BioPharm International Editors

This warning is the second on top of a previous warning not to purchase or use EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination.

Agilent’s therapeutic nucleic acids facility gains architectural design support from CRB.

Apellis Pharmaceuticals’ Syfovre is a pegcetacoplan injection intended for the treatment of geographic atrophy secondary to age-related macular degeneration.

LIfT and Minaris will work together to develop a manufacturing process for LIfT’s allogeneic neutrophil progenitor cell therapy.

Some noteworthy PSGs include dihydroergotamine mesylate nasal spray, glucagon nasal powder, afamelanotide subcutaneous implant, and triamcinolone acetonide injectable suspension.

The intention of the FOA is to address diverse topics related to improving the efficiency of biosimilar product development and advancing the development of interchangeable products.

Bill Anderson, former CEO of Roche’s pharmaceutical division, will take over as CEO of Bayer on June 1, 2023.

GenScript PrioBio and Bio Immunitas will work together to develop and fast track manufacturing of a novel therapeutic platform.

The kit is meant for use for the detection and quantitation of residual host cell protein.

Pseudoephedrine is an oral treatment that can be used alone or in combination with other medicines to treat nasal congestion resulting from a cold, flu, or allergy.

The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study.

The technology is designed to enable patients to self-inject biologic-based therapies at home instead of a hospital setting.

Roche’s Phase III global program, centered around the biologic crovalimab as a treatment for paroxysmal nocturnal haemoglobinuria, showed the drug was non-inferior to current standards of care.

iotaSciences isoPick is designed to expand handling solutions for cell biology and gene therapy applications.

Clinicians, pediatric patients, regulators, and more are being considered to further strengthen focus on unmet medical needs.

Thermo Fisher and Celltrio are introducing a new automation platform to address critical scale-up challenges in biotherapeutics.

Naoki Okamura, Astellas’ current chief strategy officer, will take over the role from Kenji Yasukawa.

The new plasmid manufacturing facility aims to increase BioNTech’s autonomy and flexibility in manufacturing.

Thermo Fisher’s sponsorship of Momentum Labs is intended to support biotech businesses in the greater Gainesville region.

Improvements to Fluid Air’s Magnaflo filter blowback system are intended to increase powder yield in PolarDry Models 001 and 004.

Any deviations from the recommendations in this guideline may be acceptable if appropriate scientific justification is provided.

Gerresheimer is presenting its new Clinical Trial Kit to accelerate drug development at Pharmapack in Paris.

Pharmapack Europe experts expect smaller and medium European packaging companies to grow or be acquired.

Be the Match BioTherapies’ and CIBMTR’s expanded service offering is intended to aid in the design, implementation, and oversight of cellular therapy clinical trials.

Scientific Laboratory Supplies’ acquisition of C&M will bolster the company’s scientific calibration, maintenance, and validation offerings.

The BsUFA facilitates the development of safe and effective biosimilars and interchangeable biosimilars for patients by supporting FDA review of biosimilar submissions.

Agilent will work with Quest Diagnostics to distribute the ctDx FIRST test.

deCODE genetics, a subsidiary of Amgen, will whole-genome sequence 35,000 African-American samples provided by Illumina and Nashville Biosciences.

The United States Patent and Trademark Office issued a Notice of Allowance for Zika vaccine patent to GeoVax.

In a response letter, FDA stated that it could not grant Eli Lilly and Company accelerated approval due to concerns surrounding insufficient quantity of clinical trial data.