Regulations

Potential Oklahoma anti-vax bill danger to health and industry

Oklahoma has introduced a bill intended to ban the state from prescribing, administering, and making medicinal products and vaccines containing human DNA. Introduced on January 15, Senate Bill 1514 is proposing prohibiting vaccine use and supply in the state of Oklahoma. “No medicine, medical product, vaccine or other injection that contains human DNA shall be prescribed, administered, dispensed, used or offered in this state,” the bill states, placing a date of November 1, 2020 as the when it hopes to…

US FDA predicts gene therapy surge and moves to clarify expectations

Gene therapy developers targeting the US market have a clearer idea of what it will take to win approval thanks to new guidance documents issued by the FDA. The US regulator set out its expectations for developers in six documents published last week. There are final guidance documents on gene therapies for hemophilia, retinal disorders and rare diseases. In addition, there are final guidance documents on chemistry, manufacturing and controls (CMC), observational studies and on the assessment of gene therapies…

Biocon receives FDA Form 483 at Bangalore plant

The US FDA has issued Indian drugmaker a 483 with five observations following a pre-approval inspection of an API plant in Bangalore. [Story corrected 01/28 9am ET] – The US Food and Drug Administration (FDA) carried out the inspection at the site in Bangalore, India last week and issued a Form 483 with five observations. “We will respond to the FDA with a Corrective and Preventive Action Plan (CAPA) and are confident of addressing these observations expeditiously. We remain committed…

Phacilitate 2020: FDA commercial cell and gene therapy forecast ‘unlikely’

Manufacturing issues and a scarcity of new commercial products leave predictions that 10-20 cell and gene therapy approvals each year by 2025 somewhat fanciful, says Dark Horse Consulting. In his plenary address at the Phacilitate conference yesterday, Anthony Davies, founder of cell and gene therapy specialist firm Dark Horse Consulting, reflected on the difficulties the sector has faced since the high of 2017 when three products achieved US Food and Drug Administration (FDA) approval: Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel),…

China Oks first CDMO-made MAb since Drug Administration law revision

China has approved tislelizumab, a drug for Hodgkin’s lymphoma developed by BeiGene and made locally by Boehringer Ingelheim. The monoclonal antibody (Mab) is the first biopharmaceutical approved under China’s recently modified Drug Administration Law (DAL). The law was revised in August introducing a marketing authorization holder (MAH) system similar to those in the US and EU. The revision also formalized rules governing contract manufacturing. Previously, regulatory approvals were contingent on the developer having its own manufacturing capacity in China. However, in 2015 the…

Hemophilia A-OK! FTC thumbs up effectively closes Roche’s $4.3bn Spark buy

There is no risk of competitive harm between Roche’s approved hemophila A monoclonal antibody and Spark’s gene therapy candidates, say the US and UK competition bodies. In February, Swiss Biopharma firm struck a deal to buy Philadelphia, Pennsylvania-based Spark Therapeutics for $4.3 billion (€3.8 billion). Now after months of investigation by the US Federal Trade Commission (FTC), Roche is on the verge of closing the deal. The FTC’s concerns centered on the potential competitive harm of overlaps between Roche and…

Enzyvant hit with CRL due to regenerative therapy manufacturing concerns

The US FDA has cited manufacturing concerns in a complete response letter (CRL) rejecting Enzyvant’s regenerative tissue therapy RVT-802. RVT-802 is a tissue-based therapy in development for congenital athymia. While the candidate has been granted Breakthrough Therapy designation, Rare Pediatric Disease designation, Orphan Drug designation, and Regenerative Medicine Advanced Therapy (RMAT), the US Food and Drug Administration (FDA) has rejected the therapy due to manufacturing concerns. Roivance Sciences subsidiary Enzyvant received the CRL this week and while there were no…

Purolite resin booming on biopharma uptake and ‘major’ regulatory milestone

The US FDA has approved a manufacturing process using a Purolite Praesto resin for the first time. Purolite says Janssen, Celgene and Biogen are among the firms working with its Praesto range of mAb capture resins. The separation tech firm told Bioprocess Insider about demand for its products last week, explaining that “Praesto resins are currently implemented into over 170 ongoing pre-clinical to Phase III projects at facilities across the globe. “This is a mix of standard and custom design…

Samsung BioLogics boost to cell line dev with patent win over Lonza

Lonza says it is “clearly disappointed” after the Intellectual Property Tribunal in Korea ruled in favor of Samsung BioLogics in invalidating a patent relating to cell line development. Samsung BioLogics challenged fellow contract development and manufacturing organization (CDMO) in July 2017 regarding Lonza’s patent 1302904, entitled ‘Mammalian Expression Vector Comprising the MCMV Promoter and First Intron of HCMV Major Immediate Early Gene.’ The patent relates to a vector for transferring a gene developed for producing an antibody into a cell…

Zolgensma data: ‘Heavy-handiness’ of FDA a warning to industry, not just Novartis

The US FDA may have made an example of Novartis in the way it handled the revelation of Zolgensma data manipulation, says the Alliance for Regenerative Medicine. A month after the US Food and Drug Administration (FDA) approved the one-time gene therapy Zolgensma (onasemnogene abeparvovec), marketing authorization holder Novartis alerted the agency to a data manipulation issue that impacted the accuracy of certain data from product testing performed in animals submitted in the biologics license application (BLA). In its response,…