Wed.Jul 24, 2024

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Oral Dissolvable Birth Control Pill Receives Approval From the FDA

Pharmacy Times

The decision offers patients with difficulty swallowing their medication expanded options for treatment administration.

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Opinion: An aging geriatrician wonders: Who will care for me?

STAT

In 1988, I became one of the first U.S. physicians certified in the new specialty of geriatric medicine, which focuses on the health care of older adults. As an idealistic and optimistic 32-year-old geriatrician, I believed that this branch of medicine would undoubtedly emerge as a vibrant field of medicine, benefiting patients and society. I was also confident that when I reached older adulthood, the health care system would be ready to care for me.

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Analysis Findings Indicate Relationship Between Maternal Asthma and Risk for Autism Spectrum Disorders

Pharmacy Times

Studies show an increased prevalence of autism spectrum disorder in children of mothers; mouse models have shown links between maternal asthma and altered behavior and brain function.

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STAT+: Jiankui He, creator of CRISPR-edited children, relocates to a Chinese medical tourism hub

STAT

Jiankui He, the Chinese scientist who s parked a global uproar in 2018 when he revealed he had created the first gene-edited children , is again out on his own after being dismissed from an academic post. In January 2019, provincial health authorities found that He’s human CRISPR experiments violated national regulations against gene-editing for reproductive purposes.

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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

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NASH Affects Millions, But the Future for Treatment Remains Brighter Than Ever

Pharmacy Times

Emerging treatments, collaboration between health care providers, and new policy proposals have led to a positive outlook for the future of nonalcoholic steatohepatitis (NASH) and its treatment.

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STAT+: Viking accelerates development of obesity drug that could rival Wegovy, Zepbound

STAT

Viking Therapeutics plans to move its injectable obesity treatment into a Phase 3 study faster than expected, bringing the biotech closer to joining the highly competitive GLP-1 drug market.  The San Diego-based biotech previously said it was anticipating to start a Phase 2b trial of the therapy, VK2735, after getting positive results from a Phase 2 study.

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Key disability civil rights law will get a big refresh under Sen. Bob Casey’s new bill

STAT

A key piece of disability civil rights law could get a much-needed refresh. Sen. Bob Casey Jr. (D-Pa.) will introduce legislation Wednesday to strengthen and extend Section 508 of the Rehabilitation Act of 1973. The proposed update would boost online accessibility for people with disabilities on federal websites and significantly expand protections and working conditions for disabled federal employees.

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CMS: Insurers to make $10.3B in 2023 risk adjustment payments

Fierce Healthcare

The Centers for Medicare & Medicaid Services (CMS) has released new data on risk adjustment payments for 2023. | The Centers for Medicare & Medicaid Services has released new data on risk adjustment payments for 2023.

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STAT+: Pfizer gene therapy reduced hemophilia bleeds, but questions remain

STAT

Pfizer said Wednesday that its gene therapy for hemophilia A successfully reduced patients’ bleeds for at least 15 months in a large phase 3 trial. The data may be enough to muster approval, but they are unlikely to quell doubts about whether the treatment can provide a cure — as had once been hoped — or a meaningful option for most patients in the U.S. and Europe with the rare blood disorder.

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Dovato Offers Similar Efficacy, Less Weight Gain to Biktarvy in Head-to-Head Trial

Drug Topics

PASO DOBLE is the largest head-to-head, phase 4 randomized clinical trial comparing DTG/3TC and BIC/FTC/TAF in patients with HIV.

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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.

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FDA Approves Cerliponase Alfa for Expanded Indication of CLN2 Disease

Pharmacy Times

In April 2017, the drug was approved to treat the slow loss of the ability to walk for symptomatic patients aged 3 and older who had Batten disease.

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EMA Accepts GSK Application for Blenrep Combinations in Multiple Myeloma Treatment

BioPharm

GSK’s submission is supported by Phase III trials showing significant progression-free survival benefit and positive overall survival trends using Blenrep combinations compared to standard care.

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Merck lays off workers amid rough pharma job market

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning. Several of my colleagues have joined the newsletter today to bring you the latest biopharma updates. It’s a busy news day, especially for a summer Wednesday, so let’s get straight into it.

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ASCO 2024 - Matteo Levisetti

pharmaphorum

Stay updated on Matteo Levisetti, the chief medical officer at CUE Biopharma, post ASCO 2024. Learn about his latest research and contributions in the field of biopharma.

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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.

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Robotic aid helped improve balance, gait in children with cerebral palsy

STAT

For many kids with cerebral palsy, walking is taxing. They might spend thousands of hours step-stepping in physical therapy to make walking easier. In recent years researchers have developed robots to aid this rehabilitation. A new JAMA Network Open study from a team in South Korea found that exoskeletons can improve a child’s gait, balance and motor function.

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FDA blasts Indian CDMO Brassica for 'routine' data falsification, poor hygiene and more

Fierce Pharma

From flubbing data to performing aseptic processing with torn and stained gowns, Brassica Pharma’s recent warning letter from the FDA reads like a textbook example of what not to do when the U.S. | From flubbing data to performing aseptic processing with torn and stained gowns, Brassica Pharma’s recent warning letter from the FDA reads like a textbook example of what not to do when the U.S. regulator comes knocking at your facility.

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Lenacapavir for PrEP Shows 100% Efficacy in Preventing HIV

Drug Topics

Full efficacy and safety results for the phase 3 PURPOSE 1 trial were announced by Gilead at AIDS 2024.

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Intravenous Immunoglobulin Temporarily Improves Bleeding in Patients With Acquired Von Willebrand Syndrome

Pharmacy Times

It is essential for clinicians to properly diagnose patients with suspected AVWS and provide them proper treatment, which could be intravenous immunoglobulin.

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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.

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Pfizer Hemophilia A Candidate Shows Positive Topline Results

Drug Topics

Data will be discussed with regulatory authorities “in the coming months.

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DIA 2024: Charting new horizons in patient-centered R&D

pharmaphorum

Explore the latest developments in the life sciences industry with a focus on patient-centred research and development (R&D) at DIA 2024. Chart new horizons and stay updated on key trends shaping the future of healthcare.

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BeiGene CEO eyes biologics deals for new US innovation center in New Jersey

Fierce Pharma

HOPEWELL, NEW JERSEY—A new 42-acre campus in New Jersey gives BeiGene CEO John Oyler hope that the company can strike new partnerships in biologics. | A new 42-acre campus in New Jersey gives BeiGene CEO John Oyler hope that the company can strike new partnerships in biologics.

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PBMs under the cosh at House hearing on drug pricing

pharmaphorum

The top three pharmacy benefit managers in the US felt the heat at a hearing of the House Oversight Committee, as lawmakers grilled executives over their business practices and accused them of monopolising the supply chain.

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Med List Review – Renal Concerns

Med Ed 101

In this post, I will share some questions that I would investigate from this medication list. I have many questions surrounding renal concerns given the use of sevelamer. Sevelamer is a phosphate binder that is typically used to lower phosphate levels for patients with CKD. If this patient truly has CKD and significant impairment, many […] The post Med List Review – Renal Concerns appeared first on Med Ed 101.

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Asarina folds as it ends search for Tourette's drug partner

pharmaphorum

Asarina Pharma has abandoned its partner search for Tourette's drug sepranolone and will go into liquidation.

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Pharma Pulse 7/24/24: Addressing OUD Treatment Gaps, Body Dysmorphic Disorder Most Common in Adolescent Girls & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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MSD stakes claim to RSV prevention market for infants

pharmaphorum

MSD's phase 2b/3 data with clesrovimab for RSV prevention in infants sets up a challenge to Sanofi and AstraZeneca's fast-growing Beyfortus

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During Summer Months, Counsel Patients on Preventing Lyme Disease

Pharmacy Times

Education about prevention measures and early signs and symptoms of the condition are crucial

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Biogen, Sage drug for essential tremor flunks mid-stage test

pharmaphorum

Biogen's $3bn alliance with Sage has had another setback after a drug for essential tremor failed a phase 2 study.

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Voices in Pharmacy: July 2024 Expert Interviews

Drug Topics

Check out these featured Drug Topics interviews from July 2024.

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Standing ovation for Gilead as it boasts perfect efficacy in HIV PReP trial

Pharmaceutical Technology

The crowd and panel gave Gilead a standing ovation after the full data from the Phase III PURPOSE trial was announced at AIDS 2024.

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Q&A: Discovering the Powerful Impact of Community Pharmacy

Drug Topics

In part 3 of his conversation with Drug Topics on Over the Counter, Mayank Amin, PharmD, RPh, MBA, continues his inspiring story of reopening Skippack Pharmacy and details the beginnings of The Superman Pharmacist.

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FDA Approves IncobotulinumtoxinA for the Simultaneous Treatment of Upper Facial Lines

Pharmacy Times

The decision expands the use of incobotulinumtoxinA beyond treatment of frown lines.

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Opinion: STAT+: Cell donors are essential for new therapies. They need to be taken care of

STAT

Cutting-edge FDA-approved therapies made from human cells are now being used to treat cancer, diabetes, and other diseases. Currently, most approved cell-based therapies use an individual’s own cells, but the next generation of these therapies will be made from donor-derived blood and tissue. That raises critical questions about how to recruit, retain, and fairly compensate donors while ensuring their safety throughout the donation process.

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