Wed.Feb 21, 2024

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NIH study of ME/CFS points to immune dysfunction and brain abnormalities at core of long-dismissed disease

STAT

Alison Sbrana was in the belly of an opera when her life changed. Down in the pit, surrounded by fellow orchestra members, she’d been straining to play her flute for half the show. As performers overhead enveloped the audience in arias, Sbrana felt like the Hulk was pulling on the tendons in the right side of her neck. “I begged anybody for meds at intermission,” she said.

Immunity 364
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Behind the breakthrough cancer therapy that just won a historic FDA nod

PharmaVoice

The first-of-its-kind TIL therapy for solid tumors developed by Iovance Biotherapeutics won FDA approval last week.

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Meet the fetal surgeon forging CRISPR’s next frontier: curing diseases in the womb

STAT

SAN FRANCISCO — Outside, the August sun wasn’t yet visible through the thick folds of fog blanketing the San Francisco skyline. Its warmth did not reach the operating room tucked into the sprawling Parnassus Heights hospital complex. In there, the light was all cold and blue fluorescence washing over the sea of scrub caps huddled around an anesthetized young woman on a gurney.

Hospitals 363
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4 biotechs to watch in 2024

PharmaVoice

A splashy IPO, first-in-class treatments and upcoming approval dates are a few reasons we’ve got our eyes on these biotechs this year.

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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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Small study adds to growing hope CAR-T cell therapy could revolutionize autoimmune disease treatment

STAT

People with autoimmune disorders don’t usually get to talk about a cure. There’s symptom management, hopeful periods of remission often followed by relapses, but rarely a lasting fix for the way their immune system attacks healthy cells. If the immune system is an army, then those with conditions like lupus, multiple sclerosis, or rheumatoid arthritis are often fighting a never-ending war of friendly fire.

Immunity 362
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NEJM paper fills in details on ‘remarkable’ CAR-T result in autoimmune disease

BioPharma Dive

The full results spotlight cell therapy’s potential to treat lupus and other inflammatory conditions, but also the problems drug developers must solve first.

More Trending

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Clinical research is about trial and error

pharmaphorum

Clinical research involves trial and error as part of the drug development process. Learn more about how to optimise drug trials and the important role of participants in clinical research.

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STAT+: Scientists take a (small) step toward universal antivenom

STAT

Antivenom, like Mexican Coke or grandma’s cookies, is still made the old-fashioned way. In antivenom’s case, the recipe is straightforward: Pump a horse full of sub-lethal doses of venom from various local snakes, wait for them to develop an immune response, tap their blood, purify out antibodies, bottle, and freeze. This vampiric, century-old process still reigns because of the unique scientific challenge posed by snake venoms.

Immunity 317
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Long-Acting Injectable Cabenuva Found More Effective Than Daily ART at Suppressing HIV in Patients With Adherence Challenges

Pharmaceutical Commerce

Cabenuva (cabotegravir + rilpivirine) showed superior efficacy in maintaining viral load suppression in patients with HIV compared with standard of care daily oral antiretroviral treatment.

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STAT+: Hospitals race to adopt generative AI, even as regulators struggle to keep up with the risks

STAT

Usually the words generative AI in health are followed by a bold claim. The technology will transform some aspect of care delivery, save gobs of money, or automate administrative tasks crucial to connecting patients with timely services. Rohit Chandra, chief digital officer of the Cleveland Clinic, said generative AI can accomplish all these things.

Hospitals 314
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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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Celebrating Thank a Resident Day 

Board Vitals - Pharmacist

Medical residents play an important role in healthcare, from providing patient care to conducting research and collaborating with healthcare teams. To honor residents and their contributions and sacrifices, we celebrate Thank a Resident Day—a day dedicated to expressing gratitude for these remarkable individuals. What is Thank a Resident Day? Medical residency is a demanding journey filled with long hours, challenging cases, and constant learning.

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Watch: What is in utero gene editing?

STAT

Recently approved gene therapies offer patients one-time, potentially curative treatments for genetic diseases such as sickle cell anemia and beta thalassemia. But “one-time” miracle solutions can often be multi-month affairs, require millions of dollars, and cause painful side effects. What if that doesn’t have to be the case? In utero gene editing , or prenatal somatic cell genome editing, envisions treating a fetus diagnosed with a genetic disease before birth, thereby pr

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Behind the new kind of cell therapy that just won FDA approval

BioPharma Dive

One expert views Amtagvi’s approval as a catalyst for further investment in TIL therapies, akin to how Kymriah’s 2017 clearance buoyed CAR-T treatment.

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STAT+: DarioHealth acquires Twill, hoping it’s a shortcut to profitability

STAT

DarioHealth, which makes apps for managing chronic diseases, today announced it will acquire digital mental health company Twill for $10 million in cash plus stock valued at over $20 million at the end of Tuesday trading. The move is a bet that a consolidated offering can attract a critical mass of large customers in a market where profits have been elusive.

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The evolution of clinical research: embracing new delivery models in the UK

pharmaphorum

Explore the evolution of clinical research in the UK, including the role of NIHR and Direct Delivery Teams in embracing new delivery models. Join our informative webinar to learn more.

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Alabama hospital pauses IVF treatments in wake of ruling saying frozen embryos are children

STAT

MONTGOMERY, Ala.  — A large Alabama hospital paused in vitro fertilization treatments Wednesday as health care providers weigh the impact of a state court ruling that frozen embryos are the legal equivalent of children. The University of Alabama at Birmingham health system said in a statement that it must evaluate whether its patients or doctors could face criminal charges or punitive damages for undergoing IVF treatments.

Hospitals 204
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Mobile ADHD awareness game launches in Germany

pharmaphorum

Attention-deficit hyperactivity disorder (ADHD) in adults is not well understood and highly underdiagnosed, but the developers of a mobile game designed to raise awareness hope to shine a light on the struggles of people struggling with the condition.

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Actually Wegovy is good for dialysis companies, dialysis provider says

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, everyone. Damian here with a look at the legacy of a pharma CEO, yet more biotech layoffs, and a reprieve from the GLP-1 panic.

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Episode 898: Knowing When Non-Medication Therapies Are First-Line Is Critical

Pharmacy Joe

In this episode, I’ll discuss the impact of giving epinephrine before defibrillation to in-hospital cardiac arrest (IHCA) patients with shockable rhythms. episode898 Subscribe on iTunes , Android , or Stitcher Knowing when a medication is the first-line treatment for a condition should be easy for pharmacists, as this is exactly what we spend our time on during training and professional development.

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Surprise! Thanks to the IRA, Part D Plans Will Prefer High-List, High-Rebate Drugs

Drug Channels

Like many of you, I have believed that the Inflation Reduction Act of 2022 (IRA) will encourage Medicare Part D plans to adopt low-list-price products over their high-list/high-rebate counterparts, thereby popping the gross-to-net bubble. Actually, maybe not. Below, I explain why the IRA will encourage Part D plans to prefer high-list, high-rebate specialty drugs , even as the government and manufacturers will prefer a low-list-price version.

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Decoding the skirmish over revised Schedule M

Express Pharma

Recent regulatory changes have underlined the fissure between the large and mid-MSME segments of the pharma sector. The most recent evidence of this fissure is the representations of the pharma MSME sector to the Prime Minister’s Office (PMO) and to state governments to defer the implementation of the Revised Schedule M of the Drugs Act 1940 that was amended by the Ministry of Health & Family Welfare vide Notification GSR 922 (E) dated December 28 last year.

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United sues FDA to try to block rival’s drug application

pharmaphorum

United sues FDA for allowing a marketing application for a competitor to its top-seller Tyvaso, filed by Liquidia, that sidesteps established procedures

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EGFR inhibitor could provide major advance in lung cancer

European Pharmaceutical Review

Small molecule treatment TAGRISSO ® (osimertinib) demonstrated a “statistically significant and highly clinically meaningful improvement” in progression-free survival (PFS) for Stage III lung cancer patients, AstraZeneca has confirmed. This was established from positive high-level results seen in the LAURA Phase III trial. The data was based on observations from patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemor

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India pharma giants and global big pharma join forces for NMEs commercialisation in India: GlobalData

Express Pharma

The pharma landscape has undergone a significant shift towards collaboration and partnership between global big pharma and Indian pharma firms in recent years to drive innovation and expand market reach. This strategic alliance brings together the strengths and resources of both parties to accelerate commercialisation. The focus is on introducing new molecular entities (NMEs) into India, with both parties contributing to accelerate commercialisation and address evolving healthcare needs, finds G

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US, EU regulators start swift reviews of Servier glioma drug

pharmaphorum

FDA and EMA start speedy reviews of Servier’s vorasidenib for IDH-mutated low-grade glioma, hoping to end decades of stagnation in therapies for the brain cancer.

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Top 20 global biopharma companies report 1.6 per cent per cent market cap growth to $3.67 tn in 2023: GlobalData

Express Pharma

The top 20 global biopharmaceutical companies experienced varied year-on-year (YoY) market capitalisation shifts in 2023 amid the macroeconomic headwinds, steep patent cliffs and the commencement of US drug price negotiations under the Inflation Reduction Act (IRA). Nonetheless, there was a resilient upturn of 1.6 per cent in aggregate market capitalisation from $3.61 trillion on 31 December 2022 to $3.67 trillion on 31 December 2023, reveals GlobalData.

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RAPT hit by FDA clinical hold on eczema, asthma drug

pharmaphorum

RAPT Therapeutics shares fell sharply after the FDA placed a clinical hold on oral CCR4 antagonist zelnecirnon in atopic dermatitis and asthma.

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Elicio’s vaccine shows promise as potential cancer treatment in phase 1 trial

Pharma Times

Results showed robust responses in patients with pancreatic and colorectal cancer

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Revolutionizing healthcare with clinical AI: Google for medical records

Outsourcing Pharma

Creating artificial intelligence to understand medical conditions, and not just the English language, sounds far-fetched, but this is what one CEO is achieving with an impressive foundational innovation.

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Researchers launch global iSPY network to research Strep A infections

Pharma Times

A streptococcal bacterial infections are estimated to affect around 50 million people worldwide

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Digital health firms DarioHealth and Twill merge

pharmaphorum

DarioHealth has bought fellow digital health company Twill in a move that combines their chronic disease and mental health platforms.

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CPE: Return of establishment payments ‘should be considered’

The Pharmacist

Establishment payments for community pharmacy premises and running costs should be considered, Community Pharmacy England (CPE) has told a parliamentary inquiry into pharmacy. In the short term, the negotiator would also like to see increased funding to ‘close the gap’ caused by inflationary costs, as well as the write-off of accrued retained margin, it said. […] The post CPE: Return of establishment payments ‘should be considered’ appeared first on The Pharmacist.

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Will smart tech revolutionise drug delivery for ulcerative colitis patients?

Pharmaceutical Technology

Biora’s new smart pill represents a new treatment modality that may increase the efficacy of therapeutics for ulcerative colitis

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UK manufacturing output expected to improve despite challenges

European Pharmaceutical Review

Based on data from the Confederation of British Industry (CBI)’s latest monthly Industrial Trends Survey on UK manufacturing, expectations for future selling price inflation rose in February, to their strongest since July 2023. Despite this, the survey noted that selling price expectations remained well below the multi-decade high observed in 2022 (+80 percent in March 2022).

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Pharmacy First GP systems ‘getting ready to go live’

The Pharmacist

The functionality that will allow community pharmacies to update GP patient records with Pharmacy First consultations is in the ‘process of getting ready to go live’, NHS England (NHSE) has said. Since the service launched on 31 January, community pharmacies have been able to send details of patient consultations to GPs via existing processes previously […] The post Pharmacy First GP systems ‘getting ready to go live’ appeared first on The Pharmacist.