Europe’s health regulator started a real-time review of Johnson & Johnson’s Covid-19 vaccine candidate after preliminary results showed that the shot triggered the production of antibodies and immune cells against the virus.

The U.S. Food and Drug Administration and Health Canada approved Inqovi (decitabine and cedazuridine) tablets as the first orally administered hypomethylating agent for the treatment for adults with intermediate and high-risk myelodysplastic syndromes (MDS).

Samsung Bioepis Co. Ltd. announced that the U.S. Food and Drug Administration accepted for review the company’s Biologics License Application under the 351(k) pathway for SB5, a biosimilar candidate referencing Humira (adalimumab).

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that Health Canada approved Erleada (apalutamide tablets), an oral treatment for patients with non-metastatic castration-resistant prostate cancer.

Actelion Ltd (ATLN.VX), Europe’s biggest biotech firm, said on Tuesday that Health Canada had granted a notice of compliance for Uptravi, a new pulmonary arterial hypertension medicine.   The approval is “a major milestone”, Chief Executive Jean-Paul Clozel said in a statement, adding that the company is working to make the drug available to patients […]