Health Canada on Dec. 9 approved the Covid-19 vaccine from Pfizer Inc. and BioNTech SE, clearing the way for shots to be delivered and administered across the country.
Economic relief and a vaccine drew nearer to reality to counter a coronavirus pandemic that has ravaged the U.S. economy and killed 286,487 people with year-end holiday gatherings expected to fuel another surge in infections.
If all things go well, the Pfizer-BioNTech Covid-19 vaccine will receive EUA from the U.S. Food and Drug Administration around December 10 or within a few days after, and the Moderna vaccine will receive EUA around December 17 or within a few days after.
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 […]