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).
Fears of Remicade competition have not manifested in significant growth declines for Johnson & Johnson, but Pfizer says US payers and physicians are slowly getting comfortable with biosimilars.
Alexion will close its Rhode Island manufacturing facility as part of a cost cutting plan that will also see it reduce its workforce by 20% over the next year.
Biocon says its insulin plant in Malaysia has been awarded a European GMP certificate after an inspection by Ireland’s Health Products Regulatory Authority (HPRA).
Merck & Co has announced it will acquire immunotherapy-focused Rigontec and lead candidate RGT100, designed to treat patients with solid tumours and lymphoma.
Spain has licensed TiGenix NV's expanded Madrid plant paving the way for a potential European launch of Cx601, its cell therapy for the Crohn's disease complications.
The US FDA has approved Mylotarg seven years after Pfizer withdrew the antibody-drug conjugate due to safety concerns and questions surrounding its clinical benefit.
US approval for Novartis’s CAR-T cancer treatment Kymriah will help cell and gene therapy firms attract the investors they need to fund development according to International Society for Cellular Therapy (ISCT).
The US FDA has approved its sixth biosimilar and second version of AbbVie’s best-selling monoclonal antibody Humira (adalimumab): Cyltezo, made by Boehringer-Ingelheim.
Imraldi becomes the second version of AbbVie’s best-selling biologic Humira (adalimumab) to be approved and the fourth biosimilar success for Samsung Bioepis in Europe.
The EMA has revised its reflection paper on API starting materials to clarify what information drug firms should provide about their starting materials under ICH Q11.
Pfizer has chosen a site in Sanford, North Carolina for a gene therapy production plant, just 40 miles from its recent acquisition Bamboo Therapeutics Inc.
Public Health England has reserved NHS hepatitis B vaccine stocks for people at high risk of infection, citing shortages caused by production interruptions at Merck & Co and GSK.
The US FDA has accepted submission of two further Herceptin (trastuzumab) biosimilars: ABP 980 developed by Amgen and Allergan, and Teva and Celltrion’s CT-P6.
Roche is confident its biologics pipeline and plan to reformulate some of its top selling monoclonal antibodies can offset sales erosion resulting from biosimilar competition.
Pfizer dropped the US price of Inflectra, its version of Johnson & Johnson's Remicade, just weeks before Merck & Co. launched its infliximab biosimilar, Renflexis.
Samsung Biologics wants Big Pharma to up biomanufacturing outsourcing and says lessons learned from the semiconductor industry will give it the advantage in the CMO space.
