Pharmaceutical Technology Editors

HeliFlex from Freudenberg Medical is a high purity TPE designed for biopharmaceutical fluid transfer applications.

Akadeum’s Life Sciences isolation kit uses microbubbles to reduce leukopak production time.

Evoqua’s Sophis digital services is a holistic monitoring and analysis solution for pharmaceutical water management.

Lonza and Singzyme will use Singzyme’s enzymatic conjugation platform to develop novel bioconjugates.

The company is expanding its contract development and manufacturing services for parenteral drugs to global customers.

Metrics from the CPHI Annual Survey suggest that confidence in the global pharma market has risen significantly in the past year.

Purolite and Repligen have extended their existing ligand partnership through 2032.

Lonza has launched a new capsule to deliver acid-sensitive APIs to the intestine.

Updates to general chapters on compounding, <795> Nonsterile Preparations and <797> Sterile Preparation, include requirements for equipment, cleaning, personnel garb, labeling, and surface contamination testing.

FDA has accepted Ashland’s Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient into the FDA Novel Excipient Review Pilot Program.

Gerresheimer has developed a new dropper insert for ophthalmic formulations that it is showcasing at CPHI 2022 in Frankfurt, Germany.

Thermo Fisher Experts will demonstrate its various capabilities at CPHI Frankfurt 2022.

Roquette has launched excipients PEARLITOL CR-H and PEARLITOL 200 GT.

The CPHI Annual Report 2022 predicts cash reserves from venture capitalists and private equities will drive expansion in the demand for contract research organizations and contract development and research organizations.

The newly formed partnership between CSafe and BioLife will expand cold chain supply chain solutions for the cell and gene therapy market.

AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.

Cambrex has expanded its stability storage business, Q1 Scientific, in Ireland and Belgium.

South Africa’s vaccine regulator has reached new WHO level to ensure safety, quality, and effectiveness.

Under two new agreements, Societal CDMO will offer analytical, technical transfer, formulation, manufacturing, and packaging services for novel therapeutics.

Under the new collaboration with Tempus, GSK will have access to de-identified patient data to accelerate drug discovery, improve clinical trial design, and speed up enrollment.

Aragen’s new 12,000 ft² facility will include various dosage form capabilities, including oral solids, liquids, topicals, and films.

Recipharm’s new high speed filling line, designed for pre-filled syringes and cartridges, is expected to be operational by May 2023.

AAPS will exclusively advise RX Global on scientific focus areas for Interphex 2023, which is set to take place at the Javits Center in New York City next spring.

Aenova Group and Microcaps are partnering to enable new customized formulations for product development and life cycle management solutions.

The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.

The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.

Gilead and MacroGenics will work together on bispecific antibodies for the treatment of blood cancers.

Ebvallo (tabelecleucel) would be the first EMA-approved therapy for patients with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease.

Takeda’s dengue vaccine is designed to prevent disease caused by virus serotypes 1, 2, 3, and 4 in individuals four and older.

Merck has exercised a $250 million option with Moderna to jointly develop and commercialize cancer vaccine mRNA-4157/V940.