The Association of the British Pharmaceutical Industry (ABPI) has suspended Novo Nordisk due to what the organisation describes as ‘serious breaches’ of its code of practice.

The decision comes after the Prescription Medicines Code of Practice Authority (PMCPA) – a self-regulatory body run by ABPI – investigated a complaint alleging that the drugmaker had sponsored courses on weight management on LinkedIn without making the company’s involvement clear.

ABPI’s board concluded that the actions were ‘likely to bring discredit on, or reduce confidence in, the pharmaceutical industry’, breaching clause two of its code of practice.

Novo Nordisk will continue to be subject to the organisation’s code and the jurisdiction of the PMCPA, but will no longer be able to access the wider benefits of ABPI membership.

The company will also be subject to further PMCPA audits in late 2023 and 2024, which will need to show a ‘clear, significant and then sustained improvement to industry standards’ in order for ABPI to consider allowing it to resume full engagement at the end of the two-year suspension.

The board has also said that Novo Nordisk must submit a quarterly update giving the company’s views on the progress being made for its improvement plan.

BioNTech has said it plans to spend up to €2.6bn on research and development this year, up from €1.54bn in 2022.

The company also expects to authorise a share repurchase programme of up to $500m during the remainder of 2023, having already spent $1.3bn on its own shares from last December to March this year.

The plans come after BioNTech ended 2022 with a cash balance of €13.9bn plus receivables, largely attributed to its COVID-19 vaccine market lead with partner Pfizer.

In December 2022, the companies announced that approximately two billion doses of Comirnaty were invoiced globally that year, including around 550 million doses of the Original/Omicron BA.4-5-adapted bivalent COVID-19 vaccine.

The company has already started clinical trials of four new infectious disease vaccines over the past few months, including a COVID-19/influenza combination candidate, as well as individual vaccines against herpes, malaria and shingles.

It has also announced a series of deals this year, including an agreement to acquire its long-standing strategic collaboration partner InstaDeep in January.

BioNTech also entered into an exclusive worldwide licensing agreement with OncoC4 in March, aimed at developing and commercialising an anti-CTLA-4 monoclonal antibody as monotherapy or combination therapy in various cancer indications.

The US Food and Drug Administration (FDA) has issued new draft guidance to improve oncology clinical trials used to support accelerated approval applications.

Under the accelerated approval pathway, the US regulator may approve therapies for serious diseases like cancer earlier, on the condition that companies conduct studies to confirm the anticipated clinical benefit.

If a confirmatory trial shows that a drug provides a clinical benefit, then the FDA grants it traditional approval. However, there have been concerns that these trials are not always conducted, and that some drugs later prove to be ineffective.

The guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, discusses a potential advantage of randomised clinical trials over single-arm studies.

‘When properly designed and executed, a randomised controlled trial provides a more robust efficacy and safety assessment and allows direct comparisons to a concurrent control arm,’ the guidance states.

The FDA suggests two approaches: conducting a single randomised controlled trial to support both an accelerated approval and to verify clinical benefit (the ‘one-trial’ approach), or conducting a trial to achieve approval in addition to a confirmatory trial.  The FDA adds that the ‘one-trial’ approach has the advantage of providing quicker verification of the benefits.

Eli Lilly has said it will be doubling the planned investment in its new biologics manufacturing facility in Ireland, bringing the total spend up to almost $1bn.

The company originally announced its plans to build the Limerick-based facility in January 2022, which it anticipates will be its ‘most technically advanced manufacturing site to date’.

Lilly said the site will utilise ‘the latest biologics manufacturing technology’, including advanced data collection and analysis systems that will deliver improvements in safety and quality, along with increased productivity and process performance.

Construction of the new 500,000 sq ft facility is currently underway at national development agency IDA’s business park in Raheen and is expected to create more than 300 highly skilled jobs across areas including engineering, scientists and operations.

Lilly made its first investment in Ireland in 1978 and currently employs more than 2,700 people in Cork, where it has a large manufacturing campus in Kinsale, as well as a Global Business Solutions Centre in Little Island.

The company cited an ‘increased demand’ for existing products when it announced its plans for the Limerick facility, adding that the site would play a key role in the manufacture of its clinical pipeline products, including its Alzheimer’s portfolio.