Sun.Jan 05, 2025

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Revised Schedule M implementation for MSMEs extended, industry welcomes move

Express Pharma

The Union Ministry of Health and Family Welfare revised the date of the implementation of the revised Schedule M of the Drugs and Cosmetics Act allowing pharma MSMEs an additional 12 months to comply, extending the date to December 31, 2025. To avail of this extension, pharma companies with a turnover of less than 250 crores must file an application with the Central Licensing Authority with details of their upgradation plan.

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Does Every Patient On Anticoagulation Need a PPI?

Med Ed 101

I’ve had some wonderful guest posts in the past and I couldn’t help but notice this awesome post on LinkedIn from a fellow pharmacist! April Oliveros is the author of this quick hitter on “Does Every Patient On Anticoagulation Need a PPI?” You can connect and follow her on LinkedIn right here. As clinical pharmacists, […] The post Does Every Patient On Anticoagulation Need a PPI?

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CSIR’s indigenously developed Paracetamol announced by Dr Jitendra Singh

Express Pharma

Addressing the 40th Foundation Day of the Department of Scientific and Industrial Research at Dr Ambedkar International Centre here, Union Minister Dr Jitendra Singh, Minister of State (Independent Charge) for Science and Technology, Earth Sciences (Independent Charge), MoS PMO, DoPT Personnel, Public Grievances and Pensions, Atomic Energy, Space, announced the indigenously developed drug Paracetamol, commonly used in pain, fever etc, by the Council of Scientific and Industrial Research (CSIR) w

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Final Rule for ACNU Arrives in Time for End of Year but Not Much New to Celebrate

FDA Law Blog: Biosimilars

By Deborah L. Livornese As promised in the Fall Unified Regulatory Agenda, FDA issued the final rule to establish the pathway to obtain marketing approval of a nonprescription drug product with an additional condition for nonprescription use (ACNU) on December 26, 2024, before the end of the calendar year. 89 Fed. Reg. 105288 (Dec. 26, 2024). We described the 2022 proposed rule and the ten-plus year history leading up to its issuance in our blog post here.

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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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LR-19155 by LG Chem for Non-Small Cell Lung Cancer: Likelihood of Approval

Pharmaceutical Technology

LR-19155 is under clinical development by LG Chem and currently in Phase I for Non-Small Cell Lung Cancer.

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Fiber-Rich Foods Improve Chronic Disease, Could Lead to Pharmaceutical Interventions

Pharmacy Times

Fiber-rich foods show improvements in health and reductions in chronic diseases, including obesity, by promoting weight management and enhancing the metabolism.

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2024 IDstewardship Year End Review

ID Stewardship

In this article we do a quick run down on IDstewardship for the end of 2024. Article Posted January 2025 It was welcomed that 2024 did not feel like an extension of the 2020 COVID-19 pandemic as 2021-2023 had. I think many of us working in the infectious diseases space were grateful not to be at the mercy of pandemic demands. 2024 was a slower year for IDstewardship in regards to content creation and online engagement, but that still meant a lot of great new things were released.

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GCC-4001 by Artiva Biotherapeutics for Rheumatoid Arthritis: Likelihood of Approval

Pharmaceutical Technology

GCC-4001 is under clinical development by Artiva Biotherapeutics and currently in Phase I for Rheumatoid Arthritis.

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Episode 989: How to Identify an ED Toxicology Patient at Risk of Delayed QTc Prolongation

Pharmacy Joe

In this episode, Ill discuss delayed QTc prolongation in overdose patients. Episode 989: How to Identify an ED Toxicology Patient at Risk of Delayed QTc Prolongation Subscribe on iTunes , Android , or Stitcher Patients who present to the ED with acute drug overdose and a QTc above 500 msec are known to have an increased risk of adverse cardiac event and are therefore proactively monitored for this development.

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HLC-001 by Human Life CORD Japan for Coronavirus Disease 2019 (COVID-19) Associated Acute Respiratory Distress Syndrome: Likelihood of Approval

Pharmaceutical Technology

HLC-001 is under clinical development by Human Life CORD Japan and currently in Phase I for Coronavirus Disease 2019 (COVID-19) Associated Acute Respiratory Distress Syndrome.

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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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CD19-CD22 CAR-T cells by Shanghai Biomed-Union Biotechnology for Unspecified B-Cell Lymphomas: Likelihood of Approval

Pharmaceutical Technology

CD19-CD22 CAR-T cells is under clinical development by Shanghai Biomed-Union Biotechnology and currently in Phase II for Unspecified B-Cell Lymphomas.

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NMDA Regulator by Boehringer Ingelheim International for Unspecified Central Nervous System Disorders: Likelihood of Approval

Pharmaceutical Technology

NMDA Regulator is under clinical development by Boehringer Ingelheim International and currently in Phase I for Unspecified Central Nervous System Disorders.

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Paclitaxel by InnoUp Farma for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

Paclitaxel is under clinical development by InnoUp Farma and currently in Phase I for Solid Tumor.

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Fosigotifator by Calico Life Sciences for Unspecified Central Nervous System Disorders: Likelihood of Approval

Pharmaceutical Technology

Fosigotifator is under clinical development by Calico Life Sciences and currently in Phase II for Unspecified Central Nervous System Disorders.

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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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Coronavirus Disease 2019 (COVID-19) vaccine by China National Biotec Group for Coronavirus Disease 2019 (COVID-19) Pneumonia: Likelihood of Approval

Pharmaceutical Technology

Coronavirus Disease 2019 (COVID-19) vaccine is under clinical development by China National Biotec Group and currently in Phase III for Coronavirus Disease 2019 (COVID-19) Pneumonia.

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BNT-325 by BioNTech for Malignant Mesothelioma: Likelihood of Approval

Pharmaceutical Technology

BNT-325 is under clinical development by BioNTech and currently in Phase II for Malignant Mesothelioma.

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RG-6315 by Genentech USA for Systemic Sclerosis (Scleroderma): Likelihood of Approval

Pharmaceutical Technology

RG-6315 is under clinical development by Genentech USA and currently in Phase I for Systemic Sclerosis (Scleroderma).

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SMART-101 by Smart Immune for Refractory Acute Myeloid Leukemia: Likelihood of Approval

Pharmaceutical Technology

SMART-101 is under clinical development by Smart Immune and currently in Phase II for Refractory Acute Myeloid Leukemia.

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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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SMART-101 by Smart Immune for Relapsed Acute Myeloid Leukemia: Likelihood of Approval

Pharmaceutical Technology

SMART-101 is under clinical development by Smart Immune and currently in Phase II for Relapsed Acute Myeloid Leukemia.

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AKS-452 by Vakston for Coronavirus Disease 2019 (COVID-19): Likelihood of Approval

Pharmaceutical Technology

AKS-452 is under clinical development by Vakston and currently in Phase II for Coronavirus Disease 2019 (COVID-19).

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SY-001 by CellOrigin Technology (Hangzhou) for Pancreatic Cancer: Likelihood of Approval

Pharmaceutical Technology

SY-001 is under clinical development by CellOrigin Technology (Hangzhou) and currently in Phase I for Pancreatic Cancer.

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(Ensifentrine + glycopyrrolate) by Verona Pharma for Chronic Obstructive Pulmonary Disease (COPD): Likelihood of Approval

Pharmaceutical Technology

(Ensifentrine + glycopyrrolate) is under clinical development by Verona Pharma and currently in Phase II for Chronic Obstructive Pulmonary Disease (COPD).

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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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LY-4052031 by Eli Lilly and Co for Ovarian Cancer: Likelihood of Approval

Pharmaceutical Technology

LY-4052031 is under clinical development by Eli Lilly and Co and currently in Phase I for Ovarian Cancer.

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LY-4052031 by Eli Lilly and Co for Head And Neck Squamous Cell Carcinoma (HNSC): Likelihood of Approval

Pharmaceutical Technology

LY-4052031 is under clinical development by Eli Lilly and Co and currently in Phase I for Head And Neck Squamous Cell Carcinoma (HNSC).

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GM-103 by Genemedicine for Metastatic Colorectal Cancer: Likelihood of Approval

Pharmaceutical Technology

GM-103 is under clinical development by Genemedicine and currently in Phase II for Metastatic Colorectal Cancer.

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SB-207 by Pelthos Therapeutics for Genital Warts (Condylomata Acuminata): Likelihood of Approval

Pharmaceutical Technology

SB-207 is under clinical development by Pelthos Therapeutics and currently in Phase II for Genital Warts (Condylomata Acuminata).

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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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RG-6315 by Genentech USA for Systemic Sclerosis (Scleroderma): Likelihood of Approval

Pharmaceutical Technology

RG-6315 is under clinical development by Genentech USA and currently in Phase I for Systemic Sclerosis (Scleroderma).

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SMART-101 by Smart Immune for Refractory Acute Myeloid Leukemia: Likelihood of Approval

Pharmaceutical Technology

SMART-101 is under clinical development by Smart Immune and currently in Phase II for Refractory Acute Myeloid Leukemia.

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SMART-101 by Smart Immune for Relapsed Acute Myeloid Leukemia: Likelihood of Approval

Pharmaceutical Technology

SMART-101 is under clinical development by Smart Immune and currently in Phase II for Relapsed Acute Myeloid Leukemia.

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AKS-452 by Vakston for Coronavirus Disease 2019 (COVID-19): Likelihood of Approval

Pharmaceutical Technology

AKS-452 is under clinical development by Vakston and currently in Phase II for Coronavirus Disease 2019 (COVID-19).

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SY-001 by CellOrigin Technology (Hangzhou) for Pancreatic Cancer: Likelihood of Approval

Pharmaceutical Technology

SY-001 is under clinical development by CellOrigin Technology (Hangzhou) and currently in Phase I for Pancreatic Cancer.

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