22:52 , Apr 26, 2019 |  BC Extra  |  Company News

European regulatory roundup: CHMP opinions and a Portola approval

EMA's CHMP recommended a basket of approvals, including Dovato dolutegravir/lamivudine, Libtayo cemiplimab and two orphan therapies. Also Friday, the European Commission granted conditional approval to Ondexxya andexanet alfa from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) to reverse...
16:15 , Apr 5, 2019 |  BC Week In Review  |  Company News

Sandoz resubmits BLA for Neulasta biosimilar

Sandoz said it resubmitted a BLA to FDA for LA-EP2006 to treat neutropenia in patients with non-myeloid malignancies receiving myelosuppressive drugs. LA-EP2006 is a biosimilar of Neulasta pegfilgrastim from Amgen Inc. (NASDAQ:AMGN). The resubmission from...
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...
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...
17:58 , Jan 11, 2019 |  BC Week In Review  |  Clinical News

Plinabulin meets in Phase III for chemotherapy-induced neutropenia

BeyondSpring Inc. (NASDAQ:BYSI) reported interim data on Dec. 6 showing that plinabulin (BPI-2358) met the primary endpoint in the Phase III portion of the Phase II/III Protective-1 trial to treat chemotherapy-induced neutropenia in patients with...
19:59 , Nov 16, 2018 |  BioCentury  |  Tools & Techniques

Benchtop manufacturing gets smaller

Publisher’s note: This story originally ran in the Nov. 15, 2018 issue of BioCentury Innovations , a comprehensive source of developments in translational research with knowledgeable perspectives on the key innovations, trends and opportunities in...
22:43 , Nov 15, 2018 |  BC Innovations  |  Tools & Techniques

Benchtop manufacturing gets smaller

MIT scientists continue to break new ground in benchtop manufacturing systems for biologics. Published in Nature Biotechnology last month, the latest advance from the institute centered on an automated, closed system capable of producing clinical-grade...
19:55 , Nov 2, 2018 |  BC Week In Review  |  Clinical News

FDA approves Coherus' Neulasta biosimilar

Coherus Biosciences Inc. (NASDAQ:CHRS) said FDA approved Udenyca pegfilgrastim-cbqv to treat cancer patients receiving myelosuppressive chemotherapy. Udenyca is the second FDA-approved biosimilar of neutropenia drug Neulasta drug pegfilgrastim. The European Commission also approved Udenyca for...
21:15 , Jul 9, 2018 |  BC Extra  |  Preclinical News

Portable device can produce GMP-quality proteins

A University of Maryland team developed a portable, customizable device that could enable the production of good manufacturing practice (GMP)-quality protein therapeutics at the point of care, which could be used in disaster-stricken or remote...