News

The agency cited VUAB Pharma, located in the Czech Republic, for cGMP deviations.

FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.

Michiel E. Ultee of Ulteemit BioConsulting discusses converting an early drug discovery into a product that is ready for clinical testing.

Baxter announces that it will partner with Mayo Clinic and Velocity Pharmaceutical to form Vitesse Biologics, a Baxalta-managed company focused on immunology, hematology, and oncology.

A new demonstration facility in New York gives Sartorius’ customers hands-on access to bioprocessing systems and lab instruments.

EMD Millipore debuts a new cell-culture media compacting technology that will turn messy, dry powders into granules.

The directorate highlights achievements accomplished during the year of its 50th anniversary.

This article reviews factors that affect protein stability at different steps of the product manufacturing process and strategies to minimize their impact on product quality.

The ICH Steering Committee will meet from June 6–11, 2015 to discuss a variety of harmonization topics.

Prescription drug usage data on more than one million Marketplace enrollees suggest that costs for specialty drugs are 36% higher for people with Obamacare.

Experts attending the European Psychiatry Association Congress in Vienna say that Adasuve has made an impact in the treatment of agitation in patients suffering from schizophrenia or bipolar I disorder.

Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients.

Eight physician groups wrote to the commissioner of FDA to stress the importance of transparency in biosimilar labeling to decrease prescribing risks.

Waters announces it will introduce its new technology at the 63rd Society of Mass Spectrometry conference.

MIT scientist Robert Langer will speak at BIO 2015 on a panel about venture capitalism in biotechnology.

Boehringer Ingelheim announces FDA approval of Stiolto Respimat inhaler for the treatment of COPD.

Visterra announces partnership with A*STAR to develop VIS513, a monoclonal antibody for the treatment of dengue fever.

The House Energy Committee’s approval of the 21st Century Cures legislation is only a first step, with critics and collaborators alike lining up to comment.

Epirus Biopharmaceuticals and mAbxience have entered into a development and future distribution deal for Epirus’ lead program, BOW015 (infliximab, reference biologic Remicade), for Latin American markets.

Medicago's new production facility will make plant-based vaccines and therapeutics.

The House Energy and Commerce Committee gave unanimous approval to the landmark 21st Century Cures Act reform bill on May 21, 2015.

The Denmark facility will incorporate CMC’s Bioreactor 6Pack configuration in one manufacturing line.

The former New England Compounding Center will pay $200 million to victims and creditors for the 2012 outbreak of meningitis that killed 64.

Physician confidence in biosimilars and extrapolation of indications are two of the most important factors governing the acceptance and sustainability of biosimilars, say industry panelists.

The method patent covers the infusion of bendamustine hydrochloride for the treatment of certain blood cancers.

Alexion will construct a biologics facility in Ireland that is its first outside the US.

Emergent gives ProMetic long-term access to its Winnipeg facility.

The Critical Path Institute launched a consortium to help develop therapies for newborns.