
Will biosimilars share a compendial identity like generic drugs do?

Peer-reviewed papers and technical articles can help advance bio/pharmaceutical development.

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

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

Teva announces the exclusive launch of its generic equivalent of Actonel in the US.

ProMetic Life Sciences will use manufacturing and plasma fractionation processes at Emergent BioSolutions’ Winnipeg, Canada facility.

The IPEC-Americas Foundation is accepting applications for graduate student, research, and industry research achievement awards.

Clinical supplies facility in Frankfurt, Germany will triple Theorem Clinical Research’s current clinical supplies capacity.

Excipient manufacturing site achieves EXCiPACT certification following regulatory inspections.

Grand River Aseptic Manufacturing named one of Michigan 50 Companies to watch.

The restructuring of the International Conference on Harmonization, which is expected to begin in late 2015, could have a significant impact on the way pharmaceutical regulations are harmonized worldwide.

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

The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.

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 biopolar I disorder.

New guidance complements ICH guidelines on impurities.

This new pharmaceutical stability storage facility will enable the company to expand its analytical and formulation offerings to the pharmaceutical and biotech industries.

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.

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

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

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.

EMA confirms its recommendation to suspend medicines approved based on GVK Biosciences studies.

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.

OXY-CAPT brings together properties of plastic and glass containers through the combination of oxygen absorption and cyclic olefin copolymer (COP) high barrier layers.

Merus and Selexis will combine technology platforms to produce colorectal cancer combination therapy.

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

CVS Health signed a definitive agreement to acquire Omnicare for $12.7 billion to expand its reach to assisted living and long-term care facilities.

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

Adjusting the tablet press and its systems can prevent manufacturing and product quality problems.