The decision came as a result of an inspection that raised concerns on how GVK carried out those studies at the Hyderabad site on behalf of marketing authorization holders.

Careful design of a single-use assembly by both the supplier and end user together can mitigate risks and create fitness for the intended use.

Tom Tappen, who passed away Jan. 1, 2015, is remembered for contributions to the pharma industry, customers, and business associates.

Bristol-Myers Squibb has announced that Giovanni Caforio will be the company’s chief executive officer effective May 5; Lamberto Andreotti has been named chairman.

Nelson Patterson has been elected to Pharma & Biopharma Outsourcing Association board. The Pharma & Biopharma Outsourcing Association (PBOA) has announced that Nelson Patterson, vice-president, sales and marketing at Baxter BioPharma Solutions, has been elected to its Board of Trustees, effective immediately. Patterson was elected after Baxter BioPharma Solutions joined the PBOA as a Sustaining Member.

The European Medicines Agency has published a guide to help industry and regulatory authorities implement safety-monitoring standards.

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.

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).

Catalent Pharma Solutions and Sanofi-Aventis R&D have entered into a collaboration to develop Sanofi’s proprietary antibodies using Catalent’s SMARTag antibody drug conjugate (ADC) platform.

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.