All
SSB, Novasep to Develop Membrane Chromatography Systems
Sartorius Stedim Biotech (SSB) and Novasep will partner to develop systems for membrane chromatography using Novasep’s BioSC platform and SSB’s single-use technology.
Biogen to Acquire Gene-Therapy Company Nightstar in $800-Million Deal
The acquisition will establish a clinical pipeline for Biogen of gene-therapy candidates in ophthalmology.
FDA Commissioner Scott Gottlieb, MD, Resigns
The FDA commissioner plans to leave the agency in April.
FDA Issues Draft Guidance on OSD Continuous Manufacturing
FDA guidance on quality considerations for continuous manufacturing should help advance implementation by providing clarity and giving companies more confidence to make investments in the new technology.
Updated Augmented Reality Platform Enhances Pharma Manufacturing
The Tandem 4.0 augmented reality-enhanced collaboration tool from Apprentice.io has a new user experience and user interface design.
Robotic Aseptic Filling and Closing Machine Designed for Cell and Gene Therapies
AST will unveil its multi-format robotic filling system, the GENiSYS R, at INTERPHEX.
Marchesini Displays CMP Pharma Inspection System at INTERPHEX
The Marchesini Group will introduce the CMP pharma inspection system to the US market at INTERPHEX 2019.
Apotex Recalls Drospirenone and Ethinyl Estradiol Tablets, USP
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.
Caught in a Conundrum
Do patients get what they pay for when they demand cheaper drugs?
Can the Price Ever be Right?
As drug pricing comes under the microscope internationally, it appears that collaboration with all stakeholders is key to tackling the issue.
Reinterpreting Benchmarks for Innovative Therapies
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.
New CPhI Japan Report Claims Japanese Pharma Market will Grow Rapidly
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 Gains Approval for ESKATA from Swedish Medical Products Agency
Aclaris Therapeutics has been granted a marketing approval from the Swedish Medical Products Agency for ESKATA.
Industry Responds to Government Strategy to Improve Services for Rare Diseases
The ABPI has responded to the UK government’s recently published plans on improvements to services for people with rare diseases
GHO Capital Acquires Sterling Pharma Solutions
GHO Capital, a European specialist investor in healthcare, announced its acquisition of Sterling Pharma Solutions, which specializes in complex and difficult-to-manufacture APIs.
Exclusive Agreement Forms for Sublingual Delivery
STA Pharmaceuticals and BioLingus have announced the formation of an exclusive technology and marketing collaboration for sublingual delivery.
Abbott, Novo Nordisk Partner Up on Integrated Digital Solution for Diabetic Patients
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 Expands Cytocell Operations in UK
Oxford Gene Technology (OGT) has revealed it is expanding its operations with a new facility in Cambridge, UK, to house its expanding Cytocell brand.
N4 Pharma Develops Nanoparticle Technology for Vaccine Delivery
The technology uses a silica nanoparticle to deliver vaccines and cancer treatments.
Recipharm Gains New ISO Certification Recognizing Sustainability Efforts
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.
CEPI, CureVac Partner to Develop mRNA Vaccine Manufacturing Platform
The Coalition for Epidemic Preparedness Innovations (CEPI) and CureVac partner to develop a transportable mRNA vaccine manufacturing platform.
New Vaccine for HIV Using Lipid-Nanoparticle Technology
A project conducted by research institute CEA-Leti led to the development of a new HIV vaccine approach based on engineered lipid nanoparticles.
Lab Management Solution with Enhanced Data Privacy
LabVantage Solutions’ LabVantage 8.4 is the latest version of the company’s comprehensive laboratory information management system.
New Microscope Combined Imaging Technology with High Speed Analysis
HORIBA’s new analytical microscope simultaneously performs elemental analysis and optical observation without destroying samples.
Affinity Chromatography Analysis Column for Antibody Drugs
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.
Roche to Acquire Spark Therapeutics
The $4.3-billion acquisition is expected to strengthen Roche’s gene therapy pipeline.
Danaher to Acquire GE’s Biopharma Business
The $21.4-billion acquisition will create stand-alone business within Danaher’s life-sciences portfolio.
FDA Provides Guidance on Bioavailability Studies
A draft guidance document provides recommendations for submitting bioavailability information in investigational new drug and new drug applications.
More Products Recalled Due to NDEA
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.
EMA Recommends Suspension of Fenspiride Medicines
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.
