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.

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.

Perrigo rejected Mylan’s second proposal for an acquisition valued at more than $34 billion, saying that the offer was too low to consider.

Takeda Pharmaceutical agrees to pay $2.4 billion to settle lawsuits from patients and family members who said the diabetes drug Actos caused bladder cancer.

Pharmaceutical companies should take into consideration intellectual property protection when outsourcing the packaging of their products.

In a seething letter, Mylan’s executive chairman announced the unanimous rejection of a $40-billion unsolicited acquisition offer from Teva.

After rejecting Teva’s unsolicited $40 billion purchase offer, Mylan has increased its own offer to purchase Perrigo from $29 billion to over $32 billion in cash in stocks.

Mylan announces a recall of eight lots of injectable products due to visible foreign particulate matter.

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

CDMO Vetter produces identifiable labeling for a top-ten pharmaceutical company.

IDT Biologika receives 2015 Facility of the Year Award or facility integration from ISPE.

Innate Pharma announces a co-development and commercialization agreement with AstraZeneca to accelerate the development of Innate’s anti-NKG2A antibody.

CPhI Russia opens in Moscow as the government seeks to boost domestic manufacturing production.