Regulations

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,…

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…