Fri.Jun 16, 2023

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Opinion: The FDA needs a risk evaluation and mitigation strategy for Alzheimer’s drug lecanemab

STAT

Over the past several months, my conversations with colleagues in the Alzheimer’s field have featured an unusual sentiment: optimism inflected with worry. Optimism because, after years of failed studies and the disastrous accelerated approval of aducanumab, we’re enjoying a less than one-year-old streak of good news. The latest bright flash is the June 9 Food and Drug Administration hearing on the anti-amyloid antibody lecanemab (to be sold by Eisai as Leqembi).

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Shaking up pharma: Change that leaders would like to see

PharmaVoice

Industry execs give voice to the “game changers” they believe would have the greatest impact on the healthcare ecosystem for all.

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Opinion: The DNA from dog tumors may hold the secret to better human cancer drugs

STAT

This year, nearly 6 million dogs in the U.S. will receive a cancer diagnosis. That’s approximately three times greater than the number of Americans who will be diagnosed with cancer this year, even though humans are estimated to outnumber pet dogs by nearly 4 to 1. Yet the genetic similarities between human and dog cancers may point the way to treatments that can save lives on both ends of the leash.

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How pharma execs are approaching drug pricing and other quandaries

PharmaVoice

From implementation of the Inflation Reduction Act, to the looming patent cliff and more, pharma leaders have a lot on their plates.

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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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Testosterone supplementation not linked to heart attacks in study, reversing earlier finding

STAT

Testosterone supplementation in men with low levels of the hormone did not increase the risk of heart attacks in a 5,246-patient study, allaying fears that were raised more than a decade ago in a smaller trial, researchers said Friday. Although the results ease a significant safety concern about testosterone-containing gels and patches, the researchers running the study emphasized it does not address the more widespread use of such products in men who have normal levels of testosterone but who h

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Black Seed Oil and Hashimoto’s

The Thyroid Pharmacist

Over the past few years, my mission to help people recover from Hashimoto’s has become increasingly focused on using food as medicine (or food pharmacology) to address many of the root causes and symptoms of thyroid conditions. In addition to incorporating healing foods into my diet, I’ve also discovered many herbs and spices that can have profound benefits for healing.

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Rosemont acquires Lucis Pharma to boost portfolio

Pharma Times

Company will gain access to a considerable pipeline of liquid products covering various disease areas - News - PharmaTimes

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STAT+: Pharmalittle: FDA cites another troubled plant at company contributing to cancer drug shortages; USDA to push food producers over antibiotic claims

STAT

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up, but we plan to manicure the grounds, promenade with the official mascots and check in on the Pharmalot ancestors. And if time permits, there may be another listening party, where the rotation may include this , this, this, and this.

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Dr Sanjay Kumar Jain, President – India Operations, Amneal Pharmaceuticals

Express Pharma

In this video: Dr Sanjay Kumar Jain, President – India Operations, Amneal Pharmaceuticals Topic: Enabling and optimising operational excellence Key Takeaway: Performance management, leadership, people, culture, continous improvement, risk and quality management etc are some of the key enablers of operational excellence. The post Dr Sanjay Kumar Jain, President – India Operations, Amneal Pharmaceuticals appeared first on Express Pharma.

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STAT+: Up and down the ladder: The latest comings and goings

STAT

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.

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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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Biopharmaceutical science powered by PRIDE

PhRMA

This June marks Lesbian, Gay, Bisexual, Transgender and Queer (LGBTQ+) Pride Month. At PhRMA, we’re proud to celebrate the diversity and inclusion of our LGBTQ+ colleagues and the patients our companies aim to help. As an industry driven by science, we believe diversity in the lab drives greater collaboration, scientific advancement and groundbreaking medicines impacting the lives of patients.

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STAT+: Trade group scolds drugmaker for ‘unethical’ attempt to gain info about rival product

STAT

In a notable move, a U.K. trade group has rebuked Leo Pharma for a “serious and extremely concerning” violation of voluntary codes after learning a company manager coerced staff into gaining competitive information. And by doing so, the drugmaker discredited and lowered confidence in the pharmaceutical industry. The incident involved an attempt by a Leo manager to gain pricing information about a rival medicine from an unnamed individual who, at the time, worked for the U.K.

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genedrive awarded test kit grant

Pharma Times

DEVOTE grant will allow acute care patient access and a supporting infrastructure for the company - News - PharmaTimes

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How can AI be best harnessed for pharmacovigilance data?

European Pharmaceutical Review

According to a recent review funded by GSK Biologicals, artificial intelligence (AI) and machine learning (ML) seems intuitively, to be well suited to perform pharmacovigilance (PV) tasks given the large volume of data, high degree of uncertainty and need to learn from data. However, the paper highlighted the challenges these technologies hold for analytics.

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Neil O’Brien: 'Balance must be found on prescription charges'

The Pharmacist

Pharmacy minister Neil O'Brien writes exclusively for The Pharmacist on why the Department for Health and Social Care considered changing the upper age limit for prescription charges - and why this week it announced its decision not to. Advances in healthcare and medicines means more people are living longer which provides great benefits, but also […] The post Neil O’Brien: 'Balance must be found on prescription charges' appeared first on The Pharmacist.

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Technology’s New Approach: One Gateway to Deliver Comprehensive Patient Support Services

Drug Channels

Today’s guest post comes from Derek Berven, Senior Director of Software Engineering at AssistRx. Derek explains how to streamline patient support services with a modular, scalable technology solution. He then discusses Advanced Gateway, a technology that integrates patient, provider, and manufacturer services. Click here to learn more about how AssistRx’s Advanced Gateway can impact patient support programs.

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Rise in sepsis deaths among newborns linked to antibiotic resistance

The Pharmacist

An increase in the number of newborns dying from sepsis is linked to antibiotic resistance, say researchers from University College London (UCL). In a recent study involving more than 3200 newborn babies in 11 different countries, the researchers found that the antibiotics used to treat sepsis are losing their effectiveness, increasing the death rate among […] The post Rise in sepsis deaths among newborns linked to antibiotic resistance appeared first on The Pharmacist.

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AMR cannot be tackled in a linear and singular manner: Union Health Secretary

Express Pharma

Union Health Secretary Chairs Inter-Sectoral Coordination Committee on Anti-Microbial Resistance Status of implementation of National Action Plan was discussed in the Inter-Sectoral Coordination Committee on Anti-Microbial Resistance (AMR) chaired by Rajesh Bhushan, Union Health Secretary. Highlighting the importance of coordinated multi-lateral actions to address the growing menace of AMR in the country, Union Health Secretary stated that “AMR cannot be tackled in a linear and singular manner.

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FDA approves off-the-shelf bispecific antibody cancer therapy

European Pharmaceutical Review

The first and only CD20xCD3 T-cell engaging bispecific antibody ( BsAb ) for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) that is given for a defined period of time has been approved by the US Food and Drug Administration (FDA). Genentech’s Columvi ® (glofitamab-gxbm) is indicated for adult DLBCL patients not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.

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New data: America is an API powerhouse

PhRMA

Policymakers and the media have been taking a close look at the medical supply chain recently, including the manufacturing locations of active pharmaceutical ingredients (APIs) for medicines used by Americans. APIs are what make a medicine a medicine — they are the substance in the medicine that treats or cures a disease or affects a condition within the body.

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Real-world evidence highlights the urgent need to act on the growing global burden of chronic kidney disease

World Pharma News

AstraZeneca, a leader in cardiorenal diseases, presented new real-world evidence (RWE) data at the European Renal Association (ERA) 2023 Congress in Milan, Italy, demonstrating the staggeringly low rate of diagnosis in chronic kidney disease (CKD). These data show that an urgent need exists for improved screening which can lead to earlier diagnosis.

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ASCO 2023 – Martin Vogel and Edmond Chan

pharmaphorum

Pharmaphorum Editor in Chief Jonah Comstock spoke with Martin Vogel and Edmond Chan, EMEA leads for oncology and haematology, respectively at Janssen.

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Unlocking the Potential of Medication Therapy Management

assurecare

In the complex landscape of modern healthcare, ensuring patient safety and optimizing medication use are critical for achieving positive health outcomes. Medication therapy management has emerged as a vital healthcare service that focuses on optimizing medication regimens to improve patient outcomes.

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Flamingo gets grant from VLAIO to accelerate RNA-focused oncology portfolio

Pharmaceutical Technology

Flamingo Therapeutics has received a research grant of €1.7m from Flanders Innovation & Entrepreneurship (VLAIO) to further advance its oncology portfolio targeting RNA. The grant will help Flamingo to support its translational research in a Phase II study of its lead clinical programme, danvatirsen, to treat head and neck squamous cell carcinoma.

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How digital transformation can revamp product and process visibility

pharmaphorum

How digital transformation can revamp product and process visibility Mike.

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Roche follows AbbVie with FDA approval for dual-targeting lymphoma drug

BioPharma Dive

The approval of Columvi adds another “bispecific antibody” to the market, highlighting the fast research progress for drugs that target two proteins rather than one.

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Look beyond ‘accuracy’ to ‘safety of supply’, says CPS chief

The Pharmacist

The chief executive of Community Pharmacy Scotland (CPS) has called on the community pharmacy profession to look beyond ‘accuracy of supply’ and towards ‘safety of supply’. Speaking at an event jointly organised by University College London School of Pharmacy, the Royal Pharmaceutical Society and National Pharmacy Association, Harry McQuillan set out his vision for ‘Community […] The post Look beyond ‘accuracy’ to ‘safety of supply’, says CPS chief appeared first on The Pharmacist.

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FDA advisers endorse updating COVID shots to match circulating virus strain

BioPharma Dive

The expert panel recommended coronavirus vaccines be tailored to target an omicron subvariant known as XBB, which Pfizer, Moderna and Novavax said they’re prepared to do.

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Sandoz launches action plan to improve access to biosimilar medicines

Pharmaceutical Business Review

Dubbed Act4Biosimilars Action Plan, the new roadmap has been designed to boost the adoption of global biosimilar products by at least 30% points in more than 30 countries by 2030. The action plan is part of Act4Biosimilars initiative, which was established by Sandoz and introduced last year. It features crucial challenges that bar patients from gaining access to biosimilar medicines.

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FDA clears Genentech’s Columvi for adults with R/R DLBCL

Pharmaceutical Technology

Roche Group member Genentech has secured approval from the US Food and Drug Administration (FDA) for its Columvi (glofitamab-gxbm) to treat adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The approval has been granted for patients with R/R DLBCL not otherwise specified or large B-cell lymphoma (LBCL) caused by follicular lymphoma, after two or more systemic therapy lines.

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Cala launches wearable to treat hand tremor in Parkinson's

pharmaphorum

Cala launches wearable to treat hand tremor in Parkinson's Phil.

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Coherus doubles down on immuno-oncology with latest deal

BioPharma Dive

Best known for its work in biosimilars, Coherus will acquire two drugs in human testing for various solid tumors through a roughly $65 million buyout of Surface Oncology.

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FDA delays review of GSK’s momelotinib for myelofibrosis

pharmaphorum

FDA delays review of GSK’s momelotinib for myelofibrosis Phil.

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FDA delays decision on GSK bone cancer drug acquired in $2B buyout

BioPharma Dive

GSK said it remains confident in its application supporting the myelofibrosis medicine momelotinib, which it bought in last year’s deal for Sierra Oncology.

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AZ, Leo, and Daiichi Sankyo rapped for ad transgressions

pharmaphorum

AZ, Leo, and Daiichi Sankyo rapped for ad transgressions Phil.

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