Industry News
Biovian Invests €50 Million in Manufacturing Facility in Finland
The expansion project is aimed to be completed in December 2024 and the new facility will be fully operational by 2025.
Update on Storm Damage to Pfizer Facility in North Carolina
The damage to the facility, which produces 8% of US injectable drug consumption, should not significantly affect the current supply.
EMA Extends OPEN Framework to More Medicines
The framework is now expanded beyond COVID-19 vaccines and treatments.
EMA Publishes Draft Reflection Paper on Artificial Intelligence in Medicine
The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it.
FDA Approves Preventative Therapy for Respiratory Syncytial Virus in Infants and Toddlers
The new drug may help vulnerable children resist RSV in the coming fall and winter season.
FDA Publishes Draft Guidance on Human Cellular and Gene Therapy Products
The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.
EU Takes Steps to Prevent Antibiotic Shortages Next Winter
These recommendations will keep key antibiotics for respiratory infections available when they are needed most.
Westlake Village BioPartners Announces $450 Million Venture Capital Funding Pool
Westlake’s third fund of $450 million will be used to grow early stage biotechnology companies.
FDA Converts Eisai Alzheimer’s Treatment to Traditional Approval
Eisai’s lecanemab-irmb was converted from an accelerated approval to a traditional approval.
EMA Reviews GLP-1 Receptor Agonists for Self-Harm Risk
The agency is reviewing the medicines after receiving reports of self-injury and suicidal thoughts in patients using the type 2 diabetes treatments.
Large Clinical Trial Supports Alzheimer Drug Full Approval
FDA's approval of Leqembi paves the way for wider coverage of the drug by Medicare and establishes a process for further clinical testing and evaluation of treatments for this widespread, debilitating condition
FDA Approves BioMarin’s Roctavian, the First Gene Therapy for Treating Severe Hemophilia A
FDA has approved Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A in adults.
FDA Approves Pfizer Human Growth Hormone Analog
FDA approved Pfizer’s once-weekly human growth hormone analog for treatment of growth failure in pediatric patients.
NCI Launches Persistent Poverty Initiative
The persistent poverty initiative aims to fight the cumulative effects of persistent poverty on cancer outcomes.
FDA Approves UCB Generalized Myasthenia Gravis Treatment
UCB’s rozanolixizumab-noli is approved for treatment of generalized myasthenia gravis in certain adult patient groups.
Gene Therapy for Duchenne Muscular Dystrophy Approved by FDA
The agency approved Elevidys to treat pediatric patients four through five years of age with Duchenne muscular dystrophy.
Maurice Michel of Sweden Wins 2023 Eppendorf Award for Young European Investigators
The prestigious award, worth €20,000 (US$22,000), goes to Maurice Michel of the Science for Life Laboratory at Karolinska Institutet, Stockholm, Sweden.
FDA Releases Draft Guidance for Section 505G of Food, Drug, and Cosmetic Act
The guidance describes the CDER formal dispute resolution (FDR) procedures for eligible requestors or sponsors that wish to appeal a scientific and/or medical issue related to a final order.
FDA Releases Updated COVID-19 Vaccine Guidelines
The new guidelines contain formulation recommendations for vaccines launching in autumn 2023.
FDA Launches Pilot Program Using Cancer Biomarkers to Mitigate Risk
FDA’s new voluntary pilot program is designed to help clinicians select appropriate cancer treatments for patients.
Long-Admired PEPFAR Program Caught in Abortion Debate
There is concern that debates will delay the five-year reauthorization of PEPFAR under review by Congress.
mRNA Global Alliance Tests the Waters at BIO
World leaders have set ambitious goals to respond more swiftly to the next pandemic, including the US goal to design, test, and review a new vaccine just 100 days after a pandemic declaration.
Merck Files Lawsuit Against US Government
The complaint alleges that Medicaid price controls implemented in the Inflation Reduction Act will negatively impact biopharmaceutical innovation.
Good Clinical Practice Draft Guidance Revealed for Clinical Studies
The document builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies.
Medicare Still Won’t Pay for Alzheimer’s Drugs without Confirmatory Data
Reimbursement for Alzheimer's medicines still will occur only with the completion of studies to support full FDA approval.
FDA Proposes Streamlined Medication Handouts
FDA has published a new system for providing basic and essential information on patient use of drugs and certain biologic products.
Vinnova Supports the Formation of Nordic CCRM Hub
The project is being coordinated by the recently formed not-for-profit CCRM Nordic AB and gathers engaged stakeholders to move the initiative forward.
Cannabis Science Conference Fall Meeting Issues Call for Abstracts
The next Cannabis Science Conference Fall meeting is soliciting a call for abstracts.
FDA Releases Final Guidance on Adjusting for Covariates in Randomized Clinical Trials
The guidance describes FDA’s current recommendations regarding adjusting for covariates in statistical analysis of randomized clinical trials.
FDA Eyes Advisory Committee Reform to Enhance Credibility
Challenges to approval decisions have prompted FDA officials to reexamine of the role and composition of the agency’s many advisory committees and to explore options for change.
