LSPedia Introduces New Traceability Solution
OneScan 7.1 is expected to boost compliance, while also improving pharma supply chain efficiencies.
Calculating the Cost-Effectiveness of Empagliflozin in Patients Experiencing Heart Failure
A trial set out to determine whether empagliflozin can help prevent hospitalizations and extend life for patients with heart failure, while not hurting the US payers’ pockets.
FDA Grants Priority Review to Novel Bispecific Antibody for Multiple Myeloma
Regeneron Pharmaceuticals’ linvoseltamab is currently in clinical development to treat adult patients with relapsed/refractory multiple myeloma who experienced disease progression following prior administration of at least three therapies.
Long-Acting Injectable Cabenuva Found More Effective Than Daily ART at Suppressing HIV in Patients With Adherence Challenges
Cabenuva (cabotegravir + rilpivirine) showed superior efficacy in maintaining viral load suppression in patients with HIV compared with standard of care daily oral antiretroviral treatment.
Merck’s Primary Advanced, Recurrent Endometrial Carcinoma Treatment Given Priority Review by FDA
Phase III results from Keytruda (pembrolizumab)’s NRG-GY018 trial help influence the agency’s decision.
FDA Approves Tecvayli at Reduced Dosing Frequency for Relapsed/Refractory Multiple Myeloma
Tecvayli (teclistamab-cqyv) was the first bispecific antibody to gain FDA approval for the treatment of multiple myeloma.
Opthea Hires New Chief Medical Advisor
Arshad M. Khanani, MD, MA, FASRS, will help lead development efforts for sozinibercept, a potential wet AMD treatment.
Almirall, Novo Nordisk Reach Licensing Agreement Surrounding IL-21 Blocking Monoclonal Antibodies
As part of the agreement, Novo will be paid both development and commercial milestone payments for NN-8828, is currently in Phase II of non-dermatological indications.
FDA Accepts, Grants Priority Review to NDA for Vorasidenib in IDH-Mutant Gliomas
The FDA has assigned Servier’s New Drug Application for vorasidenib to treat IDH-mutant gliomas with a Prescription Drug User Fee Act action date of August 20, 2024.
Krazati Combination for Advanced, Metastatic Colorectal Cancer Granted FDA Priority Review
FDA accepts Bristol Myers Squibb's application for Krazati (adagrasib) plus cetuximab for patients who received prior treatment for KRASG12C-mutated locally advanced or metastatic colorectal cancer.
FDA Accepts Biologics License Application for Datopotamab Deruxtecan
The agency will make its final decision surrounding the locally advanced or metastatic nonsquamous NSCLC drug —based on results from the TROPION-Lung01 Phase III trial—by Q4 2024.
Navigating the Complexities of Prescription Drug Pricing: Affordable Solutions Are Available to Self-Insured Plan Sponsors
The lack of transparency in the pharmaceutical industry further exacerbates the challenges faced by consumers.
FDA Approves Tagrisso With Chemotherapy for EGFR-Mutated Advanced Lung Cancer
Tagrisso (osimertinib) approved for use in combination with platinum-based chemotherapy in adults with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer harboring EGFR exon 19 deletions or exon 21 L858R mutations.
FDA Approves First One-Time, Individualized T Cell Therapy for a Solid Tumor
Iovance’s Amtagvi (lifileucel) gains FDA accelerated approval for adults with unresectable or metastatic melanoma.
ValGenesis, RxCloud Collaborate on Tackling Compliance and Quality Assurance Challenges
The partnership revolves around meeting various agency standards and industry requirements pertaining to the drug development and manufacturing lifecycle.
Schreiner MediPharm Unveils New Closure Seals for Pharma Packaging
The new seals include sustainable film material containing recyclate content of up to 90%.
FDA Approves First Treatment for Multiple Food Allergies in Adults, Children
Xolair (omalizumab) was previously granted FDA Priority Review status and Breakthrough Therapy Designation to prevent severe allergic reactions after accidental exposure to one or more foods in people with allergies.
Three Areas to Drive Supply Chain Value
Strategic and proactive thinking are vital in providing supply chain leaders with an opportunity to shift their focus to a more holistic, value-centered approach.
FDA Grants Full Approval to Tepmetko for Metastatic NSCLC Subtype
Tepmetko (tepotinib), an oral MET inhibitor, was granted accelerated approval in 2021 for metastatic non–small cell lung cancer harboring MET exon 14 skipping alterations.
Artificial Intelligence May Accelerate Time to Determine Response to Treatment
Personalized medicine approaches, informed by predictive modeling, could optimize treatment outcomes and reduce patient burden and costs.
DHL Supply Chain Invests $200M Toward Expanding Its Life Sciences and Healthcare Services
The financial commitment features construction of new warehouses in Pennsylvania and North Carolina.
First Pulse Oximeter Available Without a Prescription is Cleared by the FDA
The Masimo product is expected to address a significant gap in the market for dependable home-use medical devices.
Using Machine Learning to Predict Cancer Treatment Effectiveness
Scientists develop algorithms that can not only identify tumors that will respond well to chemotherapy, but which are also likely to resist treatment.
FDA Advisory Committee Signs Off on Tricuspid Regurgitation Device
Powered by evidence from the TRILUMINATE trial, Abbott's TriClip System’s benefits outweighed its risks, which led to the group’s positive recommendation.
Generic Drug Shortages Prompt Federal Agencies to Probe Practices of GPOs, Drug Wholesalers
The Federal Trade Commission and the Department of Health and Human Services are seeking public input to evaluate how policymakers can address chronic drug shortages and promote a resilient supply chain.
Citius Pharmaceuticals Resubmits BLA to Address Product Testing, Manufacturing Controls Identified in FDA Complete Response Letter for Immunotherapy
There were no safety or efficacy issues identified in the FDA complete response letter for Lymphir, with no additional trials required.
Aurlumyn Gets First FDA Approval for a Severe Frostbite Medication
Patients with severe frostbite who were administered Aurlumyn monotherapy experienced a significantly reduced risk of the need for amputation.
FDA Grants Priority Review to Augtyro for NTRK-Positive Solid Tumors
Augtyro was previously approved in November 2023 to treat locally advanced or metastatic ROS1-positive non-small cell lung cancer.
Ipsen Nabs FDA Approval for NALIRIFOX in First-Line Metastatic Pancreatic Adenocarcinoma
Onivyde (irinotecan liposome injection) in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) was found to improve overall survival in metastatic pancreatic adenocarcinoma.
Strategizing High-Wire, Multi-Indication Launches
Properly supporting market access for a newly launched product with a single indication is challenging. Doing so for multiple indications, or supporting subsequent indications, can have a compounding effect on the degree of difficulty for getting everything right.
485 Route 1 South,Building F, Suite 210Iselin, NJ 08830