PharmaEssentia Corp (藥華醫藥) on Monday said that Besremi (Ropeginterferon alfa-2b), its treatment for people with polycythemia vera, a rare form of blood cancer, has gained marketing approval from Taiwan's Food and Drug Administration (FDA).
It was the drug’s second regulatory approval, following approval from the European Medicines Agency in February last year.
PharmaEssentia would soon begin to mass produce the drug, it said in a statement, adding that it would apply to the National Health Insurance Administration to have the drug included in the National Health Insurance (NHI) system.
There are about 3,000 people with polycythemia vera in Taiwan and the company plans to offer the drug to those who can pay for it out of pocket until it is accepted into the NHI system, it said.
Each dose of Besremi sold for about 3,000 euros (US$3,362) in Europe last year, the company said, adding that the local price has yet to be decided.
The company submitted the application for Besremi to Taiwan's FDA on July 31 last year, saying that it took the regulator a relatively shorter review period to give it the green light.
PharmaEssentia said that after submitting an application in March, it expects the drug to gain approval from the US Food and Drug Administration at the beginning of next year.
The US regulator on May 22 gave approval for PharmaEssentia to test Besremi for use against COVID-19 under the Coronavirus Treatment Acceleration Program.
The interferon drug modulates immune response by interfering with viral proliferation.
The firm plans to recruit 40 volunteers to test if the drug can reduce the possibility of a COVID-19 infection, it said.
The Eurovision Song Contest has seen a surge in punter interest at the bookmakers, becoming a major betting event, experts said ahead of last night’s giant glamfest in Basel. “Eurovision has quietly become one of the biggest betting events of the year,” said Tomi Huttunen, senior manager of the Online Computer Finland (OCS) betting and casino platform. Betting sites have long been used to gauge which way voters might be leaning ahead of the world’s biggest televised live music event. However, bookmakers highlight a huge increase in engagement in recent years — and this year in particular. “We’ve already passed 2023’s total activity and
Nvidia Corp CEO Jensen Huang (黃仁勳) today announced that his company has selected "Beitou Shilin" in Taipei for its new Taiwan office, called Nvidia Constellation, putting an end to months of speculation. Industry sources have said that the tech giant has been eyeing the Beitou Shilin Science Park as the site of its new overseas headquarters, and speculated that the new headquarters would be built on two plots of land designated as "T17" and "T18," which span 3.89 hectares in the park. "I think it's time for us to reveal one of the largest products we've ever built," Huang said near the
China yesterday announced anti-dumping duties as high as 74.9 percent on imports of polyoxymethylene (POM) copolymers, a type of engineering plastic, from Taiwan, the US, the EU and Japan. The Chinese Ministry of Commerce’s findings conclude a probe launched in May last year, shortly after the US sharply increased tariffs on Chinese electric vehicles, computer chips and other imports. POM copolymers can partially replace metals such as copper and zinc, and have various applications, including in auto parts, electronics and medical equipment, the Chinese ministry has said. In January, it said initial investigations had determined that dumping was taking place, and implemented preliminary
Intel Corp yesterday reinforced its determination to strengthen its partnerships with Taiwan’s ecosystem partners including original-electronic-manufacturing (OEM) companies such as Hon Hai Precision Industry Co (鴻海精密) and chipmaker United Microelectronics Corp (UMC, 聯電). “Tonight marks a new beginning. We renew our new partnership with Taiwan ecosystem,” Intel new chief executive officer Tan Lip-bu (陳立武) said at a dinner with representatives from the company’s local partners, celebrating the 40th anniversary of the US chip giant’s presence in Taiwan. Tan took the reins at Intel six weeks ago aiming to reform the chipmaker and revive its past glory. This is the first time Tan
RSS