FDA Approves New Treatment for ROS1-Positive Non-Small Cell Lung Cancer
Bristol Myers Squibb’s repotrectinib (Augtyro) approved by FDA to treat locally advanced or metastatic ROS1-positive non-small cell lung cancer.
FDA Approves Defencath to Treat Catheter-Related Bloodstream Infections
Patients with kidney failure administered chronic hemodialysis who received DefenCath showed a statistically significant lower incidence of catheter-related bloodstream infections.
Study Digs into Patient Access to Electronic Health Information
Findings suggest that participants nationwide who were offered and accessed their online medical record has more than doubled in the past eight years, but racial and ethnic disparities continue.
MG America, Romaco North America Launch North American Alliance
Parties will provide processing and packaging machinery services.
AI Can Save Pharma Time and Money, But Concerns Persist With Data Security
Study estimates that up to 20% of the costs for clinical research is associated with the manual transfer and verification of data from the electronic medical record to a data capture system.
Project Highlights Benefits of Statistical Methodology Research for Patients, Pharma
New initiative highlights importance of a collaborative approach that allows patients to share their insights and contribute value to studies.
Open Access Forum Analyzes COVID-19 Stem Cell and Exosome Therapies
Stem Cell Reports takes a look at DTC online advertising claims that these are ‘immune boosters.’
Expert: Digital Transformation is Key Part of Biopharma C-Suite Goals for 2024
Stephanie L. Woerner, PhD, director and principal research scientist at the MIT Center for Information Systems Research, discusses the outlook for next year among biopharma firms.
Bayer Withdraws US Indication for Aliqopa in Treatment of Follicular Lymphoma
Bayer said it will explore access options for patients with follicular lymphoma currently receiving Aliqopa who have experienced a favorable response to treatment.
Japan Shifts Toward Environmentally Friendly Pharma Practices
JMA Journal report describes how businesses in this Asian-Pacific nation are employing various strategies to reduce GHG emissions.
Improved Data Sharing, Collaborative Learning Could Enhance Real-World Data Analysis
A demand-driven methodology for data standardization across multiple streams of acquisition could improve the sharing of real-world data worldwide.
Pacira BioSciences Announces FDA Approval of Expanded Indications for Exparel
Exparel was initially approved in 2011 for single-dose infiltration into a surgical site.
FDA Grants 510(k) Marketing Clearance to Flowflex COVID-19 Antigen Home Test
The Flowflex COVID-19 Antigen Home Test is the first over-the-counter rapid antigen test for SARS-CoV-2 to gain FDA 510(k) marketing clearance by the FDA.
TraceLink Introduces Digital Recalls Solution
New E2E workflow orchestration service is expected to simplify the processes of health systems and retail pharmacies while also reducing the risk of recalled items reaching patients.
Novel Chemotherapy-Free Fruzaqla Gets FDA Approval for Metastatic Colorectal Cancer
Fruquintinib (Fruzaqla) is a significant new therapy for patients who have had limited options to treat metastatic colorectal cancer.
Lilly's Tirzepatide Gets FDA Approval for Chronic Weight Management
Tirzepatide (Zepbound; Eli Lilly and Company) will hit the US market by the end of 2023 with a list price of $1,059.87.
Rexulti Shows Efficacy Treating Agitation Associated With Dementia Due to Alzheimer Disease
Rexulti was found to be a well-tolerated treatment for the debilitating symptoms of agitation associated with dementia due to Alzheimer’s disease.
Ayala Pharmaceuticals’ AL102 Granted Orphan Drug Designation by FDA
Ayala Pharmaceuticals’ AL102 is a gamma secretase inhibitor being studied to treat patients with desmoid tumors.
AstraZeneca Reports Positive Results Phase IIb Chronic Kidney Disease Trial
Studies with Zenith-CKD showed significant albuminuria reduction.
Boehringer Ingelheim Delivers Promising Results in Phase II Chronic Kidney Disease Trial
Creating Strategic Relationships: The Changing Face of Contract Research Organizations and Sponsor Partnerships
There are a slew of specialist and boutique companies set up to provide high quality services and to meet the changing needs of the pharma industry.
The Future State of Oncology: The Rise of Oncology Home Care
While there are still hurdles to overcome along the way, home healthcare could deliver better patient-centered cancer care, providing improved patient outcomes, enhanced quality of life, and reduced strain on resources.
Aktana Attains Tact.ai’s Field Engagement and Conversational AI Technology
With new tech acquisition, the software company also introduces a new branded AI assistant for mobile devices specifically for the life sciences sector.
Report Explores Ways to Finance, Repurpose Rare Disease Drugs
Study describes how biotech startups can avoid competing with large pharma companies for financing.
Key Challenges in Research and Development of Chemicals and Materials
R&D teams need to accelerate how they conduct their research, get to a material, and get to market.
FDA Approves Abbott's HPV Test to Run on Alinity M Assay Platform
The newly approved Alinity m high risk human papillomavirus (HPV) assay is indicated to detect HPV and for use in routine cervical cancer screening per professional medical guidelines.
Analysis Shows BRICS Nations Are Making Strides in Vaccine Production
Determination will affect future vaccine cost and accessibility, including in developing countries.
FDA Approves Vonoprazan for the Treatment of Erosive Esophagitis
Phathom Pharmaceuticals announced that it anticipates vonoprazan (Voquenza) to be commercially available by December 2023.
FDA Grants Fast Track Designation to Sellas Life Sciences’ SLS009 for Lymphoma
SLS009 is a novel CDK9 inhibitor under investigation for the treatment of relapsed/refractory peripheral T-cell lymphomas.
CRISPR Therapeutics Announces Completion of FDA Advisory Committee Meeting for Exagamglogene Autotemcel for Severe Sickle Cell Disease
Exagamglogene autotemcel (exa-cel) has shown the potential to be a landmark therapy in preventing episodes of excruciating pain among patients with sickle cell disease.
