Regulations

Coherus: FDA calls for quality process change in toripalimab CRL

Coherus and partner Junshi will resubmit the BLA for toripalimab by mid-summer after the US FDA requested a quality process change. Coherus BioSciences announced this week itself and partner Junshi Biosciences received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its metastatic nasopharyngeal carcinoma (NPC) candidate toripalimab. Toripalimab was first approved in China to treat melanoma in 2018, but Coherus acquired the North American right to the anti-PD-1 antibody in February 2021 through a…

Biogen and Aduhelm: ‘Manufacturing capabilities will align with demand’

With minimalized demand for the one-time touted blockbuster Aduhelm, Biogen could be left with 198,000 L of mammalian capacity to fill. Between its Swiss site in Solothurn and a plant in North Carolina, Biogen said last year it has a combined capacity of 198,000 L, capable of producing tens of millions of doses of Alzheimer’s drug Aduhelm (aducanumab). However, despite the US Food and Drug Administration (FDA) approving Aduhelm in June 2021, the commercial future of the monoclonal antibody (mAb)…

Gamida’s off-the-shelf lymphoma cell therapy set for trials after hold lifted

The US FDA has released Gamida Cell from a clinical hold imposed last year, clearing the way for trials of GDA-201, a candidate off-the-shelf treatment for large B cell lymphomas. The Boston biotech firm announced the decision last week, also revealing that the US regulatory agency cleared its investigational new drug (IND) application for the product. CEO Julian Adams said, “FDA clearance of our IND for the cryopreserved formulation of GDA-201 represents a significant milestone for the company and reflects…

Gilead’s Kite receives US FDA ok for Maryland CAR-T plant

The 20-acre site in Frederick, Maryland will produce CAR-T therapy Yescarta and increase its network capacity by 50%, says Kite. In 2018, Gilead Sciences, fresh from its $11.9 billion acquisition of Kite Pharma, announced plans to expand its manufacturing network with a 275,000 square foot facility in Frederick County, Marland to produce chimeric antigen receptor (CAR) T-cell therapies. Now, the firm has received approval from the US Food and Drug Administration (FDA) to manufacture CAR-T cell therapy Yescarta (axicabtagene ciloleucel), which was…

Gene therapy sector needs tech to meet regulatory requirements

Manufacturing rules are a major challenge for gene therapy firms according to researchers, who say industry needs better tech to meet regulatory requirements. The call for better technology came in a new study published in the journal Molecular Therapy earlier this month, in which progress seen in the cell therapy space was compared with the slower growth of the commercial gene therapy market. “Cell-based therapies have revolutionized the treatment of some blood cancers… Gene therapy, on the other hand, has…

China: US auditors can examine US-listed companies in policy change

China plans to furnish US auditors with full access to the financial records of China companies that have US listings. The change seems to solve a looming crisis between the two countries, as the US is currently threatening to de-list all China companies that closed their financial documents to US auditors. The revised regulation will allow scrutiny of China-based companies’ books, while detailing how to handle national security information, which will remain protected. The new policy was announced earlier this…

Moderna recalls another lot of COVID-19 vax

Moderna has recalled one lot of its COVID-19 vaccine, Spikevax, after a foreign body was found in a vial produced by CDMO Rovi.   Moderna and Spanish contract development manufacturing organization (CDMO) Laboratorios Farmacéuticos Rovi jointly announced that they have recalled lot #000190A of Spikevax in Europe, which consisted of 764,900 doses. The firms were made aware of the issue through a product complaint from a vaccination center based in Malaga, Spain. The dose in question was returned for forensic…

Trade secrets theft: ‘Unfair to the innovator, unfair to the industry’

Two co-founders of Taiwanese firm JHL Biotech were sentenced last month for plotting to steal trade secrets from Genentech and commit wire fraud exceeding $101 million. BioProcess Insider spoke to the attorneys who represented Genentech in this landmark civil and criminal case. According to the suit, the story goes back thirteen years where former principal scientist Xanthe Lam and her husband, Allen Lam, conspired to commit stealing trade secrets from Genentech and passing the information to Taiwanese company JHL Biotech (now Eden…

Alnylam RNAi candidate delayed due to packaging CDMO issues

Alnylam says an inspection at a secondary packaging facility run by a third-party has pushed the FDA’s approval date for vutrisiran back three months. Alnylam Pharmaceuticals is a pioneer in the RNAi space, becoming the first company to bring a small interfering ribonucleic acid (siRNA) treatment to the market with Onpattro (patisiran), approved by the US Food and Drug Administration (FDA) in August 2018. Since then, the firm has achieved success with Givlaari (givosiran) and Oxlumo (lumasiran) but has suffered a…

Novartis’s $115m pays off as FDA approves second Zolgensma site

The Novartis facility in North Carolina will begin shipping Zolgensma gene therapy doses immediately after receiving US FDA commercial licensure approval. The Swiss Big Pharma firm announced yesterday the US Food and Drug Administration (FDA) has granted approval to its multi-product gene therapy manufacturing facility in Durham, North Carolina. The 170,000 square-foot facility site will primarily be used to produce Zolgensma (onasemnogene abeparvovec. Novartis added Zolgensma to its pipeline through the $8.7 billion acquisition of AveXis in May 2018 and…