Regulations

Issues at Italian CDMO leads to US approval delay for Novartis’ inclisiran

The US FDA has issued a complete response letter for Leqvio (inclisiran) due to ‘unresolved facility inspection-related conditions’ at a third-party site run by Corden Pharma. In October 2020, this publication reported the US approval of Novartis’ small interfering RNA (siRNA) therapy for the treatment of adults with hypercholesterolemia or mixed dyslipidemia, Leqvio, was dependent on a regulatory inspection at a third-party manufacturer in Italy. While Novartis spoke of regulatory delays of up to five months caused by COVID-19, it…

Some cold chain issues with Pfizer’s COVID vaccine but US confident of supplies

US military officials say several trays of Pfizer and BioNTech’s COVID-19 vaccine needed to be replaced after being stored at excessively cold temperatures. Details of the replacement were disclosed yesterday during a press conference about efforts to roll out the vaccine. General Gustave F. Perna, who is running the US’ Operation Warp Speed (OWS), said some vaccine sent to California and Alabama was replaced after it was stored at a temperature lower than the recommended 70°C. “We had two trays…

BMS hit by FDA 483 with 6 observations at Washington CAR-T plant

The Form 483 is a further blow to the potential approval of Bristol-Myers Squibb’s lymphoma CAR-T candidate liso-cel, made at the Bothell, Washington facility. The form comes after the US Food and Drug Administration (FDA) visited the facility between October 7 and 16 and lists six heavily redacted observations made about manufacturing processes. These include failures in reviewing any unexplained discrepancies and questions around the reliability of Certificates of Analysis (COAs) from third-party vendors; problems with written records of investigations…

Boehringer urges FDA to correct ‘strength’ definition for biosimilars

Boehringer Ingelheim has filed a Citizen Petition to the US FDA to change its interpretation of how the strength of a biosimilar is determined. Boehringer Ingelheim filed the petition to the US Food and Drug Administration (FDA) last week to change the interpretation of the word ‘strength’ to mean total drug content. Currently, the FDA’s interpretation is based on both the total content of drug substance and the concentration of drug substance. In its Citizen Petition, Boehringer claims that this…

European Commission considers regulation for ‘bedside’ manufacturing

The European Commission has published its pharmaceutical strategy to increase access to innovative and safe medicine, including steps to adapt regulation to advanced therapies. The ‘Pharmaceutical Strategy for Europe’ was announced last week by the European Commission (EC) in order to strengthen and protect the European Union’s pharmaceutical supply chain, in light of medical innovation and the on-going pandemic. Within the subsection entitled ‘Enabling innovation and digital transformation’, the first example of innovation given is advanced therapies. In particular, the…

Pfizer looks to freezer farms and thermal shippers to make COVID vaccine distribution ‘doable’

Pfizer says it is prepped to overcome the logistical challenges of distributing its mRNA vaccine against COVID-19 as it submits an Emergency Use Authorization (EUA) to the US FDA. Today, Pfizer submitted a request to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of BNT162b2, an mRNA vaccine candidate codeveloped with Germany’s BioNTech, against SARS-CoV-2. The news follows Phase III trial data showing the vaccine has an efficacy rate of 95% and marks a major milestone…

Iovance plant on track for 2022 and lifileucel BLA set for next year

Iovance Biotherapeutics says its new cell therapy plant in Philadelphia is on track to begin commercial production in 2022. The firm updated on development of the facility at the Navy Yard complex in Philadelphia during its Q3 earnings call, telling analysts clean rooms are due to be operational for clinical trial supply production in 2021. Iovance announced plans for the $125 million Philadelphia facility in May last year, explaining it would be used to make autologous TIL products including lifileucel…

CMO deficiencies land Sanofi with CRL for sutimlimab

Sanofi says it is working with its third-party manufacturer and the US FDA to resolve issues raised in the Complete Response Letter. French pharma giant Sanofi has suffered a setback after sutimlimab, its investigational monoclonal antibody for the treatment of hemolysis in adults with cold agglutinin disease, received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA). The firm stated the letter refers to “certain deficiencies identified by the agency during a pre-license inspection of a…

Bluebird: CMC and COVID delays push sickle cell gene therapy BLA back to 2022

Bluebird bio has asked the US FDA to take a flexible and innovative approach to the CMC comparability data review for gene therapy candidate LentiGlobin. It had been estimated that bluebird bio was aiming to submit a Biologics License Application (BLA) for its gene therapy candidate LentiGlobin (autologous CD34+ cells encoding βA-T87Q-globin gene) in the second half of 2021. But following US Food and Drug Administration (FDA) concerns, guidance has been put back by a year, management said on a…

Lilly confident in remediating troubled COVID mAb plant

Eli Lilly has engaged an external firm to conduct a comprehensive independent review after the FDA found data integrity issues at a manufacturing facility in New Jersey. Earlier this month, Reuters broke the news that the US Food and Drug Administration (FDA) issued Eli Lilly’s Branchburg, New Jersey manufacturing site with an “Official Action Indicated” (OAI) notice. This came after an inspection in November last year found that processing data had been deleted and not appropriately reviewed by the firm’s…