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.
Following a sluggish third quarter for biopharma IPOs, the sector isn't exactly starting the fourth quarter off with a bang, with Azurrx Biopharma Inc. lowering its already-low IPO sights to price a micro offering of 960,000 shares Wednesday at $5.50 apiece.
Continuing a flurry of dealmaking that has spanned both the generic and branded drug markets, Teva Pharmaceutical Industries Ltd. inked its latest deal, a North American alliance with Korean firm Celltrion Inc. aimed at expanding its role in the growing biosimilars space.
Earlier this year, the quiet joining of two recent San Diego-based startups led to the creation of Oncternal Therapeutics Inc., an oncology-focused firm boasting two potentially first-in-class drugs, both of which already have entered the clinic.
