Takeda is in talks to sell Shire’s experimental inflammatory bowel disease pipeline in an effort to meet European regulators approval for the acquisition.
Thermo Fisher opened a new business center and biorepository along with an expanded distribution center, to help support mounting demand for clinical trial supply chain logistics.
President Donald Trump signed the SUPPORT Act granting the FDA additional authority to combat the opioid epidemic, but a pain management CRO argues that opioid addiction isn't the only crisis.
The US FDA has rejected Regeneron Pharmaceuticals’ prior-approval supplement for Elyea pre-filled syringe, requesting additional clinical data and manufacturing information.
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’.
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.
The first MabThera biosimilar is expected to enter the US market in the first half of 2019, followed by Herceptin and Avastin versions in the second half of the year, says CEO.
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.
Sarepta Therapeutics signed a long-term, strategic manufacturing partnership with Paragon Bioservices to produce micro-dystrophin to grow its gene therapy program.
Lonza Pharma & Biotech will expand two of its manufacturing sites to reach the capabilities necessary to produce compounds bio-conjugates through to commercialization.
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.
AGC Biologics has announced plans to build a mammalian cell culture facility in Japan, where the company says demand is growing for antibody-based therapies.
Leaf Expression Systems’ technology enables the manufacture of proteins, vaccines and complex biomolecules without using animal-based products, says recently appointed chief executive.
Daiichi Sankyo announced it has entered into a clinical trial collaboration agreement with Merck & Co. to evaluate an investigational lung cancer treatment.
Increased cell and gene therapy production and reduced development timelines are listed among bioprocessing trends predicted over the next five years, says consultant.
Having now secured regulatory approval for all three of its haemophilia A therapies made in Berkeley, Bayer is implementing “organisational changes” across the facility.
Novartis’ experimental marketing strategy, whereby the pharma giant used its scale to insure against failed CAR-T therapies, helped defend Kymriah from competition, 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.
Novo Nordisk will take over the lease of a manufacturing facility in Fremont, California, where the company will make stem cell-based therapies with optionally licensed technology.
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.