News

AbbVie Inc, which for years marketed Humira, a former blockbuster medicine, is to replenish its portfolio with the acquisition of Apogee Therapeutics, a clinical stage biotech company with candidate products for inflammatory and immunological diseases. Announced on 22 June, the all-cash transaction values Apogee at $135.11 per share or approximately $10.9 billion. This represents a premium of about 49.5% over Apogee’s closing price on Nasdaq the day before the announcement.

A new study on the economic impact of pharmaceutical innovation in Europe shows sustained benefits across society, according to EFPIA, the European industry federation. Data from the study, released on 22 June, shows that between 2014 and 2024 Europe’s investment of €11.67 billion in new medicines returned more than five times the amount in social, economic and hospital cost savings – equating to €66 billion in total. This figure includes more than €9 billion in direct hospital savings. Key findings include:

The US Food and Drug Administration issued new draft guidance on 29 May about how companies can reduce the use of animals in drug testing – this time for cancer medicines. Entitled, Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products, the guidance recommends new criteria for general toxicology studies, including when animal testing may be unnecessary because there is no binding or pharmacologic activity.

The European Medicines Agency, in coordination with the African Medicines Agency and national regulators in Africa, started talks in early June about organising clinical trials to evaluate possible vaccines and therapies against Ebola disease caused by the Bundibugyo virus. The virus is currently circulating in the Democratic Republic of Congo and Uganda and was declared a public health emergency of international concern by the World Health Organization on 17 May. As of 18 June, the WHO had reported just over 900 cases of the disease and approximately 235 deaths.

The US Food and Drug Administration has approved a new carbapenem antibiotic from GSK Plc to treat complicated urinary tract infections – the first oral treatment of its kind for the disease. The authorisation, announced on 17 June, is for Utebzi (tebipenem pivoxil), a broad-spectrum carbapenem antibiotic of the beta-lactam class. The treatment will be available as a tablet, in addition to its availability as an in-hospital intravenous therapy.

uniQure NV has reached an agreement with the US Food and Drug Administration to proceed with a marketing authorisation application for its gene therapy for Huntington’s disease, a rare, inherited neurodegenerative disorder. The application is expected to be filed in the third quarter of this year, the company announced on 17 June.

Ona Therapeutics SL, a 2019 spin-out from a Spanish research institute and foundation, has raised $86.6 million from venture capitalists to advance a portfolio of early-stage antibody-drug conjugates (ADCs) for refractory cancers. The Series B round was co-led by Columbus Venture Partners of Spain and Mérieux Equity Partners of France. They were joined by the existing Spain-based investors Alta Life Sciences and Asabys Partners and Bpifrance, the French public investment bank.

GSK Plc is to acquire the US oncology developer Nuvalent Inc for $10.6 billion, giving it two late-stage products for non-small cell lung cancer to complement its own Phase 3 antibody-drug conjugate (ADC) for a different lung cancer. The deal, which will be financed with new and existing debt facilities, also gives the UK company a third lung cancer drug in Phase 1 and a preclinical portfolio of undisclosed cancer assets.

A biotechnology company in Scotland, backed by Archangel Investors Ltd, made its first public appearance on 8 June as a potential player in the rapidly expanding field of antibody-drug conjugates (ADCs). Emerging from stealth mode, Bead BioPharma Ltd disclosed its leadership and technology for the first time. The company’s interim chief executive is Dan Ozanne a serial entrepreneur, and its chair is Mike Sun. Mr Sun formerly worked for Seattle Genetics Inc (now Seagen), a pioneer in ADC field. Bead BioPharma has reportedly raised $1.14 million since its founding in 2023.

Collaborative networks have been a driving force for innovation across the life sciences for decades. They connect universities, governments and venture capitalists to create conditions for the launch of new companies. The ecosystem around the Massachusetts Institute of Technology in Cambridge, US, is probably the best-known incubator of new companies.  Less common are ecosystems focused on a single therapeutic area. This is the unique feature of a new cluster in France called The Hive and Campus Grand Parc, located in outer Paris.