This three-year partnership will explore and identify new tools and methods to modify and optimize the Chinese hamster ovary (CHO) cell line performance.

The investment will be used to advance Nemaura’s R&D programs, which include liquid vaccines that have been reformulated for administration through the skin using its micropatch drug delivery technology.

On a recent call, Catalent revealed that it has reached more than 90% of its current capacity and discussed how tax policy changes could affect the outsourcing industry.

The International Society for Pharmaceutical Engineering (ISPE) and its Facility of the Year Awards program announced its 2017 category award winners.

Aggressive petitioning by ViroPharma kept a generic equivalent to Vancocin off the market for more than two years.

According to results from the FOURIER trial, Repatha significantly reduced the risk of cardiovascular events and death in patients with atherosclerotic cardiovascular disease.

Pump systems must be designed to meet the needs of specific processes, including preventing cross-contamination and damage due to shear forces.

The warning letter cited GMP violations for finished drug products.

Companies were recognized for their innovative packaging technologies.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates,  discusses how to ensure sterility when manufacturing small-scale parenteral batches.

The £14-million research project aims to better understand adverse drug reactions through a variety of modeling approaches.

A change in the tax code could help the company create more jobs in the United States, while fewer FDA regulations could help reduce drug prices, according to Pfizer CEO Ian Read.

In promising to expedite and simplify the FDA approval process, Donald Trump fails to take account of industry's appreciation of an efficient, rigorous FDA regulatory system.

FDA issued a warning letter to Cixi Zhixin Bird Clean-Care Product Co., Ltd for violations of cGMP for finished pharmaceuticals.

The company announced an investment in a new facility in Dundalk, County Louth, Ireland. On Jan. 26, 2017 Almac Group announced that as part of its ongoing global expansion, the company has secured a new facility in Dundalk, County Louth, Ireland. The new facility will be located at IDA Business Park. The new facility will increase the group’s European footprint by 32,000 ft2. The Dundalk facility will be utilized by Almac Pharma Services and Almac Clinical Services.

Pharmco Laboratories received an FDA warning letter for significant violations of CGMP for finished drugs and APIs at its Florida, US facility as well as misbranding of over-the-counter (OTC) acne and sunscreen drug products.

Novo Nordisk entered a research collaboration with the University of Oxford focused on Type 2 diabetes.

Local manufacturing, regulatory strategies, market entry, and harmonization to be featured at CPhI Istanbul.

Lek, a Sandoz company, adds capacity to its plant in Prevalje, Slovenia.

Trump met with pharma manufacturers and makes a statement focused on domestic manufacturing, FDA approvals, and drug pricing.

Teva said it plans to appeal a district court decision that invalidated several of the company’s Copaxone patents.

Operational improvements at Pall contributed to the overall growth in the Danaher life-sciences sector.

Alexandre Juillerat, PhD, innovation senior scientist at Cellectis, discusses novel construct UCART123, an investigational agent that is on deck to be the first gene-edited T-cell product in the United States.

Despite the threat of competition, both from biosimilars to Humira and new therapies that work through other mechanisms of action, AbbVie says Humira is still number one.

The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.

ADMA will acquire BPC’s plasma-based fractionation and purification plant in Boca Raton, FL and plans to resolve issues at the facility noted in an FDA warning letter.

The company will gain the rights to a mutein that is believed to help maintain immune system homeostasis.

PAT, quality by design, process controls, and analytical advances for small- and large-molecule drugs are on agenda for IFPAC 2017.