Fri.Jul 26, 2024

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Morning Rounds: Three new bird flu cases in humans brings total to 13 in U.S.

STAT

Want to stay on top of health news? Sign up to get our Morning Rounds newsletter in your inbox. I’m Brittany Trang, STAT health tech reporter and your new Friday morning host.

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Citius’ first FDA decision date is approaching — and its CEO has millions on the line

PharmaVoice

Citius Pharmaceuticals CEO Leonard Mazur has personally invested $22.5 million into the company, which is fast approaching a potential turning point.

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STAT+: How Pfizer’s grand gene therapy ambitions crumbled

STAT

A decade ago, Pfizer began investing heavily in gene therapy, bringing in experimental treatments for a range of genetic diseases, pumping $800 million into “state-of-the-art” manufacturing facilities and announcing its intention to become an “industry leader” that would deliver “one-time, transformative therapies” for rare diseases.

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How Cure51’s AI breakthroughs are turning cancer into a manageable disease – an insider’s look

Outsourcing Pharma

Discover the groundbreaking work of Cure51, co-founded by Nicolas Wolikow and Simon Istolainen, revolutionizing cancer treatment through advanced AI and biotechnology.

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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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STAT+: European regulators say Alzheimer’s therapy Leqembi should be rejected

STAT

LONDON — European regulators on Friday said that an Alzheimer’s therapy from Eisai and Biogen should be rejected, again diverging from their U.S. counterparts on a medicine for a condition where treatments are desperately needed. In a statement, the regulators said that the benefits of Leqembi did not outweigh the risks of potentially dangerous side effects.

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Leqembi voted down by European regulators

BioPharma Dive

Eisai plans to appeal the EMA’s negative recommendation, hoping to break into a market analysts expect could eventually bring billions of dollars in sales for the Alzheimer’s drug.

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AZ joins call for new UK PM to back Oxford-Cambridge hub

pharmaphorum

Leading figures from industry and academia, including AstraZeneca, have urged UK PM Keir Starmer to turn the Oxford-Cambridge region into the "crown jewel" of his industrial growth plan

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Opinion: Without federal oversight, nursing homes will put profit ahead of care

STAT

About 5% of Americans require skilled care at some point as they age. The horrific reports of more than 200,000 deaths of nursing home residents and staff during the Covid-19 pandemic put the nursing home industry under intense national scrutiny. But not all nursing homes experienced this level of tragedy and loss. One major reason why some fared better than others was adequate nurse staffing.

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AC Immune’s pTau-targeting immunotherapy awarded Fast Track designation by FDA

Pharmafile

Clinical-stage biopharmaceutical company AC Immune announced that the US Food and Drug Administration (FDA) has granted its Alzheimer’s disease (AD) candidate ACI-35.030 (now called JNJ-2056) Fast Track designation. ACI-35.030 is an active-immunotherapy targeting phosphorylated Tau (pTau). It has been shown to induce a strong polyclonal antibody response against Tau aggregation, thereby potentially reducing the pathological […] The post AC Immune’s pTau-targeting immunotherapy awarded Fast

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STAT+: Pharmalittle: We’re reading about a thumbs down for an Alzheimer’s drug, Pfizer gene therapy struggles, and more

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 fairly modest. We hope to catch up on our reading, spend time with our Pharmalot ancestor, and promenade with the official mascots. We also hope to hold another listening party, where the rotation will likely feature this , this , this , and this.

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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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Shingles shot could be a simple way to delay dementia

pharmaphorum

Vaccination with GSK's recombinant shingles vaccine Shingrix could delay the onset of dementia, according to researchers in the UK.A study published in Nature Medicine suggests that people administered Shingrix have a lower risk of dementia compared to those given Zostavax - an older shingles shot based on a different technology – and builds on earlier research suggesting a benefit from this type of vaccination.

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The worst for Dexcom may not be over

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. We’ve made it to the end of the week! I don’t know about you, but it’s felt like an especially long week for me. It’s probably cause of all the news that we will get into right now.

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Study reveals blood proteins predict risk of developing many diverse diseases

Pharma Times

Researchers predicted the onset of 67 diseases, out-performing current standard models

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Opinion: Sonya Massey’s death: How to prevent more killings of defenseless Black women

STAT

On July 6, 2024, Sonya Massey, 36, called 911 to report a potential home intruder at her home in Springfield, Ill. “Don’t hurt me,” were her first words to the two officers who responded. Deputy Sean Grayson reassured her, “Why would I hurt you? You called us.” When Massey was questioned about her mental well-being, she confirmed taking her medicine.

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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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STADA and Alvotech Announce Launch of UZPROVO® in Europe

Big Molecule Watch

On July 22, 2024, STADA Arzeimittel AG (“STADA”) and Alvotech announced the launch of ustekinumab biosimilar AVT04 under the name UZPROVO® across a majority of European countries. UZPROVO®, the first approved ustekinumab biosimilar to STELARA® in Europe, is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis. As we previously reported, Alvotech and STADA announced that the European Commission issued a marketing authorization for AVT04 in January 2024, and Alvotech

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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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In shock move, EU panel rejects Alzheimer's drug Leqembi

pharmaphorum

CHMP recommends against approval of Eisai, Biogen's Alzheimer's disease therapy Leqembi, saying side effects outweigh its benefits

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Scottish Government 'monitoring' payment system issues

The Pharmacist

The Scottish Government has said it is 'aware' of issues following the introduction of a new payment system for community pharmacies, and has been assured that any incorrect payments have been or are being 'rectified'. And it said it was engaging with stakeholders as it continued to monitor the situation. Issues with the Data Capture […] The post Scottish Government 'monitoring' payment system issues appeared first on The Pharmacist.

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NutrifyGenie AI: Pioneering the future of AI-driven nutraceutical innovation

Express Pharma

India is making significant strides in the nutraceutical industry with the launch of NutrifyGenie AI, a revolutionary technology set to transform new product ideation and commercialisation globally. Nutraceuticals, often seen as proactive health investments, are experiencing a strong compound annual growth rate (CAGR) of 7.8 per cent. This growth drives the need for innovative product development and new botanical and biochemical discoveries to enhance health outcomes.

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BREAKING: Over 423,000 Pharmacy First consultations delivered in first three months

The Pharmacist

Some 423,310 Pharmacy First consultations were delivered in the first three months of the service, official figures from the NHS Business Service Authority (NHSBSA) have revealed. A total of 9,976 community pharmacies claimed payments for the service, although the number of those claiming on a monthly basis in February, March and April appears to be […] The post BREAKING: Over 423,000 Pharmacy First consultations delivered in first three months appeared first on The Pharmacist.

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Eisai selects Medidata’s Clinical Data Studio to enhance clinical trial efficiency

Express Pharma

Medidata , a Dassault Systèmes brand and provider of clinical trial solutions to the life sciences industry, announced Eisai Inc the US pharmaceutical subsidiary of Tokyo-based Eisai Co, as one of the first customers to harness its recently announced AI-driven Medidata Clinical Data Studio. Eisai Inc aims to leverage this innovative data experience to gain control over its clinical data, enable the execution of scalable and complex clinical trials, and enhance patient experience.

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Two biotechs cut staff; AbbVie weathers biosimilar threat

BioPharma Dive

Glycomimetics and Cue Biopharma both revealed layoffs. Elsewhere, AbbVie’s earnings impressed Wall Street and an FDA panel recommended changing testing requirements for some lung cancer drugs.

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NovaLead’s patented repurposed drug gets CDSCO nod for DFU patients in India

Express Pharma

NovaLead Pharma announced that the drug regulator in India, CDSCO has approved their patented repurposed drug for the treatment of Diabetic Foot Ulcer (DFU). DFU is one of the most prevalent complications caused by chronic diabetes. The approval of NovaLead’s patented repurposed drug is significant because DFU is the leading cause of lower limb amputations globally, with about 100,000 annual incidences in India alone.

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New gut microbiome atlas could offer better treatment for digestive disorders

Pharma Times

The new Human Gut Microbiome Atlas could help treat conditions including IBS and AMR

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Calliditas Therapeutics announces positive phase 2b data in Primary Biliary Cholangitis trial

Pharmafile

Calliditas Therapeutics AB today announced that the phase 2b TRANSFORM trial met its primary endpoint. The trial showed statistically significant improvement in alkaline phosphatase (ALP) for both doses tested versus placebo. The trial evaluated setanaxib, a NOX enzyme inhibitor, in patients with primary biliary cholangitis (PBC) and elevated liver stiffness.

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Cohance, Suven merger get approval from NSE and BSE

Express Pharma

Suven Pharmaceuticals recently received approval from the National Stock Exchange (NSE) and Bombay Stock Exchange (BSE) for the proposed merger with Cohance Lifesciences. A joint application by Suven and Cohanc has been filed before NCLT. Expected timelines for the completion of the merger process as indicated prior: 12-15 months. The newly formed company will operate three main verticals: Pharma CDMO, Agrochemicals CDMO, and API manufacturing.

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Bristol Myers’ beat completes strong week of pharma earnings

BioPharma Dive

All five large pharmaceutical companies to report earnings this week raised either their profit or revenue guidance for the year.

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Revolutionising cancer treatment: The promise of point-of-care CAR-T therapy

Express Pharma

CAR-T cell therapy, a groundbreaking approach that genetically modifies patients’ T-cells, offers a targeted and effective means of combating cancer cells. Traditionally, CAR-T manufacturing has been confined to highly specialised laboratories, primarily in Western nations, resulting in prohibitive costs for many Indian patients. To address this challenge, promoting local manufacturing of CAR-T cells, aligned with the “Make in India” initiative, can significantly reduce expense

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New tentative approval for Alembic drug dabigatran etexilate mesylate

Drug Patent Watch

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five NDAs.

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Nearly half of UK adults 'unaware' of Pharmacy First, survey suggests

The Pharmacist

Almost half (46%) of UK adults were unaware of Pharmacy First around three months into the service being available in England, a survey has shown. However nearly three-quarters (73%) thought that pharmacists should be able to update medical records with any advice or treatment supplied – up from 65% last year. The survey was conducted […] The post Nearly half of UK adults 'unaware' of Pharmacy First, survey suggests appeared first on The Pharmacist.

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New patent for Springworks drug OGSIVEO

Drug Patent Watch

Annual Drug Patent Expirations for OGSIVEO Ogsiveo is a drug marketed by Springworks and is included in one NDA. It is available from one supplier. There are twenty-one patents protecting this drug.

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AI revolution in pharma: Qinecsa's James Bellamy unveils groundbreaking PV tech insights

Outsourcing Pharma

In a candid interview at the DIA conference, James Bellamy, leader of the Solutions Consulting team at Qinecsa, shared his insights into the evolving landscape of pharmacovigilance (PV) technology.

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Biggest Reasons the GPhC Fail Pharmacies who Prescribe Online

pharmacy mentor

The General Pharmaceutical Council (GPhC) is the regulatory body responsible for ensuring that pharmacies in the UK operate safely and effectively, particularly when it comes to online services. Despite the increasing demand for online pharmaceutical services, some online pharmacies fall short of the GPhC’s stringent standards. With that in mind, we are bringing you the latest guidance on what the GPhC is talking about during inspections, and why they are failing some pharmacies that prescribe o

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Health Innovators - Steve Damon

pharmaphorum

Discover the innovative work of Steven Damon, the CEO of Micron Biomedical, a company specialising in microneedle technology for improved healthcare delivery. Learn about his cutting-edge innovations in the field.

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