STAT

NOVEMBER 16, 2023

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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Drug Development 364

PharmaVoice

NOVEMBER 16, 2023

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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STAT

NOVEMBER 16, 2023

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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PharmaVoice

NOVEMBER 16, 2023

The 37-year veteran helmed the agency’s pandemic response, and was a key decision-maker in controversial calls on opioids, an Alzheimer's therapy and muscular dystrophy drugs.

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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

Communication

STAT

NOVEMBER 16, 2023

A dangerous decline in the rate of children vaccinated against measles is spurring a global increase in cases and deaths from the highly contagious virus, according to a report released Thursday. Estimated measles cases rose 18% to 9 million in 2022 when compared to the previous year, and deaths rose by 43% to 136,200, according to the report , jointly authored by the World Health Organization and the Centers for Disease Control and Prevention.

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Vaccines 363

Big Molecule Watch

NOVEMBER 16, 2023

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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European Pharmaceutical Review

NOVEMBER 16, 2023

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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STAT

NOVEMBER 16, 2023

In 1993, I published “Listening to Prozac,” a book that grew out of my clinical experience prescribing what was then a new class of medications, ones thought to moderate depression through their effect on the way that the brain handles the neurotransmitter serotonin. Some of my patients had reported marked favorable reactions to the drugs — first Prozac and, soon after, Zoloft.

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BioPharma Dive

NOVEMBER 16, 2023

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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STAT

NOVEMBER 16, 2023

Three months ago, my aunt Margaret had a stroke. Days before, she was repainting her bathroom and driving herself. Now, she needs help with dressing and getting in and out of bed, and our family is grappling with the fact that this fiercely self-sufficient woman will never live independently again. This health crisis has been compounded at every turn by failures of the health care system — failures that are particularly infuriating to me because I have devoted my life to solving these ver

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Compounding 324

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European Pharmaceutical Review

NOVEMBER 16, 2023

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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Biosimilars 110

STAT

NOVEMBER 16, 2023

Dr. Reddy’s Laboratories, one of the world’s largest generic drugmakers, was cited by the U.S. Food and Drug Administration for a host of manufacturing violations at one of its plants in India, the latest instance in which the company was tagged by the regulator for quality-control problems. In a recent inspection report , the agency found several notable failures, such as major production equipment that was not appropriately cleaned; a quality-control unit that did not investigate

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pharmaphorum

NOVEMBER 16, 2023

In this episode of the pharmaphorum podcast, web editor Nicole Raleigh speaks with Venu Mallarapu, vice president of global strategy and operations at eClinical Solutions, about the ins and outs of successful AI implementation within pharma and healthcare.

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STAT

NOVEMBER 16, 2023

More than a tenth of fecal immunochemical tests, used for routine colorectal cancer screening, contained samples that could not be processed by labs, according to a study published this week in Cancer Epidemiology, Biomarkers and Prevention, a journal of the American Association for Cancer Research. This is over twice the amount recommended by the U.S.

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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.

Pharma Times

NOVEMBER 16, 2023

The bacteriocin development programme will first target pseudomonas aeruginosa - News - PharmaTimes

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STAT

NOVEMBER 16, 2023

The Food and Drug Administration on Wednesday approved a new treatment for people with non-small cell lung cancer that contains a rare genetic alteration called Ros1. The genetically targeted medicine, called Augtyro, will be sold by Bristol Myers Squibb. It was developed by a small biotech company, Turning Point Therapeutics, that was acquired by Bristol in June 2022.

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PharmExec

NOVEMBER 16, 2023

Emerging technologies like digital twins offer supply chain efficiency solutions, allowing the industry to integrate sustainable practices while ensuring patient safety.

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STAT

NOVEMBER 16, 2023

Advances in  childhood cancer  are a success story in modern medicine. But in the past decade, those strides have stalled for Black and Hispanic youth, opening a gap in death rates, according to a new report published Thursday. Childhood cancers are rare and treatments have improved drastically in recent decades, saving lives.

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Pharma Times

NOVEMBER 16, 2023

The funding will be used to develop new diagnostic tests, treatments and devices - News - PharmaTimes

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STAT

NOVEMBER 16, 2023

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, everyone. Damian here with an update on a thwarted gene therapy study, a head-to-head fight in GLP-1, and a critical look at Alzheimer’s treatment.

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BioPharma Dive

NOVEMBER 16, 2023

Acquired via a $4 billion biotech buyout, Augtyro is one of an array of new products the pharma hopes will offset patent expirations for current top sellers.

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STAT

NOVEMBER 16, 2023

Who polices algorithms? How would you name the first approved CRISPR medicine? And what pairs well with a biotech downturn? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Our colleague Casey Ross joins us to tell the bombshell story of how the nation’s largest health insurer used a computer algorithm to deny patient care and boost its profitability.

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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.

BioPharma Dive

NOVEMBER 16, 2023

Red Tree Venture Capital plans to tap into San Diego’s biotech pipeline as it works to build a West Coast competitor to Boston-area investors.

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STAT

NOVEMBER 16, 2023

Rise and shine, everyone, another busy day is on the way. We can tell because the official mascots are racing about the Pharmalot grounds and the parade of vehicles outside our window is picking up. As for us, we are dutifully firing up the coffee kettle to brew another cup of needed stimulation. Our choice today is butter pecan. Please feel free to join us.

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Drug Pricing 166

BioPharma Dive

NOVEMBER 16, 2023

The deal, which will result in a combined company operating under Q32's name, comes months after Homology laid off much of its staff and halted research.

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The Pharmacist

NOVEMBER 16, 2023

All suitably trained members of the pharmacy team will be able to deliver blood pressure checks from 1 December, it has been announced today. And there will be a 'renewed focus' on ambulatory blood pressure monitoring, helping to identify even more people at risk of heart attack and stroke, the pharmacy negotiator said. Currently, under […] The post More pharmacy staff able to deliver blood pressure checks from December appeared first on The Pharmacist.

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Pharmacy Management

European Pharmaceutical Review

NOVEMBER 16, 2023

The global single-use bioprocessing market is expected to value estimated $84.14 billion by 2032, according to Towards Healthcare. This is due to rising demand for personalised medicines, rising investment in R&D, and adoption of decentralised clinical trials. The organisation’s report asserted that growth of the market is being driven by numerous factors including the greater demand for biologics, the expanding biopharmaceutical industry, and the numerous advantages that single-use bioproce

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The Pharmacist

NOVEMBER 16, 2023

The first electronic prescription service (EPS) in Wales has launched today, allowing patients and healthcare professionals to benefit from ‘easier, safer and more efficient’ prescribing and dispensing, the Welsh Government has said. Instead of printing, signing and giving a patient a paper form to take to a pharmacy, GPs will be able to send the […] The post Wales launches first electronic prescription service appeared first on The Pharmacist.

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BioPharma Dive

NOVEMBER 16, 2023

The company, which is working with regulators to lift a clinical hold, said the treatment could still help people with X-linked myotubular myopathy.

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Pharmaceutical Technology

NOVEMBER 16, 2023

Vertex and CRISPR's Casgevy has received conditional approval in the UK for treating sickle cell and transfusion-dependent beta-thalassemia.

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The Pharmacist

NOVEMBER 16, 2023

Community pharmacists will be able access and add to patient records currently maintained by GPs from January next year, in a bid to free up millions of GP appointments. The Government, NHS England and Community Pharmacy England said they agreed that the Pharmacy First scheme will launch on 31 January 2024, subject to the ‘appropriate digital […] The post Community pharmacists to gain greater access to GP record from January appeared first on The Pharmacist.

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Community Pharmacies 93