Pharmaceutical Technology Editors

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.

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).

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.

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.

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.

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.

The Parenteral Drug Association report addresses prevention and communication of drug shortages caused by manufacturing and quality related disruptions.

FDA delays enforcement of product tracing requirements to May 1, 2015, providing trading partners more time to comply.

Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.