TWi Pharmaceuticals Inc (安成國際藥業) expects to return to the black by the end of the first half of this year on the back of quickened regulatory processes in the US, the generic drug maker said yesterday at the firm’s annual general meeting.
The US House Energy and Commerce Committee on Wednesday last week unanimously advanced a US Food and Drug Administration (FDA) bill that would reauthorize a program in which the regulator collects a fee for new drug and medical device applications from companies to expedite the approval process, TWi Pharmaceuticals chairman Chen Chih-ming (陳志明) told reporters on the sidelines of the company’s shareholders’ meeting in Taipei.
Chen said that the bill is expected to speed up the company’s abbreviated new drug application for the company’s generic drugs in the US market.
The bill, which would reauthorize the Generic Drug User Fee Act (GDUFA) that was first signed into US law in 2012, has since made the approval process quicker in 2014 and 2015, Chen said.
Although a number of generic drug applications submitted by the company were not able to take advantage of the GDUFA in 2012 due to subsequent amendments, Chen said he is upbeat over its anticipated reauthorization, which must be approved every five years.
The company has plans to submit four new applications this year and three had been sent as of the end of last month, Chen said, adding that the company has received preliminary responses from the US FDA.
The company has taken back distribution rights for guanfacine, a treatment for attention deficit hyperactivity disorder from New Jersey-headquartered Par Pharmaceuticals Inc, which has garnered lower-than-expected sales since the partnership was formed in 2015, Chen said.
Among the rows of vibrators, rubber torsos and leather harnesses at a Chinese sex toys exhibition in Shanghai this weekend, the beginnings of an artificial intelligence (AI)-driven shift in the industry quietly pulsed. China manufactures about 70 percent of the world’s sex toys, most of it the “hardware” on display at the fair — whether that be technicolor tentacled dildos or hyper-realistic personalized silicone dolls. Yet smart toys have been rising in popularity for some time. Many major European and US brands already offer tech-enhanced products that can enable long-distance love, monitor well-being and even bring people one step closer to
Malaysia’s leader yesterday announced plans to build a massive semiconductor design park, aiming to boost the Southeast Asian nation’s role in the global chip industry. A prominent player in the semiconductor industry for decades, Malaysia accounts for an estimated 13 percent of global back-end manufacturing, according to German tech giant Bosch. Now it wants to go beyond production and emerge as a chip design powerhouse too, Malaysian Prime Minister Anwar Ibrahim said. “I am pleased to announce the largest IC (integrated circuit) Design Park in Southeast Asia, that will house world-class anchor tenants and collaborate with global companies such as Arm [Holdings PLC],”
Thousands of parents in Singapore are furious after a Cordlife Group Ltd (康盛人生集團), a major operator of cord blood banks in Asia, irreparably damaged their children’s samples through improper handling, with some now pursuing legal action. The ongoing case, one of the worst to hit the largely untested industry, has renewed concerns over companies marketing themselves to anxious parents with mostly unproven assurances. This has implications across the region, given Cordlife’s operations in Hong Kong, Macau, Indonesia, the Philippines and India. The parents paid for years to have their infants’ cord blood stored, with the understanding that the stem cells they contained
Sales in the retail, and food and beverage sectors last month continued to rise, increasing 0.7 percent and 13.6 percent respectively from a year earlier, setting record highs for the month of March, the Ministry of Economic Affairs said yesterday. Sales in the wholesale sector also grew last month by 4.6 annually, mainly due to the business opportunities for emerging applications related to artificial intelligence (AI) and high-performance computing technologies, the ministry said in a report. The ministry forecast that retail, and food and beverage sales this month would retain their growth momentum as the former would benefit from Tomb Sweeping Day