SAN DIEGO – Imbruvica (ibrutinib), the Bruton's tyrosine kinase (BTK) inhibitor that has racked up FDA approvals in B-cell cancers such as mantle cell lymphoma, chronic lymphocytic leukemia and Waldenström's macroglobulinemia has impressed in a non-oncology indication, chronic graft-vs.-host disease (cGVHD), with phase II data showing an overall response rate (ORR) of 67 percent.
SAN DIEGO – Despite four decades of clinical research in acute myeloid leukemia (AML), the current standard-of-care induction therapy remains the 7 + 3 regimen, usually referring to seven days of cytarabine plus three days of daunorubicin, based on an initial paper published in 1973, said Harry Erba, during a Saturday media briefing at the American Society of Hematology (ASH) meeting.
SAN DIEGO – Acute myeloid leukemia (AML) has joined the ranks of other cancers now getting the precision medicine treatment, so to speak. As researchers have identified different genetic mutations in AML patients, the next challenge has been to find ways to recruit and enroll patients quickly into appropriate treatment arms. That's where the newly launched BEAT-AML Master study comes in.
SAN DIEGO – Gazyva (obinutuzumab), the drug considered a follow-on to blockbuster Rituxan (rituximab) – as well as a buffer to impending biosimilar versions of rituximab – improved progression-free survival (PFS) by 34 percent compared to Rituxan in patients with previously untreated follicular lymphoma (FL), according to detailed data presented at the American Society of Hematology (ASH) meeting, though the side-effect profile could give some physicians pause, as could the lack of an overall survival benefit.
Aclaris Therapeutics Inc. is aiming for a first quarter NDA filing – and a mid-2017 marketing authorization application – for A-101, a topical high-concentration hydrogen peroxide formulation, for seborrheic keratosis (SK), on the back of successful results from two phase III trials.
Thanks to the emergence of paradigm-shifting all-oral antiviral regimens, the hepatitis C virus (HCV) space has surged to become one of the sector's most lucrative markets. But as sales figures flatten – due to both fewer new patient starts and pricing pushback – analysts are looking at what could be the next big antiviral drug market: hepatitis B virus (HBV).
Thanks to the emergence of paradigm-shifting all-oral antiviral regimens, the hepatitis C virus (HCV) space has surged to become one of the sector’s most lucrative markets.
Gilead Sciences Inc.'s Vemlidy – better known as tenofovir alafenamide, or TAF – won FDA approval as expected for treating adults with chronic hepatitis B virus (HBV) infection with compensated liver disease.
For about two years, Gilead Sciences Inc. rode the glorious wave that was its paradigm-shattering – and profit-busting – hepatitis C virus (HCV) franchise to become a top Wall Street big biotech by market cap. But, with sales declining for the third quarter in a row, it seems the ride is over, at least for now.
Alexion Pharmaceuticals Inc. bested consensus estimates for the third quarter and disclosed promising advancements in its pipeline, notably the launch of registrational trials for ALXN1210, its next-generation anti-C5 antibody, expected to bolster the firm's blockbuster complement franchise.
