Pharmaceutical Technology Editors

iBio granted a license to CC-Pharming for the commercialization of its iBio Rituximab drug for treatment of B cell non-Hodgkin lymphomas, chronic lymphocytic leukemia, and autoimmune diseases.

GSK will handle the development, regulatory, commercialization activities, and costs of the drug, while Ionis will obtain license fees and milestone payments of up to $262 million, including a $25 million license fee.

A ruling in Oklahoma that Johnson & Johnson’s marketing efforts created a public nuisance may establish a precedent of other jurisdictions.

The new vaccine will offer protection against the Nipah virus after a single dose.

The supplemental new drug application seeks to add an indication for men with prostate cancer that has spread but is sensitive to hormone therapy.

The transaction is part of Bristol-Myers Squibb’s proposed acquisition of Celgene.

AstraZeneca announced that its therapy for the treatment of patients with heart failure, Farxiga (dapagliflozin), has met the DAPA-HF trial primary endpoint.

ABPI has issued a statement of support in response to the United Kingdom’s Prime Minister’s recent order of urgent action to boost the numbers of children receiving vaccinations.

Joint analysis from the EMA and the US FDA has shown that the regulatory bodies are highly aligned in the majority of marketing authorization decisions.

Innovate UK has awarded a grant worth thousands to the Atelerix Consortium for the collaborative work with the Cell and Gene Therapy Catapult and Rexgenero on development of cell stabilization technology.

GSK has submitted a Japanese New Drug Application (JNDA) for its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), daprodustat.

A biosimilar to Eli Lilly’s Forsteo, biosimilar teriparatide, has been launched across Europe by Gedeon Richter following the patent expiration of the reference product.

The new lab will be dedicated to improving materials and electronics using advanced imaging and surface analysis expertise.

The agreement gives Biotheus access to Alligator’s antibody, Alligator-Gold, for the creation of up to three bispecific molecules.

Working to Fight AMR will work to raise public awareness of the threat of antimicrobial resistance, the third-leading cause of death in the United States.

The divestiture is in line with Bayer’s strategy to focus on its life sciences business.

FDA sent a warning letter to NingBo Huize Commodity Co. after an investigation of the company’s Zhejiang facility found falsified quality documents.

The companies will work together to produce enFuse, a patient-administered subcutaneous delivery device.

The company’s new training center in Greenville, NC, will use virtual and augmented reality to train employees on its sterile injectables manufacturing line, which is expected to cut training time in half.

Pfizer is investing $500 million for the construction of a state-of-the-art gene therapy manufacturing facility in Sanford, NC.

FDA has approved Regeneron Pharmaceuticals’ Eylea (aflibercept), an anti-vascular endothelial growth factor inhibitor, to treat four retinal conditions.

The US Pharmacopeial Convention is proposing a policy change to the inclusion of reporting thresholds in drug substance and drug product monographs.

The agency approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia.

The ACGcaps H+ capsules work to meet pharmaceutical and nutraceutical needs while remaining gelatin-free.

FDA has issued a complete response letter to Sarepta Therapeutics for its new drug application seeking approval for a new Duchenne muscular dystrophy drug.

The new treatment achieved primary endpoint of overall response rate (ORR) by investigator review and by the independent review committee (IRC) assessment.

The new drug is meant to be used in combination therapy for treating pediatric patients with pulmonary multidrug-resistant tuberculosis.

The Birtley, UK facility added cleanroom, manufacturing, and testing facilities for biopharma manufacturing single-use systems.

RINVOQ for the treatment of adults with moderately to severely active rheumatoid arthritis has been approved by FDA

Olympus will launch its first Global Image of the Year Life Science Light Microscopy Award to recognize life science imaging.