Novo Nordisk has bought a biomanufacturing facility earmarked for closure by Olympus Biotech and begun rehiring staff in order to support its haemophilia product pipeline.
A candidate Ebola vaccine that uses Immunovaccine's formulation technology has stopped cynomolgus monkeys from catching the disease in a preclinical study.
Merck Millipore has set out to win more biomanufacturing business in Japan by consolidating testing and technical operations in the country into a newly expanded Tokyo training hub.
Patheon has acquired Gallus BioPharmaceuticals adding two US biologics plants and says with an industry shift towards medium sized bioreactors it now holds the market advantage.
Johnson & Johnson subsidiary Janssen has acquired monoclonal antibody (mAb) platform FynomAb through its purchase of private Swiss biopharma company Covagen.
EMD Millipore has been contracted to supply raw materials to the Samsung Biologics plant where ingredients for BM-S’ anticancer monoclonal antibody Yervoy (ipilimumab) are made.
Ampio Biopharmaceuticals will delay the release of Ampion trial data after discovering the drug was damaged by temperature fluctuations during shipment.
Oncology-focused Progenics Pharmaceuticals has selected CMO Gallus BioPharmaceuticals to manufacture the anti-prostate specific membrane antigen (PSMA) monoclonal antibody used in Progenics’ PSMA ADC product candidate.
CRISPR gene editing will make cell line development cheaper and faster according to Horizon Discovery, which says that new tech has application in both biomanufacturing and preclinical disease modelling.
G-CON has responded to the ongoing Ebola virus outbreak in West Africa by retooling its “vaccine facility in a box” PODs as patient isolation units to help stop the spread of the disease.
The American Academies of Clinical Endocrinologists, dermatologists and neurologists, as well as eight other physician groups and a number of individual physicians are calling for unique names for biosimilars to better track adverse events and ensure...
Miltenyi Biotec has acquired the lentiviral vector manufacturing business and related assets from Lentigen, a lentiviral technology provider for cell and gene therapy applications.
Japanese biotech company Unigen has implemented in only four months Werum's PAS-X Manufacturing Execution System (MES), which can help optimize production output at the world’s largest plant for the contract manufacturing of recombinant flu vaccines.
Industry groups BIO and PhRMA, as well as biotech company Genentech, are taking issue with US FDA draft guidance that is designed to help companies design and use clinical pharmacology studies to help prove that a developing biosimilar is similar to its...
The lack of a biopharmaceutical "Orange book" means biosimilar developers face greater litigation risk than their generic counterparts according to one IP lawyer, who says full knowledge of all relevant patents is a must for such firms.
US FDA researchers are developing tools to help cell therapy developers improve how they manufacture stem cells in a new lab consortium unveiled by the agency this week.
Bacterial contamination issues at a GlaxoSmithKline flu vaccine production plant are now being dealt with by an action plan that Health Canada has approved.
China Biologic Products is set to become the second Chinese producer of a prothrombin complex concentrate (PCC) blood clotting product following an inspection by the CFDA
As the death toll from the world’s most expansive Ebola outbreak nears 1,000, multiple companies are stepping up efforts to bring antibodies and other vaccines to human trials, though none seem likely to be ready until 2015 at the earliest.
As Celltrion announced Monday that it filed the first monoclonal antibody for approval with the US FDA, investor groups are crying foul over some of the tactics used by others in industry to discourage the uptake of biosimilars in the US.
Carbogen Amcis has expanded its operations in light of unrelenting demand for antibody-drug conjugate (ADC) services by signing a long-term lease for a facility in Switzerland.
Second quarter sales of cryopreservation media grew 14% but BioLife Solutions says it expects revenues to skyrocket as clients’ biologics move out of the clinical stage..
Though mostly known for its work in measurements, the National Institute of Standards and Technology’s work is expanding in biomanufacturing and specifically looking to standardize the identification of CHO (Chinese hamster ovary) and rat cell lines as...
US demand for biosimilar preclinical services is expected to rocket on the back of the US FDA’s acceptance of Sandoz’s biosimilar filing, according to Harlan Laboratories.
The US Food and Drug Administration (FDA) has issued guidance on biologics exclusivity, stipulating the evidence drugmakers must provide to ensure a 12-year exclusivity period.
With the EMA’s CHMP (Committee for Medicinal Products for Human use) recommending approval for a new insulin biosimilar early last month, some in the industry are expecting an increasingly competitive field moving forward.
Two Americans stricken with the Ebola virus in Liberia were flown back to the US following treatment with an unapproved treatment manufactured from tobacco plants in Kentucky. Manufacturing of the treatment is expected to ramp up as the patients improve.
Redbiotec has selected GE Healthcare’s single-use processing offering to aid development of its Herpesvirus vaccines which use viral antigen complexes and virus-like particles.
Roche has renewed its interest in gene silencing drugs, paying $250m (€187m) for Santaris Pharma including its ‘antisense’ Locked Nucleic Acid (LNA) platform.
As the fight over naming biosimilars continues in the US, the WHO has drafted its own system of biological qualifiers to ensure biosimilars remain unique from their biologic counterparts.
A newly discovered virus which infects intestinal bacteria might be a cause of obesity, but could increasing interest in bacteriophages drive new personalised medicines and alternatives to antibiotics?
Scientists from USP (US Pharmacopoeia), Apotex and an advisory board established by Amgen are all weighing in with suggestions and points of further clarity on the latest US FDA draft guidance on biosimilars.
The European Medicines Agency (EMA) has released a second module of a new guideline on influenza vaccines for a six-month public consultation, which covers the non-clinical and clinical requirements for the development of new flu vaccines.