Fri.Jun 21, 2024

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STAT+: Vertex reports positive results in stem cell trial for type 1 diabetes

STAT

ORLANDO — Twelve people with type 1 diabetes who received a therapy derived from stem cells were able to produce enough of their own insulin to maintain healthy blood glucose levels 90 days later, Vertex Pharmaceuticals said Friday. All but one reduced or eliminated the need to inject insulin over those three months and three people followed for one year no longer needed to inject insulin at all.

Diabetes 362
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3 windows of opportunity in women’s health

PharmaVoice

Despite a recent surge of interest, the femtech and women’s health markets are far from reaching their full potential.

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Supreme Court outlawed segregation of disabled people 25 years ago. But change has come slowly

STAT

As a toddler, Veronica Ayala loved Fridays. At 5 o’clock sharp, her mom whisked her away from the grim Moody State School for Cerebral Palsied Children for a 48-hour reprieve. Ayala’s house was mere minutes away, but the doctors insisted that she had to live at the Galveston, Texas institution during the week so she could learn how to walk.

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Duchenne approval exposes FDA rift over Sarepta gene therapy

BioPharma Dive

Peter Marks’ decision to override the objections of agency staff and broaden use of Elevidys could have a “lasting impact” on gene therapy as well as the FDA, one analyst wrote.

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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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Opinion: Medical experts must step up if health justice is to enter the courtroom

STAT

Danyel Smith has served 21 years of a life sentence at Dooly Correctional Facility in Unadilla, Georgia, for the 2003 murder of his two-month-old son, Chandler. The sole evidence against him at trial was the testimony of three physicians who said that child abuse — in this case shaken baby syndrome — was the only explanation for his son’s symptoms.

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Pharmacists with a disability: Standing Up for Sitting Down campaign

The Pharmacist

When pharmacists with a disability told the Pharmacists’ Defence Association (PDA) they were having problems with suitable adjustments in their workplace, a campaign was launched to raise awareness of what employers need to consider. Liz Larkin reviews the issues. When members of the PDA’s Ability Network named their campaign against disability discrimination, ‘Standing Up for […] The post Pharmacists with a disability: Standing Up for Sitting Down campaign appeared first on The Pharmacist

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Public support 'Save Our Pharmacies' petition with over 100k signatures

The Pharmacist

A cross-sector petition to ‘save’ community pharmacies reached over 100,000 signatures even before yesterday’s ‘day of action’, during which even more members of the public were invited to sign. The National Pharmacy Association (NPA) reported ‘hundreds of signatures being collected at pharmacies across the four nations each day’, which, when combined with signatures collected online, […] The post Public support 'Save Our Pharmacies' petition with over 100k signatures appeared fi

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STAT+: Jury orders Stanford to pay millions to employee in racial harassment case

STAT

A jury has found Stanford University and Stanford Health Care liable for millions of dollars in damages to a longtime employee who sued the institution over its handling of racial harassment and discrimination against her a decade ago. After a seven-week trial, the jury ordered the award to be $20 million, but the Alameda County Superior Court concluded last week the award should be reduced to $10 million.

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RPS to issue call for evidence on self-selection of P medicines

The Pharmacist

The Royal Pharmaceutical Society (RPS) will issue a call for evidence ‘very shortly’ ahead of ‘any potential forthcoming changes’ to its professional guidance on self-selection of P medicines. The Pharmacist understands that the society wants to understand how self-selection of P medicines is working in practice, and how risks are managed. This follows concerns raised by […] The post RPS to issue call for evidence on self-selection of P medicines appeared first on The Pharmacist.

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‘We’re failing right now’ in type 2 diabetes, FDA chief says

STAT

ORLANDO — The United States is at a critical juncture in its efforts to treat chronic diseases, particularly type 2 diabetes, and now has a chance to change the dangerous trajectory it’s currently following, FDA Commissioner Robert Califf said Friday. “The U.S. is leading the world in technology development, innovation, new gadgets of all kinds, new drugs, you name it,” he said.

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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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Adam Fabriwerk inaugurates its New Testing Facility in Ambad, Nashik

Express Pharma

Headquartered in Kandivali, Mumbai, Adam Fabriwerk inaugurated its new dedicated testing facility at Plot No. D-57, Ambad, MIDC on June 20 2024. The state-of-the-art facility specialises in Factory Acceptance Testing (FAT), capable of integrating and testing vessels up to 250,000 litres. Established in 1982, Adam Fabriwerk specialised in customised process system solutions for Pharmaceutical and Bio-pharmaceutical industries.

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STAT+: Kaiser adds a small North Carolina health system to its Risant Health network

STAT

Kaiser Permanente on Friday announced the next deal to build out its Risant Health network of health systems. Risant plans to acquire North Carolina’s Cone Health, a Greensboro, N.C.-based system with four acute-care hospitals, more than 700 doctors, and — crucially for Risant — an accountable care organization and a health plan.

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FDA expands approval of gene therapy for patients with Duchenne Muscular Dystrophy

Express Pharma

The U.S. Food and Drug Administration recently expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for the treatment of Duchenne muscular dystrophy (DMD) for ambulatory and non-ambulatory individuals four years of age and older with DMD with a confirmed mutation in the DMD gene. Elevidys was previously approved under accelerated approval for ambulatory individuals four through five years of age with DMD with a confirmed mutation in the DMD gene.

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Can JAK inhibitors bolster checkpoint inhibitors? 

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Buenos dias! Writing from one of the more unique locations in my tenure as a Readout author… Hola from a mercado in Mexico City. On tap today: Early studies show that checkpoint inhibitors may be more effective if combined with JAK inhibitors.

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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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Gilead small molecule demonstrates strong capability for HIV prevention

European Pharmaceutical Review

Gilead Sciences ’ twice-yearly injectable HIV-1 capsid inhibitor enabled 100 percent efficacy for investigational use of HIV prevention in cisgender women. This is according to interim analysis topline results of the Phase III PURPOSE 1 trial. Lenacapavir showed superiority to once-daily oral Truvada ® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) and background HIV incidence (bHIV).

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STAT+: The CEO of Kaiser’s new health network shares why he’s making a bet on a tiny North Carolina hospital system

STAT

Outside of North Carolina, most people probably haven’t heard of Cone Health. But the relatively small system has an outsized reputation for keeping locals healthy and out of hospitals, according to the CEO of the health care network that struck a deal to acquire it. Improving health outcomes is the stated mission of that network, called Risant Health.

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Sustainable innovation for patients, people, and planet

pharmaphorum

Sustainability is all important for the planet and its people, and in today’s podcast web editor Nicole Raleigh speaks with Harriet Lewis, director of public affairs and communications at Chiesi UK & Ireland, about how partnerships between the NHS and pharma industry can support the journey to more sustainable practices, from R&D and drug reimbursement to medicines and recycling.

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STAT+: Federal judge rules in favor of hospital lobby in privacy lawsuit

STAT

A federal judge has sided with a powerful hospital lobby in a legal battle with regulators over hospitals’ use of third-party website trackers to gather details about visitors’ online behavior. North Texas U.S. District Court Judge Mark Pittman ruled that federal guidance limiting hospital websites’ use of these trackers exceeds the Health and Human Services Department’s authority under HIPAA, according to an opinion filed Thursday.

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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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The new genomic frontier: Next-generation data management takes flight

pharmaphorum

Explore the latest advancements in genomics and sequencing technologies, and learn how next-generation data management tools are transforming genomic research and applications in this new genomic frontier.

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Opinion: ‘Patients like mine’ technologies must rest on solid evidence

STAT

Vendors of electronic health records and other health technology platforms have begun to publicize and demonstrate “patients like mine” capabilities, which insert analytics distilled from EHR data into the physician workflow to guide clinical decisions. While these implementations could be helpful, simple analytics must not be passed off as evidence, and care must be taken to rigorously implement and vet these tools to avoid the negative clinical and cost outcomes associated with i

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KCL’s mini liver model promises more effective drug testing method

Pharma Times

The method provides a more accurate and ethical approach to drug testing for medicines

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STAT+: Pharmalittle: We’re reading about FDA approval for Sarepta drug, MSF closing access campaign and more

STAT

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda, so far, appears quite modest. We hope to tidy up around the castle, promenade with the official mascots and hold another listening party, where the rotation will likely include this , this , this , this and this.

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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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EHA 2024: Monoclonal antibodies continue to dominate multiple myeloma treatments

Pharmaceutical Technology

Trial investigators anticipate that the FDA will decide on approval for linvoseltamab in relapsed/refractory multiple myeloma by the end of 2024.

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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Pharma Pulse 6/21/24: Global Mortality and Disability from Type 1 Diabetes Have Decreased, What Leaders of Effective Teams Know & more

Pharmaceutical Commerce

Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.

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STAT+: What the Sarepta decision means for Duchenne patients, the company, and the FDA

STAT

Sarepta Therapeutics always wins. That was a given, even before the Food and Drug Administration expanded approval of the company’s Duchenne muscular dystrophy drug on Thursday. Will boys with Duchenne also benefit? I hope they do, but it’s uncertain. And is this a good look for the FDA? No, it is not. There is much to unpack from the unilateral decision by Peter Marks, the FDA’s top regulator of gene therapies, to expand the use of Sarepta’s Elevidys to nearly all Du

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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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New ‘space hairdryer’ to regenerate heart tissue after bypass surgery

Pharma Times

According to WHO, cardiovascular diseases are responsible for 17.

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Melodia Therapeutics and Alivexis sign exclusive licence agreement for Cathepsin C Inhibitor program MOD-A

Express Pharma

Alivexis, and Melodia Therapeutics AG , a company established by Forty51 Ventures, announced that they have entered into an exclusive licence agreement for the worldwide development, manufacturing, and commercialisation of Alivexis’ MDI-0151, a novel Cathepsin C inhibitor with best-in-class potential. MDI-0151 is an innovative clinical candidate identified in Alivexis’ MOD-A discovery program.

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Gilead’s twice-yearly HIV PrEP 100% effective, says study

pharmaphorum

Twice-yearly lenacapavir injection provides 100% protection from HIV when used as PrEP in cisgender women, says Gilead.

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M&A trends to watch out in pharma

Express Pharma

India’s pharmaceutical sector is on a growth trajectory. In 2023, while the deal volume declined, the deal value grew1, due to strategic megadeals in the pharma sector. Pharma services have witnessed extensive innovation from contract development and manufacturing organisation (CDMO), contract research organisation, pharma information technology (Pharma IT).

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WHO warns of “harmful” fake Ozempic in circulation in Americas and Europe

Pharmaceutical Technology

Both Novo Nordisk and Eli Lilly have filed lawsuits against unapproved sellers of their diabetes and weight loss drugs.