BioCentury | Mar 3, 2020
Product Development

March 2 Quick Takes: FDA Priority Review for MorphoSys-Incyte lymphoma therapy; plus Pfizer-Lilly, Merck, AbbVie, Novartis, Cerovene

Priority Review for MorphoSys follows Incyte deal  FDA accepted and granted Priority Review to a BLA for tafasitamab from MorphoSys AG (NASDAQ:MOR; Xetra:MOR) to treat relapsed or refractory diffuse large B cell lymphoma in combination...
BioCentury | Mar 3, 2020
Product Development

Following Phase III readout, Karyopharm seeks approval of Xpovio for second-line MM

Karyopharm gained $11.38 (70%) to $27.72 on Monday, adding about $746 million in market value, after announcing that Xpovio selinexor met the primary endpoint of improving PFS in the confirmatory Phase III BOSTON trial to...
BioCentury | Mar 3, 2020
Regulation

Sanofi sees first fruit of renewed oncology commitment with Sarclisa approval

Sarclisa isatuximab will be the first oncology drug Sanofi launches in more than a decade, its approval Monday marking the pharma’s first cancer win after its re-entry into the space. The company’s next step is...
BioCentury | Feb 29, 2020
Translation in Brief

Genentech finds non-exhausted antitumor T cell source in blood, plus updates on Penn and Chordoma Foundation-Mark Foundation

Genentech identifies blood as source of antitumor T cells   In a Nature article , a Genentech Inc. team reported that non-exhausted T cell clones in the blood could act as a source of antitumor T...
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 | Jan 22, 2020
Clinical News

BeiGene gearing up for PD-1 competition with Merck, Innovent in 1L squamous NSCLC in China

BeiGene announced Tuesday that tislelizumab met the primary endpoint in a Chinese Phase III trial for first-line squamous non-small cell lung cancer. The readout keeps BeiGene’s PD-1 mAb on track as it vies with Innovent’s...
BC Extra | Jan 13, 2020
Company News

Jan. 13 Company Quick Takes: AZ ends fish oil trial; plus Lynparza, Lilly-NextCure, Innovent, Amgen-Qiagen-Guardant, Axsome-Pfizer

AstraZeneca ends CV outcomes trial of Epanova  AstraZeneca plc (LSE:AZN; NYSE:AZN) discontinued the Phase III STRENGTH trial after an IDMC determined it is unlikely to show that Epanova improved cardiovascular outcomes in patients with mixed...
BC Extra | Dec 30, 2019
Company News

FDA approves Lynparza as first PARP inhibitor for pancreatic cancer

FDA’s approval of Lynparza for pancreatic cancer notches a trio of firsts: the first drug approved for the indication based on PFS rather than OS, the first PARP inhibitor approved to treat the disease, and...
BC Extra | Dec 17, 2019
Clinical News

BeiGene looks beyond Phase III setback to build case for Brukinsa

Although a Phase III miss in Waldenström’s macroglobulinemia scuttles Brukinsa’s near-term chances to add a superiority claim to its label, BeiGene believes the Btk inhibitor's combined efficacy and safety profile differentiates it from Imbruvica. BeiGene...
BC Extra | Dec 11, 2019
Clinical News

AstraZeneca, Daiichi’s trastuzumab ADC sets new efficacy bar in breast cancer

Trastuzumab deruxtecan from AstraZeneca and Daiichi Sankyo may have established a new threshold for efficacy in HER2+ breast cancer based on pivotal Phase II data. The data were better, in a sicker patient population, than...
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