The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.

The company has voluntarily recalled all lots of of human chorionic gonadotropin because of a lack of sterility assurance.

Baricitinib (Olumiant) is the first JAK inhibitor licensed to treat rheumatoid arthritis in Europe.

Aurobindo has added four cell-culture derived biosimilars to its product line.

The Generic Pharmaceutical Association announces a rebranding campaign to expand access to medicines.

Evaluate and BioPharm International highlight the antibody-based therapeutics that may have 2017 launch dates in the United States.

Quotient Clinical’s addition of CDMO QS Pharma increases the company’s footprint in the US an adds high potency molecule capability.

The company announced results from a Phase II trial with its THC:CBD drug for the treatment of glioblastoma multiforme.

The companies entered into a license agreement for Immunomedic’s antibody-drug conjugate sacituzumab govitecan.

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.

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.