Sat.Jun 24, 2023 - Fri.Jun 30, 2023

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STAT+: Grail faces uphill battle to get Medicare to cover its cancer screening test

STAT

WASHINGTON — Grail is aggressively lobbying to get Medicare to pay for its cancer-screening test Galleri — but experts tell STAT that the company has a far more complicated path to that end than the makers of most medicines or medical devices. Grail’s controversial blood test Galleri screens for multiple cancers. The Food and Drug Administration has not yet approved it, so Medicare hasn’t had to make a decision on whether to cover it or not.

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Pursuing a Career in Pharmacy: Empowering LGBTQIA+ Students through Advocacy and Diversity

Pharmacy Is Right For Me

Join us as we explore the inspiring journey of Cayden Miller, a passionate pharmacy graduate from Southern Illinois University at Edwardsville School of Pharmacy. Cayden’s experience as a member of the LGBTQIA+ community has shaped his path in pharmacy, driving him to become an advocate for diversity, equity, and inclusion (DEI) within the profession.

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Transgender patients are rarely included in clinical trials. Can pharma fix it?

PharmaVoice

Transgender and nonbinary patients suffer more adverse health outcomes than the general population, yet are often underrepresented in clinical research. Now, there’s momentum to change the status quo.

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BioMarin finally secures FDA approval of hemophilia gene therapy

BioPharma Dive

After a prolonged journey, the medicine, known as Roctavian, is now cleared for certain patients with hemophilia A, the more common form of the rare bleeding disorder.

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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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ADA says all diabetes patients should be screened for nonalcoholic fatty liver disease

STAT

SAN DIEGO — The American Diabetes Association said Sunday that all adults with type 2 diabetes or prediabetes should be screened for nonalcoholic fatty liver disease, an increasingly prevalent condition that can lead to serious liver damage. There are no approved medications for the disease, but among available diabetes drugs, the ADA singled out GLP-1 treatments as an option doctors could consider, according to recommendations published during the annual ADA conference.

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Your favourite nutraceuticals can be toxic: Discovered by Nutrify Genie

Express Pharma

Nutrify Genie combines information, speed, accuracy, and quality in the design of new products. However, it is crucial to consider potential concentrations of unwanted substances like pesticides and contaminants, including mycotoxins, during the extraction process The integration of plant-based nutraceuticals into a diverse diet has gained global attention due to their ability to promote health.

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5 FDA decisions to watch in the third quarter

BioPharma Dive

By the end of September, the FDA will hold two anticipated advisory meetings and issue important decisions on drugs for Alzheimer’s, depression and a type of vision loss.

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STAT+: Illumina to lay off 10% of research and development team in bid to cut costs by $100 million

STAT

SAN DIEGO — Months after announcing plans to cut costs by $100 million, DNA sequencing giant Illumina has begun to lay off 10% of its research and development team, according to internal emails obtained and reviewed by STAT. The layoffs, which began last Wednesday, impact research teams across the company’s California sites in San Diego and Foster City, as well as locations in Madison, Wisconsin; Singapore; and the United Kingdom.

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In Depth Focus QA/QC Microbiology/RMM 2023

European Pharmaceutical Review

A collaborative approach to advancing adoption of RMMs EPR ’s Caroline Peachey explores collaborative efforts to accelerate validation and adoption of rapid microbial methods across the pharmaceutical industry. The power of rapid methods for fungal ID By leveraging rapid identification techniques, pharmaceutical facilities can enhance their ability to detect and mitigate fungal contamination, safeguarding product quality and patient safety.

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A pharma summer — how leaders unwind and recharge their teams in the warmer months

PharmaVoice

Vacation is calling, but so are patients. Here's how the industry adjusts in the summer.

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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With FDA approval in hand, BioMarin lays out plan to sell $2.9M gene therapy

BioPharma Dive

The agency granted a long-awaited clearance on Thursday, but unexpected aspects of the hemophilia treatment’s label had some investors worried about its commercial prospects.

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Malaria cases in Florida and Texas: Here’s what you need to know

STAT

The five cases of malaria diagnosed in Florida and Texas in recent weeks — the first cases of local transmission in the United States in 20 years — have worried some residents and led state and federal officials to issue public alerts about the cluster of infections. But scientists and public health officials, while advising people in the affected areas to take precautions, say there is little cause for alarm, for several reasons: The number of cases is very low; there are easy, lo

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Microbiome therapies: a maturing movement

European Pharmaceutical Review

Riding on the momentum of the first faecal microbiota product approved for C. difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. Recent developments in microbiome therapeutics In May this year, first-in-human study interim results revealed that a CRISPR-based microbial gene therapy can “eliminate antibiotic-resistant E. coli strains in the gut”.

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A unique study on COVID shows how machine learning can help personalize medicine

PharmaVoice

Based on real-world data from patients in China, researchers were able to pinpoint factors that led to recurring infections — and which drug combos helped.

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Best Practices to Streamline Compensation Management: A Foundation for Growth

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

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Health Canada approves Endo’s anti-seizure pills

Pharmaceutical Technology

Health Canada has approved Endo International’s Xcopri as adjunctive therapy in the management of partial-onset seizures in adults with epilepsy.

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Medical leaders decry Supreme Court decision on affirmative action

STAT

Medical leaders on Thursday reacted swiftly to the Supreme Court’s decision to severely restrict the use of race in college admissions, saying the ruling could reverse decades of progress toward diversifying the nation’s physician workforce — something seen as key to helping end the country’s widespread and deeply entrenched health disparities.

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Alzheimer’s vaccine granted Fast Track designation

European Pharmaceutical Review

AC Immune SA has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy vaccine candidate for Alzheimer’s disease. This follows FDA clearance of the Investigational New Drug (IND) application, enabling expansion to the US of the ongoing Phase Ib/II ABATE study of ACI-24.060 in Alzheimer’s patients and individuals with Down’s syndrome.

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F-Prime’s Ketan Patel on ‘reverse ageism’ in biotech and investing in a downturn

BioPharma Dive

The life sciences investor spoke with BioPharma Dive about emerging life sciences markets around the globe and why the firm invests in first-time biotech founders.

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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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NASH drugs race to cross the finish line

Pharmaceutical Technology

After Intercept’s Ocaliva rejection, multiple companies are taking aim at becoming the first US-approved NASH therapy.

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Gates Foundation to fund trial of long-awaited new tuberculosis vaccine candidate

STAT

The Gates Foundation unveiled plans Wednesday to fund a long-awaited trial for what, if proven effective, would be the first new tuberculosis vaccine in over a century. The 26,000-person, Phase 3 study, set to begin next year, will test a vaccine known as M72/AS01 that showed promising results from a smaller trial in 2019. The findings stoked excitement at the time.

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More than 60 researchers ask Congress to support innovation

PhRMA

Earlier this month, 62 researchers from our member companies came to Washington, DC to meet with congressional offices during our annual fly-in event. This year included a record-breaking number of meetings — 145 over the course of the day.

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10 clinical trials to watch in the second half of 2023

BioPharma Dive

A Duchenne gene therapy faces a crucial test, while highly anticipated study results are expected in lung cancer, obesity and heart disease.

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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Genfit and Ipsen announce elafibranor results

Pharma Times

ELATIVE, a randomised PBC trial involving 161 patients, has successfully met its primary endpoint - News - PharmaTimes

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Supreme Court strikes down use of affirmative action, a blow to efforts to diversify medical schools

STAT

Overturning decades of precedent, the U.S. Supreme Court on Thursday struck down the use of affirmative action, ruling that it is unconstitutional for colleges, universities — and professional schools for law, medicine, and nursing — to consider race as one factor in deciding who they will admit. The decision comes as a blow to many in the field of medicine, which has been unable to appreciably increase the numbers of Black, Hispanic, and Indigenous doctors in recent decades.

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Low Dose Naltrexone and Hashimoto’s

The Thyroid Pharmacist

Have you heard of low dose naltrexone, or LDN? Since the beginning of my Hashimoto’s journey, this medication has been on my radar – and in recent years, I have learned so much more about it. In 2015, I conducted a survey of over 2000 readers with Hashimoto’s , asking for the most helpful interventions in their health journeys. One reader wrote: “Low Dose Naltrexone changed my life for the better.

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Lilly takes over partner working on cell therapies for diabetes

BioPharma Dive

Sigilon Therapeutics, a biotech that’s been collaborating with Lilly since 2018, has agreed to be bought for up to $310 million in the pharma’s second announced buyout this month.

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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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Global PAT market expected to exceed $10b in 2032

European Pharmaceutical Review

Demand for process analytical technology ( PAT ) is being driven by the growing adoption of automation and digitalisation in sectors such as pharmaceutical industry, a report by Market.us has found. With PAT being widely used in pharma, rising R&D expenses are anticipated to boost demand for these technologies. Growth and limitations in the global PAT market The PAT market is expected to grow $10.6 billion in 2032, the report suggested.

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STAT+: Protesters slam health insurance lobby for Medicare Advantage coverage restrictions

STAT

WASHINGTON — Hundreds of activists rallied today outside of the headquarters of the country’s largest health insurance lobbying group to protest against restrictions to coverage in private Medicare plans. The protesters were crammed into an already busy part of the city. A 10-minute walk from the Capitol building and a block off the National Mall, the headquarters for America’s Health Insurance Plans is located in a part of Washington that is crowded with tourists during the

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Orsini Selected by Sarepta Therapeutics to Dispense ELEVIDYS (delandistrogene moxeparvovec-rokl), the First Gene Therapy to Treat Duchenne Muscular Dystrophy

Orsini Pharmacy

Orsini Specialty Pharmacy, a leading independent specialty pharmacy focused on rare diseases and gene therapies, has been selected by Sarepta Therapeutics, Inc. as one of its limited distribution providers of ELEVIDYS (delandistrogene moxeparvovec-rokl). ELEVIDYS is the first gene therapy for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne Muscular Dystrophy (DMD) with a confirmed mutation in the DMD gene and is contraindicated in patients with any deletion in

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Novartis, continuing revamp, sells eye drugs to Bausch + Lomb for up to $2.5B

BioPharma Dive

An agreement to divest the dry eye disease treatment Xiidra and a few other medicines adds to the Swiss pharma's yearslong push to slim down from the healthcare conglomerate it once was.

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First cell therapy approved for Type 1 diabetes

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Lantidra, the first cell therapy for certain adults with Type 1 diabetes. The allogeneic pancreatic islet therapy is made from deceased donor pancreatic cells and is indicated for Type 1 diabetes patients who are unable to approach target glycated haemoglobin due to current repeated severe hypoglycaemia episodes even with intensive diabetes management and education.