
EMA announces that the European Union’s PAS Register has received its 1000th upload.

EMA announces that the European Union’s PAS Register has received its 1000th upload.

A total of 166 biotech executives penned an open letter expressing concern over President Donald Trump’s executive order on immigration.

Pharmaceutical Technology spoke with Tommy Fanning, head of biopharmaceuticals for IDA Ireland, to get a perspective on how Brexit may affect the pharmaceutical industry.

The company is voluntarily recalling product due to particulate matter.

Dr. Reddy’s has expanded its commercial operations in Europe with the introduction of its range of generic drugs in France.

Modular Automated Sampling Technology (MAST) allows direct aseptic transfer of bioreactor samples to analytical devices, providing rapid and reliable data in bioprocessing.

PTSM: Pharmaceutical Technology Sourcing and Management
Research by Pew Charitable Trust and ISPE suggests that inability to forecast internal demand, and poor partner alignment are among the reasons for drug shortages

FDA's Warning Letter to an Indian API manufacturer alleges cGMP violations and improper cleaning and validation

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.

Reducing regulatory roadblocks requires more than the stroke of a pen.

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.