Now that Pfizer Inc.-Biontech SE has submitted initial phase II/III study data to the FDA bolstering the case for an emergency use authorization (EUA) for its COVID-19 vaccine to children ages 5 through 11 years, the competition, including Moderna Inc., Novavax Inc. and Sanofi SA, falls further behind.
LONDON – Self-amplifying RNA (saRNA) specialist Vaxequity Ltd. has sealed a commercialization deal with Astrazeneca plc after delivering safety data in a phase I/II trial of the technology in a COVID-19 vaccine.
Sanofi SA’s high-profile phase III blow-up Sept. 9 with the oral BTK inhibitor rilzabrutinib in pemphigus brought fresh attention to the group of rare diseases – which cause blisters on the skin and mucous membranes throughout the body – and to players pushing for a new treatment.
LONDON – There were well-deserved celebrations in Paris on Sept. 20, as Jeito Capital toasted the oversubscribed close of its first fund at €534 million (US$625.5 million). This is claimed as the largest European venture fund dedicated to life sciences, exceeding the original target of €500 million, and with €340 million of the total raised under the constraints of the pandemic from January 2020 onward.
Sanofi SA has added to its general medicines portfolio with a $1.9 billion acquisition of Kadmon Holding Inc. and its recently-approved graft-vs.-host disease drug Rezurock (belumosudil).
Though Revolution Medicines Inc.’s SHP2 inhibitor, RMC-4630, fell short of internally set benchmarks in a pair of phase I combo trials, the prospect remains alive, as the company has been “very publicly moving towards combining the companion inhibitors that we have, which include RMC-4630 with RAS inhibitor therapies that we and others make,” said Steve Kelsey, president of R&D.
A three-month delay proved to be of no concern for Nexviazyme (avalglucosidase alfa-ngpt, neoGAA), Sanofi SA’s long-term enzyme replacement therapy (ERT), which gained FDA approval for intravenous infusion to treat patients 1 and older with late-onset Pompe disease.
Just weeks after announcing plans to invest billions in an mRNA therapeutics research center, Sanofi SA has acquired Translate Bio Inc. for $3.2 billion, building on a development partnership focused around the technology.
Ushering in a new era for the U.S. biosimilar marketplace, the FDA, on July 28, approved its first interchangeable biosimilar, which also will be the first to bring biosimilar competition to the U.S. insulin space. The honor went to Viatris Inc.’s Semglee, which the FDA recognized as both biosimilar to and interchangeable with Sanofi SA’s blockbuster drug Lantus (insulin glargine), a long-acting insulin analogue.
More than a decade after the Biologics Price Competition and Innovation Act became law and nearly six years after the first biosimilar launched in the U.S., the country’s first potential interchangeable is on deck awaiting an FDA decision.
