
The agency is adding data points to its Paragraph IV Patent Certifications List, which provides brand exclusivity information, in order to help generic-drug applicants determine if their product can be approved and marketed.

The agency is adding data points to its Paragraph IV Patent Certifications List, which provides brand exclusivity information, in order to help generic-drug applicants determine if their product can be approved and marketed.

The companies have signed a strategic multi-year manufacturing agreement for the future commercial production a late-phase investigational cell therapy.

Pharmaceutical Technology's In the Lab eNewsletter
The companies will use emerging data technologies to create a new virtual innovation lab to develop both scientific and commercial solutions.

The company is voluntarily recalling all unexpired products that are intended to be sterile because of a lack of sterility assurance.

Catalent will manufacture products for Bristol-Myers Squibb while adding sterile biologics fill/finish and oral solids manufacturing and packaging capacity.

Lyophilization Services of New England acquired a sterile injectables manufacturing facility in León, Spain.

New CDMO facility supports early-stage API manufacturing and scale up.

Centre for Process Innovation (CPI) is set to host an event in Darlington, UK, on June 26, 2019 to showcase the results of a £11.2-million (US$14.03-million) collaborative project to optimize biotherapeutic development.

Congress is weighing in on drug pricing with a range of measures that differ in style and substance.

The US Federal Trade Commission (FTC) has requested additional information from Roche and Spark Therapeutics regarding Roche’s pending $4.3-billion acquisition of Spark.

Two additional production lines expand Lonza’s HPAPI capacity at Visp, Switzerland facility.

Pfizer’s acquisition of Array BioPharma expands the company’s pipeline of investigational cancer therapies.

SenzaGen has revealed that is has been granted a patent in Europe for GARDpotency, a testing application that enables the measurement of the allergenicity of chemical substances without animal research.

The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has issued a drug alert concerning a class 2 medicines recall of paracetamol tablets.

Pharmaceutical Technology's In the Lab eNewsletter
GSK has revealed that it has entered into a five-year collaboration with the University of California to advance genomic research and improve drug discovery.

Sphere Fluidics has secured a total of $4.8 million (£3.7 million) in investment after closing its additional tranche investment work $2.9 million (£2.2 million).

ABPI has published a guide for pharmaceutical companies on how to work successfully, collaboratively, and ethically with patients and patient groups, in line with the ABPI Code of Practice.

Dassault Systèmes, a provider of virtual universes to imagine sustainable innovations, has signed a definitive agreement to acquire Medidata Solutions in an all-cash transaction.

Recently presented and published study results have demonstrated the ability of AstraZeneca’s Farxiga on reducing the progression of kidney disease or renal death in type-2 diabetes.

OGT has announced the expansion of its SureSeq portfolio with a complete library preparation solution for hybridization-based target capture in NGS.

A groundbreaking ceremony was held in Rahway, NJ for Merck’s new FLEx facility that incorporates G-CON’s prefabricated cleanroom units.

Pharmaceutical Technology's In the Lab eNewsletter
The Michelson Medical Research Foundation and the Human Vaccines Project have awarded three young scientists $150,000 for their novel approaches toward human immune system research.

Vida International received an FDA warning letter after an inspection found quality control violations.

The companies will form a biometrics organization focused on delivering analytical solutions for drug development.

Pharmaceutical Technology's In the Lab eNewsletter
The acquisitions, totaling $50 million, are expected expand Aptar Pharma’s service offerings to support complex product development.

The acquisition will boost Merck’s pipeline for cancer, fibrosis, and autoimmune disease therapeutics.

In this collaboration, AbCellera will apply its expertise to generate panels of antibody candidates for Gilead to evaluate.

The two countries have been included into the mutual recognition agreement between the European Union and the US FDA that recognizes facility inspections conducted in different territories.

Kingston Pharma LLC received a warning letter after an FDA inspection found violations of current good manufacturing practices including inadequate quality control.

The $10-million investment will include a 500-L single-use perfusion bioreactor and seven patented downstream processing units.