Sat.Nov 11, 2023 - Fri.Nov 17, 2023

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AI-Driven Strategies: Pharma’s Answer to Patent Expirations

Drug Patent Watch

In a recent article in Pharmaceutical Executive, Alan Kalton, Senior Vice President of Commercial Strategy at Aktana, sheds light on the critical challenges facing pharmaceutical companies as they confront impending… The post AI-Driven Strategies: Pharma’s Answer to Patent Expirations appeared first on DrugPatentWatch - Make Better Decisions.

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STAT+: U.K. approves world’s first CRISPR-based medicine, giving greenlight to therapy for sickle cell, thalassemia

STAT

LONDON — Regulators in the U.K. on Thursday approved a CRISPR-based medicine to treat both sickle cell disease and beta thalassemia, making it the world’s first therapy built on the revolutionary gene-editing technology and ushering in a new phase of genetic medicine.   The authorization of the therapy, from Vertex Pharmaceuticals and CRISPR Therapeutics, is itself not a surprise.

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AstraZeneca showed the pandemic isn’t over for immunocompromised patients. What’s next?

PharmaVoice

Dr. Paul Moss, a hematology expert in the U.K., conducted a study with AstraZeneca showing the alarming extent to which immunocompromised patients are burdened with COVID-19.

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SAEM Clinical Images Series: Pediatric Genitourinary Bleeding

ALiEM - Pharm Pearls

A 4-year-old female with no significant past medical history is brought to the Emergency Department by her grandmother for concern for two days of progressive vaginal bleeding. The grandmother first noted blood in the patient’s underwear the previous morning when she was helping the patient wipe and she noticed it again prior to arrival, this time saturating the patient’s underwear.

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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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Breaking: Pharmacy First to launch end of January

The Pharmacist

The highly anticipated Pharmacy First common conditions service in England is set to launch at the end of January, it has been announced. The news comes as part of a series of announcements confirmed by NHS England (NHSE) and Community Pharmacy England (CPE) today, which also included updates on contraception and hypertension services. And CPE […] The post Breaking: Pharmacy First to launch end of January appeared first on The Pharmacist.

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STAT+: UnitedHealth faces class action lawsuit over algorithmic care denials in Medicare Advantage plans

STAT

A class action lawsuit was filed Tuesday against UnitedHealth Group and a subsidiary alleging that they are illegally using an algorithm to deny rehabilitation care to seriously ill patients, even though the companies know the algorithm has a high error rate. The class action suit, filed on behalf of deceased patients who had a UnitedHealthcare Medicare Advantage plan and their families by the California-based Clarkson Law Firm, follows the publication of a STAT investigation Tuesday.

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SAEM Clinical Images Series: More Than Skin Deep

ALiEM - Pharm Pearls

A 57-year-old female college counselor living in the northeastern United States with no PMH presented for evaluation of rash, joint pain, and dyspnea for the past three weeks. The patient first noticed the rash on her upper back, describing it as being itchy. The rash then spread to her face, scalp, and thighs. Two weeks ago, she noticed swelling in her hands and had a gradual onset of dyspnea on exertion.

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FDA Approves CorMedix Inc’s Treatment for Bloodstream Infections in Patients Receiving Dialysis

PharmExec

Defencath is indicated for the prevention and treatment of catheter-related bloodstream infections in adults with kidney failure administered chronic hemodialysis via a central venous catheter.

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STAT+: UnitedHealth pushed employees to follow an algorithm to cut off Medicare patients’ rehab care

STAT

The nation’s largest health insurance company pressured its medical staff to cut off payments for seriously ill patients in lockstep with a computer algorithm’s calculations, denying rehabilitation care for older and disabled Americans as profits soared, a STAT investigation has found. UnitedHealth Group has repeatedly said its algorithm, which predicts how long patients will need to stay in rehab, is merely a guidepost for their recoveries.

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Humans can’t shake the mosquito threat. Here’s what pharma has in the pipeline.

PharmaVoice

The arsenal against the world’s deadliest creature is growing and a universal vaccine is in the works.

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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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UK Authorizes World-First Gene Therapy from Vertex and CRISPR Therapeutics for Blood Disorders

Big Molecule Watch

Earlier today, UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization to Vertex Pharmaceuticals and CRISPR Therapeutics for their CRISPR/Cas9 gene therapy, CASGEVY (exagamglogene autotemcel), marking the world’s first regulatory approval for a CRISPR-based gene-edited therapy. CASGEVY is the first medicine to be licensed that uses the innovative gene-editing tool CRISPR.

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CHMP recommends new immunotherapy delivery method

European Pharmaceutical Review

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of subcutaneous (SC) Tecentriq ® (atezolizumab). Roche’s monoclonal antibody cancer immunotherapy was recommended for all indications in which Tecentriq intravenous (IV) has been previously approved, including certain lung, liver, bladder and breast cancer types.

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Life expectancy for men in U.S. falls to 73 years — six years less than for women, per study

STAT

The life expectancy of men in the U.S. is nearly six years shorter than that of women, according to new research published on Monday in JAMA Internal Medicine. At least partially as a consequence of over 1 million Covid-19 deaths, life expectancy in the U.S. has declined significantly over the past few years, falling from 78.8 years in 2019 to 77 in 2020 and 76.1 in 2022 — undoing over two decades of progress.

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A biotech tackles drug discovery with transcription factor know-how

PharmaVoice

Talus Bio, which developed a platform to map transcription factors, has a lead cancer candidate in the works and consults with other industry players in the complicated biology.

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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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World’s first CRISPR medicine approved in UK for sickle cell, beta thalassemia

BioPharma Dive

Clearance of Vertex Pharmaceuticals and CRISPR Therapeutics' Casgevy in the U.K. comes ahead of expected regulatory decisions in the U.S. and Europe.

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First CRISPR-based gene-editing therapy authorised

European Pharmaceutical Review

Casgevy (exagamglogene autotemcel), also known as exa-cel, is the first treatment to be licensed that uses CRISPR. It has been conditionally authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) as a gene-editing therapy for certain patients 12 years old and over with sickle-cell disease and transfusion-dependent β-thalassemia.

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Study suggests Covid rebound is far more common with Paxlovid than without

STAT

A small and preliminary study published Monday seems to indicate that patients receiving the drug Paxlovid are far more likely to experience Covid rebound than those who did not take it. That conclusion runs counter to previous statements by Pfizer, which makes Paxlovid, and by researchers at the Food and Drug Administration who have argued that while it is not uncommon for people with Covid to have symptoms reemerge after they seem to have recovered, it is not clear that Paxlovid increases the

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NHS trials artificial intelligence system to prevent avoidable admissions

Pharma Times

The AI system will identify those most at risk and reduce pressure on the NHS - News - PharmaTimes

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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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Regeneron Sues Celltrion For Proposed Biosimilar of Eylea in West Virginia District Court

Big Molecule Watch

Regeneron filed a Complaint on November 8 against Celltrion in the U.S. District Court for the Northern District of West Virginia, alleging infringement of thirty-eight patents under the BPCIA based on Celltrion’s submission of an aBLA for CT-P42, a proposed biosimilar of EYLEA (aflibercept), and Celltrion’s provision of Notice of Commercial Marketing with respect to the same.

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Ajinomoto spices up its biopharma business with gene therapy deal

BioPharma Dive

Forge Biologics operates a contract manufacturing business as well as develops its own gene therapies, which appears to have attracted the Japan-based food and biotechnology company.

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FDA grants approval for first time to a home test for chlamydia and gonorrhea

STAT

The Food and Drug Administration granted marketing approval to a home test for chlamydia and gonorrhea on Wednesday, the first such authorization of a home test to detect the two most common sexually transmitted infections in this country. The marketing approval was granted to LetsGetChecked’s Simple 2 Test, which allows individuals to collect a sample at home that is then submitted to a laboratory for processing.

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Novel siRNA therapeutic could lower cardiovascular disease risk

European Pharmaceutical Review

A single dose of lepodisiran, a small interfering RNA ( siRNA ) therapeutic, produced over 94 percent reductions in blood levels of lipoprotein(a), also known as Lp(a), with the results lasting for nearly a year, findings from a Phase I trial show. Lepodisiran Lepodisiran is a siRNA therapeutic that blocks the messenger RNA needed to manufacture a key component of lipoprotein(a) in the liver.

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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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2024 Pipeline Report: First-World Focus

PharmExec

Pharm Exec’s 19th annual report on the trends of the day in drug development examines the surging investment in new treatments and advances for so-called “first-world” conditions, capturing the landscape of five expanding therapeutic areas: weight loss, osteoarthritis, Alzheimer’s disease, COPD, and psychedelics.

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Anthos blood thinner bests Xarelto on safety in mid-stage study

BioPharma Dive

Trial results add to evidence that so-called Factor XIa inhibitors could have less bleeding risk than currently available oral anticoagulants like Xarelto.

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How the Bad River Tribe flipped the script on the Native American opioid crisis

STAT

BAD RIVER RESERVATION, Wis. — Sunlight is streaming through holes in the walls of a disused, corrugated metal shack, revealing its modest insides: Dirt floors, stacks of two-by-fours, and a pile of Little Caesars pizza boxes under attack by a work crew on lunch break. This building is clearly not ready to be a home. But in the next 24 hours, it must become one.

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Unified vision essential in UK advanced manufacturing

European Pharmaceutical Review

The Association of the British Pharmaceutical Industry (ABPI) has drawn attention to a new report , which has emphasised the importance of UK advanced manufacturing requiring a long-term strategy to ensure its continued success. This ‘manifesto for growth’, developed by the Manufacturing Five (M5), a coalition of the UK’s leading advanced trade associations, proposed the reforms necessary for the UK to close the gap with global competitors and growth of innovative manufacturing in the country.

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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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Study shows how congenital heart disease affects blood supply before birth

Pharma Times

CHD is a common birth defect that affects the development of the heart and brain - News - PharmaTimes

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A gene editing biotech’s struggles end with reverse merger

BioPharma Dive

Since halting work on a sickle cell treatment early this year, Graphite Bio has laid off staff, shed assets and, now, agreed to be subsumed via a merger with Lenz Therapeutics.

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Wegovy cuts risk of heart attacks in milestone cardiovascular trial

STAT

PHILADELPHIA — Novo Nordisk’s obesity drug Wegovy notably cut the risk of heart attacks in a landmark cardiovascular trial that affirms the treatment offers health benefits beyond weight loss. The company in August had announced that in this trial, called Select, Wegovy reduced the overall rate of major heart problems — heart attacks, stroke, or cardiovascular-related death — by 20%.

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Regional inequalities threatening Europe’s biosimilars market

European Pharmaceutical Review

While Europe has historically been a pioneer in the adoption of biosimilars, a new report by the global initiative Act4Biosimilars has revealed differences country by country, including disparities between Eastern and Western Europe. This is based on research from a report published in April this year by IQVIA. [Act4Biosimilars’ Regional Deep Dive Report Europe] noted that biosimilar adoption levels vary significantly across Europe” Act4Biosimilars shared that their Deep Dive Report

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Guest Post: Five Things You Need to Know About Prediabetes

Putting Patients First Blog

Guest Post: Five Things You Need to Know About Prediabetes November 17, 2023 By: Robert A. Gabbay, MD, PhD, the ADA’s Chief Science and Medical Officer, American Diabetes Association November is American Diabetes Month® (ADM) at the American Diabetes Association® (ADA). This month often focuses on type 1 and type 2 diabetes. However, prediabetes is also a pressing health concern in the U.S.

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