Wed.Jan 24, 2024

article thumbnail

Oral Simnotrelvir May Shorten Recovery Time of Patients With Mild-to-Moderate COVID-19

Drug Topics

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.

201
201
article thumbnail

FDA Adds Boxed Warning to Denosumab for Increased Risk of Hypocalcemia in Patients With CKD

Pharmacy Times

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.

FDA 149
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

FDA Requests Black Box Warning for Approved CAR-T Therapies Over Secondary Cancer Concern

Drug Topics

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.

FDA 199
article thumbnail

New chronic Covid study offers insight into which immunocompromised patients are most at risk

STAT

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.

article thumbnail

From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

article thumbnail

Pharmacy Focus: Policy Edition - PBM Audits

Pharmacy Times

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.

139
139
article thumbnail

Opinion: Defunding liberal arts is dangerous for health care

STAT

If you want an argument in favor of teaching the humanities, I suggest you ask a medical educator. Across the U.S., the age-old debate about the value of a liberal arts education has seemingly devolved into mortal combat, leaving the humanities in dire straits on college campuses. For example, the Atlantic recently reported on West Virginia University’s decision to gut its humanities programming, and the New York Times wondered whether the liberal arts will exist after the budget cuts hap

More Trending

article thumbnail

Opinion: After 20 years in rehabilitation research, my young daughter’s traumatic brain injury transformed my mind and my career

STAT

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?

Hospitals 145
article thumbnail

CG Oncology is first biotech IPO of 2024, raising $380m

pharmaphorum

CG Oncology completes the first biotech IPO of 2024, raising $380 million for its oncolytic virus bladder cancer immunotherapy.

132
132
article thumbnail

‘The response defies belief’: Year of inaction leaves children at risk from bad cancer drugs

STAT

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.

article thumbnail

Pharma Horizons: Artificial Intelligence

European Pharmaceutical Review

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.

130
130
article thumbnail

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.

article thumbnail

STAT+: Osteoarthritis might be linked to protein known for its role in Alzheimer’s, study says

STAT

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.

139
139
article thumbnail

Instacart taps DispatchHealth to expand its reach to home care providers

Fierce Healthcare

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.

128
128
article thumbnail

STAT+: FDA OKs — but doesn’t require — a non-cancer-causing chemical for sterilizing devices

STAT

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.

FDA 135
article thumbnail

Patients With Migraines Often Experience Stigma Related to Symptoms

Pharmacy Times

Migraines are not a one-size-fits-all condition, and there is no one-size-fits-all solution.

123
123
article thumbnail

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.

article thumbnail

As NIH grant runs out, Dog Aging Project founders look to raise up to $50 million

STAT

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.

134
134
article thumbnail

Walgreens exploring sale of specialty pharmacy company Shields Health: media report

Fierce Healthcare

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.

article thumbnail

Lilly’s gene therapy restores hearing in an 11-year-old, paving way for more treatment

STAT

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.

126
126
article thumbnail

Why this Fortune 100 company swapped from Caremark to a startup PBM

Fierce Healthcare

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.

122
122
article thumbnail

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.

article thumbnail

Choosing Multiple Myeloma Regimens

Pharmacy Times

Gabriel Hinojosa, PharmD, BCOP, provides insights on selecting the best treatment regimen, and considers comorbidities, adverse events, and therapy modifications in multiple myeloma treatment.

121
121
article thumbnail

The Omni Advantage: A concise roadmap for change, for the people

pharmaphorum

"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.

116
116
article thumbnail

Nivolumab Plus Ipilimumab Improves PFS in Patients with MSI-H/dMMR mCRC

Pharmacy Times

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.

article thumbnail

Gilead's Tecartus gets revised safety demand amid FDA's push for CAR-T boxed warnings

Fierce Pharma

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.

FDA 115
article thumbnail

A year of major M&A ahead?

pharmaphorum

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.

113
113
article thumbnail

Federal officials trumpet record high ACA enrollment

Fierce Healthcare

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.

Insurance 111
article thumbnail

LEO says chronic hand eczema drug bests its only rival

pharmaphorum

LEO Pharma's chronic hand eczema drug delgocitinib has outperformed the only approved drug for the condition in a phase 3 trial.

111
111
article thumbnail

Accent Therapeutics secures funding to advance cancer therapies

Pharmaceutical Technology

Accent Therapeutics has raised $75m in a Series C financing round to progress the development of precision cancer therapies.

109
109
article thumbnail

Consultation on draft Standards for Chief Pharmacists launched by GPhC

Hospital Pharmacy Europe

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.

Hospitals 105
article thumbnail

BARDA backs Locus phage therapy for resistant E coli

pharmaphorum

BARDA has given $24 million to Locus Bio to support a mid-stage trial of bacteriophage therapy LBP-EC01 for resistant E coli infections.

105
105
article thumbnail

Drug safety update says fluoroquinolone antibiotics should be last resort

Hospital Pharmacy Europe

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.

article thumbnail

BenevolentAI names pharma vet Jörg Möller as its new CEO

pharmaphorum

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.

105
105
article thumbnail

Evidence presented for use of whole genome sequencing in optimising cancer treatment

Hospital Pharmacy Europe

Combining routine clinical data with whole genome sequence (WGS) data at scale supports clinicians in the delivery of precision cancer care, according to new landmark research. Published in the journal Nature Medicine , the study showed that WGS could provide a more comprehensive view of a tumour’s genetic landscape by detecting various genetic changes using a single test.

Hospitals 105
article thumbnail

4DMT secures rare paediatric designation for cystic fibrosis gene therapy

Pharmaceutical Technology

The company could be in line for a priority review voucher if 4D-710, currently in Phase I/II clinical trials, is approved.

104
104
article thumbnail

What are the most common depression medications?

The Checkup by Singlecare

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.