An Eli Lilly small molecule plant in Puerto Rico has been earmarked for closure as the company shifts its focus towards its insulin and biologics pipeline.
The WHO has accused biopharma firms of failing to invest in R&D to tackle Ebola due to the disease’s prevalence in poor African nations, as the death toll surpasses 4,000.
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.
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.
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...
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.
Amgen says it will continue to invest in manufacturing technologies to support its biosimilar pipeline despite announcing a restructuring that will reduce its manufacturing footprint by 23%.
Mailroom and legal staff at Sandoz and Amgen are in for a busy six months after the US FDA agreed to review a biosimilar version of the anti-infective, Neupogen.
Interest in creating alternatives to Protein A has waned in light of more viable cost-saving opportunities in bioprocessing, such as single-use adoption, says Repligen.
The EU’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion and recommended granting a marketing authorisation to Boehringer Ingelheim and Eli Lilly’s biosimilar insulin treatment for Type 1 and Type 2 diabetes patients.
Lonza has invested in single-use technology at its Swiss clinical manufacturing facility citing a rise in demand as customer’s grow their antibody-drug conjugate (ADC) pipelines.
Oncology development company Celsion will acquire Egen, a biotech company that is developing nucleic acid-based therapeutics, for $14m upfront, with the chance for more than $30m in milestone payments.
The World Health Assembly (WHA) has called on governments and regulators to improve public access to affordable biosimilars, saying the price of medicines can be ‘catastrophic.’
Thermo Fisher Scientific has licensed rights to gene editing technology for bioproduction applications that it claims targets DNA more precisely and reliably than current approaches.
European Provenge contractor PharmaCell BV is looking for new business after completing the acquisition of TiGenix’s biomanufacturing facility in the Netherlands.
BioAtla has received a broad patent covering conditionally active biologics (CABs) and says this antibody platform could shake up the development of this new class of therapeutics.
A collaboration involving academia and industry is to develop new ways of delivering antibodies to the brain using molecular envelop technology developed by Nanomerics, a UCL spin-out company.
A government funded bioprocessing institute is helping to drive biopharma investment and retrain workers in Ireland, and Biopharma-Reporter.com visited to find out what happens in this "flight simulator for biopharma manufacturing."
Horizon, which supplies genomics research services, has bought cell-screening business CombinatoRx from Zalicus for £4.74m ($8m) and plans more acquisitions.
DISPATCHES FROM THE BIOLOGICAL PRODUCTION FORUM, DUBLIN
Single-use technology for high volume biomanufacturing is riddled with problems and will only be fully implemented by industry once the cost drops, according to Pfizer.
Hospira has predicted its biosimilar Retacrit will be approved by the US FDA from late 2016, making it among the first wave of biosimilars to be sold in the US.
GE Healthcare Life Sciences has signed a licensing agreement for Promosome’s suite of mammalian cell line development technologies, which aim to increase protein expression in mammalian cell culture.
The latest generation of “biobetters” which are engineered to be more effective than branded biologics are hitting the market before biosimilars and could make development of the latter pointless, an expert has said.
Development of new anti-choloesterol drugs containing proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibiting monoclonal antibodies could double Repligen Bioprocessing’s earning power, according to a Jefferies analyst.
Takeda has licensed a biodegradable polymer and customisable linker platform from Mersana Therapeutics who says the tech offers advantages over other antibody-drug conjugate (ADC) approaches.
Baxter has announced plans to buy gene therapy developer Chatham Therapeutics for $70m in a deal focused on the latter’s pipeline of haemophilia candidates and gene therapy delivery platform.
An expression system developed by Cevec Pharmaceuticals has achieved 'very high' titres and bypassed problems that beset other platforms, moving the possibility of a commercial respiratory syncytial virus (RSV) one step closer.
Government-backing for a large-scale cell therapy centre is justified because it will help developers navigate the “valley of death” in which many early-phase projects fail says the team planning the new manufacturing hub.
Bayer is investing over €500m ($700m) in manufacturing recombinant factor VIII (rFVIII) products citing growing demand for long-term prophylactic treatment rather than ‘on-demand’ haemophilia drugs.
Ireland is seeing a renewed interest from biotech, the Industrial Development Agency (IDA) says, as Bristol-Myers Squibbs shuts a Dublin API plant to focus on biopharmaceuticals.
The new Centre for Cell Manufacturing Ireland (CCMI) in Galway means Ireland-based scientists will be able to manufacture culture-expanded stem cells for drug research for the first time.
