Eli Lilly announces that it will establish a drug delivery and device center in Cambridge, Massachusetts.

Juno Therapeutics announces that it will expand its cellular therapies pipeline with the acquisition of Stage Cell Therapeutics for €52.5 million.

Pluristem Therapeutics announces that Japan’s Pharmaceuticals and Medical Devices Agency agreed with its methods for the manufacture of PLX-PAD cells.

Pfizer acquires minority equity stake in AM-Pharma and secures option to acquire remaining equity.

With acquisition of Oncaspar portfolio for leukemia from Sigma-Tau Finanziaria, Baxter BioScience adds an oncology infrastructure and biologic.

CombiLac is a lactose-based, co-processed excipient, designed to ease oral solid dosage form development and manufacture in direct compression.

The new Kaye Validator AVS combines accurate sensor measurements with all GMP requirements for calibration and traceability.

Turkey continues to dominate the MENA pharma region as regional manufactures expand at double-digit pace with the arrival of international players.

The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.

FDA issues a Form 483 following inspection of Impax Laboratories' Hayward, CA facility.

The basic principle behind QbD is that quality should be built into a product with an understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks.

Novartis announces that its lung cancer drug, Zykadia, gained European Union approval.

A range of packages is available for industry partners to implement charity giving.

Johnson & Johnson announces partnership with NYU School of Medicine to launch a compassionate care committee for individual patient requests of investigational drugs.

BASF announces that it will sell its custom synthesis business and parts of its API business to focus its expertise on pharmaceutical excipients.

The US Court of Appeals granted Amgen’s request to block Novartis’ Neupogen biosimilar, Zarxio, from the US market until the court resolves litigation between the two companies.

Alexion announces it will expand its rare disease pipeline with a definitive agreement to acquire Synageva.

Eleven of the leading US biosimilar developers have collaborated to form the Biosimilars Forum, a nonprofit organization formed to expand patient access to biosimilars.

The company voluntarily recalls select lots of Adrucil due to particulate matter.

Bayer announces that it will pay up to $155 million, plus royalties, for the rights to Isis Pharma’s anti-clotting drug, ISIS-FXI.

Novo Nordisk announces that it will invest DKK1.5 billion (US$224 million) in a haemophilia treatment manufacturing facility in Denmark.

Capsugel extends inhaled biotherapeutics delivery capability to Phase 2 clinical trials.

FDA cites Yunnan Hande Bio-Tech for cGMP violations related to data collection and security.

Intellectual property lawyers estimate biosimilar litigation will swell as early as 2018.

Adjusting the tablet press and its systems can prevent manufacturing and product quality problems.

Pharma can boast of big-picture successes, but needs to work on operational issues.

The restructuring of the International Conference on Harmonization, which is expected to begin in late 2015, could have a significant impact on the way pharmaceutical regulations are harmonized worldwide.

The revised "21st Century Cures” proposal includes provisions for research for continuous manufacturing, biomarker development, and NIH funding.