BioCentury | Feb 14, 2020
Product Development

Feb. 13 Product Development Quick Takes: Priority Review for BMS, Seattle Genetics, Deciphera therapies; plus Roche, Ipsen, Merck, Eisai and Amgen-Pfizer

August decision dates for BMS, Seattle Genetics, Deciphera  A trio of cancer therapies have received Priority Review from FDA with August PDUFA dates. Bristol-Myers Squibb Co. (NYSE:BMY) said FDA accepted a BLA for lisocabtagene maraleucel...
BC Extra | Dec 26, 2019
Clinical News

Spectrum’s value halved after poziotinib’s failure in NSCLC cohort

Eleven months after Spectrum divested its marketed products to sharpen its focus on a pair of clinical candidates, one of the two has failed in the first cohort of a Phase II trial, while the...
BC Extra | Apr 26, 2019
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...
BC Week In Review | Apr 5, 2019
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...
BC Extra | Mar 15, 2019
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...
BC Week In Review | Jan 18, 2019
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...
BC Extra | Jan 17, 2019
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...
BC Week In Review | Jan 11, 2019
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...
BioCentury | Nov 16, 2018
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 early...
BC Innovations | Nov 15, 2018
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...
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