Industry News
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
Europe Phases Out COVID-19 Flexible Regulations
EMA, the European Commission, and HMAs are phasing out the flexible regulations put into place during the pandemic.
COVID-19 Vaccine, Nuvaxovid, Gains EU Approval
Full Marketing Authorization has been granted for Novavax’s COVID-19 vaccine by the European Commission.
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 UCB Generalized Myasthenia Gravis Treatment
UCB’s rozanolixizumab-noli is approved for treatment of generalized myasthenia gravis in certain adult patient groups.
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.
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.
NIH Develops Novel Tumor Identification Technology
The Segmentation by Exogenous Perfusion system uses a cell’s location in the tumor to find differences in gene activity.
FDA Releases Psychedelic Drugs Draft Guidance
FDA’s new draft guidance outlines key considerations for psychedelic drug development programs.
FDA Releases Draft Guidance for Section 505G of Food, Drug, and Cosmetic Act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.
University of Waterloo Researchers Announce Sustainable Encapsulation Technology
Researchers at the University of Waterloo have developed a liquid-liquid encapsulation system for use in sustainable encapsulation processes.
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.
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.
Planning the Future of Pharma at CPHI
The future is set to be a running theme for this year’s CPHI event, which will take place in-person at the Fira Barcelona Gran Via in Spain between 24–26 October 2023.
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.
Cannabis Science Conference Fall Meeting Issues Call for Abstracts
The next Cannabis Science Conference Fall meeting is soliciting a call for abstracts.
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.
FDA Approves Topical Gene Therapy for Treating Wounds Associated with Rare Genetic Skin Disorder
FDA has approved the first topical gene therapy product for treating wounds in patients with dystrophic epidermolysis bullosa.
FDA Approves AbbVie’s Bispecific Antibody for Treating Lymphoma
FDA has approved AbbVie’s EPKINLY (epcoritamab-bysp), a bispecific antibody for treating relapsed or refractory diffuse large B-cell lymphoma.
FDA Approves Blueprint Medicines’ Rare Blood Disorder Treatment
Blueprint Medicines’ avapritinib has been approved by FDA for the treatment of indolent systemic mastocytosis.
Partnership Forms to Commercialize Five Biosimilars in Europe
Alvotech and Advanz Pharma have signed a strategic partnership agreement for the supply and commercialization of five biosimilar candidates in Europe.
UK Government Boosts AMR Research with Cash Injection
UK government supports AMR research with significant cash injection, provided through the Global AMR Innovation Fund (GAMRIF).
