Data from two Novavax Inc. clinical trials show its COVID-19 vaccine had 100% protection against severe disease, including hospitalization and death, paving the way for an emergency use authorization submission in the U.S. Mild and moderate COVID-19 was dramatically reduced in both studies, according to the data, and some efficacy was confirmed in variant strains.
Positive COVID-19 efficacy numbers from Vir Biotechnology Inc. and Glaxosmithkline plc (GSK) has prompted them to immediately seek an emergency use authorization (EUA) with the FDA and similar authorizations in other countries for their monoclonal antibody, VIR-7831. Meanwhile, the phase III Remdacta study of Actemra/RoActemra (tocilizumab) plus Veklury (remdesivir) vs. placebo plus Veklury, from Roche Holding AG and Gilead Sciences Inc., missed its primary endpoint in treating hospitalized patients with severe COVID-19 pneumonia receiving standard of care.
Following an interim futility analysis, Affimed NV has decided to continue enrolling its phase II, registration-directed study of AFM-13, a tetravalent, bispecific innate cell engager, as a monotherapy for treating relapsed or refractory CD30-positive peripheral T-cell lymphoma.
In a year impeded by the monumental challenges of a worldwide pandemic yet powered by near-record drug development and approvals, the Drugs to Watch 2021 report has narrowed a wide and tough field to four treatments that could achieve blockbuster status in the next five years. The drugs included in the report, an annual view of powerhouse drug development that Clarivate plc began issuing in 2013, are cited as possibly being well on their way to annual sales of more than $1 billion each.
Five years after its initial investment in Maverick Therapeutics Inc., Takeda Pharmaceutical Co. Ltd. is exercising its option to buy the privately held company for a pre-negotiated up-front payment plus development and regulatory milestones of up to $525 million.
Anaptysbio Inc. is calling it quits for developing imsidolimab in treating moderate to severe palmoplantar pustulosis (PPP) after its phase II Poplar trial failed to hit its primary endpoint. However, the company said it would continue imsidolimab development for five other indications, including a phase III trial in treating generalized pustular psoriasis (GPP) that’s set to begin in mid-2021.
Little more than two months after cutting a deal with Merck & Co. Inc. that could top $1 billion, Janux Therapeutics Inc. has closed on a $56 million series A. Janux is developing immunotherapies designed to trigger the immune system to kill specific tumors while leaving the healthy tissue safely alone. T-cell engagers bind to a tumor cell and use the patient’s T cells to eliminate the tumor.
The cost of newly FDA approved Pepaxto (melphalan flufenamide) from Oncopeptides AB is designed to put the therapy in the middle of the range compared to other multiple myeloma therapies, CEO Marty Duvall told BioWorld. “There are products well entrenched in that space,” he added.
With the FDA’s granting of emergency use authorization (EUA) to Johnson & Johnson (J&J), there is now a third vaccine – and the first requiring only a single shot – against COVID-19 for adult Americans. Though it packs less of an efficacy punch, the EUA allows J&J’s Ad26.COV2.S to join mRNA vaccines from Moderna Inc. and Pfizer Inc./Biontech SE as protection against the virus.
Roivant Sciences Ltd. is buying Silicon Therapeutics LLC for $450 million in Roivant equity plus regulatory and commercial milestone payments. The combination of Silicon’s computational physics platform for in silico design or optimizing small-molecule drugs with Roivant’s newly unveiled protein degradation platform will be powered by Roivant’s machine learning models.
