Biogen Inc. plans to make newly approved spinal muscular atrophy (SMA) drug Spinraza (nusinersen) available within a week of its FDA nod late Friday, marking the first drug indicated for SMA, a genetic disease characterized by a loss of motor neurons in the spinal cord and lower brain stem that causes death in infants and toddlers.
It's probably an understatement to say that scientist and co-founder of 2015 startup Rational Vaccines Inc. (RVx) William Halford is not impressed by the current state of efforts aimed at treatment and prevention of the rapid spread of the herpes virus – neither the persistent use of subunit vaccine technology nor the lengthy FDA development timelines.
Wednesday's FDA approval of topical PDE4 inhibitor crisaborole in atopic dermatitis could give Pfizer Inc. a few months head start over much-heralded breakthrough-designated systemic candidate dupilumab in what's expected to be a blockbuster market, even as other potential competitors advance in the clinic.
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).
