Industry News
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Good Clinical Practice Draft Guidance Revealed for Clinical Studies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.
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 Grants Lumen Bioscience Fast Track Designation for Oral Biologic
Biotech firm Lumen Bioscience has received fast track designation from FDA for its oral biologic drug candidate for treating C. difficile infection.
FDA Sends Warning Letter to Arizona Facility
The agency found insanity conditions and CGMP violations at Pharmedica USA, LLC’s Phoenix facility during an inspection.
Waters Set for Growth in Bioanalytical Characterization with Wyatt Acquisition
Waters Corporation expected to boost growth in bioanalytical characterization for new modalities with acquisition of Wyatt Technology.
FDA Issues Guidance on Pediatric Drugs
The two draft guidance documents provide recommendations for the approval of pediatric drugs, biologics, and vaccines under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act.
CATTI Starts Up CGT Training Center at University of Guelph
CATTI has launched an in-person training site at the University of Guelph in Ontario, Canada, for training personnel in cell and gene therapy manufacturing.
EMA Issues Drug Safety Reminders
The agency’s safety committee is reviewing hydroxyprogesterone medicines and issuing a reminder on safety issues regarding fluoroquinolone antibiotics.
EMA Guidance Looks to Prevent Drug Shortages
The agency has published guidance on good practices for securing the supply of medicines.
EMA Publishes Annual Report for 2022
The report outlines highlights from the agency’s medicines evaluations and milestones for 2022.
FTC Sues to Block Amgen’s $27.8 Billion Acquisition of Horizon Therapeutics
In a brief, the Federal Trade Commission cited concerns about the acquisition resulting in an increased monopoly on Amgen’s newly acquired thyroid eye disease and chronic refractory gout treatments.
Bright Path Laboratories to Collaborate in NSF Engines Development Program
The NSF-sponsored program aims to help partners collaborate to create opportunities for significant economic, societal, and technological opportunities for growth in their regions.
BioNTech and Roche Publish Personalized Vaccine Data
The data, published in the scientific journal Nature, demonstrated that half of patients developed T cells that could potentially fight pancreatic ductal adenocarcinoma.
Pharma-PBM Battles Escalates on Capitol Hill
Congress have initiated a range of legislative proposals to further manage PBMs and the pharma market.
Europe Lifts COVID-19 Business Continuity Status
EMA and European regulators are lifting their COVID-19 business continuity measures as the pandemic’s peak ends.
FDA Approves First RSV Vaccine
GSK’s Alexvy vaccine is the first to receive FDA approval for respiratory syncytial virus.
ICH Q9(R1) Quality Risk Management Guidance Document Available
The recent revision is intended to provide guidance on QRM principles and tools that can be used for different aspects of pharmaceutical quality.
FDA Gives Guidance for Decentralized Clinical Trials for Drugs, Devices
This specific guidance refers to a DCT as a clinical trial where some or all the trial-related activities occur at locations other than traditional clinical trial sites.
Continuous and Modular Manufacturing Innovations: Discussion with JP Bornholdt (INTERPHEX 2023)
JP Bornholdt, director of modular operations, CRB, discusses continuous and modular manufacturing.
