CPhI, a UBM EMEA organization, launched a new advisory board for 2015.

Catalent announced that it would partner with Mitsubishi Gas Chemical Company, and its subsidiary MGC Pharma, to promote GPEx technology, a high-titer vector for stable mammalian cell lines.

FDA aims is to collect data regularly from manufacturers that will indicate the ability of a firm and its facilities to produce high-quality therapies on a continual, error-free basis.

The European Medicines Agency plans on sharing generic-drug assessment reports with regulators outside the European Union.

Coquí RadioPharmaceuticals announced that it met an agreement with the University of Florida Foundation to acquire 25 acres of land to build a medical isotope facility.

Eli Lilly collaborates with Bristol-Myers Squibb and Merck on clinical trials of oncology treatments.

Boehringer Ingelheim announced that it would partner with Vanderbilt University to research and develop Ras inhibitors for the treatment of cancers affected by Ras mutation.

USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.

Sanofi has entered into a strategic manufacturing collaboration with Boehringer Ingelheim for the manufacture of therapeutic monoclonal antibodies (mAbs).

Eight new projects will focus on the diverse needs of the Ebola epidemic, such as new vaccine development, production and distribution, and new diagnostic methods.

Child-resistant packaging requirements for products containing a specified imidazoline will come into effect June 10, 2015.

Boehringer Ingelheim announced that it would collaborate with Yale University to research novel therapeutic targets in immune-modulation.

Shire adds rare-disease portfolio with acquisition of NPS Pharma.

Mexichem announced that it acquired the distribution and sale license for HFC-227ea/P from Du Pont.

Bristol-Myers Squibb announced that it stopped its study of Opdivo for the treatment of 2nd line squamous cell lung cancer due to superior overall survival of study participants.

NovoBiotic’s first-in-class antibiotic, teixobactin, proves strong in the battle to kill drug-resistant bacteria.

Single-use components aid efficiency in automated personalized therapy manufacturing.

A guidance document published just before the Jan. 1, 2015 deadline adds a four-month grace period.

The acquisition of Aptuit's Glasgow, UK and Indiana, US facilities will add sterile injectable formulation development and expand AMRI's analytical services capabilities.

An FDA expert committee has recommend approval of Zarizio, the first US biosimilar application from Sandoz, setting a milestone for generic biologic drugs and setting the stage for future approvals.

Impax Pharmaceuticals received FDA approval of Rytary for use in patients with Parkinson’s disease.

Cardio3 BioSciences acquired Celdara Medical’s immuno-oncology platform, OnCyte, for up to $180 million in cash, stock, and royalties.

SK Capital Partners announced that it completed a strategic investment in Halo Pharmaceutical.

The FDA center released a list of the guidance documents it plans to publish in 2015.

The exclusivity deal mirrors that of the recent deal between Express Scripts and AbbVie for Viekira Pak.

Isis Pharmaceuticals announced that it entered into an agreement with Janssen Biotech to discover and develop antisense drugs for autoimmune disorders of the GI tract.

Bio/pharmaceutical manufacturers in the UK face challenges in proving that their drugs are worth the price.

Risks associated with single-use technologies, such as product loss and sterility assurance, are magnified in the filling operation because of its closeness to the product in its final form. A thorough evaluation of the assembly design process, manufacture, and use can assist in identifying and mitigating these risks.