Regulations

J&J preps to enter cell therapy space as CAR-T approval decision approaches

J&J says it will learn from pioneers in the cell therapy space as it preps its production network for the potential launch of its BCMA CAR-T product. J&J division Janssen Biotech entered the cell and gene therapy space in 2017, teaming up with Legend Biotech for the development of ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor (CAR) T-cell candidate specifically targeting the B-cell maturation antigen (BCMA) and is known as LCAR-B38M in China . Nearly four years on, and the…

Boehringer’s adalimumab becomes first interchangeable mAb biosimilar

The US FDA has approved Boehringer Ingelheim’s Cyltezo as the first biosimilar interchangeable with AbbVie’s blockbuster monoclonal antibody Humira (adalimumab). While biosimilars have offered cheaper versions of biological drugs in the US for six years, the issue of interchangeability has muddied the waters. An interchangeable biosimilar is one that can be substituted at the pharmacy level for the reference product without the prescriber having to change the prescription. Interchangeability is an additional standard beyond the requirement for biosimilarity and thus…

CureVac manufacturing switch-up as it shelves COVID-19 vax

CureVac will shift its manufacturing setup to produce clinical material for second-generation mRNA vaccine candidates as it abandons CVnCoV.   Just one month ago, CureVac dropped two contract development manufacturing organization’s (CDMOs) after demand for mRNA COVID-19 candidate CVnCoV diminished but the firm remained confident future clinical trials would still go ahead.   Now, CureVac has decided to withdraw the first-generation vaccine candidate from the approval process with the European Medicines Agency (EMA) in a bid to “refocus efforts on improved second-generation vaccine candidates we are developing in collaboration with GSK.” According to the firm, its second-generation candidates are based on an improved mRNA setup and includes flu…

How biopharma dealt with COVID: ‘We science-ed the crap out of it!’

COVID-19 showed biopharma at its best and worst says a former regulator, who argues that the scrutiny which came with the pandemic highlighted some key industry challenges. The pandemic put biopharma in the spotlight according to Jeff Baker, former deputy director of the Office of Biotechnology Products in CDER, who told delegates at the BPI East hybrid conference last month the crisis highlighted industry’s strengths and weaknesses. “There will be a lot of books written about the COVID-19 crisis and…

Human error at CDMO led to Moderna vaccine contamination in Japan

An investigation has found an incorrectly assembled production line at Spanish CDMO Rovi led to the presence of foreign particles in a lot of Moderna’s COVID-19 vaccine. In August, Japan put on hold the rollout of 1.6 million doses of Moderna’s vaccine after “foreign materials” were discovered in approximately 565,000 vials. Moderna and Takeda Pharmaceuticals, which distributes the vaccine in Japan, pointed the finger at contract development manufacturing organization (CDMO) Laboratorios Farmacéuticos Rovi, and this week confirmed the issue stemmed…

FDA authorizes 9th batch of J&J COVID vax from troubled Emergent plant

The US FDA has authorized an emergency use authorization (EUA) for one additional batch of the Janssen COVID-19 vaccine manufactured at Emergent’ Bayview facility. Contamination issues stemming from Emergent BioSolutions marred rollout of J&J’s ‘Janssen’ single dose COVID-19 vaccine earlier this year. The contract development and manufacturing organization’s (CDMO) Bayview, Maryland facility had been contracted by both J&J and AstraZeneca, but an ingredient mix up rendered 15 million doses unusable and landed the plant with an FDA Form 483 and a…

US House approves bill to take on biosimilar ‘patent dance’

The bill aims to reduce US drug prices and could limit IP strategies undertaken by reference biologic makers to ward off biosimilar competition. Having been first introduce to the House in April, H R 2884 was approved by the House Judiciary Committee yesterday as part of four bills aimed at tackling the high prices of drugs in the US. According to the text, the bill “limits in certain instances the number of patents that the manufacturer of a biologic drug…

Biocon hit by FDA 483 with 6 observations at Malaysian plant

Biocon’s insulin manufacturing facility in Malaysia has received a US FDA Form 483 with six observations but firm says it will not affect commercialization plans in the US. Indian biopharma giant Biocon reported this week it has been issued with a Form 483 by the US Food and Drug Administration (FDA) after the agency conducted an on-site pre-approval inspection (PAI) at its Malaysian  manufacturing plant for its biosimilar insulin product. “The US FDA conducted a (PAI) of our Malaysian subsidiary…

AstraZeneca vaccines: Further problems at Emergent but FDA okays exports

The US FDA has determined several lots of a COVID-19 vaccine are acceptable to use despite AstraZeneca identifying further manufacturing deviations at CDMO partner Emergent.  Efforts to scale up COVID-19 vaccines in the wake of the pandemic have been exceptional, but in April Emergent BioSolution fell afoul of the US Food and Drug Administration (FDA).  The contract development and manufacturing organization (CDMO) had been contracted by both Johnson & Johnson and AstraZeneca (AZ) to make their respective COVID-19 vaccines, but an ingredient mix up rendered 15 million doses unusable and landed the…

Tivdak approval marks another ADC success for Seagen

The US FDA has approved a fourth product for Seagen and the twelfth ADC therapeutic in the form of cervical cancer drug Tivdak. First up, it’s Seagen (previously Seattle Genetics), which received accelerated approval for Tivdak (tisotumab vedotin), an antibody drug conjugate (ADC) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. On a conference call discussing the approval, Seagen CEO Clay Siegall described the approval as “another significant milestone”…