News

The investigation into the root cause of the NDMA impurity found in API is still ongoing, but the agency believes the impurities may be caused by specific chemicals and reaction conditions in manufacturing processes.

The guidance describes how to develop a REMS Assessment Plan, discusses the impact of REMS on patient access to drugs, and gives recommendations on reporting REMS findings to FDA.

The European Medicines Agency has announced that its physical relocation to Amsterdam will be complete in March 2019.

CPhI Worldwide organizers have revealed that the 2020 edition of the pharma event will return to the Fiera Milano venue in Milan, Italy.

The European Medicines Agency has recommended that no new patients should start treatment with Lartruvo (olaratumab).

TC BioPharm (TCB), developer of CAR-T immuno-oncology products, has completed its first allogenic Gamma Delta T (GDT) cell banks.

The Wasdell Group has been granted a Health Products Regulatory Authority (HPRA) license for its new European headquarters, based in Dundalk, Ireland.

The company is voluntarily recalling six lots of Losartan potassium and hydrochlorothiazide tablets, USP because of the impurity, NDEA.

Full commercial launch of the drug is underway in the United States, with Europe to follow.

G-CON will provide a complete cleanroom infrastructure for GE Healthcare’s cell therapy and viral vector production platforms that will simplify early-stage manufacturing efforts.

Lonza’s PyroTec PRO system combines robotic liquid-handling technology with an automation software module.

Company to focus on innovation, growth, and productivity with creation of new units.

The company has built a fit-for-purpose liquid chromatography–mass spectrometry (LC–MS) system to streamline analytical monitoring tests for biopharmaceuticals.

The companies will embark on a multi-year research collaboration to develop in-vivo delivery modalities for CRISPR/Cas9 by leveraging ProBioGen’s existing technology and expertise.

The acquisition of biopharmaceutical company TESARO is expected to strengthen GSK’s oncology pipeline and commercial footprint.

Following the defeat of the UK's Prime Minister’s proposed Brexit withdrawal deal, substantial uncertainty around Brexit remains and risks to public heath and the economy are mounting.

MilliporeSigma’s use of modified amino acids can simplify the fed-batch process in biomanufacturing.

Taconic Biosciences, a provider of genetically engineered rodent model solutions, sent mice into space to advance research on new therapies for aging-related disease processes.

Dublin, Ireland-based biopharmaceutical company Allergan will establish an R&D presence in Cambridge, MA.

The EU FMD deadline is closing in, so now is the time to look beyond the short term.

The new year has started with a bang in terms of mergers and acquisitions.

Univercells, a business-to-business provider focused on biologics, has commercially launched its proprietary bioproduction system, NevoLine.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has made two significant changes to its new 2019 Code of Practice with the aim of boosting business integrity on a global scale.

A strategic collaboration has been formed between 4D pharma and The University of Texas MD Anderson Cancer Center.

Cell and gene therapy platform company, Locate Bio, has announced that it is set to receive key patents for its IntraStem technology covering the United States and Europe

Solentim and ATUM have announced a technology collaboration agreement that will focus on the creation of an efficient cell line development solution for biotherapeutic drug developers.

Lonza and Takeda have furthered their multiproduct partnership through collaborative efforts on a new cancer treatment-Alunbrig (brigatinib).

The Centre for Process Innovation (CPI) has led an Innovate UK project focused on the establishment of a generic framework and core capability to improve industrial productivity using computer models.

Almac Sciences has announced the expansion of its technology capabilities within its API services and chemical development portfolio through implementation of continuous flow expertise.

The companies will offer an IT platform that enhances the visibility and performance of the overall personalized medicine treatment process.