November, 2023

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Pharma benefited from basing business overseas. An international tax effort could spur a rethink.

BioPharma Dive

U.S. tax law changes enacted six years ago slashed large pharma companies' rates and saved them billions. Now, a push for an international floor could disrupt their R&D accounting.

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STAT+: FDA investigating whether CAR-T, a treatment for cancer, can also cause lymphoma

STAT

The Food and Drug Administration said Tuesday that it is investigating whether CAR-T therapy, which uses genetically modified white blood cells to attack tumors, can in rare cases cause lymphoma, a blood cancer. “Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory

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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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ACMT Toxicology Visual Pearl: Poison Dart Frog

ALiEM - Pharm Pearls

The toxin from the golden poison dart frog most resembles which of the following in its mechanism of action? Botulinum toxin Bufotoxin Grayanotoxin Palytoxin Tetrodotoxin Photo adapted from Wilfried Berns (Wikimedia Commons) Reveal the Answer 3. Grayanotoxin – a sodium channel opener Background The golden poison dart frog ( Phyllobates terribilis ), often considered one of the most poisonous animals on the planet, secretes onto its skin the lipophilic alkaloid batrachotoxin , which irreversibly

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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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‘They thought I had cancer’: painkiller banned in UK linked to Britons’ deaths in Spain

The Guardian - Pharmaceutical Industry

Patients’ group says reactions to metamizole can cause sepsis and organ failure – and British and Irish people are at higher risk A patients group representing several British victims has launched legal action against the Spanish government over claims it failed to safeguard people against the potentially fatal side effects of one of the country’s most popular painkillers, involved in a series of serious illnesses and deaths.

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Long COVID study expanded across Europe

European Pharmaceutical Review

Biotech Berlin Cures, a company focusing on neutralising functional autoantibodies (fAABs), is expanding its Phase II clinical trial on Long COVID (post-COVID syndrome). into a pan-European, multi-center collaboration. The study will provide “meaningful and robust results on the efficacy and tolerability” of its lead drug candidate BC 007 in individuals with Long COVID.

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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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??A startling drop in U.S. life expectancy — and how pharma could help turn the tide

PharmaVoice

The recently observed dip was particularly acute for men, who now live an average of 5.8 fewer years than women.

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Texas AG sues Pfiz­er and Tris Phar­ma for adul­ter­at­ed ADHD drug

Pharmaceutical Technology

Texas AG has sued Pfizer and Tris Pharma for providing adulterated attention-deficit/hyperactivity disorder drug, Quillivant XR, to children.

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Shock of the old: 10 scandalous vintage medicines – from asthma cigarettes to cocaine wine

The Guardian - Pharmaceutical Industry

Cure any ailment! Never known to fail! Early medicine adverts made grand claims but they look alarming today The confusion with patent medicines starts with the name, since they were rarely ever patented; manufacturers just thought it sounded cool. Bamboozling was always part of the package: from the 17th century, concoctions of water, alcohol and herbs were sold with wild claims and exotic origin stories.

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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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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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Moderna adjusts to changing outlook for COVID vaccine demand

BioPharma Dive

The company recorded a net loss in the third quarter as it “resizes” its manufacturing footprint, and now expects revenue to come in at low end of its previous guidance.

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STAT+: Antitrust lawsuit alleges UnitedHealth’s Optum pressured a California hospital to stop competing over physicians

STAT

UnitedHealth Group’s Optum division is already the largest employer of physicians in the United States, but allegations in a new lawsuit suggest Optum is hungry for more. Emanate Health, a nonprofit group of hospitals and physicians in California, filed a federal lawsuit Monday, alleging Optum pushed it to agree not to compete for primary care physicians, a violation of antitrust law.

Hospitals 362
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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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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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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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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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New Amgen immunotherapy could treat common solid tumour

European Pharmaceutical Review

Amgen’s new immunotherapeutic agent Tarlatamab has been shown in a Phase II trial to provide sustained anti-tumour activity in 40 percent of the small cell lung cancer patients. The international DeLLphi-301study was investigated as a new anti-cancer treatment option for patients previously considered to be beyond treatment. Results from the trial were published in the New England Journal of Medicine.

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Roche’s Genentech partners with Nvidia in AI drug deal

BioPharma Dive

The partnership is another investment by the biotech subsidiary in artificial intelligence for drug discovery and development, continuing an industry trend.

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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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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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Tools like ChatGPT can personalize clinical trials tech — if companies avoid the pitfalls

PharmaVoice

From hallucinations to data privacy, pharma looks to iron out the kinks of generative AI.

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Innoviva and GARDP reveal positive results for antibiotic to treat gonorrhoea

Pharma Times

Zoliflodacin inhibits the vital bacterial enzyme for bacterial function and reproduction - News - PharmaTimes

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AstraZeneca and Cellectis to collaborate for cell therapy and genomic medicine development

Pharmafile

AstraZeneca has announced a collaboration and investment agreement with Cellectis for the development of next generation cell and gene therapeutics (CGTs) in areas such as oncology, immunology and rare diseases. Under terms of this agreement, AstraZeneca will utilise Cellectis’ proprietary gene editing technologies and manufacturing capabilities with the intention of designing novel CGT products. 25 […] The post AstraZeneca and Cellectis to collaborate for cell therapy and genomic medicine

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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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Boehringer Ingelheim to advance bacterial cancer therapeutics

European Pharmaceutical Review

Boehringer Ingelheim is acquiring Swiss biotech T3 Pharmaceuticals AG (T3 Pharma), for up to £406 million (450 million CHF), boosting its immuno-oncology portfolio. The pharmaceutical company will utilise T3 Pharmaceutical’s proprietary bacterial cancer therapy platform that consisting that delivers immune-modulating bioactive proteins to cancer cells and tumour micro-environments.

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FDA investigating cancer risk linked to CAR-T cell therapy

BioPharma Dive

The agency said the benefit of approved treatments like Gilead’s Yescarta still outweighs any such risk, but the alert could slow drugmaker efforts to develop the treatments for wider use.

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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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Legalized medical cannabis five years on - Releaf discusses how far the industry hasn't come

Outsourcing Pharma

It is five years this month since a ground-breaking change in UK healthcare history happened â with doctors being able to prescribe cannabis-based medicines for the first time.

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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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Milner Therapeutics to establish new genomics laboratory for drug discovery

Pharma Times

The new state-of-the-art facility is set to be operational in early 2024 - News - PharmaTimes

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AbbVie agrees $10.1bn deal to buy ImmunoGen

pharmaphorum

AbbVie has moved to shore up its pipeline following the loss of patent protection for its top-selling drug with a $10.1 billion deal to buy ImmunoGen and its marketed ovarian cancer drug.

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GSK propels its progress to Net Zero

European Pharmaceutical Review

Phase III trials of a low carbon version of GSK’s metered dose inhaler, Ventolin (salbutamol), using a next generation, lower carbon propellant, are set to start in 2024. The pharma company stated that if successful, it has the potential to reduce greenhouse gas emissions from use of the inhaler by approximately 90 percent. According to GSK, thirty-five million patients with respiratory conditions globally relying on its metered dose inhaler.

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FDA names chief scientist Bumpus as Woodcock’s successor

BioPharma Dive

Bumpus, a former Johns Hopkins professor, named “creating a new model” for the FDA’s Office of Regulatory Affairs as one of her priorities when she steps into the role.

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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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