Pricing of VBI Vaccines Inc.’s just-approved hepatitis B virus (HBV) vaccine, Prehevbrio, won’t be known before launch in the first quarter of next year, but CEO Jeff Baxter said the company will take into account that the sector is “one of the most price-intensive and price-competitive. A lot of the market-access research says that the wholesale acquisition cost is one of the key determinants” in avoiding sluggish adoption, he said, so that by staying moderate the firm can “supply [its] product on a much quicker basis than you might do, say, if you went with a 30% or 40% premium to standard of care.”
Ursula Matulonis, a co-principal investigator in the latest study with Immunogen Inc.’s antibody-drug conjugate mirvetuximab soravtansine in stubborn ovarian cancer, said the top-line data are “truly spectacular” and bring “the potential to be transformative for patients.”
What one analyst called “the single most important” nucleoside reverse transcriptase inhibitor in development – Merck & Co. Inc.’s islatravir – has met rocky terrain, with the firm and its partner, Gilead Sciences Inc., pausing combo trials.
Glaxosmithkline plc (GSK) tapped Arrowhead Pharmaceuticals Inc. for its foray into nonalcoholic steatohepatitis (NASH), as the pair signed an exclusive global licensing deal (excluding China) for GSK to develop and commercialize phase I/II-stage ARO-HSD, Arrowhead’s RNAi therapy targeting HSD17B13.
The FDA amended emergency use authorizations (EUAs) for the Moderna Inc. COVID-19 vaccine as well as the shot from Pfizer Inc. and Biontech SE. A single booster dose was green-lighted for people 18 years and older at least six months after finishing the primary regimen with either of the vaccines, or at least two months after getting the Johnson & Johnson shot.
New conditioning agents for hematopoietic stem cell transplant (HSCT) are in the works at a handful of companies, with Jasper Therapeutics Inc. ushering through the pipeline a candidate viewed by some on Wall Street as especially promising.
Pfizer Inc. scored a $5.29 billion deal with the U.S. government to provide 10 million courses of the company’s oral antiviral candidate Paxlovid (PF-07321332; ritonavir) for COVID-19, as Astrazeneca plc and Novavax Inc. also generated news in the space. Paxlovid, if approved or authorized, would be the first oral antiviral of its kind: a 3CL protease inhibitor specifically designed to combat SARS-CoV-2. New York-based Pfizer is seeking emergency use authorization (EUA) from the FDA. Rolling submissions have also commenced in several other countries, and the company continues to build its case for regulatory agencies around the world.
Kezar Life Sciences Inc. shares (NASDAQ:KZR) rose 37%, or $3.18, to close Nov. 16 at $11.59 on interim results from the phase II part of the study called Mission, testing KZR-616, a first-in-class selective immunoproteasome inhibitor, in patients with active, proliferative lupus nephritis (LN).
Recludix Pharma Inc. launched with a $60 million series A round to target Src homology 2 (SH2) domains, and the new money will get the San Diego-based firm to reach the IND-enabling stage, CEO Nancy Whiting told BioWorld.
Oncorus Inc. offered initial safety, tolerability and immune activation and clinical response data from its ongoing phase I trial with ONCR-177 at the Society for Immunotherapy of Cancer (SITC) meeting. In the fully enrolled and completed surface lesion, dose-escalation part of the study, single-agent ONCR-177, an oncolytic herpes simplex virus for intratumoral injection, proved well-tolerated with no dose-limiting toxicities.
