22:41 , Jun 4, 2019 |  BC Extra  |  Company News

Management tracks: Vericel, Theravance, Eisai

Cell therapy company Vericel Corp. (NASDAQ:VCEL) disclosed in an SEC filing that Daniel Orlando resigned as COO on May 28 to become CEO of a private biotech company. SVP, Quality and Regulatory Affairs Michael Halpin...
22:43 , May 15, 2019 |  BC Extra  |  Company News

May 15 Company Quick Takes: Approvals for Bavencio in RCC, Venclexta-Gazyva combo; plus Adaptimmune, Alpine, Advaxis

Bavencio gets RCC approval with Inlyta  FDA approved Bavencio avelumab from Merck KGaA (Xetra:MRK) and Pfizer Inc. (NYSE:PFE) for first-line treatment of advanced renal cell carcinoma in combination with Pfizer's Inlyta axitinib, making Bavencio the...
19:29 , Dec 21, 2018 |  BC Week In Review  |  Company News

Amgen pulls out of Advaxis immunotherapy deal

Advaxis Inc. (NASDAQ:ADXS) will continue to enroll patients in a Phase I trial of its ADXS-NEO program despite Amgen Inc. (NASDAQ:AMGN) pulling out of a 2016 deal to develop the immunotherapy. Advaxis shares slid 37%...
23:37 , Dec 14, 2018 |  BC Extra  |  Company News

Amgen pulls out of Advaxis immunotherapy deal

Advaxis Inc. (NASDAQ:ADXS) will continue to enroll patients in a Phase I trial of its ADXS-NEO program despite Amgen Inc. (NASDAQ:AMGN) pulling out of a 2016 deal to develop the immunotherapy. Advaxis shares slid 37%...
17:53 , Aug 29, 2018 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Cervical cancer; skin cancer Mouse studies suggest a vaccine based on a nanoparticle-HpV16gp2 peptide conjugate could help treat human papillomavirus (HPV)-associated cancers. The conjugate consists of nanoparticles with a polypropylene sulfide core and HpV16gp2...
18:53 , Jul 13, 2018 |  BC Week In Review  |  Clinical News

FDA lifts hold on Phase I/II of axalimogene filolisbac for SCCHN

Advaxis Inc. (NASDAQ:ADXS) said FDA lifted a clinical hold on a Phase I/II combination study that includes the company's axalimogene filolisbac (ADXS11-001). The trial is evaluating the therapy in combination with PD-L1 inhibitor Imfinzi durvalumab...
16:24 , Jul 13, 2018 |  BC Extra  |  Clinical News

Advaxis rises after FDA lifts clinical hold

Advaxis Inc. (NASDAQ:ADXS) jumped $0.12 (10%) to $1.34 Friday after it said FDA lifted a clinical hold on a Phase I/II combination study that includes the company's axalimogene filolisbac (ADXS11-001). The trial is evaluating the...
17:11 , Mar 16, 2018 |  BC Week In Review  |  Clinical News

FDA places hold on Advaxis' combo trial

Advaxis Inc. (NASDAQ:ADXS) said FDA placed a clinical hold on a Phase I/II trial of axalimogene filolisbac (ADXS11-001) in combination with PD-L1 inhibitor Imfinzi durvalumab to treat HPV-related cancers. According to the company, the hold...
17:07 , Mar 13, 2018 |  BC Extra  |  Financial News

Clinical hold sinks Advaxis shares

Advaxis Inc. (NASDAQ:ADXS) tumbled $0.26 (12%) to $1.95 on Tuesday after the company announced late Monday that FDA had placed a clinical hold on a Phase I/II trial of axalimogene filolisbac (ADXS11-001) (see BioCentury Extra,...
23:33 , Mar 12, 2018 |  BC Extra  |  Clinical News

FDA places hold on Advaxis' combo trial

Advaxis Inc. (NASDAQ:ADXS) fell $0.49 (22%) to $1.72 in after-hours trading Monday after it said FDA placed a clinical hold on a Phase I/II trial of axalimogene filolisbac (ADXS11-001) in combination with PD-L1 inhibitor Imfinzi...