Pharmaceutical Technology Editors

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.

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.

FDA sent a warning letter to Stemell, Inc. for manufacturing and distributing unapproved products derived from umbilical cord blood and umbilical cord and for significant deviations from current good tissue practice and current good manufacturing practices.

FDA announced it is developing a series of guidance documents to promote methodological patient-focused drug development.

A US District Court judge in Tennessee entered a consent decree of permanent injunction against Basic Reset and Biogenyx after multiple FDA inspections of the companies’ facility found violations of the Federal Food, Drug, and Cosmetic Act.

EMA has started a data review of Picato (ingenol mebutate) to investigate the potential for skin cancer risk.

A new report by GlobalData projects 2.9% growth by 2028 for the hemophilia A and B market across the eight major world markets.

JW Pharmaceutical Corp will acquire the rights to 100% of the shares of Euvipharm along with a state-of-the-art pharmaceutical plant located in Vietnam.

The new facility will handle clinical supply management, primary and secondary packaging, complex labeling services, clinical storage, distribution, and drug returns and destruction and will include stability chambers.

The drug will improve the treatment and prevention of invasive fungal infections.

The drug displayed improvement in progression-free survival and increased the time patients lived without disease progression or death by a median of 18.9 months.

In a Phase III trial for advanced small-cell lung cancer, the investigational antibody drug conjugate, Rova-T (rovalpituzumab tesirine), did not demonstrate a survival benefit for patients taking it.

The company has received breakthrough therapy designation for its prophylactic respiratory syncytial virus vaccine candidate for treating adults aged 60 years or older.

Roche has extended its offering period for the purchase of Spark to provide US and UK regulatory authorities with additional time to complete their review of the acquisition.