Express Pharma
APRIL 8, 2025
A successful campaign drives engagement and shapes social norms through consistent digital communication – Bhavna Singh, Vice President Corporate Communications at Bharat Serums and Vaccines (BSV) “Communication is as effective as the content and the channels used. Digital Multi stakeholder communication rests heavily on engagement with the audience.
Putting Patients First Blog
APRIL 8, 2025
NHC Submits Comments on FDA Draft Guidance for AI/ML-Enabled Medical Devices (PDF) April 7, 2025 Dockets Management Staff U.S. Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD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
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FDA Law Blog: Biosimilars
APRIL 8, 2025
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
STAT
APRIL 9, 2025
Two decades ago, when I first began practicing emergency medicine, patient documentation was a manual process. I would write on carbon-copy forms that were later stored in the belly of the hospital, in archives, as patient files. To get a lab test, an X-ray, or a medication for a patient, I had to jot down instructions on a piece of paper, track down the right nurse, and verbally convey what orders I had put in.
Speaker: Jennifer Hill
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.
Express Pharma
APRIL 8, 2025
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.
European Pharmaceutical Review
APRIL 8, 2025
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
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
STAT
APRIL 10, 2025
Mark Ratain’s First Opinion piece of Feb. 4, 2025 , implies that the oncologists in NCI’s Investigational Drug Branch (IDB) colluded with the drug company Exilixis to sponsor two Phase 3 studies of its drug cabozantanib. He claims these studies showed minimal benefit, yet the results were used to inflate the value of Exilixis stock. Ratain concludes by recommending that IDB be abolished.
Express Pharma
APRIL 8, 2025
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
European Pharmaceutical Review
APRIL 9, 2025
A new Digital Architecture framework is anticipated to help transform the process of manufacturing pharmaceuticals, by helping companies to progress towards autonomous manufacturing.The digitalisation-focused initiative is a collaborationbetween the Centre for Process Innovation (CPI) and industry partners including AstraZeneca and GSK. This framework delivers a clear strategy for companies to incorporate digital technologies, enable real-time release for drug manufacturing and address key chall
Pharmafile
APRIL 9, 2025
The cancer biotech company Infinitopes has gained approval by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to evaluate its ITOP1 vaccine targeting oesophageal cancer. This marks the first ever trial to administer a cancer vaccine in a neoadjuvant setting while the primary tumour remains. With Clinical Trial Application (CTA) approval, the upcoming phase […] The post Infinitopes launches first-in-human trial of vaccine targeting oesophageal cancer appeared first on Phar
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
STAT
APRIL 9, 2025
A national public health organization is calling for Health Secretary Robert F. Kennedy Jr. to resign the federal post he assumed just weeks ago, citing “implicit and explicit bias and complete disregard for science.” Georges Benjamin, executive director of the American Public Health Association, said in a statement on Wednesday that concerns raised during Kennedy’s confirmation hearing last month have been realized, followed by massive reductions in staff at key health agen
Express Pharma
APRIL 9, 2025
The Federation of Pharma Entrepreneurs (FOPE), in collaboration with PharmaState Academy, conducted the 18th session of its ongoing PULSE (Pharma Upgradation & Learning Series for Excellence) initiative. The session focused on the manufacture of sterile drug products in line with the Revised Schedule M, bringing together key stakeholders and experts from across the pharmaceutical manufacturing ecosystem.
European Pharmaceutical Review
APRIL 10, 2025
There is worldwide concern around the use of PFAS. In the EU, a joint PFAS Restriction Proposal under REACH was submitted, aiming for a full ban by 2028/2030. This poses a significant challenge for pharmaceutical manufacturers, not least because of the technical challenges related to operations, supply chain and the environment. This article explores the potential impact of the proposal and considers how manufacturers can ensure the safety and reliability of their products.
Pharmaceutical Business Review
APRIL 8, 2025
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.
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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.
STAT
APRIL 8, 2025
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
Express Pharma
APRIL 8, 2025
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.
Drug Patent Watch
APRIL 9, 2025
Just spent the day diving into the world of biosimilars and regulatory considerations. Key takeaways from the article on DrugPatentWatch: Biosimilar extrapolation of indications is a complex process that requires a deep understanding of the regulatory landscape. The FDA has established a framework for evaluating biosimilarity, but there is still a lack of clarity around extrapolation.
Pharmafile
APRIL 10, 2025
TauRx Pharmaceutics reports that hydromethylthionine mesylate (HMTM) could be an oral treatment for slowing the progression of Alzheimer’s disease over a period of at least 18 months. If approved by regulators, HMTM could be the first oral treatment for the disease that targets the tau protein. Conventionally, targeted therapies for Alzheimers focused on amyloid protein […] The post Research finds tablet effective in slowing progression of Alzheimers disease over 18 months appeared f
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.
STAT
APRIL 10, 2025
NEW YORK — A top Centers for Disease Control and Prevention official told staff this week to start planning for the agency’s splintering. Several parts of CDC — mostly those devoted to health threats that aren’t infectious — are being spun off into the soon-to-be-created Administration for a Healthy America, the agency official told senior leaders in calls and meetings.
Express Pharma
APRIL 8, 2025
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.
Pharma Marketing Network
APRIL 9, 2025
Imagine launching a breakthrough therapybut the right people never see it. In a world dominated by digital conversations, failing to master pharma digital marketing is no longer an optionits a risk to market performance. Pharma marketers today must navigate not only consumer expectations but also a tightly regulated environment. The stakes are high, but so are the opportunities.
National Association of Boards of Pharmacy
APRIL 9, 2025
At NABP, one of the ways in which we support patient safety is by offering examinations that assess a pharmacists competency to practice. The Multistate Pharmacy Jurisprudence Examination (MPJE ) is specifically designed to evaluate candidates understanding and application of federal and state-specific laws and regulations. The exam measures both candidates’ knowledge of these laws and their ability to apply that knowledge to their pharmacy practice.
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.
STAT
APRIL 10, 2025
A group of academics is arguing that countries seeking access to a groundbreaking HIV prevention drug from Gilead Sciences should issue compulsory licenses if the company fails to modify an existing licensing program with half a dozen generic makers. In an essay in Clinical Infectious Diseases , they complained Gilead pursued voluntary licenses that are too restrictive, which will delay or deny access to its drug.
Express Pharma
APRIL 9, 2025
Jazz Pharmaceuticals said on Tuesday that it had agreed to a settlement of $145 million to resolve a series of antitrust lawsuits related to its narcolepsy drug, Xyrem. Xyrem, a medication approved in the U.S., is used for the treatment of excessive daytime sleepiness and sudden loss of muscle control in patients suffering from narcolepsy, a chronic neurological disorder.
The Pharmacist
APRIL 9, 2025
General practice staff who are members of the NHS pension and affected by the McCloud case face losing out financially because of delays in receiving key paperwork, experts have said. Just under 400,000 members of the pension scheme all of whom have already retired were due to receive remediable service statements (RSS), that provide […] The post McCloud NHS pensioners face financial disadvantage due to admin delays appeared first on The Pharmacist.
Drug Channels
APRIL 9, 2025
It's time for Drug Channels annual update of vertical integration among insurers, PBMs, specialty pharmacies, and healthcare services within U.S. drug channels. As you can see below, we have revised, renovated, and refurbished our infamous illustration of the major vertical business relationships among the largest companies. Proponents of these vertical integration arrangements argue that they create opportunities to mine healthcare costs.
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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.
STAT
APRIL 10, 2025
Mayo Clinic has hired Micky Tripathi, a former top health technology official under President Biden, to be its chief AI implementation officer, a role that involves overseeing the technology’s development and adoption within the sprawling health system. Tripathi most recently was the assistant secretary for technology policy and the national coordinator for health information technology.
Express Pharma
APRIL 7, 2025
Fixed-dose combinations (FDCs), which contain two or more active ingredients in a single dosage form, have seen a significant rise in production and usage across the pharmaceutical industry. This increase has been driven by several factors, including the need for simplified treatment regimens, efforts to improve patient adherence, and the demand for cost-effective therapeutic solutions.
The Pharmacist
APRIL 8, 2025
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
Drug Patent Watch
APRIL 8, 2025
"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.
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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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