Regulations Archives - Page 13 of 21 - BioProcess InternationalBioProcess International

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

by Gareth Macdonald

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

by Dan Stanton

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

by Dan Stanton

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

by BPI Staff

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

by Dan Stanton

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…

EU thumbs up for Biocon biosimilar insulin plant

by BPI Staff

A Biocon insulin production site in Malaysia, the subject of a recent US FDA Form 483, has received a Certificate of GMP compliance from the European Medicines Agency (EMA). Ireland’s Health Products Regulatory Authority inspected the facility in Malaysia in May this year resulting in the issuing of the certificate, meaning the insulin drug substance, drug product and delivery devices made there comply with the EMA’s good manufacturing practice (GMP) guidelines. “The recombinant human Insulin (rh-Insulin) and Insulin Glargine manufactured…

FDA and NIIMBL partner to advanced biomanufacturing innovation

by Dan Stanton

The US FDA has expanded its partnership with NIIMBL to strengthen biomanufacturing through innovations such as 3D printing and continuous manufacturing. The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) launched in March 2017 to accelerate innovation in biopharmaceutical manufacturing and support the development of standards to drive more efficient and rapid manufacturing capabilities. Institute Director, Kelvin Lee told Bioprocess Insider the institute is already working with the US Food and Drug Administration (FDA) in a variety of contexts –…

Pro-biosimilar policies will not ignite US market, Amgen

by Dan Stanton

Amgen says the US needs a vibrant competitive biologics market but must avoid policies that tilt the playing field in favor of biosimilar makers. Biosimilars made an initial mark in the US when the Food and Drug Administration (FDA) approved Sandoz’s Zarxio (filgrastim) in 2015. But in the proceeding four years, the sector has somewhat stalled – despite 22 more approvals – amid ongoing political debate, legal complexities and pricing/reimbursement. The idea of Congress addressing drug pricing and patent issues,…

FDA and Novartis back Zolgensma amid data manipulation issues

by Dan Stanton

The US FDA remains confident that Zolgensma will not be pulled after being alerted to allegations of data manipulation by the gene therapy manufacturer AveXis. In May 2019, Novartis company AveXis received US Food and Drug Administration (FDA) approval for its $2.1 million single-dose, one-time gene therapy Zolgensma (onasemnogene abeparvovec) to treat children less than two years of age with spinal muscular atrophy (SMA). A month later, AveXis informed the Agency “about a data manipulation issue that impacts the accuracy…