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Eli Lilly’s Zepbound (tirzepatide) has received approval from the US Food and Drug Administration (FDA) for the treatment of overweight or obese adults with weight-related medical problems.

The drug also received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for weight loss and weight management.

Zepbound is an incretin hormone receptor agonist that targets glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors. It has previously been approved by the FDA for the treatment of type 2 diabetes and is sold as Mounjaro.

Weight loss management is a growing market, with Novo Nordisk being the market leader in the field. The company’s weight loss drugs, Wegovy (semaglutide) and Saxenda (liraglutide), generated Dkr30.4bn ($4.36bn) in combined global sales in the first nine months of 2023, as per Novo Nordisk’s Q3 financials.

Lilly plans to launch the drug in the US in six doses, ranging from 2.5mg to 15mg, by the end of this year.

The US Food and Drug Administration (FDA) has granted accelerated approval to the first chikungunya vaccine, Valneva’s Ixchiq.

Ixchiq is a single-dose live-attenuated vaccine which has been approved for preventing chikungunya viral disease in adults, aged 18 years and older. The vaccine development was partly funded by a $24.6m award from the Coalition for Epidemic Preparedness Innovations (CEPI).

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus which is transmitted by Aedes mosquitoes. According to the World Health Organization (WHO), chikungunya is prevalent in Africa, Asia, and the Americas.

Valneva has also applied for marketing approval for Ixchiq in Canada and Europe. The FDA approval for the vaccine was based on the immune response data from the Phase III trial (NCT04546724). Of the 266 trial participants, 263 showed neutralising antibody levels 28 days post-vaccination following a single vaccination with Ixchiq.

Pyxis Oncology will reduce its workforce by 40% amid a larger effort to cut costs and stretch its cash runway into 2026.

Alongside this, the company is considering partnering with other companies for the development of several assets that Pyxis will not be moving into the clinic.

Pyxis is also looking for additional non-dilutive funding by monetising the royalty schemes it inherited as part of its Apexigen acquisition. The acquisition was completed as an all-stock transaction in August.

Now, Pyxis plans to focus on developing its clinical pipeline, which consists of an antibody-drug conjugate (ADC) PYX-201 and a monoclonal antibody PYX-106. PYX-201 is an ADC that binds to extradomain-B (EDB) fibronectin present in tumour stroma, which is overexpressed in multiple cancers. 

PYX-201 is currently in a dose-determining, open-label Phase I trial (NCT05720117) in patients with relapsed/refractory (r/r) solid tumours. 

The UK Medicines and Healthcare products Regulatory Agency (MHRA) celebrated 15 years since the launch of Operation Pangea by providing UK statistics from the programme.

The news of counterfeit Ozempic (semaglutide) pens has raised alarms over the last few months with the manufacturer, Novo Nordisk, and multiple countries reporting the harms of these products along with highlighting the differences in the packaging of the fake products, compared to the original.

Operation Pangea is coordinated by Interpol with support from multiple global organisations including the World Customs Organization, the World Health Organization (WHO), the United Nations Office on Drugs and Crime, the International Narcotics Control Board, and national health regulatory agencies. 

The agency stated that the MHRA’s Criminal Enforcement Unit (CEU) has seized over 25 million illegally traded medicines and devices in the UK, which are valued at more than £84m ($101.9m) in the past 15 years. Furthermore, the agency seized illegal medicines worth £5m in 2023.

The European Commission (EC) announced its new strategy to reduce critical medicine shortages in the EU.

This October, the EC is launching the European Voluntary Solidarity Mechanism for medicines which will alert member states of critical medicine needs of another member state, so medicines can be redistributed from the available stock. The European Union will also establish a list of critical medicines by the end of 2023. The agency described this as “the first step to analyse the supply chain of selected medicines by April 2024”, per a 24 October press release. From this, it will ascertain what additional measures are needed. 

The EC’s plans to avoid shortages, come after shortages of different drugs, including antibiotics, last winter. The EU announced steps to mitigate shortages in winter, including the role the European Health Emergency Preparedness and Response Authority (HERA) and the European Medicines Agency will play in the identification of critical antibiotics with anticipated shortages.