BioPharm International Editors

FDA Commissioner Scott Gottlieb issued a statement that FDA will be modernizing regulatory programs in order to advance novel treatments.

Fluarix Tetra has been approved for use in children aged six months and above.

The companies will work together on developing regenerative medicine therapies for heart failure.

Ompi EZ-fill vials and Daikyo Seiko PLASCAP press-fit closures are a confirmed product set for use with Vanrx Pharmasystems' Aseptic Filling Workcells.

Ferring Pharmaceuticals will expand its biologics capabilities at its headquarters and manufacturing site in Saint-Prex, Switzerland.

Unlike current approaches where bioconjugation is typically done following the manufacture of the monoclonal antibody and the cytotoxic drug, the new method begins with the antibody supernatants and eliminates the need for extensive chromatographic purification.

Honeywell offers an augmented/virtual reality approach to train the industrial workforce.

A $800-million acquisition of MPI Research expands Charles River's offerings for early-stage contract research.

FDA sent a warning letter to Celltrion detailing CGMP violations, including poor microbial contamination control.

A new report states that more research and clinical development must be done in the treatment of pain and addiction.

The companies have been awarded a collaborative grant of £1.9 million (US$2.6 million) from Innovate UK.

The acquisition strengthens an already existing collaboration between the companies to advance clinical development of therapies across multiple drug categories.

The companies will partner to further immuno-oncology research using humanized mice.

Through its Janssen pharmaceutical companies, Johnson & Johnson, has partnered with Theravance to develop and commercialize a therapeutic for inflammatory bowel diseases.

CPhI North America 2018, taking place Apr. 24-26 in Philadelphia, PA, has announced Dr. Bertalan Mesko as its first keynote speaker.

The agency met to discuss its new temporary and permanent premises in Amsterdam.

The guidance addresses the development, analysis, and presentation of microbiology data during antibacterial drug development.

Paratek has completed submission of two new drug applications for oral and intravenous omadacycline, a new antibiotic for pneumonia and skin infections.

Amgen plans to invest approximately $300 million in a new biomanufacturing plant in the United States.

The company announced the winner of its 2018 Young Chemist Award.

Shire will receive exclusive license to develop and commercialize AB Biosciences' pan receptor interacting molecule program for autoimmune and inflammatory diseases.

Corning will become the exclusive supplier of CytoSMART's new cell counter device that simplifies mammalian cell counting.

The NECC supervisory pharmacist at the center of the 2012 fungal meningitis outbreak was sentenced to 8 years in prison.

Federal agencies have partnered to develop a roadmap that offers a new framework for the safety testing of drugs and chemicals without the use of animals.

A collaboration between The Centre for Process Innovation and The Roslin Institute aims to develop commercially viable and scalable methods of producing biologics using transgenic animals.

FDA Commissioner Scott Gottlieb says FDA is committed to meet the challenges faced by the saline shortage during an aggressive flu season.

Biopharm industry veteran Ralf Otto named to lead development and manufacturing at Rentschler Biopharma.

The new Acquity Arc Bio System by Waters is specifically engineered to enable efficient transfer and improvement of bioseparation analytical methods.

The acquisition will strengthen Sanofi's R&D strategy and expands its franchise for rare blood disorders.

A manufacturing disruption has led to an EpiPen shortage in Canada, which currently has no alternative auto-injectors available on the market.