Regulations

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,…

Bavarian Nordic gets FDA tick for monkeypox vaccine

Jynneos has become the first vaccine to be approved for non-replicating smallpox in the US and monkeypox in the world. The US Food and Drug Administration (FDA) has given Danish drugmaker the go ahead to manufacture and supply the liquid-frozen suspension of its vaccine Jynneos for smallpox and monkeypox in adults aged 18 years and over. The approval is “the culmination of a fifteen-year partnership that started with a call from the NIH [National Institutes of Health] for a safer…

Novavax poised to step up to Executive Order with recombinant flu vaccine

President Trump has called for the modernization of influenza vaccine manufacturing. With its recombinant vaccine NanoFlu set to enter Phase III, Novavax says it offers the solution. Last week, the White House issued an ‘Executive Order [EO] on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health’ (reprinted below) aimed at addressing the “critical shortcomings” in the manufacture of such products. “Most influenza vaccines are made in chicken eggs, using a 70-year-old process that requires…

Novo Nordisk: Danish and NC plants onside for oral GLP-1 launch

The US Food and Drug Administration (FDA) has approved its first oral GLP-1 receptor protein: Novo Nordisk’s Rybelsus (semaglutide). Last week, Rybelsus became the first oral glucagon-like peptide (GLP-1) receptor protein treatment approved in the US as a non-insulin treatment for people with type 2 diabetes. The drug, marketed and made by Danish drugmaker Novo Nordisk, is used to increase the amount of insulin that the pancreas releases in response to food. The firm already has an approved subcutaneous semaglutide…

China laws settle CDMO status but leave regulator lacking capacity for oversight

New GMP and licensing laws will reshape biopharma contracting in China. But exactly what the sector will look like will depend on how they are implemented and enforced by the country’s regulator, says an expert. The Chinese National People’s Congress passed final amendments to the country’s Drug Administration Law (DAL) on August 26. The law introduces a suite of measures, including a marketing authorisation holder (MAH) system similar to those in place in the US and EU. It also reforms…

FDA warns another unapproved cell therapy firm

The US FDA has slammed a self-described regenerative cellular therapy manufacturer for selling unapproved umbilical cord blood and umbilical cord products. California-based Stemell describes itself as an “organization dedicated to leadership, education, service, research and manufacturing of regenerative cellular and cell-free products,” making products StemL UCB-Plus and StemL UCT-Plus, derived from human umbilical cord blood and umbilical cord, for allogeneic use. However, in the latest example of a crackdown on unapproved stem cell therapies the firm has been at the…

FDA rejects Mylan and Biocon’s insulin glargine again

The US FDA has issued a second complete response letter for a follow-on insulin glargine product referencing Lantus made by Biocon at its facility in Malaysia. In June 2018, the US Food and Drug Administration (FDA) issued a complete response letter (CRL) to Mylan and its manufacturing partner Biocon rejecting their insulin glargine product submitted through the 505(b)(2) regulatory pathway as a follow-on biologic referencing Sanofi’s Lantus. Just over a year later and the firms have reported a second CRL…

Lineage granted stem cell production patent for cancer vax

The patent validates a system for production of antigen presenting dendritic cells from human embryonic stem cells (hESCs), used in Lineage Cell Therapeutics’ cancer immunotherapy program VAC2. The United States Patent and Trademark Office (USPTO) issued Patent No. 10,344,262, entitled ‘Differentiation of primate pluripotent stem cells to hematopoietic lineage cells,’ to Lineage Cell Therapeutics in July. The patent was filed by Asterias Biotherapeutics in February 2017. Asterias was acquired by clinical-stage biotech BioTime in March 2019, and since then BioTime…

Think your CMO is high maintenance? Let’s hope so

Having a well-managed facility maintenance schedule can avoid lengthy shutdowns and lost revenues, says a regulatory expert. During the Q2 2019 reporting season, Samsung BioLogics reported revenues of KRW 78.1 billion ($65 million) compared to KRQ 15.1 billion recorded in the previous quarter. The Korean contract manufacturing organization (CMO) attributed the 38% drop to the plant operation rate temporarily decreasing at its 152,000 L plant number 2 during the quarter due to “regular maintenance essential for biopharmaceutical manufacturing.” According to…