Tue.Apr 16, 2024

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STAT+: UnitedHealth skips hearing in the wake of Change cyberattack, triggering call for subpoena

STAT

In the first federal hearing focused on the massive cyberattack on Change Healthcare , lawmakers had many important questions for UnitedHealth, which owns Change: Did it meet Health and Human Services’ cybersecurity performance goals ? Has UnitedHealth exploited physicians’ cash shortfalls caused by the Change outage to acquire struggling practices?

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Ukraine was pharma’s ‘darling’ of clinical trials. As war drags on, will the industry come back?

PharmaVoice

New clinical trial starts are picking back up, but are still far below their bustling pre-war level.

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STAT+: Grocers are pushing legislation they claim would enhance food safety. Advocates say it would gut FDA rules

STAT

WASHINGTON – In the last decade, Americans have been sickened by salmonella from cucumbers, listeria from Mexican-style cheese, and E. coli from romaine lettuce. Now, it would seem that Washington is finally getting serious about making sure the Food and Drug Administration has the power to promptly investigate and respond to foodborne outbreaks.

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Smart sensor cleared for use with AZ asthma, COPD inhalers

pharmaphorum

A smart sensor developed by Adherium has been cleared by the FDA for use with AstraZeneca's asthma inhaler Airsupra and Breztri for COPD.

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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: Autism doesn’t discriminate. Autism research shouldn’t either

STAT

The face of autism was once predominantly white. No longer. The Centers for Disease Control and Prevention reported last year that the prevalence of autism across all racial and ethnic groups is reaching parity. Among 8-year-olds in particular, autism was more commonly identified among Black, Hispanic and Asian American/Pacific Islander children than among their white counterparts for the first time ever.

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India sees insignificant revision to price ceiling in 2024

Pharmaceutical Technology

The price ceiling policy has been in place for more than 20 years, but it has neither been very successful nor free of consequences for pharma companies.

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How global healthcare partners and Indian pharma companies are contributing to affordable medicines

Express Pharma

In the expansive landscape of global healthcare, India has emerged as a pivotal player, shaping the accessibility and affordability of essential medicines worldwide. As the world’s leading supplier of generic drugs, India’s pharmaceutical industry has become a ray of hope for millions as it ensures quality-assured and cost-effective treatments reach those who need them the most.

Vaccines 105
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U.S. to set limits on silica exposure first recommended half a century ago

STAT

Most people know silica as the mysterious contents of desiccation packets found in vitamin bottles, high-end leather purses, clothing, and other items. But for miners and other stone cutters, silica is a serious health hazard, and new rules announced on Tuesday by a U.S. government agency set strict limits on how much of the mineral they can be exposed to.

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Bio-Rad and Oncocyte partner to develop and commercialise transplant monitoring products

Pharma Times

Solid organ transplantation is used to treat end-stage organ failure, including the kidneys

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STAT+: Intra-Cellular reports positive results in depression study aimed at expanding use of antipsychotic medicine

STAT

Intra-Cellular Therapies reported positive results Tuesday from a late-stage clinical trial seeking to expand the use of its antipsychotic medicine Caplyta to patients with major depressive disorder. In the Phase 3 study, Caplyta reduced depressive symptoms by 4.9 points compared to a placebo on the Montgomery-Asberg Depression Rating Scale (MADRS), a widely used, clinician-rated measure of depression severity.

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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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Boehringer says R&D pipeline is the best in its long history

pharmaphorum

Boehringer Ingelheim says the strongest R&D pipeline in its history is set to deliver 25 new product launches between now and 2030

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STAT+: UnitedHealth reaffirms financial outlook despite up to $1.6 billion hit from Change Healthcare cyberattack

STAT

Hospitals and medical groups say they’re still reeling from the effects of the cyberattack on a UnitedHealth Group subsidiary, but the massive company at the center of the debacle has so far emerged largely unscathed, with executives on Tuesday praising its strength and resilience. The almost $8 billion UnitedHealth made on operations in the first three months of 2024 was roughly the same as the prior-year period.

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‘Stiffness’ of cells could give early warning of cancer

pharmaphorum

Researchers from the UK have developed an endoscopic device that uses 3D imaging to look at the stiffness of cells and could diagnose cancer earlier.

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Opinion: Practicing medicine at a predominantly Black institution gave me the gift I didn’t realize I needed

STAT

“You have a big voice, Dr. Grubbs,” the clinic manager said. I flinched. The last time I heard similar words, they were part of a common refrain that I had encountered often. “You’re too direct.” “Too outspoken.” “Intimidating.” Peers who looked like me encouraged me to put my head down, make myself smaller, endure — and never, ever call out racism.

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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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UCL study reveals carbon beads could help reduce progression of liver disease

Pharma Times

Liver cirrhosis, caused by long-term liver damage, is estimated to affect around 100 million people worldwide

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Biohaven’s data delay degrades stock price

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello! Today, we dig into Biohaven’s plans and see Humira biosimilar prescriptions shoot up.

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GSK trails after Pfizer in 5-in-1 meningococcal vaccine race

pharmaphorum

FDA starts review of GSK’s 5-in-1 meningitis vaccine, cueing up a decision early next year, as it tries to chase down Pfizer's recently-approved Penbraya

Vaccines 110
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STAT+: Pharmalittle: We’re reading about CVS and Humira biosimilars, Schumer’s broken insulin promise, and more

STAT

Top of the morning to you, and a fine one it is. Clear blue skies and cool breezes are currently enveloping the placid Pharmalot campus, where the official mascots are snoozing cozily in their respective corners and the usual din of motor cars is nowhere to be heard. So this calls for a celebratory cup of stimulation. Our choice today is the oh-so tasty hazelnut mocha.

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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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Novartis releases new data for innovative rare kidney disease treatment

European Pharmaceutical Review

Novartis has released new data from the first and only Phase III study to demonstrate significant proteinuria reduction by targeting the complement system in patients with the rare kidney disease IgA nephropathy (IgAN). Pre-specified interim analysis results from the Phase III APPLAUSE-IgAN clinical trial were presented at the 2024 World Congress of Nephrology (WCN).

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STAT+: A new PIPE lawsuit challenges the fairness of sharing confidential, stock-moving information

STAT

The fairness of PIPEs, particularly the preferential sharing of confidential, stock-moving information, is now a legal question. A shareholder is suing Taysha Gene Therapies insiders and a group of health care investment firms for allegedly enriching themselves in a $150 million PIPE transaction that involved delaying the public disclosure of positive results from a gene therapy clinical trial.

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Teva enters into oncology biosimilar licensing agreement

European Pharmaceutical Review

A new global licensing agreement is set to advance development of an oncology biosimilar candidate. Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. and Spain-based biopharmaceutical company mAbxience, have entered into a strategic deal for a drug candidate that is in development for treating multiple indications in the oncology space.

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AskBio presents 18-month Phase Ib trial results of AB-1005 gene therapy for patients with Parkinson's disease

World Pharma News

Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, on Sunday April 14 presented results from the 18-month Phase Ib clinical trial for AB-1005, an investigational gene therapy for treating patients with Parkinson's disease (PD).(1,2) The data were presented at the American Academy of Neurology 2024 Annual Meeting in Denver, Colorado, USA.

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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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European and Japanese Pharmacopoeias partner to harmonise pharmacopoeial standards

European Pharmaceutical Review

A new bilateral prospective harmonisation project between the European Pharmacopoeia (Ph. Eur.) and the Japanese Pharmacopoeia (JP) will focus on pharmacopoeial standards for active substance and medicinal product monographs. Through the harmonisation, alignment of the pharmacopoeial standards in different regulatory jurisdictions, is aimed at decreasing the burden on drug manufacturers to do different compendial tests, according to the organisation European Directorate for the Quality of Medici

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Norgine seeks approval for high-risk neuroblastoma treatment

Pharmaceutical Technology

Norgine has sought approval for eflornithine (DFMO) for the treatment of patients with high-risk neuroblastoma (HRNB).

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Passive smoking linked to increased risk of atrial fibrillation, new study finds

The Pharmacist

Any level of passive smoking universally elevates the risk of atrial fibrillation, according to new research presented at the recent European Heart Rhythm Association congress. The researchers examined the association between secondhand smoke exposure and the long-term risk of incident atrial fibrillation, aiming to add to existing research that has established links between passive smoking and […] The post Passive smoking linked to increased risk of atrial fibrillation, new study finds ap

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Panel Discussion: Decoding the path to progress

Express Pharma

Panelists in this video: + Mr Prashant Sharma, CTO, Zydus (Moderator) + Mr Pradipta Kumar Swain, COO, Innoxel Lifesciences + Dr Mahesh Bhalgat, Group CEO, Veeda + Mr Parag Swadia, CEO, Otsuka Pharma + Mr Sudhir Vaid, CMD, Concord Biotech Key Highlights: [1] Vision and values need to be aligned across all levels for organisations to succeed [2] Superhero leaders are overrated and can even prove to be liabilities in the long run.

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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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Qinecsa Solutions acquires Insife to strengthen pharmacovigilance technology

Outsourcing Pharma

Qinecsa Solutions (Qinecsa), a lead company in technology-driven end-to-end pharmacovigilance solutions has announced its acquisition of Insife ApS (Insife), a Danish-based firm specializing in innovative pharmacovigilance platforms.

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Significant proportion of RTIs given more than one antibiotic course

The Pharmacist

Almost one in five adults and one in ten children receive a second course of antibiotics for the same respiratory tract infection, researchers have found. Analysis of GP records of more than 900,000 cases of respiratory tract infection across 530 practices in England also found that in half the cases of repeat antibiotic prescribing, the […] The post Significant proportion of RTIs given more than one antibiotic course appeared first on The Pharmacist.

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Innovating drug development: Charles River embracing alternatives to animal testing

Outsourcing Pharma

Charles River Laboratories International, Inc. has unveiled its Alternative Methods Advancement Project (AMAP), a strong initiative aimed at changing drug discovery and development by exploring alternatives to animal testing.

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The Catalyst Connect 2024 Survival Guide

PioneerRx

It’s the most wonderful time of year for PioneerRx. Catalyst Connect 2024 is rapidly approaching, where pharmacists and other healthcare professionals.

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DCAT Debrief: Lonza's perspective on pharma's path forward with AI and drug development

Outsourcing Pharma

In a recent discussion with Jan Vertommen, vice president and head of commercial development for the small molecules division at Lonza, key insights were shared regarding the pharmaceutical industry's current landscape and future trajectory.