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Janssen has withdrawn a lawsuit against Samsung Bioepis alleging infliximab manufacturing patent infringements after receiving process information from the Korean drugmaker.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in Europe, but a duplicate marketing authorisation application for an Avastin (bevacizumab) biosimilar has been withdrawn by Amgen.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).
Gilead says it is looking to make as many as 90 academic centres available to administer CAR-T Yescarta (axicabtagene ciloleucel) following its approval in the US.
Irish regulators say it is still not clear how Brexit will affect companies that make drugs in the UK, raising issues like MA status and mutual inspection agreements between the EMA and US FDA as areas of concern.
The US approval recommendation for Spark Therapeutics’ blindness gene therapy voretigene neparvovec is also an endorsement of AAV delivery technologies according to the Alliance for Regenerative Medicine.
Storm Ophelia hit the Green Isle this week, forcing the closure of schools, public institutions, and a number of drug manufacturing sites across the country.
The world’s largest single bioproduction plant has received its first US regulatory approval to make a monoclonal antibody, says CDMO Samsung Biologics.
Mylan and Biocon have received a complete response letter for a version of Amgen’s Neulasta (pegfilgrastim) in the latest regulatory blow to their biosimilar ambition.
AbbVie has opened a mammalian cell culture-based drug manufacturing facility equipped with both stainless and single-use equipment, as part of a $320m investment in Singapore.
The US FDA has finalised guidance supporting new technologies which look to modernise pharmaceutical manufacturing, such as 3D printing and continuous processing.
The Biophorum Operations Group (BPOG) has begun working on 11 technology development projects after publishing its first roadmap, but the bioprocessing industry’s visions are forever evolving, says Sanofi-Genzyme.
The US FDA has rejected Janssen Biotech’s application for sirukumab, a monoclonal antibody (mAb) designed to treat severely active rheumatoid arthritis (RA).
Pfizer has accused J&J of restricting biosimilar uptake through uncompetitive practises in its efforts to maintain a monopoly for its bestselling mAb Remicade (infliximab).
US regulators have approved Amgen Inc’s Mvasi (bevacizumab-awwb), a biosimilar version of Roche’s monoclonal antibody (mAb) cancer treatment Avastin (bevacizumab).
