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Last week’s layoffs across the Department of Health and Human Services left a significant casualty in the vast ecosystem of government-backed science: an entire division focused on researching pain. The reduction in force enacted last week by Health Secretary Robert F. Kennedy Jr. eliminated all but one full-time position, out of roughly a dozen, within the National Institutes of Health Office of Pain Policy and Planning, a unit devoted to coordinating pain-related research across t
By Kurt R. Karst The FDA Reduction-in-Force (Termination)or RIF(T)announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIFd. As the dust begins to settle and we all assess what this means for the future of FDA and the public health, generally, this blogger wanted to call out one particular division in the Office of Generic Drugs (OGD), funded by user fees under the Generic Drug User Fee Amendments (GDUFA), that was eradicated and what t
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. I’m writing to you from San Diego, where STAT held an event during the American Academy of Neurology annual meeting this past weekend. We’ll get into a highlight from the event below, along with all the other biotech news today.
The Indian Society for Clinical Research (ISCR) has announced the appointment of Dr Seema Pai as President for the 20252028 term. Dr Pai succeeds Dr Sanish Davis, who served as President from 2021 to 2025. The new leadership team also includes Anirban Roychowdhury as Honorary General Secretary and Amita Bhave as Treasurer. Dr Pais appointment comes at a time when the clinical research sector in India is adapting to changes in technology and evolving regulatory structures.
Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.
Editor’s note: This story contains a description of self-harm. Oncologist Mark Lewis has never had much of a poker face. When he walked into his cancer patient’s visit in 2022, he was wearing a big smile: The nodules in his patient’s lungs, he saw in the radiology report, were shrinking in response to treatment. His patient, though, was already upset.
To address growing demand from the pharmaceutical industry, Asahi Kasei has launched a new division, Asahi Kasei Life Science, effective from 1 April 2025. The new structure is designed to unify its bioprocess businesses and streamline services offered to pharmaceutical partners across drug development and manufacturing. Asahi Kasei Life Science now houses the companys bioprocess-related units, including Planova virus removal filters, Microfilters BioOptimal, and associated equipment used in the
To address growing demand from the pharmaceutical industry, Asahi Kasei has launched a new division, Asahi Kasei Life Science, effective from 1 April 2025. The new structure is designed to unify its bioprocess businesses and streamline services offered to pharmaceutical partners across drug development and manufacturing. Asahi Kasei Life Science now houses the companys bioprocess-related units, including Planova virus removal filters, Microfilters BioOptimal, and associated equipment used in the
Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here. Good morning. In case you missed it yesterday, we have a winner for this year’s STAT Madness competition. From the same institution as last year — is that a dynasty I see forming?
Steris Healthcare, a pharmaceutical company headquartered in Mumbai with operations in Navi Mumbai, has unveiled a 50 crore growth strategy aimed at expanding its manufacturing capacity, entering new regional markets, and launching an Initial Public Offering (IPO) in FY 202627. The company, which recently crossed 100 crore in annual revenue, plans to strengthen its national presence through a multi-pronged approach.
NHC Submits Comments on FDA Draft Guidance for AI/ML-Enabled Medical Devices (PDF) April 7, 2025 Dockets Management Staff U.S. Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 RE: Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations [FDA-2024-D-4488] Submitted via regulations.gov To Whom It May Concern, The National Health Council (NHC) appreciates the opportunity to submit comments on the Food and D
Cadila Pharmaceuticals has announced the launch of Vasograin EC, a reformulated version of its established migraine treatment, Vasograin. The updated formulation is now manufactured in a US FDA-approved facility, aligning with international regulatory and quality standards. Vasograin EC has been designed with a reduced tablet size aimed at improving patient compliance and adherence.
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
Process analytical technology (PAT), namely at-line, online or inline instruments, may be represented by univariate sensors or more complex analysers and systems resulting in multivariate datasets. These can be pivotal for achieving high precision, efficiency and control, as well as continuous and automated manufacturing. Here we provide an overview of the tasks involved in implementing PAT in a GMP environment, as well as opportunities for organisations to consider in the face of common challen
Some 2.7 million patients could have saved on their prescription charges by using a pre-payment certificate (PPC) in 2023/24, latest analysis from the NHS Business Services Authority (NHSBSA) has suggested. For 61% of those, a three-month PPC may have been the best choice, saving each patient 16 on average, the NHSBSA said. And a further […] The post Millions could save on prescriptions using a pre-payment certificate, suggests NHSBSA appeared first on The Pharmacist.
ALX2004 has been designed using the companys topoisomerase I inhibitor payload platform to enhance anti-tumour activity and improve patient outcomes in EGFR-expressing tumours. The molecule, developed entirely within ALX Oncology’s laboratories, features an engineered antibody backbone to optimise anti-EGFR activity, a stable linker, and a topoisomerase I payload that is expected to produce an enhanced bystander effect.
An estimated 296m of the 645m primary care recovery plan pharmacy fund was 'absorbed by the NHS for other purposes', Community Pharmacy England (CPE) has confirmed. From the 645m announced in May 2023, an estimated 349m has been spenton: Pharmacy First set-up payments, monthly payments and service fees the hypertension case-finding service the pharmacy contraception […] The post Almost 300m of pharmacy investment 'absorbed by NHS for other purposes' appeared first on The Pharmaci
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.
The Scottish Medicines Consortium (SMC) has accepted the use of Ipsens Iqirvo (elafibranor) in NHS Scotland for the treatment of primary biliary cholangitis (PBC), a rare liver disease. This marks the first new medicine for PBC to be accepted by the medical body in nearly a decade. Iqirvo is a peroxisome proliferator activated receptor (PPAR) […] The post Ipsens Iqirvo approved for use in NHS Scotland to treat rare liver disease appeared first on Pharmafile.
"5 Key Considerations for Valuing Pharma Companies As the pharmaceutical industry continues to evolve, accurately valuing pharma companies has become increasingly complex. At DrugPatentWatch, we've identified 5 key considerations that can help you make informed investment decisions. Patent Portfolio Strength : A strong patent portfolio can significantly impact a company's valuation.
High Force Research has announced that it has appointed Nathalie Huther as its first chief commercial officer (CCO) following the companys recent management buyout (MBO). This forms an important part of its business development and market expansion strategy. Huther will lead High Forces research commercial strategy, and brings a wealth of experience in commercial leadership […] The post High Force Research appoints Nathalie Huther as chief commercial officer appeared first on Pharmafile.
Patient Safety in the Era of Generic Drugs: A Call to Action As the pharmaceutical industry continues to evolve, one thing remains constant: the need for patient safety. With the rise of generic drugs, it's more important than ever to ensure that these alternatives meet the same high standards as their brand-name counterparts. At DrugPatentWatch, we've seen firsthand the impact that generic drugs can have on patients.
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.
ELRIG, a non-profit volunteer-led organisation dedicated to the drug discovery community, has appointed Del Trezise as chair of the board. He succeeds Melanie Leveridge, who completed her four-year term as chair. He will lead ELRIGs mission to deliver highly accessible scientific meetings and conferences. It serves a global network of over 22,000 life sciences professionals. […] The post ELRIG appoints Del Trezise as chair appeared first on Pharmafile.
GSK has agreed to develop novel medicines for neurodegenerative diseases, as part of a global licensing agreement with ABL Bio Inc, for up to 2.075 billion. This is subject to certain milestone payments across multiple potential programmes.The licensing deal will utilise ABL Bios blood-brain barrier shuttle platform Grabody-B, to advance multiple programmes across therapeutic modalities including antibody , polynucleotide or oligonucleotides, such as siRNA and ASOs.
“There will be a ChatGPT moment for biotechnology,” a bipartisan commission wrote in the new report, which calls for the U.S. to invest at least $15 billion into the sector over the next five years.
Five years ago, Michelle Werner received her son’s Duchenne muscular dystrophy diagnosis with fear and desperation. Now, as CEO of Alltrna, she’s finding ways to turn those feelings into a better way of treating rare diseases.
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.
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.
A significant discovery has identified a missing "gatekeeper" protein as the root cause of dry mouth in Sjgren's syndrome - a finding that could change the way the disease is treated. Researchers pinpointed tricellulin, a protein that helps seal the junctions between saliva gland cells, as the key factor. When inflammation damages tricellulin, saliva production stops and harmful substances leak through.
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