BioCentury | Aug 1, 2020
Product Development

July 31 Quick Takes: FDA approves MorphoSys’ tafasitamab; Truvian, AbbVie, Boehringer, Lilly, Alector, Henlius-Accord, Ascletis, Roche, Merck

MorphoSys follows Kress’ first big deal with U.S. approval FDA granted accelerated approval to Monjuvi tafasitamab-cxix from MorphoSys AG (Xetra:MOR; NASDAQ:MOR) and Incyte Corp. (NASDAQ:INCY) in combination with lenalidomide to treat patients with relapsed or...
BioCentury | Dec 7, 2018
Clinical News

RedHill planning NDA for H. pylori antibiotic following second Phase III readout

RedHill Biopharma Ltd. (Tel Aviv:RDHL; NASDAQ:RDHL) said on Dec. 3 that it plans to submit an NDA to FDA next half for Talicia (RHB-105) as first-line treatment of Helicobacter pylori infection regardless of ulcer status...
BioCentury | Dec 3, 2018
Clinical News

RedHill planning NDA for H. pylori antibiotic following second Phase III readout

RedHill Biopharma Ltd. (Tel Aviv:RDHL; NASDAQ:RDHL) plans to submit an NDA to FDA next half for Talicia (RHB-105) as first-line treatment of Helicobacter pylori infection regardless of ulcer status after reporting that the antibiotic met...
BioCentury | Aug 3, 2018
Clinical News

Ascletis' NDA for second HCV therapy accepted in China, company begins trading in Hong Kong

Ascletis Pharma Inc. (HKSE:1672) said China's State Drug Administration accepted its NDA for HCV therapy ravidasvir, a second-generation HCV NS5A protein inhibitor. In June, Ascletis launched HCV drug Ganovo danoprevir in China. Ascletis has rights...
BioCentury | Aug 1, 2018
Financial News

Ascletis trades flat in Hong Kong debut

Ascletis Pharma Inc. (HKSE:1672) shares ended the day unchanged at HK$14 in the company's first day of trading Wednesday. The antiviral company raised HK$3.1 billion ($400 million) in its IPO through the sale of 224.1...
BioCentury | Jul 31, 2018
Company News

Ascletis submits Chinese NDA for second HCV therapy

Ahead of its Hong Kong trading debut Wednesday, Ascletis Pharma Inc. (HKSE:1672) said Tuesday it submitted an NDA to China's State Drug Administration for HCV therapy ravidasvir. The second-generation HCV NS5A protein inhibitor received expedited...
BioCentury | Jul 20, 2018
Financial News

Ascletis sets terms for Hong Kong IPO

In a regulatory filing , antiviral company Ascletis Pharma Inc. (Hangzhou, China) revealed terms of its planned IPO on the Hong Kong exchange. The company hopes to raise HK$2.7-HK$3.6 billion ($342.7-$456.9 million) through the sale of...
BioCentury | May 11, 2018
Financial News

Ascletis first to apply for HKEX biotech chapter

Ascletis Pharma Inc. (Hangzhou, China) plans to list on Hong Kong Exchanges and Clearing Ltd. (HKEX) in an IPO underwritten by Morgan Stanley, Goldman Sachs and China Merchants, according to a regulatory filing on May...
BioCentury | May 7, 2018
Financial News

Ascletis first to apply for HKEX biotech chapter

Ascletis Pharma Inc. (Hangzhou, China) plans to list on Hong Kong Exchanges and Clearing Ltd. (HKEX) in an IPO underwritten by Morgan Stanley, Goldman Sachs and China Merchants Securities, according to a regulatory filing . The...
BioCentury | Mar 9, 2018
Company News

DNDi, partners aim to bring cheaper HCV combo to Latin America

The Drugs for Neglected Diseases initiative said it will partner with three pharmaceutical companies and a non-profit to sell a cheaper HCV regimen in Latin America. HCV patients pay at least $7,000 in Argentina, $12,000...
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