Regulations

Sandoz roadmap aims to up biosimilar use 30% by 2030

The 12 goals within Sandoz’ Act4Biosimilars initiative hope to increase the global adoption of biosimilars by at least 30% in over 30 countries by 2030. Novartis’s Sandoz division is a pioneer in the biosimilars space, being the first company to receive approval of a biosimilar in the US through Zarxio, a version of Amgen’s Neupogen(filgrastim), in 2015. It has also been an advocate of these medicines, which have the potential to reduce the cost of medicine for patients and payors.…

FDA AdCom endorses bluebird’s CALD gene therapy

An FDA Advisory Committee has unanimously agreed bluebird bio’s gene therapy elivaldogene autotemcel (eli-cel) outweigh the risks in treating early active cerebral adrenoleukodystrophy (CALD). The US Food and Drug Administration’s (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) met yesterday to evaluate bluebird bio’s eli-cel as a treatment of early active cerebral adrenoleukodystrophy (CALD) in patients less than 18 years of age who do not have an available and willing human leukocyte antigen (HLA)-matched sibling hematopoietic stem cell (HSC)…

Emergent claims J&J owes up to $420m in vaccine contract breach

J&J has terminated a COVID-19 vaccine contract because of breaches in GMP compliance at CDMO Emergent BioSolutions. J&J’s Janssen entered into an agreement with Emergent BioSolutions in 2020 for the manufacture of its viral vector-based COVID-19 vaccine. However, the contract development and manufacturing organization (CDMO) has been hit with numerous quality issues at its Bayview, Maryland facility causing an ingredient mix up and culminating in the destruction of nearly 400 million doses of vaccines, according to a recent US Government…

Time to competency must be reduced to get to market faster, says Virtuosi

Talent shortages and training issues were identified at Advanced Therapies 2022  as one of the challenges restricting ATMPs pathway to commercialization.   The difficulty to recruit highly-skilled individuals in the advanced therapy space has been heavily documented, and companies such as Lonza, SwedenBIO, and MilliporeSigma have expressed their talent shortage concerns to this publication at different times over the past couple of years. With its high cost and potential to affect time-to-market, it was no surprise that recruitment was at the forefront of…

FDA issues draft guide to tackle supply chain disruptions

The FDA says that implementing risk management principles should be applied throughout the drug supply chain to help mitigate the risk of shortages. “Today’s draft guidance is an important step in what the nation needs to achieve an increasingly secure and resilient drug supply,” the US Food and Drug Administration (FDA) said in a statement. “For Americans to have access to an uninterrupted supply of safe, effective and high-quality drugs, all entities involved in the manufacture of a drug should…

Emergent ditched 400m vaccines amid quality and staff issues, report finds

Emergent BioSolutions hid evidence of contamination and destroyed nearly 400 million doses of J&J and AstraZeneca vaccines, a US Government staff report has found. Emergent was one of the benefactors from the US Government’s efforts in countering COVID-19, winning a Trump Administration contract worth $628 million to make the Johnson & Johnson (J&J) and AstraZeneca vaccines. However, the contract development and manufacturing organization (CDMO) was hit with an FDA Form 483 and a directive to stop production at its Bayview,…

Regenxbio: ‘CDMO issue validates inhouse gene therapy investment’

Regenxbio will begin inhouse production of material for its Duchenne Muscular Dystrophy (DMD) gene therapy after a quality issue at a third-party manufacturer delayed clinical trial dosing. The initiation of dosing adeno-associated viral (AAV) based gene therapy candidate RGX-202 for a Phase I/II clinical trial has been delayed by between six and 12 months, Regenxbio announced last week during its first quarter 2022 financial results. According to CEO Ken Mills, the delay is due to an issue at an undisclosed contract…

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…