Author Archives: Gareth Macdonald

Oligo-based meds a major opportunity, says Novo Nordisk

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Oligonucleotide-based therapies have the potential to accelerate every stage of its drug development effort, according to healthcare company Novo Nordisk. Marcus Schindler, executive vice president of research and early development at Novo, talked about oligonucleotide development during his presentation at the TIDES oligonucleotides and peptide therapeutics conference in May this year. “We are at a turning point in our trajectory … we have worked for close to a century on insulin innovations. … But more recently we have opened our…

October 27, 2023

EMA plans for work-in-progress oligo manufacturing guideline

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Oligonucleotide drugs are at the interface of small molecules and biologics, but developers face some unique production challenges, a spokesman for the EU regulator working on new manufacturing guidelines says. Oligonucleotide R&D activity has increased in recent years, according to Rene Thurmer, a regulator from Germany’s Federal Institute for Drugs and Medical Devices (BfArM), who told delegates about the dynamism in the sector at the TIDES oligonucleotides and peptide therapeutics conference in May this year. “There has been a lot of…

October 2, 2023

Novo Nordisk says Clayton API site still running after reports of Form 483

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The US FDA has raised concerns about manufacturing operations at Novo Nordisk’s API facility in Clayton, North Carolina. According to a search of the US FDA’s database, agency inspectors issued a Form 483 to Novo Nordisk after visiting the facility – which is assigned the FEI number 1000158576 – on July 13. A Form 483 is issued to management at the conclusion of an inspection when an investigator has observed any conditions that “in their judgment may constitute violations of…

September 20, 2023

The Rise of Antibody–Drug Conjugates and Related Modalities: Innovations and Partnerships Lead the Way

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Antibody–drug conjugates (ADCs) are straightforward as a concept. When a cytotoxic small-molecule drug is attached to an antibody raised against a specific molecular receptor, it theoretically creates a highly targeted and effective therapy. And the ability to target cells precisely has obvious applications for indications such as cancer. However, in practice, developing and manufacturing ADCs has proven difficult, said Janice M. Reichert, chief operating officer of The Antibody Society, which is an international nonprofit organization that supports antibody-related research and…

September 19, 2023

ARM says EU plans would take 90% of advanced therapies off the market

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The Alliance for Regenerative Medicine (ARM) says 90% of advanced therapies on the market would have been rejected under proposed EU clinical assessment methods. The industry raised the concerns about the European Union (EU) joint clinical assessment (JCA) regulation in June, based on an assessment of 18 ATMPs that currently hold EU marketing authorization, including several cell and gene therapies (CGTs). According to the ARM the methodologies proposed by the EUnetHTA-21 consortium for consideration by the HTA Coordination Group would…

July 4, 2023

IP will encourage investment in capacity needed for next pandemic

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Intellectual property rules will encourage drug and vaccine firms to invest in the production capacity needed during future pandemics, according to industry group IFPMA. The industry group stressed the need for “robust” IP laws in a statement issued earlier this month, arguing access to vaccines and medical countermeasures is in part determined by developers’ willingness to invest in local manufacturing capacity. “Fostering sustainable manufacturing globally that can scale-up for high volume supply in future pandemics. The right enabling environment to…

May 22, 2023

Trial regs a challenge for vaccine developers, study

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Running vaccine trials in developing countries is a significant challenge due to complex regulations and CRO management difficulties according to new analysis. The study – published in the current edition of the journal Vaccine X – looked at approaches to clinical development vaccine developers in emerging countries are using. The overall aim is to identify industry needs in terms of organizational development and training. The authors quizzed members of the Developing Countries Vaccine Manufacturers Network (DCVMN) – a voluntary alliance…

May 10, 2023

IgE antibodies could be potential solid tumor treatments, says UCL

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Antibodies that cause allergic reactions also have potential as treatments for solid tumors, according to UCL researchers exploring the new field of allegro-oncology.  Immunoglobulin E (IgE) antibodies consist of two heavy chains and two light chains, with the ε chain containing four Ig-like constant domains. They are an important part of the immune response, particularly against parasites and infection by members of the helminth family of worms. However, IgE antibodies are more commonly known for their role in life-threatening hypersensitivity…

April 24, 2023

UK Gov sets up £10m CGT manufacturing center

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The National Health Service has opened a £10 ($12.5) million cell and gene therapy manufacturing plant in Bristol that will increase UK capacity for plasmids and vectors. The Government-funded Clinical Biotechnology Centre (CBC) is designed to expand the UK’s ability to make the clinical grade products required for the research and development of new cell and gene therapies. The center will manufacture both plasmids and viral vectors. It will support early phase clinical trials and pre-clinical work. In time, the…

April 4, 2023

Australian mRNA training center to support Moderna plant

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Recruiting for its Melbourne plant will be straightforward for Moderna after Victoria State Government and Monash University announced plans for an mRNA training center. The Victoria Government and Monash University teamed up to create the training center – at Monash’s Clayton campus in Melbourne, Victoria – this month, explaining the plan is to will teach the skills required for mRNA vaccine and therapeutic manufacturing. The idea is to draw on Monash’s pool of biotechnology talent and knowledge to deliver best-practice…

April 3, 2023