The World Health Organisation says a meeting between drugmakers and high-level government representatives last week has yielded plans to fast-track scale-up of Ebola vaccines in the face of incomplete trials and leaked production problems.
The UK beats Finland for business opportunities according to the CEO of microbial growth system developer BioSilta, who said moving the firm to St. Ives, Cambridgeshire has improved its access to larger markets.
Personalized immunotherapy developer Argos Therapeutics has broken ground on a new 100,000 square-foot biomanufacturing facility in Durham, North Carolina.
A bioanalytical consultant has stressed the importance of drug developers testing commercial off-the-shelf (COTS) software following the discovery of potential issues with Thermo Scientific’s bioequivalence Kinetica platform.
Biopharmas struggle to comply with GMP requirements for personalised meds and the outstanding questions mean some are reluctant to invest according to German firm immatics.
Ramesses II didn't need Enbrel, Remicade, Humira or any other TNFα blocker according to a study that rejects the idea the pharaoh was plagued, all puns intended, by ankylosing spondylitis.
Nova’s vaccine stabilisation device, which enables vaccines to be dried and stabilized across a wide range of temperatures, has been awarded a US patent, though one researcher questions the utility of the device.
Making active pharmaceutical ingredients (API) is a dirty business and you’d have to be pretty green to believe claims drug industry 'demand' will create a $100bn market for environmentally-friendly production methods by 2020.
As more than half a dozen companies are now vying to help treat and vaccinate Ebola victims in West Africa, where nearly 3,000 people have died from the illness, GlaxoSmithKline is taking the lead in getting product manufactured.
French biotech Calixar has developed a tech platform process it says makes flu vaccines six times more effective in terms of immunogenicity than others on the market.
CRISPR, the gene-editing technology that could revolutionise biologics, is set to become a patent battleground as companies vie over who owns the tool and its products, says an intellectual property expert.
UK researchers have created “designer” amino acids which they say will allow them to build custom biologics from the ground up and avoid the pitfalls of recombinant expression.
Emergent BioSolutions has initiated a non-clinical study to demonstrate it can scale-up production of its anthrax vaccine, BioThrax, without making it less effective.
Boehringer Ingelheim will pay mRNA drug developer CureVac up to €465m ($600m) for an exclusive global license and development collaboration on CureVac’s potential mRNA vaccine in early clinical development for the treatment of lung cancer.
European authorities have revoked a Regeneron patent covering a genetic modification technique used to generate mouse monoclonal antibody (mAb) production platforms after an appeal by several European firms.
Merck Serono is planning to invest between €130m ($168m) and €150m ($194m) in biosimilars in 2015, depending on the outcome of ongoing Phase I studies, the company announced Thursday.
Citing “insufficient” labelling for biosimilars “given their unique scientific and regulatory status,” EuropaBio is calling on the EMA (European Medicines Agency) to amend their labelling requirements.
Biotech company MedGenesis Therapeutix has granted Pfizer an exclusive, worldwide option to license its glial cell line-derived neurotrophic factor (GDNF) protein and convection enhanced delivery (CED) technology to be used in research for potential treatments...
Almost all of the biosimilars currently approved have been developed using a third-party research organisation according to a survey from the Association of Clinical Research Organizations (ACRO).
Baxter International will spin off its biopharmaceutical treatments and manufacturing facilities to form a new company known as Baxalta, which is expected to launch in mid-2015.
Seattle Genetics and Genmab have entered into another antibody-drug conjugate (ADC)partnership under which Genmab will pay $11m upfront for use of Seattle’s auristatin-based ADC technology.
Regenerative medicine company Advanced Cell Technology (ACT) has been issued a US patent from the US Patent and Trademark Office covering methods of manufacturing dendritic cells using a scalable process involving a renewable stem cell source as the starting...
AMRI has added protein expression and purification services to its drug discovery services citing the shift in pipelines towards larger molecule drugs as a driver.
Sanofi and Regeneron may overtake Roche and Astrazeneca at the head of the increasingly monoclonal antibody (mAb) dominated asthma treatment market according to an industry analyst.
A German biobank has made stem cells available to active pharmaceutical ingredient (API) firms this week in a bid to support industry drug development efforts.
A candidate Ebola vaccine that uses Immunovaccine's formulation technology has stopped cynomolgus monkeys from catching the disease in a preclinical study.
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.
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.
Bacterial contamination issues at a GlaxoSmithKline flu vaccine production plant are now being dealt with by an action plan that Health Canada has approved.
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.
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.
