprisingly, those with overweight BMI at diagnosis did not have a poor prognosis.
Fierce Healthcare
SEPTEMBER 6, 2024
As the country gears up for November elections, health systems say they are keeping an eye on, but not severely concerned about, potential major changes in the Affordable Care Act exchanges or Medi | Regardless of who takes charge in Washington, the heads of America's largest for-profit health systems are downplaying the likelihood of major political interference in populations and programs that have become increasingly important to their bottom lines.
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.
STAT
SEPTEMBER 6, 2024
Private equity firms are leading the buyout of R1 RCM , a major provider of billing and administrative services for hospitals and physician groups. But R1’s hospital customers — some of the biggest systems in the country — were influential in steering the company to that outcome. Ascension, a nonprofit Catholic health system, is R1’s largest client and biggest shareholder through an investment fund with private equity firm TowerBrook Capital Partners.
Fierce Pharma
SEPTEMBER 6, 2024
GSK is heading into the weekend with a win for its respiratory blockbuster Nucala—but for now, the details are slim. | On Friday, GSK said that its IL-5 antibody Nucala plus inhaled maintenance therapy lowered the annualized rate of moderate or severe exacerbations among chronic obstructive pulmonary disease (COPD) patients for up to 2 years. Nucala is already approved in a range of respiratory conditions, but a COPD nod could present another big opportunity for the drug.
Pharmacy Times
SEPTEMBER 6, 2024
A pharmacist with Allegheny Health Network discusses travel vaccines and what resources are valuable when determining which vaccinations are needed prior to travel.
Fierce Pharma
SEPTEMBER 6, 2024
Gilead Sciences has been looking for a win for Trodelvy after two surprise trial failures earlier this year. | Gilead Sciences has been looking for a win for Trodelvy after two surprise trial failures earlier this year. But it looks like that win won’t come from a triplet regimen that combines the antibody-drug conjugate with Merck’s Keytruda and chemotherapy in newly diagnosed non-small cell lung cancer.
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Pharmacy Times
SEPTEMBER 6, 2024
RSV vaccination was 75% effective in preventing RSV-associated hospitalizations among adults aged 60 years and older.
Drug Topics
SEPTEMBER 6, 2024
Nymalize is an effective alternative to capsule extraction for adult patients with subarachnoid hemorrhage who are unable to swallow capsules.
Pharmacy Times
SEPTEMBER 6, 2024
Edaravone and dexborneol sublingual tablets are an innovative first drug to be designed for treatment of stroke and granted this designation.
Fierce Healthcare
SEPTEMBER 6, 2024
Two years after Mississippi awarded Medicaid contracts to three insurers, the state is finally moving forward with its decision following challenges from UnitedHealthcare and Elevance Health. | Protests from UnitedHealth and Elevance Health, which have delayed implementation of Mississippi's Medicaid awards, are so far proving unsuccessful.
pharmaphorum
SEPTEMBER 6, 2024
Financings in the biotech sector this week include an IPO filing for BioAge and private rounds for eGenesis, Navigator, and Circle Pharma.
The Checkup by Singlecare
SEPTEMBER 6, 2024
You took your morning Zyrtec dose to manage pesky allergy symptoms, only to remember you’re supposed to go wine tasting later. This situation raises an important question: can you safely mix Zyrtec and alcohol without adverse effects? It’s a common scenario for many and worth exploring how allergy medications and alcohol interact. Generally, mixing Zyrtec and alcohol is not recommended without a healthcare provider’s guidance.
pharmaphorum
SEPTEMBER 6, 2024
GSK's severe asthma therapy Nucala could find a new lease of life as a treatment for chronic obstructive pulmonary disease (COPD) after showing a clear benefit in a phase 3 trial.
Drug Topics
SEPTEMBER 6, 2024
Transform your pharmacy operations with centralized fulfillment. This whitepaper reveals how advanced automation can help you manage rising prescription volumes and workforce challenges. Learn how leading pharmacies optimize efficiency and reduce costs with proprietary software and automated robotic solutions. Download now and discover the future of pharmacy fulfillment.
pharmaphorum
SEPTEMBER 6, 2024
The fallout from the FDA's recent decision not to approve Lykos Therapeutics' psychedelic treatment has spread to its senior management, with chief executive Amy Emerson stepping down.
STAT
SEPTEMBER 6, 2024
Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here. Hello! Timmy here. I will be spending ten hours on Sunday carrying my wonderfully chaotic niece on my shoulders while she points at mascots at Kings Island amusement park. Please pray for my shoulders!
pharmaphorum
SEPTEMBER 6, 2024
Eli Lilly signs another genetic medicines deal, this time with Genetic Leap, a start-up that applies AI to the discovery of RNA-targeted drugs.
Pharmaceutical Technology
SEPTEMBER 6, 2024
The US FDA has approved Amneal Pharmaceuticals and Shilpa Medicare’s oncology product BORUZU for subcutaneous administration.
pharmaphorum
SEPTEMBER 6, 2024
Embracing diversity in psychiatry and neurology clinical trials is crucial for ensuring that treatments are effective for all populations. Learn about the importance of diversity in clinical trials and how to promote inclusivity in research.
STAT
SEPTEMBER 6, 2024
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.
pharmaphorum
SEPTEMBER 6, 2024
Understanding the impact of Medtech regulations on balancing innovation and safety is crucial for the industry. Discover how compliance with regulations plays a vital role in fostering innovation while ensuring patient safety in the field of medical technology.
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