The Marchesini Group will introduce the CMP pharma inspection system to the US market at INTERPHEX 2019.

The company is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP because of the possibility they may contain defective blister packs and incorrect tablet arrangements.

Do patients get what they pay for when they demand cheaper drugs?

As drug pricing comes under the microscope internationally, it appears that collaboration with all stakeholders is key to tackling the issue.

While allogeneic therapies can use existing regulatory and quality frameworks, autologous treatments will require pharma’s adoption of true just-in-time and right-first-time concepts, says consultant James Blackwell.

A new report that has been published prior to CPhI Japan has stated that there will be rapid growth in the Japanese pharma market during 2019.

Aclaris Therapeutics has been granted a marketing approval from the Swedish Medical Products Agency for ESKATA.

The ABPI has responded to the UK government’s recently published plans on improvements to services for people with rare diseases

GHO Capital, a European specialist investor in healthcare, announced its acquisition of Sterling Pharma Solutions, which specializes in complex and difficult-to-manufacture APIs.

Abbott and Novo Nordisk have entered into a non-exclusive partnership aimed at providing an integrated digital solution for diabetic patients using insulin,

Oxford Gene Technology (OGT) has revealed it is expanding its operations with a new facility in Cambridge, UK, to house its expanding Cytocell brand.

The technology uses a silica nanoparticle to deliver vaccines and cancer treatments.

Recipharm has received ISO 45001 certification for its Wasserberg facility in Germany as a result of the facility’s program to enhance sustainability and safety.

The Coalition for Epidemic Preparedness Innovations (CEPI) and CureVac partner to develop a transportable mRNA vaccine manufacturing platform.

A project conducted by research institute CEA-Leti led to the development of a new HIV vaccine approach based on engineered lipid nanoparticles.

LabVantage Solutions’ LabVantage 8.4 is the latest version of the company’s comprehensive laboratory information management system.

HORIBA’s new analytical microscope simultaneously performs elemental analysis and optical observation without destroying samples.

The TSKgel FcR-IIIA-NPR HPLC column from Tosoh Bioscience is a FcRγ affinity chromatography analysis column suited for the analysis of immunoglobulin G glycoforms.

The $4.3-billion acquisition is expected to strengthen Roche’s gene therapy pipeline.

The $21.4-billion acquisition will create stand-alone business within Danaher’s life-sciences portfolio.

A draft guidance document provides recommendations for submitting bioavailability information in investigational new drug and new drug applications.

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg after NDEA is found in finished product manufactured with API made by Hetero Labs Limited.

The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has issued a recommendation for the suspension of fenspiride medicines across the whole of the European Union.

ACG Group highlighted its expanded footprint in Brazil through the launch of a new capsules manufacturing plant in Pouso Alegre-Minas Gerais.

Valitacell and Solentim, have announced a collaboration aimed at the acceleration of discovery and development of biologic drugs and advanced cell therapies.

A multi-partner collaboration has been announced, which will target the acceleration of the development of automated microfluidic systems for rapid and high-throughput gene editing in mammalian cell lines.

In a statement, FDA Commissioner Scott Gottlieb laid out the case for the safety and effectiveness of generic drugs compared to brand drugs.

Mustang intends to combine an oncolytic virus with an interleukin-13 Rα2-(IL13Rα2)-specific chimeric antigen receptor to potentially enhance efficacy in treating glioblastoma multiforme.