Wed.Dec 20, 2023

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Pregnant cancer patients often have to terminate. Abortion pill restrictions could make that choice even harder

STAT

WASHINGTON — The patient had already made the agonizing decision to start chemotherapy to address her colon cancer, even though she was 30 weeks pregnant. Within a day, the decisions got harder: her colon perforated, and the pain was excruciating. She would need urgent surgery — and she would have to undergo an emergency C-section immediately.

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What are pharma’s next blockbusters?

PharmaVoice

In a shifting market focused on targeted therapeutics, drugs that generate big profits are still a priority.

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After ‘SNL’ skit on sickle cell CRISPR therapy, advocates cite errors and stereotypes

STAT

Mary Brown was sipping coffee at home in Ontario, Calif., Sunday morning when a friend sent a video clip that ruined her breakfast. It contained a skit from “Saturday Night Live” the night before about the new gene therapies for sickle cell disease. In it, workers gather for an office white-elephant-style gift exchange. A white employee, played by Kate McKinnon, gives a Black employee with sickle cell, played by Kenan Thompson, enrollment in “Vertex Pharmaceutical and CRISPR

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As ALS research booms, one treatment center finds itself in the spotlight

BioPharma Dive

The Healey center is at the front of ALS research and care, earning acclaim from patients, doctors and scientists. Still, the complexities of the disease and of drug development have brought hard-felt losses.

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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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Inhaled vaccines could stop Covid infections, monkey studies show

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hey there. Today, we get into why Amy Abernethy is leaving Verily, and why the ongoing reckoning with AI doesn’t necessarily need the voice of Google to chime in. Plus, Jason Mast pops in to give an update on Uniqure’s puzzling approach to presenting trial results.

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ASBM Submits Comments to Oregon PDAB Opposing Proposal to Permit Automatic Substitution of Non-Interchangeable Biosimilars 

Safe Biologics

On December 13, Oregon’s Prescription Drug Affordability Board (PDAB) met to consider – and ultimately rejected – a proposal to permit the automatic substitution of non-interchangeable biosimilars; that is, the substitution at the pharmacy level of a biosimilar without prescriber involvement. The automatic substitution of biosimilars is a controversial practice, banned in many countries including nearly all of Western Europe.

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MHRA update on links between aripiprazole and gambling disorder

The Pharmacist

Healthcare professionals prescribing aripiprazole for schizophrenia and bipolar disorder should be alert to the known risk of patients developing addictive gambling, according to a new drug safety update. This reminder about aripiprazole from the Medicines and Healthcare products Regulatory Agency (MHRA) comes after a rise in the number of reports of gambling or gambling disorder it received […] The post MHRA update on links between aripiprazole and gambling disorder appeared first on The

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STAT+: 3 trends to watch in biotech in 2024

STAT

Every winter, like Punxsutawney nobles, biotech’s many thought leaders gather in San Francisco to pick apart the year that was and prognosticate about the one to come. The consensus, in good markets and bad, is almost always cautious optimism for boom times ahead, a prediction that in recent years has had groundhog-level accuracy. But after two years of steady decline, 2024 might finally prove them right.

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Key Parkinson’s protein could offer new potential targets for treatment

Pharma Times

The findings could lead to new treatments to target the mTOR and ease PD symptoms - News - PharmaTimes

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A medical student was isolated by an autoimmune disorder. Poetry was a way out

STAT

When Leena Danawala’s poetry was published in JAMA last month, the medical journal became just about the only place online to publicly showcase her art. Danawala, a 34-year-old rheumatologist in the Chicago area, had been writing poetry for over a decade but only posted about it occasionally on her Instagram. During her two-year rheumatology fellowship at Ohio State University, she suddenly felt the urge to share.

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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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BioNTech wins round in CureVac mRNA patent dispute

pharmaphorum

Shares in CureVac have plummeted after a German court ruled that a patent it holds on mRNA-based COVID-19 vaccines was invalid. The validity of the patent is at the heart of patent litigation between CureVac and fellow German biotech BioNTech and its partner Pfizer, claiming infringement by their Comirnaty coronavirus shot.

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Opinion: The U.S. must raise federal alcohol taxes to address the alarming rise in alcohol use

STAT

Eleven years ago, two days before Christmas, my 24-year-old brother, who was a university graduate and former law student, died from a self-inflicted gunshot wound. After a decade of hard and continuous drinking interspersed with addiction and mental health treatment, he could not sustain his recovery. His suicide came on the heels of my mother’s death a year before, and just weeks later, my grandfather died in a car accident.

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Apixaban Diltiazem Interaction

Med Ed 101

I recently came across a clinical issue in my practice as a consultant pharmacist to assisted living and long-term care facilities. The item in question was how to manage the apixaban diltiazem interaction. Apixaban Diltiazem Interaction Defined Apixaban is significantly metabolized by CYP3A4. This liver enzyme is significantly inhibited by diltiazem.

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STAT+: SEC charges former CEO of pain relief device company with $41 million fraud

STAT

The Securities and Exchange Commission on Tuesday charged the former CEO of Stimwave, a company that sold devices containing dummy pieces of plastic, with defrauding investors out of $41 million.  Laura Perryman led Stimwave, which sold nerve stimulation devices to combat pain, from 2010 to 2019, when the fraud came to light. Under her leadership, Stimwave warped the design of the device to better align with insurance codes, resulting in unnecessary plastic components that allowed the compa

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Key Parkinson’s protein could offer new potential targets for treatment

Pharma Times

Researchers from Johns Hopkins University School of Medicine have revealed new findings about a key pathological protein associated with Parkinson’s disease (PD), which could lead to new treatments. Published in Science Translational Medicine , the study found that the pathological form of alpha-synuclein triggers cells to increase protein synthesis in the neurodegenerative condition.

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STAT+: In another blow, Argenx antibody therapy fails in trial for skin blistering condition

STAT

LONDON — The Belgian company Argenx said Wednesday that its closely watched antibody therapy failed to outperform placebo in a Phase 3 trial in an autoimmune condition that causes the skin to blister — the second setback in less than a month for the biotech and its drug. Argenx’s stock was down roughly 30% in early trading. Argenx said that it was stopping development of its drug, called efgartigimod, in pemphigus, a disease that causes blisters and sores on the skin and muc

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Novo Nordisk Foundation establishes new vaccine initiative worth $260m

Pharma Times

NIVI aims to create new or improve vaccines to combat deadly airborne infections - News - PharmaTimes

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Opinion: Racism infects neuroscience’s past and present. What about its future?

STAT

De-Shaine Murray is working at the cutting edge of neurotechnology. As a postdoctoral fellow at Yale, he is developing a device to monitor the brain following traumatic brain injury or stroke. He is also trying to fight the long legacy of racism in neuroscience. During 2020, when it was difficult to conduct research, he said, “I got the chance and the ability to read more widely and to just look into the legacy of neuroscience.

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FDA grants priority review to omalizumab for food allergies

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has granted priority review to Roche’s supplemental Biologics License Application for Xolair ® (omalizumab) for treatment of children and adults with food allergies. The drug, a monoclonal antibody, could be used in adults and children over 1 year of age for reduction of allergic reactions, including anaphylaxis, that may occur following accidental exposure to one or more foods.

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STAT+: Pharmalittle: Curevac loses key patent in battle with BioNTech; Abernethy to step down as Verily CMO

STAT

Good morning, everyone, and how are you today? We are doing just fine, thank you. Given that this is already the middle of the week and we have survived this far, no reason not to continue, yes? Just consider the alternatives. In fact, this modest accomplishment calls for celebration. So please join us in quaffing a ritual cup of needed stimulation.

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Novo Nordisk Foundation establishes new vaccine initiative worth $260m

Pharma Times

The Novo Nordisk Foundation has committed $260m to establish a new state-of-the-art research and vaccine development initiative to help combat deadly airborne infections. The initiative aims to create new or improved vaccines for deadly respiratory diseases, including tuberculosis (TB) and influenza. Developed in partnership with the University of Copenhagen and Denmark’s Statens Serum Institut, the vaccine initiative is the first-ever to focus on understanding how to generate immunity in the ai

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Morning Rounds: Americans put faith in nurses as overall confidence in health care ebbs

STAT

Understand how science, health policy, and medicine shape the world everyday. Sign up for our Morning Rounds newsletter  here. Good morning. Today we take a look at how health care happens outside the exam room: in a kitchen, in politics, in the courts, and in poetry.

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Aclaris slashes staff as it trims its pipeline

pharmaphorum

Aclaris will cut 46% of its workforce after stopping development of MK2 inhibitor zunsemetinib (ATI-450) for immuno-inflammatory diseases.

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RPS Wales: ‘We want to move away from sector-specific roles’

The Pharmacist

Alongside advances in independent prescribing and digital connectivity, pharmacists in Wales are exploring how working across settings can improve patient care. In a recent interview with The Pharmacist, Royal Pharmaceutical Society director for Wales Elen Jones outlined some of the the opportunities and challenges facing the profession. I think the obvious place for us […] The post RPS Wales: ‘We want to move away from sector-specific roles’ appeared first on The Pharmacist.

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The Link Between Omega-3s and Inflammation Reduction

Welltopia Pharmacy

Omega-3s and Inflammation Reduction Introduction Omega-3 Fatty Acids have an essential role in brain and heart function, they are

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EU pharmaceutical legislation revisions: what are the implications for biopharma?

European Pharmaceutical Review

In Q1 2023, the European Commission (EC) announced proposed changes to EU pharmaceutical legislation. 1 The changes form part of the 2020 Pharmaceutical Strategy for Europe will impact pharma and biopharma companies operating in Europe. The proposed changes to EU pharmaceutical legislation broadly aim to: Support innovation and boost attractiveness of EU market Ensure timely and equitable access to medicines for patients across the EU Address other ongoing issues, including antimicrobial resist

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GSK taps Hansoh for another cancer ADC candidate

pharmaphorum

GSK has turned to China’s Hansoh for another antibody-drug conjugate (ADC), licensing B7-H3-targeting HS-20093 for $185 million upfront.

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Roche and Novartis’ Xolair set for FDA priority review in food allergies

Pharmaceutical Technology

The FDA accepted the filing based on NIH-funded Phase III trial interim results, with an approval decision expected in Q1 2024

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Argenx dealt another blow as Vyvgart Hytrulo fails again

pharmaphorum

Argenx's subcutaneous version of Vyvgart has failed a second phase 3 trial, this time in autoimmune disease pemphigus vulgaris

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Women in Science: 'I take pride in my role as a mother and it makes me a stronger, more compassionate employee'

Outsourcing Pharma

Kelly Dumais, director of eCOA Science and consulting at Clario, has over 10 years of behavioral and life sciences research experience.

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The Importance of Data in 2024: Q&A With Christoph Bug, Vice President of Global Medical at Veeva

PharmExec

Data will continue to grow in importance in 2024.

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FDA OKs test to spot patients at risk of opioid use disorder

pharmaphorum

FDA OKs test to spot patients at risk of opioid use disorder Phil.

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Natto consumption suppresses arteriosclerosis

World Pharma News

Atherosclerosis, a chronic condition characterized by the accumulation of lipid and inflammatory cells within the blood vessel walls, causes cardiovascular diseases, such as heart disease and stroke. Natto, a food rich in vitamin K2, has shown promise in mitigating cardiovascular diseases by enhancing arterial flexibility and modulating inflammatory responses.

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Argenx autoimmune drug study fails in blow to expansion hopes

BioPharma Dive

The Dutch biotech’s star product has lost some luster after a second failed Phase 3 trial in two months, this time for a skin condition called pemphigus.

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Getting Started With Pharmacy Facebook Ads

Digital Pharmacist

Facebook advertising is a powerful promotional platform for businesses of all industries. T he third-most visited site in the world, Facebook also ranks as the most used social media platform online. As of the third quarter of 2023, 3 billion people have active accounts on Facebook accounts. Pharmacy Facebook ads are a great way to connect with millions of potential patients.

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