AbbVie (NYSE:ABBV) and Janssen Pharmaceutical (NYSE:JNJ) have revealed their intent to voluntarily withdraw the accelerated approvals for Imbruvica (ibrutinib) for patients with mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) in the U.S. Ibrutinib is a selective Bruton’s tyrosine kinase (BTK). The main reasons for the move relate to FDA’s request for additional studies…
Janssen gets positive CHMP opinion for Imbruvica for adults with untreated chronic lymphocytic leukemia
Janssen (NYSE:JNJ) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Imbruvica (ibrutinib) with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukemia (CLL). In the EU, the drug is also indicated for certain patients with mantle cell lymphoma, previously treated chronic…
50 of 2021’s best-selling pharmaceuticals
Drug sales in 2021 hit record heights, with a handful of pharmaceutical companies handsomely rewarded for creating COVID-19 vaccines and treatments. This roundup of best-selling pharmaceuticals in 2021 highlighted a banner year for the industry. Pfizer alone raked in $36.9 billion in sales from the Comirnaty vaccine it developed jointly with BioNTech. Demand for the…
AbbVie faces Senate questions related to tax practices
Senate Finance Committee Chair Ron Wyden (D-Ore.) has announced an investigation of AbbVie’s (NYSE: ABBV) tax practices. In a statement, the senator argued that the company’s tax rate from 2018 to 2020 was 9.5% — less than half of the 20% rate it paid in 2016. Wyden has sent a letter to AbbVie CEO Richard…