A prequalification pilot designed to assess biosimilar versions of Roche’s Rituxan and Herceptin has attracted global interest from manufacturers, says WHO executive.
As an increasing number of biosimilar developers target the European market, lesser-known firms may explore alternative commercialisation strategies, says Iqvia executive.
MSD announced that the EMA’s CHMP has adopted a positive opinion recommending approval of Keytruda as an adjuvant therapy for the treatment of patients with melanoma.
Sarepta Therapeutics signed a long-term, strategic manufacturing partnership with Paragon Bioservices to produce micro-dystrophin to grow its gene therapy program.
CBMG announced a manufacturing collaboration agreement with Novartis at the end of last month to produce CAR-T treatment Kymriah for the Chinese market and the company has further ambitions in the pipeline.
Eli Lilly’s migraine treatment was approved by the US FDA, closely following a positive CHMP opinion, and will potentially be made available without cost for the first year.
BioProcess International has kicked off at Biotech Week Boston. BioPharma-Reporter is here to cover the best of the sessions and the reactions from everyone present.
China’s authorities’ condemnation of Changsheng Biotechnology, after it was found to have falsified data regarding a rabies virus, has caused public concern over the domestic vaccine market.
President Trump’s immigration travel ban will deny pharmaceutical companies the opportunity to hire the ‘best and brightest,’ says Massachusetts Biotechnology Council CEO.
Sanofi will support development of polypeptides, gene therapy, monoclonal antibodies and multi-specific antibodies through the expansion of its R&D plant in Chengdu, Sichuan province, China.
The CMO says adding the single-use offering from ABEC will make the newly opened biomanufacturing site in China comparable to stainless steel for commercial mAb production.
BeiGene’s tislelizumab will be the first commercial product to be made from Boehringer-Ingelheim’s site in Shanghai, and the first to be made by a foreign CMO in China.
Long life-cycles and significant consolidation in the manufacturing space have led to a lack of skilled workers in the vaccine space, says Sanofi Pasteur.
Donald Trump’s withdrawal from the Trans-Pacific Partnership (TPP) could end up benefitting Asian biosimilar makers and reducing US jobs, says an IP lawyer.
Sanpower Group says Dendreon's in-house manufacturing set-up will remain in place as it looks to increase US and Asian penetration of the prostate cancer cell therapy.
A lack of investment and government support has stunted biomanufacturing in India, but Biocon says this will change through the country’s 'Make in India' programme.
South Korea is a key opportunity for biopharma services firms says Thermo Fisher, reporting its third quarter which saw it up capabilities in the region.
A recently opened facility will double production of Sanofi Pasteur’s vaccine Stamaril which could alleviate shortages in the wake of recent yellow fever outbreaks in parts of Africa.
More plants in China will close says a US-based analyst who predicts that some drugmakers' inability to comply with stricter quality rules will create an opportunity for those that can.
CSL Behring will target growing Russian demand for protein-based therapies through a new Moscow office but says for now there are no plans for a local manufacturing site.
As GE ships the world’s largest ready-made biomanufacturing plant to China, the team involved tells us modular facilities are in demand from southeast Asian governments – and could hold the key to future pandemic treatments.
The $2.4bn market for “unproven” and “unethical” biologics market “preys on vulnerable patients” and harms development of legitimate large molecule drugs, says the International Society for Cellular Therapy (ISCT).
Sanofi’s decision to stop manufacturing an anti-venom will contribute to “needless death and disability” for snake bite victims, according to Médecins Sans Frontières.
A surge in UK cell therapy production last year means available manufacturing capacity has declined considerably according to a report by Cell Therapy Catapult.
The European Commission has approved Pfizer’s acquisition of Hospira, providing the larger company first divests of its infliximab candidate and several sterile injectables.
The Netherlands and India have signed a MOU (Memorandum of Understanding) under which a government-based institute of the Netherlands will extend technical support for the development and manufacturing of the measles-rubella vaccine.
In a reversal from three years ago, the Court of Justice of the European Union (CJEU) ruled on Thursday that an organism incapable of developing into a human being is not a human embryo and may be patented.