Industry News
Janssen Seeks European Approval of Extended Indication for Rybrevant
Janssen has requested an extension to the indication application of its fully-human, bispecific antibody treatment, Rybrevant (amivantamab).
Millions Raised for the Development of Precision Oncology Platform
Orakl Oncology has raised funds to develop its precision oncology platform and accelerate drug development.
The Era of Digital Data in Bio/Pharma Manufacturing
Laks Pernenkil, principal and practice leader, US Life Sciences Product & Supply Operations, Deloitte, discusses the impact that digitalization is having on data generation and data integrity in bio/pharma manufacturing.
UK Poised to Lead Global Delivery of Next-Gen mRNA Medicines
The BioIndustry Association reports that with a strong foundation in research and development in mRNA the United Kingdom will be a major player in this rapidly growing industry.
NIH Awards $45.1 Million Grant for ALS Treatment
Clene was awarded the four-year grant for the National Institute of Neurological Disorders and Stroke to support an Expanded Access Protocol for ALS drug.
FDA Establishes Pilot Program to Accelerate Rare Disease Therapy Development
The program will allow sponsors of certain CBER and/or CDER-regulated products more frequent communication with FDA staff.
2023 Nobel Prize in Medicine Awarded for Development of mRNA Vaccines Against COVID-19
The prize was awarded jointly to Katalin Karikó and Drew Weissman for their groundbreaking discovery regarding modification of the bases in mRNA.
FDA Gets Its Arms Around Advanced Therapy Medicinal Products Early
Government provides a spoonful of sugar, and genuine leadership, for good medicines.
FDA Releases Guidance on Using Remote Oversight Tools for Drug Approval
The tools, originally utilized during the COVID-19 pandemic, are now intended to work alongside FDA’s standard procedures.
Sucralfate Oral Suspension Recalled Due to Microbial Contamination
VistaPharm is recalling Sucralfate Oral Suspension, 1g/10mL because of Bacillus cereus contamination.
The European Commission Approves Severe Alopecia Areata Treatment
Pfizer reports ritlecitinib is the first and only treatment for alopecia areata to selectively inhibit Janus kinase 3, and to treat patients as young as 12.
EC Approves Fixed-Dose Oral Combination Treatment for AML
Otsuka Pharmaceutical Europe and Astex Pharmaceuticals have announced the approval of INAQOVI by the European Commission.
ICH Q9 R1 Hits Major Milestones for the Pharmaceutical Industry
As for the topic of subjectivity, Viehmann said how high levels of subjectivity in risk assessments and in QRM are problematic and are not aligned with the 1st QRM principle of Q9.
Samsung Biologics Expands Strategic Manufacturing Agreement with Bristol Myers Squibb
Samsung Biologics and Bristol Myers Squibb have further expanded their strategic manufacturing agreement to include the large-scale manufacture of an antibody cancer drug substance.
Staying Compliant in 2023
Leaders at CDER and CBER give update on organizational changes at FDA.
Pharma Award Finalists for CPHI Barcelona Have Been Announced
The finalists for this year’s CPHI Barcelona Pharma Awards span 12 categories with awards ranging from accelerating innovations through to improved sustainability and best start-up initiative.
EMA Prepares for Regulation on Health Technology Assessment
The agency’s work with EUnetHTA 21 helped it to prepare the EU for implementation of the regulation.
FDA Approves Treatment for Myelofibrosis Patients with Anemia
Anemia, experienced by most myelofibrosis patients, has caused over 30% of patients to discontinue their treatment.
Being Innovative in CGMP Training While Adapting to Change
Experts discussed how to transform companies into learning organizations at the 2023 PDA/FDA Joint Regulatory Conference.
EMA Grants Priority Medicine Status to Cellectar’s Waldenstrom Macroglobulinemia Treatment
Iopofosine provides targeted delivery of idodine-131 directly to cancer cells.
EMA Committee Issues Positive Opinion on Sandoz’ Biosimilar Trastuzumab
The EMA’s Committee for Medicinal Products for Human Use has given a positive opinion on Sandoz’ biosimilar trastuzumab for breast and gastric cancer.
FDA Issues Guidance on Biosimilar Labeling
The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.
Janssen Submits Marketing Authorization Application to EMA For Approval of Erdafitinib
The safety profile of erdafitinib observed in THOR was consistent with the previously reported safety profile of erdafitinib in metastatic urothelial carcinoma (mUC).
CPHI Annual Report Predicts AI Transformation of All Drug Development Processes by 2026
According to a press release, the implications go to the extent that within the next 10 years, more than 50% of approved drugs will involve AI in their development and/or manufacturing.
PRAC Recommends New Measures to Avoid Topiramate Exposure in Pregnancy
Topiramate can cause serious birth defects if exposed to children in the womb.
FDA Establishes Stabilization Period for Updated DSCSA Compliance Policies
The new policy will require trading partners to supply, accept, and manage all documentation of product and ownership of prescription drugs electronically.
Booster Shot for Pharma
European vaccine manufacturing is being boosted with high level investments.
Bristol Myers Squibb Joins Cellares Program Focused on Automated Cell Therapy Manufacturing as Cellares is Launched as First IDMO
Bristol Myers Squibb has joined Cellares’ Technology Adoption Partnership program just as Cellares launches operations as an integrated development and manufacturing organization.
White House Sets Medicare Price Negotiation Targets
The Centers for Medicare & Medicaid Services (CMS) has announced the first 10 drugs covered under Medicare Part D selected for negotiation.
FDA Approves Bristol Myers Squibb Anemia Treatment
Bristol Myers Squibb’s Reblozyl (luspatercept-aamt) is approved as a first-line treatment for anemia in adults with lower-risk myelodysplastic syndromes.
