SAN DIEGO, Jan. 15, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Janssen Biotech, Inc. (Janssen) has received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.1 DARZALEX FASPRO® is the first and only FDA-approved treatment for patients with this rare and serious blood disorder associated with the production of an abnormal protein which leads to the deterioration of vital organs, most notably the heart, kidneys and liver.1 This indication is approved under accelerated approval and is based on the combination's hematologic complete response rate (hemCR) measure. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. DARZALEX FASPRO® is not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.
"We are delighted that DARZALEX FASPRO® utilizing our ENHANZE® technology has become the first and only FDA-approved treatment for newly diagnosed patients with AL amyloidosis," said Dr. Helen Torley, president and chief executive officer. "AL amyloidosis represents an area of high unmet medical need."
The FDA approval is based on positive results from the Phase 3 ANDROMEDA study, which were recently presented at the American Society of Hematology (ASH) 2020 Annual Meeting. The study evaluated DARZALEX FASPRO® in combination with VCd, compared with VCd alone, a common treatment regimen offered to adult patients with newly diagnosed AL amyloidosis. 5 Patients receiving treatment with DARZALEX FASPRO® experienced a hemCR more than triple that of patients receiving VCd alone (42 percent for D-VCd and 13 percent for VCd; P
REUTERS/Eric ThayerBlackRock has authorized two of its funds to invest in bitcoin futures, according to filings released Wednesday with the Securities and Exchange Commission.
The move allows exposure to cryptocurrencies for clients of the world's largest asset manager for the first time.
The $8.7 trillion asset manager said it could use bitcoin derivatives, among other assets, under the BlackRock Strategic Income Opportunities and the BlackRock Global Allocation Fund.
The funds are only permitted to trade cash-settled bitcoin futures, meaning the holder will receive a simple cash credit once the contract expires. Such settlements do not require physical delivery of the underlying asset.
More specifically, BlackRock's two funds will trade only in those bitcoin futures that trade on exchanges registered with the Commodity Futures Trading Commission. At present, the only exchange registered to do so is the CME.
Read More: We spoke to Winklevoss-backed crypto platform Gemini about bitcoin, how to use stable coins, and why regulation won't kill the boom in digital currencies
Bitcoin scored an all-time high above $41,000 earlier this month, driven largely by record amounts of money being pumped into economies by governments and central banks to aid relief from the coronavirus crisis. The token was trading around $33,181 on Thursday - a drop of almost 6% on the day.
BlackRock reported assets under management of $8.68 trillion as of December 31. In December, CEO Larry Fink noted that the world's most popular cryptocurrency is seeing giant moves on a daily basis and could possibly unfold into a global market.
Rick Rieder, the firm's chief investment officer, told Bloomberg shortly after that there is a clear demand for bitcoin and that "it's going to be part of the asset suite for investors for a long time."
Not everyone is a fan of cryptocurrencies. US Treasury Secretary nominee Janet Yellen, who previously was head of the Federal Reserve, said earlier this week bitcoin and the like were "mainly" used for illegal activity and their use should be curtailed.
Read More: Bubbly behavior is brewing in markets and Big Tech is reeling from 2 major political events this month - Three investing heavyweights that jointly manage almost $1 trillion break down the impact on these stocks and how to position
(RTTNews) - The Malaysia stock market has moved lower in back-to-back sessions, dropping almost 10 points or 0.6 percent along the way. The Kuala Lumpur Composite Index now rests just above the 1,625-point plateau and it may take further damage on Monday.
The global forecast for the Asian markets is negative on disappointing earnings news and...
