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
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Regulatory News:
Eutelsat Communications (Paris:ETL) (Euronext Paris: ETL) and Sky Italia have reached a strategic agreement for the renewal of Sky’s capacity contract at Eutelsat’s HOTBIRD position.
The agreement represents the latest step in the long-standing partnership between Sky, the pre-eminent anchor customer on HOTBIRD, and Eutelsat which has supported since 2003 the development of Sky, the market leader in Italy, in broadcasting its premium content to some five million households.
The multi-year contract represents a secured backlog of circa 450 million euros and guarantees broadly stable annual revenues for Eutelsat in the medium term. The contract also includes future extension options representing additional potential revenues.
The HOTBIRD fleet forms one of the largest broadcasting systems over Europe. It will be upgraded with the entry into service of two HOTBIRD new generation satellites, to be launched in 2021, that will replace the current spacecraft at Eutelsat’s premium 13° East broadcasting position. The new satellites will deliver improved performances over the European footprint reinforced by a powerful European super-beam.
Commenting on the agreement, Rodolphe Belmer, CEO of Eutelsat said: "We are delighted that Sky continues to rely on Eutelsat to reach one of its key markets in Europe. This agreement ensures long term service continuity for the millions of households in Italy which depend on satellite to receive television, and highlights the key role of satellite for broadcast distribution in Western Europe, today and in the future, by providing reach beyond the limits of terrestrial networks. It also reflects the unmatched coverage of the 13° East orbital position for Europe, and the general resilience of Eutelsat’s Broadcast revenues.”
Maximo Ibarra, CEO of Sky Italia added: "We are glad to continue working with Eutelsat, one of the world's leading satellite operators, that has supported Sky since its inception. This agreement represents the latest step in a long and successful partnership that has lasted for many years.”
About Eutelsat Communications
Founded in 1977, Eutelsat Communications is one of the world's leading satellite operators. With a global fleet of satellites and associated ground infrastructure, Eutelsat enables clients across Video, Data, Government, Fixed and Mobile Broadband markets to communicate effectively to their customers, irrespective of their location. Around 7,000 television channels operated by leading media groups are broadcast by Eutelsat to one billion viewers equipped for DTH reception or connected to terrestrial networks. Headquartered in Paris, with offices and teleports around the globe, Eutelsat assembles 1,000 men and women from 46 countries who are dedicated to delivering the highest quality of service.
Eutelsat Communications is listed on the Euronext Paris Stock Exchange (ticker: ETL).
For more about Eutelsat go to www.eutelsat.com.
www.eutelsat.com – Follow us on Twitter @Eutelsat_SA
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