Leap Therapeutics will get a swift FDA review for its lead drug DKN-01 for a form of gastric and gastroesophageal junction (G/GEJ) cancer after being awarded fast-track status by the regula
Boehringer Ingelheim is to manufacture the first biologic drug approved in China using a new regulatory system, designed to strengthen the country’s domestic pharma infrastructure.
BeiGene’s Brukinsa (zanubrutinib) has failed to outperform its class rival from Johnson & Johnson/AbbVie in the rare white blood cell cancer Waldenstrom’s macroglublinemia (WM).
BeiGene’s plans for an early approval for BTK inhibitor zanubrutinib in the US and to start challenging Janssen/AbbVie’s blockbuster Imbruvica have suffered a setback.