BioPharm International Editors

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.

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.

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

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

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.

Alexion’s acquisition of LogicBio is designed to accelerate the company’s growth in genomic medicines.

FDA amended its authorization for the Moderna and Pfizer-BioNTech bivalent booster vaccines to permit their use in children as young as five years old.

CRB’s Horizons: Life Sciences report covers challenges facing manufacturers and how to keep pace with rapid innovation.

Cytiva’s acquisition of CEVEC Pharmaceuticals strengthens the company’s cell line development and biomanufacturing capabilities.

Amphista Therapeutics and Domainex will work together to develop treatments focusing on targeted protein degradation.

OGT has launched the SureSeq Myeloid Plus panel and OGT Universal NGS Complete Workflow.

Thermo Fisher’s new centrifuge technology is designed to enable efficient, sustainable cell culture harvesting.

Freudenberg Medical’s Heflix TPE tubing is a high purity TPE intended for bioprocessing applications.

The UK’s MHRA has approved Colonis’ melatonin oral solution for sleep onset insomnia in children and adolescents with ADHD.

H.I.G. Capital’s portfolio company Aspire Pharma has acquired Morningside Healthcare and Morningside Pharmaceuticals.

FDA has granted Fast Track designation for CUE-101, a treatment of recurrent/metastatic head and neck squamous cell carcinoma.

Pfizer has completed its acquisition of Biohaven Pharmaceuticals for approximately $11.6 billion.

Citius and the University of Pittsburgh will investigate I/ONTAK in combination with pembrolizumab for treatment of recurrent or metastatic solid tumors.

Forge Biologics will offer three grades of plasmid manufacturing services at its Columbus, Ohio, location.

PerkinElmer has unveiled a cell analysis solution to streamline cell and gene therapy research and manufacturing.

Biogen has agreed to pay $900 million to settle federal and state claims that it paid kickbacks to physicians to encourage them to prescribe its drugs.