The US FDA has approved Genentech’s auto-injector formulation of Actemra, which the firm says offers an additional administration option for patients and caregivers.
The UK has a ‘rich and vibrant’ advanced therapeutic manufacturing sector well placed to attract companies post-Brexit, says Keith Thompson, CEO of CGTC.
Funding of £7.3m will be provided across three initiatives, with the long-term aim of providing patients with access to cell and gene therapies at a faster rate.
We will not stand behind non-competitive pricing schemes that undermine the incentive to innovate and invest in drug development, says BIO VP of industry research, David Thomas.
Construction has started at WuXi Biologics’ eighth drug substance manufacturing facility, which CEO Chris Chen says will enable the CDMO to “develop and manufacture biologics more cost effectively”.
Denmark played host to its first BIO Europe this week, welcoming 4,500 attendees from across the globe – including growing numbers from China and South Korea.
After the business was asked by the US FDA to provide more data to secure an approval for its biosimilar, Sandoz decided not to pursue its regulatory filing any further.
The Danish drugmaker announced that job losses at the company will number 1,300 before the end of the year, with the majority of those already having left their roles.
Johnson & Johnson has unveiled a vaccine facility in Leiden, the Netherlands, which will focus on R&D, technological development, and large-scale production of vaccines for late-stage clinical trials.
Within days of Samsung Bioepis sending its Soliris candidate to the clinic, the firm details its development process, novel biologics ambitions, and plans to become ‘the single dominant player in biosimilars’.
BIA’s Bioscience Forum brought together four experts on cell and gene manufacture to discuss what difficulties are being faced in the industry and how they are reacting to them.
Increased cell and gene therapy production and reduced development timelines are listed among bioprocessing trends predicted over the next five years, says consultant.
Alexion has agreed to pay up to $1.2bn for Syntimmune and its lead asset SNT001, a monoclonal antibody designed to treat warm autoimmune haemolytic anaemia.
Think of big biotech hubs in the US and two areas will immediately come to mind: Boston, on the east coast, and San Francisco, on the west – Los Angeles wants to change that.
BioPharma-Reporter (BPR) discusses with Jennifer Fox (JF), co-chair of Brinks Gilson & Lione’s biopharma practice group, the provisional detail revealed from the US administration’s proposed trade deal with Mexico, and its potential impact on the...
A fortuitous finding in preclinical research, whereby mice injected with a modified protein developed hair, has prompted Follicum AB’s research and development into the alopecia space.
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.
On the eve of Boston Biotech Week, a report was released by MassBio that claimed 48% of all biotech investment in 2017 was accounted for by Massachusetts-based companies.
It has been revealed that the EMA is awarding significantly fewer contracts to evaluate the application of new drugs to the MHRA, as the Brexit deadline nears.
The Testa BioProcess Innovation Center in Sweden will help academics, startups, and biopharmaceutical companies secure industrial proof-of-concepts quicker, and with less cost, says GE Healthcare.
Biotech M&A started off a bang this year and as the first half of the year has drawn to a close, biotech IPOs have reached a number that could see 2018 become a record-breaker.
The National Institute of Allergy and Infectious Diseases is enrolling volunteers for a first-in-human experimental treatment trial for its mAb to treat the Ebola virus.
Rubius has announced plans to acquire Alexion’s manufacturing facility in Rhode Island, where the latter made immunosuppressant Soliris before exiting the site last year.
Researchers from MIT have devised a way for T cells to be engineered to carry nanoparticle ‘backpacks’ that can deliver the payload only when interacting with the target tumour cells.
