EMA plans to issue new guidance, as US and European regulators respond to reports of nitrosamine contamination in H2 blockers, including Zantac, that contain rantidine.

The companies aim to integrate glucose sensing with insulin delivery technologies to help change the way diabetes is managed.

The venture will focus on single-use and modular systems designed to develop novel biotherapeutics.

States oppose the company’s plans for a Chapter 11 settlement, which would restructure the company as a trust and cap funding to plaintiffs, Reuters and other news outlets report.

Nephron Pharma and the University of South Carolina plan to build a sterile compounding lab at the University for research and training.

Bora Pharmaceuticals has announced it has achieved success in the latest FDA general inspection of its Zhunan facility with zero 483 observations.

ACG Group has announced the winners of its ‘Art in a Capsule’ competition, where entrants were challenged to create miniature works of art that could fit inside a capsule.

BioCity has invested in Maxwellia, a company based at Alderley Park in the United Kingdom that is driving industry movement towards self-care therapeutics.

BIA has signed a memorandum of understanding with AstraZeneca and the Wuxi International Life-science Innovation Campus (I-Campus) to boost access for UK SMEs in China.

The ABPI and BMA have issued responses to the publication of a government report into the scale and distribution of prescribed medicines in England.

TrakCel and McKesson have formed a collaboration that is aimed at accelerating commercialization of cell and gene therapies by leveraging services to enable a more efficient development pathway.

FDA approved the drug after a successful open-label study of children aged six to 11 years and living with the condition.

The companies will develop and commercialize a Phase III cell therapy candidate for treating chronic low back pain in a deal worth potentially $1 billion.

The supply agreement comes after an eight-year collaboration between the companies.

Time is running out on Ned Sharpless’ term as FDA acting commissioner, generating much talk as the administration shows interest in naming a new head for the agency.

FDA issued a statement about the importance of reporting adverse events resulting from the use of compounded drugs.

The company is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the hospital/retail level because of a lack of confirmation of sterilization for some vials from this lot.

The companies plan to create a new curriculum focusing on single-use applications training, cell therapy technology, process efficiency strategies, process development methodologies, and chromatography proficiency.

The company will hold exclusive ownership of patents supporting a mini-tablet dispenser to accommodate the oral dispensing needs of patients.

The company’s Custom Single Run product line now has available bioreactors with working volumes of up to 6000 L.

Passage Bio has licensed a sixth gene therapy development program under its partnership with the University of Pennsylvania for the clinical development of a potential treatment for a nerve disorder.

The agency has approved Boehringer Ingelheim’s Ofev (nintedanib), its lung disease drug, for the treatment of patients with systemic sclerosis associated with lung disease.

Xeris Pharmaceuticals has received FDA approval for GVOKE (glucagon), a liquid glucagon for treating hypoglycemia.

Bayer will use ProBioGen’s GlymaxX technology to maximize the potency of its antibody drug candidate in development for oncological indications.

The contest encouraged artists to create miniature pieces of art that could fit inside the company’s signature capsules for a $5000 grand prize.

The transaction is set to be completed in the fourth quarter of 2019.

The new antibody, Citryll’s CIT-013, could offer new treatment options for various human diseases including lupus, vasculitis, pulmonary fibrosis, and organ damage due to sepsis.

The organization will utilize the cancer center’s Research for Biologics and Immunotherapy Translation platform for the development of therapeutic monoclonal antibodies against a novel immune checkpoint target.