Drug Topics
JANUARY 24, 2024
As per US law Section 505(o)(4), the manufacturers are required to make the requested changes, respond with a modified version of the requested changes for review, or respond with a rebuttal within 30 days of the FDA's ask.
Pharmacy Times
JANUARY 24, 2024
According to the FDA review, patients with CKD receiving denosumab for osteoporosis who are on dialysis or have CKD-MBD are at the highest risk of severe hypocalcemia.
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Drug Topics
JANUARY 24, 2024
Patients who received oral simnotrelvir recovered up to 1.5 days faster from COVID-19 compared to patients who received a placebo in the new study.
Pharmacy Times
JANUARY 24, 2024
On this episode, Dae Lee, Pharm.D., Esq., CPBS , and Harini Bupathi, Esq, attorneys at Frier Levitt, engage in a thought-provoking conversation on the evolving landscape of pharmacy benefit manager (PBM) audit strategies, regulations, and enforcement.
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.
STAT
JANUARY 24, 2024
You’ve heard of long Covid, a condition in which the acute infection subsides but troubling symptoms persist. Less well known is chronic Covid: The virus just doesn’t leave, sometimes staying in patients’ bodies long enough to mutate into new variants. This happens to people whose immune systems are compromised, whether through disease or treatment, leaving them vulnerable to infections that last weeks, months, or, in one known case, a year.
Fierce Healthcare
JANUARY 24, 2024
The Department for Health and Human Services (HHS) has published voluntary cybersecurity performance goals tailored for healthcare organizations, the first move in the administration’s
Pharmacy Technician Pulse brings together the best content for pharmacy technicians from the widest variety of industry thought leaders.
European Pharmaceutical Review
JANUARY 24, 2024
The first in our inaugural Pharma Horizons report series is dedicated to exploring the latest advances in artificial intelligence (AI) and machine learning (ML) for drug development, pharmaceutical manufacturing and quality control. AI/ML is predicted to be the top technology investment for 60 percent of life sciences companies over the next two years, according to a recent survey 1 from the Pistoia Alliance.
STAT
JANUARY 24, 2024
In the spring of 2020, my almost 4-year-old daughter Livie sustained a severe traumatic brain injury (TBI) when a tree branch fell on her head in our backyard, devastating our whole family. Returning home after five months in the hospital, the real journey began : How do we best care for and support our daughter, who cannot do any daily activities on her own, cannot walk or talk, and has become cognitively impaired?
Fierce Healthcare
JANUARY 24, 2024
Grocery delivery company Instacart notched another partnership with a care provider as it extends its reach into healthcare. | The company will work with in-home care provider DispatchHealth to enable providers to prescribe food interventions, much like traditional medications, right to patients' homes.
STAT
JANUARY 24, 2024
A year after an investigation revealed widespread use of a substandard cancer drug, the World Health Organization and national drug regulators around the world have come under fire for failing to protect children from the dangerous chemotherapy. The WHO plays a major role in protecting people worldwide from bad medicines. One of the fastest ways it is able to warn governments about a dangerous or ineffective drug is by issuing a medical product alert.
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
JANUARY 24, 2024
Gabriel Hinojosa, PharmD, BCOP, provides insights on selecting the best treatment regimen, and considers comorbidities, adverse events, and therapy modifications in multiple myeloma treatment.
STAT
JANUARY 24, 2024
The chemical used to sterilize half of all medical devices in the United States is also known to cause cancer. After years of deliberating on alternatives, the Food and Drug Administration this month deemed a safer gas , vaporized hydrogen peroxide, a legitimate way to decontaminate devices. It’s a small step in pushing the medical device industry away from the carcinogenic chemical, called ethylene oxide.
Pharmacy Times
JANUARY 24, 2024
Compared with chemotherapy, nivolumab plus ipilimumab reduced the risk of disease progression or death by 79%, but further research is needed to assess overall survival.
STAT
JANUARY 24, 2024
A kind of protein implicated in Alzheimer’s disease might also contribute to the breakdown of cartilage that’s characteristic of osteoarthritis. In a new study, published in Science Translational Medicine on Wednesday, researchers analyzed tissue samples and joint fluid from 12 people, both those with osteoarthritis and healthy controls.
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Fierce Healthcare
JANUARY 24, 2024
Walgreens is exploring a potential sale of its specialty pharmacy business Shields Health Solutions, just two-and-half years after it bought a majority stake in the business. | Walgreens is exploring a potential sale of its specialty pharmacy business Shields Health Solutions, just two-and-half years after it bought a majority stake in the business, according to a Bloomberg report.
STAT
JANUARY 24, 2024
The Dog Aging Project , which researchers say could yield promising leads for human longevity research, is at a critical crossroads after the National Institute on Aging declined to renew their grant funding. The massive project has been tracking the aging process of almost 50,000 companion dogs across the country through surveys and a biobank with over 14,000 tissue and other samples.
Fierce Healthcare
JANUARY 24, 2024
Amid an ongoing conversation about pharmacy benefit managers and the role they play in rising drug costs, a Fortune 100 company is making the jump from one of the industry's biggest players to a st | Amid an ongoing conversation about pharmacy benefit managers and the role they play in rising drug costs, a Fortune 100 company is making the jump from one of the industry's biggest players to a startup.
Drug Store News
JANUARY 24, 2024
Labor challenges, the expansion of healthcare services, store-count rationalization and PBM reform are among the front-burner issues in the year ahead.
pharmaphorum
JANUARY 24, 2024
"The Omni Advantage: Accelerating the Behavioural Change with Omnichannel in Pharma Sales Engagement" is a game-changing book by businesswoman Merhnaz Campbell. Discover insights, strategies, and inspiration for pharma sales field team success.
Fierce Pharma
JANUARY 24, 2024
The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. | The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. Turns out, the FDA didn’t drop the CD19 CAR-T from a classwide safety alert list. Instead, it's adjusted the wording of a proposed boxed warning.
STAT
JANUARY 24, 2024
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hey there. So, today we talk about how Eli Lilly’s gene therapy, developed by Akuous, worked in a child born with an inherited form of deafness. Also, we see some interesting biopharma trends from Stifel, and consider Novo Nordisk’s new obesity investment that is tangential to GLP-1s.
pharmaphorum
JANUARY 24, 2024
Is the upcoming year set to be a year of major expansion, acquisitions, and deal-making in the business world? Stay informed about the potential trends and opportunities that await in the M&A landscape.
Fierce Healthcare
JANUARY 24, 2024
More than 21.3 million people will be enrolled in an Affordable Care Act during this year's open enrollment period, Centers for Medicare & Medicaid Services (CMS) announced today. | Affordable Care Act enrollment has hit an all-time high, prompting federal officials to recognize its importance to the insurance marketplace today.
pharmaphorum
JANUARY 24, 2024
CG Oncology completes the first biotech IPO of 2024, raising $380 million for its oncolytic virus bladder cancer immunotherapy.
Hospital Pharmacy Europe
JANUARY 24, 2024
A consultation on draft standards setting out the professional responsibilities of a chief pharmacist has been launched by the General Pharmaceutical Council (GPhC). Aiming to support healthcare organisations and staff to deliver safe and effective pharmacy services, the four draft standards detail the knowledge, conduct and performance required of a chief pharmacist , or equivalent role, such as a director of pharmacy.
pharmaphorum
JANUARY 24, 2024
BenevolentAI’s search for a new chief executive has concluded with the appointment of industry bigwig Dr Jörg Möller to the role, four months after Joanna Shields stepped down and as the company emerges from a restructuring drive. The UK artificial intelligence specialist said in a statement that Möller is “an accomplished R&D leader and champion of the application of AI to drug discovery.
Hospital Pharmacy Europe
JANUARY 24, 2024
Fluoroquinolone antibiotics should only be prescribed when ‘no other antibiotics are appropriate for use’, according to a new MHRA drug safety update. From 22 January 2024, fluoroquinolone antibiotics given systemically – by mouth, injection or inhalation – must only be administered when other recommended antibiotics ‘have failed, will not work due to resistance, or are unsafe to use in an individual patient’, the regulatory agency said.
The Checkup by Singlecare
JANUARY 24, 2024
Whether you need support during a short-term period of grief and loss or you live with long-term depression , your healthcare provider may recommend the use of an antidepressant. Medications like SSRIs, SNRIs, atypical antidepressants, TCAs, and MAOIs are primarily used to alleviate depression symptoms like sadness, hopelessness, difficulty concentrating, and loss of interest in activities you once enjoyed.
Board Vitals - Pharmacist
JANUARY 24, 2024
The American Board of Internal Medicine (ABIM) offers initial certification exams across 19 medical specialties. Newly released pass rate data for 2023 sheds light on trends and challenges faced by healthcare professionals pursuing board certification. These statistics provide some extra insight on just how difficult the ABIM board exams are, and the importance of adequate exam prep.
Hospital Pharmacy Europe
JANUARY 24, 2024
The poly ADP-ribose polymerase (PARP) inhibitor talazoparib (brand name Talzenna) has been recommended by the National Institute for Health and Care Excellence (NICE) to treat a type of locally advanced or metastatic breast cancer. The final draft guidance from NICE recommends talazoparib for the treatment of adults with BRCA 1 or 2 mutated HER2-negative locally advanced or metastatic breast cancer after prior chemotherapy.
Fierce Healthcare
JANUARY 24, 2024
Cleveland Clinic CEO and President Tom Mihaljevic, M.D., is promising his team a year of workforce development, physical security initiatives and sustainable growth amid an industry rife with risin | Despite 2023's tight 0.4% operating margin, CEO Tom Mihaljevic, M.D., told employees that the nonprofit system is prioritizing continued workforce investments and worldwide expansion.
Fierce Pharma
JANUARY 24, 2024
It’s been four years since Japan Tobacco snagged approval in its home country for its topical JAK inhibitor delgoci | It’s been four years since Japan Tobacco snagged approval in its home country for its topical JAK inhibitor delgocitinib to treat atopic dermatitis. Slowly but surely, Denmark’s Leo Pharma—which gained the rights to develop and commercialize delgocitinib in the rest of the world a decade ago—is working toward its first green light for the topical cream.
Drug Topics
JANUARY 24, 2024
The Affordable Care Act mandates that contraceptives must be covered by health plans and insurers without cost-sharing.
Outsourcing Pharma
JANUARY 24, 2024
Andrew Mills, executive vice president of global commercial Lokavant and says the company can help businesses identify risk trends in trials much earlier than traditional methods.
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