BioPharm International Editors

The agency issues draft guidance on the development of drugs to treat Duchenne muscular dystrophy.

A year after its merger with DSM Pharmaceutical Products, Patheon announces that it has filed an IPO.

The Canadian Green Cross facility will produce intravenous immunoglobulin and albumin.

CPhI Pharma Insights’ Turkey Market Report reveals, the growth and strategic plans for the future of the pharmaceutical industry in Turkey.

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.

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The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.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

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.

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 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.

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.

The Irish company Endo International announced that it would acquire Par Pharmaceutical for $8.05 billion.

AstraZeneca announces that it will invest $285 million in a new manufacturing facility in Sweden.

Raplixa fibrin sealant, the first approved spray-dried biologic, is a hemostatic agent that helps control bleeding from small blood vessels during surgery.

UK-based Circassia invests approximately $377 million on Aerocrine and Prosonix, two companies focused on asthma.

CPhI Worldwide announces the 2015 Expert Panel, including 2014 panel veterans and three new members.

Supply chain consortium establishes a working group to address quality problems in India.