The company is recalling one lot of Topotecan Injection 4 mg/4 mL (1 mg/mL) after a glass particle was found in a vial.

The approved changes to the API manufacturing plant in Leiden, the Netherlands will enable an increase in API capacity.

LGM Pharma will offer contract analytical testing and stability services to pharmaceutical developers and manufacturers.

An additional batch of the Janssen COVID-19 vaccine has been authorized by FDA under the Emergency Use Authorization.

The rise of COVID variants has made public health officials anxious to expand immunity more widely and quickly in areas with low vaccination rates, and experts hope that full approval of existing and new vaccines will increase public confidence in their value.

An updated version of legislation to modernize clinical research policies and FDA expedited approval pathways is circulating on Capitol Hill.

Advances in technology are accelerating the development and manufacture of subunit vaccines, an established class of vaccines.

Despite some improved understanding of adapted processes in light of the pandemic, information is still not filtered throughout the qualified persons community fully and more work by authorities and associations is required to improve communications.

Vaccines define the path to putting the pandemic in the rear-view mirror.

The acquisition of Intermountain Life Sciences will double Cytiva’s capacity for buffers and liquid cell culture media at its manufacturing site in Logan, Utah.

The extended manufacturing agreement between Pinteon and Lonza enables future clinical production of PNT001, a novel Tau antibody therapeutic that targets Alzheimer's disease and traumatic brain injury.

Selexis and KBI Biopharma will use integrated services to advance Immatics’ TCR bispecifics drug development program to the IND stage.

Catalent expands capabilities for stem cell-based therapies with acquisition of RheinCell’s GMP-grade human iPSCs.

Vectura will provide preclinical development services for Incannex’s inhaled drug product for the treatment of traumatic brain injury.

The first participants, both previously vaccinated and unvaccinated, receive AstraZeneca’s new COVID-19 variant vaccine AZD2816.

WuXi STA’s Delaware campus will contain clinical and commercial manufacturing capabilities for small molecules and novel molecular modalities.

Arthrex to receive exclusive rights to distribute and commercialize Celularity’s placental-derived biomaterial products for orthopedics and sport medicine in the United States.

With COVID-19 vaccine facilities receiving recent citations, it is evident that failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.

Corbus Pharmaceuticals has licensed two integrin-targeting mAbs, expanding its therapeutics pipeline into inflammatory, fibrotic, and metabolic diseases as well as cancer.

Chalmers University researchers have developed a method to label and track mRNA molecules.

Amgen’s greenfield facility near Columbus, Ohio to assemble and package vials and syringes is expected to be operational by 2024.

CDMO Yposkesi will increase its current gene therapy vector capacity through French government’s “Plan de Relance” scheme.

Thermo Fisher Scientific has introduced its new Quick to Clinic solution, which is designed to accelerate biologic drug development from discovery to the IND phase in a shortened period.

CatSci has opened its new Dagenham, UK-based laboratory, which is dedicated to analytical excellence.

The Cell and Gene Therapy Catapult will establish offices and laboratories in Edinburgh, Scotland.

Evonik has released an innovative green technology that can enable the large-scale synthesis of APIs in water.

Pharmapack Europe event organizers have revealed increased levels of innovation in drug delivery across the industry, substantiated by the level of regulatory approvals.

The CYTRIX Microfluidic Hydrogel Kit is the first in Sphere Fluidics’ new range of 3D cell culture kits in partnership with ClexBio.