News

The US Food and Drug Administration has suspended the licence of a vaccine developed by Valneva SE to prevent chikungunya virus infection following 32 serious adverse event reports, including 21 hospitalisations and three deaths. The vaccine, Ixchiq (chikungunya vaccine, life), was given an accelerated approval by the FDA in November 2023 and since then has been approved in several other countries, some of which are also reviewing patient data. Valneva is expected to start a post-marketing study of the vaccine on 1 October to further assess the risks.

Efpia, the European federation of pharmaceutical industries and associations, has criticised a new US-EU trade agreement as potentially harmful to patients and the European pharma industry and called for exemptions for innovative medicines. The Efpia statement was issued on 21 August shortly after the European Commission published details of the framework agreement setting a maximum, all-inclusive tariff of 15% for the majority of EU exports to the US, including pharmaceuticals. The exact pharma rate is still to be determined but it would not exceed the 15% ceiling.

Anocca AB has raised SEK 440 million ($46 million) from Mellby Gård, a Swedish investment group, and existing shareholders to conduct a programme of trials of T cell immunotherapies for pancreatic cancer. The trials will investigate multiple approaches for targeting mutations in the KRAS gene which is involved in the regulation of cell division. KRAS mutations are drivers of pancreatic cancer, as well as lung and colorectal cancers.

Evotec SE ended the half year with a decline in revenue and an operating loss. However with a reorganisation and spending cuts underway, the company expects a recovery in earnings by 2028. Group revenue in the first half year was €371.2 million, down by 5% from a year earlier while the operating loss was €47.8 million. The loss was less than the year-earlier shortfall of €122.8 million, but still reflected weak demand for the company’s traditional services. Group revenue for the year is expected to be in a range of €760 to €800 million compared with €797 million in 2024.

The private equity and investment groups Nordic Capital and Permira, are poised to take over Bavarian Nordic A/S of Denmark in order to help the company scale up its vaccine work globally. An offer of DKK 19 billion ($2.95 billion) was published on 28 July and accepted by the company’s management subject to the approval of shareholders. Bavarian Nordic is listed on Nasdaq Copenhagen and also has an American Depository Share (ADS) programme allowing US investors to trade the shares locally.

Novo Nordisk A/S confirmed on 6 August that sales growth for the year is expected to be between 8 and 14% at constant exchange rates while the increase in operating profit is expected to amount to 10 to 16%, also at constant exchange rates. This confirms an announcement on 29 July and is considerably lower than the projection in May, reflecting a reassessment of the business outlook for the rest of the year when demand for the company’s obesity and diabetes products is expected to be less robust. 

Merck & Co Inc’s $10 billion acquisition of Verona Pharma Plc is set to close in the 2025 fourth quarter marking one of the larger transactions in the biopharma space in recent times. The deal will give Merck a recently approved asset for chronic obstructive pulmonary disease (COPD) that is on a promising trajectory. When Merck announced its offer on 9 July, some share analysts were already predicting blockbuster status for the asset, Ohtuvayre (ensifentrine), which was approved by the US Food and Drug Administration on 26 June 2024.

The European Commission has expressed confidence that a recent trade agreement between the EU and US will provide stability and predictability for the two parties even as the full details are still to be worked out. In a briefing for journalists on 7 August, a Commission spokesperson said the agreement is the best result possible given the challenging circumstances. This is because it creates a uniform tariff of 15% across multiple product groups, down from an initial 30% demanded by the US.

argenx SE continued to build momentum towards its goal of treating 50,000 patients with its medicines by 2030 as both its pipeline and clinical development activities increased. By 30 June, the company’s lead product Vyvgart (efgartigimod), which was first approved in 2021, had already achieved three approved indications, and the company was conducting or making plans for registrational studies for two other products.

Sanofi SA has become the latest European pharma company to retreat from the consumer healthcare business in order to focus on proprietary drug development. On 30 April it divested its controlling stake in Opella, one of the world’s largest producers of over-the-counter medicines, to the private equity group Clayton, Dubilier & Rice – a deal that generated €10 billion in cash for the French company whilst still leaving it with a 48.2% interest. Bpifrance, the French public investment bank, holds the remaining 1.8%.