Industry News, Content and Resources
Elinzanetant Shows Promise in Managing Vasomotor Symptoms for Menopausal and Breast Cancer Patients
Discover how Bayer's elinzanetant offers promising relief for vasomotor symptoms in menopausal and breast cancer patients, with significant trial results showing reduced hot flashes and improved sleep.
FDA Issues GBS Warning for GSK and Pfizer RSV Vaccines
The FDA's issues a new warning on GSK and Pfizer's RSV vaccines regarding a potential risk of Guillain-Barré syndrome.
Metsera’s MET-097i: A Promising Advancement in Long-Acting Obesity Treatment
Metsera announces promising obesity therapy, improving upon current incretin-based drugs by offering longer-lasting effects and fewer side effects, potentially transforming weight management and heart health strategies.
FDA Announces Guidelines for Implementing Artificial Intelligence in Drug Development
The FDA announces their first official guideline on the implementation of artificial intelligence in the drug development process.
HHS Proposes New Cybersecurity Measures to Address Rising Healthcare Data Breaches
In response to a 102% increase in large data breaches from 2018 to 2023, the U.S. Department of Health and Human Services has proposed new measures under HIPAA to strengthen cybersecurity in healthcare.
Enhancing Clinical Trial Diversity: Insights on Action Plans and Regulatory Alignment
In a recent interview, Rachael Fones, director of government and public affairs at IQVIA, emphasized the importance of diversity action plans in clinical trials.
TEV’749: Teva’s Controlled-Release Schizophrenia Treatment in Phase 3 Trials
In an effort to further address CNS and mental health conditions, Teva Pharmaceuticals is developing TEV'749, a long-acting formulation of olanzapine.
Bridge Biotherapeutics to Present Key Developments at JPM 2025
Bridge Biotherapeutics, a clinical-stage biotech company focusing on therapeutic areas with high unmet needs, has officially been slated to present at the 43rd annual J.P. Morgan Healthcare Conference.
Johnson & Johnson Expands Atopic Dermatitis Portfolio
Johnson & Johnson has entered an exclusive licensing agreement with Kaken Pharmaceutical for Kaken's STAT6 program, including lead candidate KP-723, an oral treatment which targets autoimmune and allergic diseases such as atopic dermatitis.
WuXi AppTec to Sell WuXi Advanced Therapies to Altaris, LLC
WuXi AppTec announced the sale of WuXi Advanced Therapies (ATU) operations to healthcare investment firm Altaris, LLC.
Ionis Pharmaceuticals Achieves Milestone with FDA Approval of Treatment for Familial Chylomicronemia Syndrome (FCS)
Ionis Pharmaceuticals marks a new commercial era with the FDA approval of Tryngolza, a novel RNA-targeted treatment for familial chylomicronemia syndrome, embarking on its first solo drug launch to address unmet medical needs.
FDA Updates “Healthy” Claim to Empower Consumer Nutrition Choices
The FDA has finalized an updated definition for the "healthy" nutrient content claim on food labels, helping consumers identify nutritious foods and encouraging manufacturers to develop healthier products.
Bipartisan Bill Introduces Key Healthcare Reforms to Enhance Transparency and Access
On December 18, 2024, U.S. lawmakers unveiled a bipartisan stopgap funding bill to finance the federal government through March, incorporating significant healthcare provisions.
SiteOne Therapeutics Secures $100M to Advance Non-Opioid Pain Drug Research
SiteOne Therapeutics lands $100M in funding to develop non-opioid pain medications. Backed by Novo Holdings, the biotech firm aims to demonstrate the effectiveness of its ion channel-focused treatments amidst a challenging market landscape.
Pfizer Projects $1 Billion Revenue Impact from IRA Changes and Foresees No Major M&A in 2025
Pfizer anticipates a $1 billion revenue reduction in 2025 due to Medicare Part D redesign while maintaining revenue forecasts. The company plans no major acquisitions, focusing instead on cost savings and operational growth.