An advisory committee’s vote to remove Makena from the market illustrates how difficult it is for regulators to ensure that such drugs document safety and effectiveness in a timely manner.

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.

Pharma supply chains are no longer hidden beyond the reach of ESG agendas, making it important for companies to accelerate adoption of new manufacturing processes and environmental technology

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 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.

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.

Russell Kneipp, who has been Spectrum’s COO since 2018, will assume the roles effective immediately.

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

Eli Lilly and Company will partner with Schrödinger to develop and optimize small molecule compounds.

CBER maps modernization plan to handle surge in research and applications.

Agilent Technologies opened a Dissolution Center of Excellence in Craven Arms, United Kingdom, on Oct. 12, 2022.

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.