Wed.Feb 26, 2025

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STAT+: FDA cancels vaccine advisory committee meeting

STAT

The Food and Drug Administration canceled an upcoming vaccine advisory committee meeting to discuss influenza virus strains, according to committee member Paul Offit.  The meeting was scheduled for March 13. Committee members received a cancellation email — which was first reported by Jeremy Faust of Inside Medicine — on Wednesday afternoon.

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Motilal Oswal Alternates invests up to INR 460 crores for majority stake in Megafine

Express Pharma

MO Alternate Investment Advisors (MO Alts) has agreed to invest up to INR 460 crores for a majority stake in Mega Fine Pharma (Megafine).The Sanghvi Family, one of the founding-promoter groups, has also participated in this transaction, increasing their stake in the Company. Megafine, established in 1995, is an export-focused Active Pharmaceutical Ingredient (API) company based in Mumbai.

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GPhC updates education and training guidance to support sustainability commitments

The Pharmacist

Guidance for the education and training of pharmacists and pharmacist independent prescribers has been updated to reflect commitments to sustainability, the General Pharmaceutical Council (GPhC) has announced. The updated guidance highlights the crucial role of pharmacists as medicines experts in working towards the more environmentally sustainable use of medicines and decreasing their associated carbon footprint […] The post GPhC updates education and training guidance to support sustaina

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Could novel 3D printing method enhance intestinal drug delivery?

European Pharmaceutical Review

A study has demonstrated a new approach to prepare tablets for intestinal drug delivery by combining two 3D printing techniques. Using both selective laser sintering (SLS) and fused deposition modelling (FDM), the technique has potential to achieve delayed and prolonged drug release, according to the findings. Key findings from the 3D printing drug delivery study [a] laser speed of 90 mm s1 was suitable for producing [3D printed tablet] cores with relatively short disintegration time and suffici

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Navigating Payroll Compliance: Future-Proofing Payroll in an Evolving Regulatory Landscape

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.

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USFDA classifies inspection at Dr Reddy’s API facility as Voluntary Action Indicated

Express Pharma

Dr Reddys Laboratories has recently announced that it has received the Establishment Inspection Report (EIR) from the United States Food & Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) manufacturing facility (CTO-2) in Bollaram, Hyderabad. The update follows the companys earlier intimation on November 19, 2024 regarding the USFDA inspection at the facility.

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Mitazalimab shows promising survival rates in cancer study

Pharma Times

Updated data from phase 2 study reveals survival benefit

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In Uncertain Times, Good Compliance and Quality Communication Habits Can Offer a Port in the Storm

FDA Law Blog: Biosimilars

By John W.M. Claud The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. How will the cuts at FDA impact inspections and enforcement? Will there be a heightened appetite for mergers and acquisitions in the space?

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Available for Preorder: The 2025 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

Drug Channels

On March 18, 2025, Drug Channels Institute will release The 2025 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers. This reportour sixteenth editionremains the most comprehensive, fact-based tool for understanding the entire U.S. drug pricing, reimbursement, and dispensing system. This unique, encyclopedic resource is your ultimate guide to the complex web of interactions within U.S. prescription drug channels. 12 chapters, 500+ pages, 267 exhibits, nearly 1,200 endnotes: There is

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Microbiotica unveils new data on MB097 at AACR IO meeting

Pharma Times

Data presented in Los Angeles showcases therapys potential

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Drafting Drug Patent Applications for Biologic Drugs

Drug Patent Watch

The Complex World of Biologic Drugs: Navigating Patent Applications As a biotech professional, you're likely no stranger to the intricacies of developing life-changing treatments. But have you ever stopped to think about the patent landscape surrounding biologic drugs? It's a complex world, to say the least. Biologic drugs, also known as biologics, are a type of medication made from living organisms or their components.

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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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Enhancing medical education through gamification and innovative technologies

pharmaphorum

Explore how gamification and innovative technologies can revolutionise medical education, making learning more engaging and effective. Discover the benefits and best practices for integrating gamification into medical training.

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Eikon raises almost $351m to advance cancer candidates through the clinic

Pharmaceutical Technology

Eikons lead candidate EIK1001 is being investigated for melanoma in combination with MSDs Keytruda in a Phase III trial.

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Women in science: Where are we now?

pharmaphorum

Explore the current state and achievements of women in science with insights from Michelle Bridenbaker, Alexandra Tabbitt, Agnes Cwienczek, Jean Redmond, Dr Jessica Steier, and Sabine Glden. Learn about their contributions and the progress being made in the field.

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Eikon raises $351M in one of the year’s largest biotech venture rounds

BioPharma Dive

The funding comes as Eikon, run by former Merck research chief Roger Perlmutter, has started a Phase 3 trial testing one of its cancer drugs against Keytruda.

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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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Bayer reveals phase 3 data for improved MRI contrast agent

pharmaphorum

Bayer is close to filing a new MRI contrast agent that can reduce levels of gadolinium, which can have health and environmental consequences.

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Government progress on antimicrobial resistance ‘limited’, warns NAO

The Pharmacist

The government has made limited progress in achieving its vision of containing antimicrobial resistance (AMR), the public spending watchdog has warned. The National Audit Office (NAO)investigated AMRin light of it being a serious public health threat and after the Covid-19pandemic showed that the UK was not as resilient to such threats asitexpected tobe.

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Can Keytruda finally break into early head and neck cancer?

pharmaphorum

The FDA is set to decide on MSD's Keytruda as perioperative treatment of locally advanced head and neck squamous cell carcinoma in June

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Lilly CEO wields manufacturing plans to push pharma-friendly policies

BioPharma Dive

While announcing billions of dollars in new U.S. investments, company chief David Ricks called for an extension of 2017 tax cuts and changes to Medicare's drug negotiation program.

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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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Successfully Patenting Drug Combinations: Strategies and Challenges

Drug Patent Watch

Unlocking the Secrets to Patenting Drug Combinations: Strategies and Challenges As a pharmaceutical professional, you know how crucial it is to stay ahead of the curve when it comes to patenting innovative treatments. One area that's gaining significant attention is drug combinations pairing two or more active ingredients to create a more effective therapy.

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AstraZeneca’s next breast cancer drug; Madrigal’s accelerating MASH launch

BioPharma Dive

The British drugmaker claimed study success in a first-line setting in breast cancer. Elsewhere, Rezdiffra sales continued to grow and a cancer biotech cut staff.

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Perlmutter's Eikon raises $351m in major financing round

pharmaphorum

Eikon has added to its already copious cash reserves with a $351m round for its expanding pipeline of cancer therapies.

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Emalex eyes FDA approval for Tourette syndrome therapy after Phase III success

Pharmaceutical Technology

The Phase III trial met the primary and secondary endpoints of reducing tics in children and adult patients with Tourette syndrome.

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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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Data cues up AZ oral SERD filing in first-line breast cancer

pharmaphorum

AstraZeneca could be the first to bring an oral SERD to market in first-line breast cancer after camizestrant hit the mark in a phase 3 trial.

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Idorsia’s Tryvio deal collapses, forcing company to find cash urgently

Pharmaceutical Technology

With a potential buyer not working out, Idorsia has adjusted an existing partnership and restructured bonds to raise cash.

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Why non-diabetics using CGM may not be a good idea

pharmaphorum

A clinical trial has found that a continuous glucose monitor device systemically overestimated blood glucose levels when used by non-diabetic people.

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RedHill and Hyloris sign agreement for Bekinda’s development

Pharmaceutical Technology

RedHill has signed an exclusive licensing agreement with Hyloris for the global development and commercialisation of RHB-102 (Bekinda).

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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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Strategic Partnerships

PharmaTech

Webinar Date/Time: Fri, Mar 21, 2025 11:00 AM EDT

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FDA approvals decline but drug innovation remains strong even among small sponsors

Pharmaceutical Technology

The US Food and Drug Administration (FDA) approved 126 innovator and biosimilar drugs in 2024, significantly lower than the 149 approvals in 2023.

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Episode 1004: An Example of a Study Where the Forest is More Important Than the Trees

Pharmacy Joe

In this episode, I’ll discuss oral sedation strategies for young patients presenting to the ED with acute severe behavioral disturbance. Episode 1004: An Example of a Study Where the Forest is More Important Than the Trees Subscribe on iTunes , Android , or Stitcher When treating children and adolescents who present to the ED with acute behavioral disturbances, the American Association for Emergency Psychiatry states: There is consensus that PO administration should be tried whenever possi

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Eli Lilly pays $10m upfront for Organovo’s FXR agonist

Pharmaceutical Technology

Organovos lead asset FXR314 will be investigated in a Phase II trial for inflammatory bowel disease (IBD).

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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.