Pfizer announces that its Phase III trial for Ibrance met its primary endpoint and was ended early due to efficacy based on an assessment by an independent Data Monitoring Committee.

The document serves as guidance for the pharmaceutical industry in data integrity issues and complements existing EU GMP relating to APIs and dosage forms.

This is the first time a single strategy document for both EMA and HMA is presented, reflecting the need for a coordinated approach to address the challenges and opportunities facing the European regulatory system network.

The single-use clarification system eliminates centrigues; harvesting can be performed in one step; and process robustness and predictability are ensured.

CPhI report notes that the Indonesian pharma market is on the brink of a regional manufacturing boom, with market capitalizations and company values rising.

Japanese pharma market evolves towards generics and innovative products, reports CPhI, as CPhI Japan 2015 commences.

Spending on prescription medications reached $373.9 billion in 2014, representing the largest increase in 13 years.

Hydra Biosciences enters into an agreement with Boehringer Ingelheim to research and develop small-molecule TRP inhibitors for renal diseases and disorders.

The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.

The pharmaceutical market in Japan is moving towards generic and innovative products, and is expected to hit US$166 billion by 2023.

Agency teams work together to encourage manufacturers to seek approval for previously unapproved drugs.

Udit Batra, current head of Merck KGaA’s life science business, will lead the combined life science businesses following successful completion of Sigma-Aldrich acquisition.

As the prevalence of falsified medicines continues to increase, Switzerland is taking measures to secure its supply chain such as the implementation of serialization.

FDA issues a Warning Letter to Hospira S.p.A. for GMP violations at the company’s Liscate, Italy facility.

Baxter voluntarily recalls select lots of IV solutions due to possible particulate matter.

The grants will be offered to investigators conducting research in the field of PCSK9 biology.

Aptar Pharma has partnered with Shanghai Sine Promod Pharmaceutical to develop and launch its new budesonide dry powder inhaler (DPI), which features Aptar Pharma’s user-friendly and cost-effective Twister DPI.

Eppendorf announces that it won the Best New General Lab Product at the Scientists’ Choice Awards.

Companies manufacturing cytotoxic drugs must ensure that staff are given the highest possible levels of protection.

Meggle’s business group, Excipients and Technology, has appointed Alexander Torster, MBA, as its new head of sales and marketing.

Avomeen Analytical Services announces that David W. Riggs, PE will take the role of president of the company.

Cornell Stamoran, Catalent Pharma Solutions vice-president, is elected to the board of trustees of the Pharma & Biopharma Outsourcing Association.

Mylan announces that it would offer Perrigo $29 billion in cash and stock to buy the Irish company.

Theravectys has been granted authorization by the French National Agency for Medicines and Health Product Safety to produce lentiviral vectors for Phase I to Phase III testing at its manufacturing plant.

The move was made to meet an upsurge in Phase I/II GMP campaigns from clients in Europe and the United States.

Novartis will make payments to Juno to settle a patent dispute covering chimeric antigen receptor T-cell (CAR-T) therapies.

The system is compatible with a wide range of industrial CHO cell lines.

Facilities in China, Ireland, Germany, and the United States have been recognized by ISPE in the 2015 Facility of the Year Awards program.