19:24 , May 17, 2019 |  BioCentury  |  Product Development

Pushing China to the forefront: When a first-in-China regulatory strategy makes sense

As reforms in China shorten clinical and regulatory timelines for biotechs across the board, the country has a growing chance to become the first stop for regulatory approvals of first-in-class drugs. The decision to do...
17:15 , Apr 5, 2019 |  BC Week In Review  |  Company News

Pierre Fabre gets European, African rights to Puma's Nerlynx

Pierre Fabre will pay $60 million up front for commercialization rights to Puma's Nerlynx neratinib in Europe, excluding Russia and Ukraine, and in certain North and West African countries. Puma Biotechnology Inc. (NASDAQ:PBYI) is also...
19:01 , Mar 15, 2019 |  BC Extra  |  Company News

Another setback for Spectrum's remaining pipeline after Rolontis BLA withdrawal

Spectrum said Friday that it withdrew a BLA for Rolontis eflapegrastim to treat chemotherapy-induced neutropenia. Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) said it needs more time to provide additional manufacturing-related information to FDA, which was due before...
18:55 , Feb 7, 2019 |  BC Week In Review  |  Clinical News

CHMP recommendations include Ajovy, Vizimpro, Humira biosimilars

EMA's CHMP recommended a basket of approvals and label extensions on Feb. 1, including Ajovy fremanezumab, Vizimpro dacomitinib and two Humira biosimilars. CHMP also backed an expanded label for Forxiga dapagliflozin to include Type I...
23:18 , Feb 1, 2019 |  BioCentury  |  Product Development

Year of the lion

With three data readouts coming in 2019, Aslan Pharmaceuticals Ltd. is hoping this will be the year it starts to reap the benefits of its 2012 strategy rethink, giving the biotech more options for advancing...
21:12 , Feb 1, 2019 |  BC Extra  |  Company News

CHMP recommendations include Ajovy, Vizimpro, Humira biosimilars

EMA's CHMP recommended a basket of approvals and label extensions on Friday, including Ajovy fremanezumab, Vizimpro dacomitinib and two Humira biosimilars. CHMP also backed an expanded label for Forxiga dapagliflozin to include Type I diabetes....
20:31 , Jan 18, 2019 |  BC Week In Review  |  Company News

Spectrum divesting marketed products to focus on late-stage programs

Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) is selling its marketed hematology/oncology portfolio to Acrotech Biopharma LLC to focus on developing and commercializing its two remaining late-stage compounds, Rolontis eflapegrastim and poziotinib. Spectrum will receive $160 million up...
23:28 , Jan 17, 2019 |  BC Extra  |  Company News

Spectrum divesting marketed products to focus on late-stage programs

Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) is selling its marketed hematology/oncology portfolio to Acrotech Biopharma LLC to focus on developing and commercializing its two remaining late-stage compounds, Rolontis eflapegrastim and poziotinib. Spectrum will receive $160 million up...
17:34 , Jan 17, 2019 |  BC Week In Review  |  Clinical News

Aslan reports gastric, biliary tract cancer data for varlitinib

Aslan Pharmaceuticals Ltd. (TPEx:6497; NASDAQ:ASLN) said Jan. 14 that its pan-HER inhibitor varlitinib missed the primary endpoint of a Phase II trial to treat gastric cancer. The study evaluated varlitinib as a first-line therapy in...
15:08 , Jan 14, 2019 |  BC Extra  |  Clinical News

Aslan dips after Phase II gastric cancer miss

Aslan Pharmaceuticals Ltd. (TPEx:6497; NASDAQ:ASLN) said its pan-HER inhibitor varlitinib missed the primary endpoint of a Phase II trial to treat gastric cancer. Aslan shares slid $2.75 (10%) to $24.90 in Taipei on Monday, and...