A complaint against the EMA’s handling of a referral procedure relating to potential side effects of Sanofi/MSD’s HPV vaccine Gardasil and GSK’s HPV jab Cervarix promoted by the Nordic Cochrane Centre and physicians has been rejected by the European Ombudsman.
The European Medicines Agency (EMA) has upgraded Roche’s Alecensa (Alectinib) from second-line to first-line treatment for patients with locally advanced of metastasing ALK-positive non-small cell lung cancer (NSCLC).
German infection specialist InflaRx (Jena) raised US$55m in a Series D financing co-led by Bain Capital Life Sciences LP, Cormorant Asset Management LLC and RA Capital Management LLC to finance its clinical programmes with its lead asset IFX-1.
Norwegian Targovax ASA (Oslo) has reported tremendous safety, immunogenicity, and one-year survival data, of in the modified cohort of the TG01 trial in resected pancreatic cancer patients.
Sanofi is investing €170m to expand its vaccine manufacturing site in Val de Reuil, France, which produces 900 million vaccine doses worldwide each year.
British researchers have identified interleukin 36 (IL-36) as a druggable proinflammatory driver of psoriasis. Because of its very targeted effects of antibodies directed against the cytokine they want to start clinical tests in man.
German-Israeli Neurim Pharmaceuticals announced top line efficacy results of its insomnia drug PedPRM in children with autism spectrum disorders (ASD).
French cancer drug encapsulation specialist Erytech Pharma SA wants to raise US$100m (€85m) in an IPO at NASDAQ and a subsequent private placement outside Northern America to finance pivotal trials of eryaspase in ALL and pancreatic cancer.
As first gene therapy ever, AMT-130 has been granted FDA Orphan Drug status in Huntington’s Disease.
Promethera Biosciences and Shibuya collaborate to establish a breakthrough cell therapy manufacturing platform.