Mundipharma says it is not concerned at arriving second to market with a trastuzumab biosimilar after inking a deal to commercialise Celltrion’s Herzuma in seven European countries.
Merck Sharp & Dohme (MSD) plans to build a biologics facility at a former small molecule manufacturing site in Swords, Ireland, which it closed last year.
Patient advocacy groups have called on Congress to address patient safety concerns in oversight hearings, following an influx of US FDA biosimilar drug approvals.
Celgene will add chimeric antigen receptor (CAR) and T-cell receptor (TCR) technologies through the acquisition of its immune-oncology partner Juno Therapeutics.
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.
Takeda has said it will review the manufacturing of Alofisel (darvadstrocel) if its €520m ($620m) bid for off-the-shelf stem cell developer TiGenix is successful.
Drug firms that want to trial or sell vaccines in India, or import them into the country, will need to seek CDSCO permission via an online portal from now on.
Did you miss any of the biosimilar approvals, launches or guidance this year? Well Biopharma-Reporter brings you a special timeline of events to help guide you into the new year.
Spark Therapeutics has received US approval for Luxturna (voretigene neparvovec-rzyl), its one-time gene therapy treatment for an inherited form of vision loss.
Merck KGaA says it will provide technology and training to a local team in Sub-Saharan Africa, to help establish a dedicated human vaccine manufacturing facility.
Pfizer says it remains committed to Inflectra and partner Celltrion after gaining US FDA approval for another infliximab biosimilar, Ixifi, developed in-house.
The US FDA has approved Admelog as a follow-on drug five months after it received European market authorisation as a biosimilar of Eli Lilly’s Humalog (insulin lispro).
Roche, Merck and Lilly are among those calling for regulatory harmonisation and free movement of goods between the EU and the UK once the latter leaves the Union.
Brammer Bio has completed renovations at its gene therapy manufacturing facility in Cambridge, MA amid industrywide capacity concerns as more biologics enter late-stage clinical trials.
The UK government has outlined its industrial strategy as it prepares to leave the European Union and boasts of investments and collaborations driving the life science sector.
Physicians and patients still lack information about biosimilars says an industry consultant, despite efforts from advocacy groups and national healthcare systems.
Samsung Bioepis has received European Commission approval for Ontruzant, its version of Roche’s best-selling breast cancer mAb Herceptin (trastuzumab).
Janssen has withdrawn a lawsuit against Samsung Bioepis alleging infliximab manufacturing patent infringements after receiving process information from the Korean drugmaker.
Mvasi has been recommended for approval in Europe, but a duplicate marketing authorisation application for an Avastin (bevacizumab) biosimilar has been withdrawn by Amgen.
Heavy investment in quality control, quality assurance and dedicated equipment is likely to keep CAR T-cell manufacturing in-house, says Juno Therapeutics.
Novartis has announced plans to buy radiopharmaceutical firm Advanced Accelerator Applications (AAA), which will add neuroendocrine tumour treatment Lutathera to its portfolio.
Firms should identify risks prior to inspection, make staff available during regulator visits, and respond promptly post-inspection when undergoing GMP site checks, says Ireland’s Health Products Regulatory Authority (HPRA).
