21:44 , Mar 22, 2019 |  BC Extra  |  Clinical News

After aducanumab failure, Eisai to test another anti-amyloid mAb

With the announcement that Eisai plans to start yet another Phase III trial of an anti-amyloid candidate, Alzheimer's disease researcher Rudolph Tanzi told BioCentury he wouldn't enroll any more AD patients in trials of therapies...
18:05 , Mar 15, 2019 |  BC Week In Review  |  Clinical News

Lilly looks to expand Cyramza's label into first-line NSCLC

Eli Lilly said it plans to initiate global regulatory applications mid-year seeking to expand the label of Cyramza ramucirumab to include first-line treatment of metastatic non-small cell lung cancer in patients whose tumors have activating...
23:51 , Mar 14, 2019 |  BC Week In Review  |  Company News

GTx and Oncternal merging

GTx and Oncternal will merge to create a company focused on developing cancer therapies. Oncternal Therapeutics Inc. (San Diego, Calif.) will hold about 75% of the combined company, which will trade on NASDAQ under the...
21:32 , Mar 14, 2019 |  BC Extra  |  Preclinical News

Antibody-drug conjugate against ALK could selectively treat neuroblastoma

Researchers from CHOP and Celldex showed that an antibody-drug conjugate targeting ALK selectively kills neuroblastoma cells, suggesting the ADC could have a better safety profile than marketed drug dinutuximab. Unituxin dinutuximab from United Therapeutics Corp....
18:02 , Mar 13, 2019 |  BC Innovations  |  Distillery Therapeutics

Cocktails of AAV vectors encoding anti-HIV bNAbs to treat the infection

DISEASE CATEGORY: Infectious disease INDICATION: HIV/AIDS Non-human primate studies suggest cocktails of viral vectors encoding broadly neutralizing antibodies (bNAbs) against multiple HIV antigens could help treat HIV. The antibodies consist of variable regions of previously...
17:36 , Mar 8, 2019 |  BC Week In Review  |  Company News

CHMP recommendations include Ondexxya, Waylivra

EMA's CHMP recommended a basket of approvals and label extensions on March 1, including Ondexxya andexanet alfa and Waylivra volanesorsen. The agency recommended conditional approval of Ondexxya from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) as the first...
22:10 , Mar 1, 2019 |  BC Extra  |  Company News

CHMP recommendations include Ondexxya, Waylivra

EMA's CHMP recommended a basket of approvals and label extensions Friday, including Ondexxya andexanet alfa and Waylivra volanesorsen. The agency recommended conditional approval of Ondexxya from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) as the first approved antidote...
01:44 , Feb 21, 2019 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Multiple myeloma (MM) Studies in mice characterized two immunotoxins that could help treat BCMA-expressing MM. The immunotoxins consist of the cytotoxic Pseudomonas aeruginosa exotoxin domain III linked to a BCMA-targeting Fab fragment or variable...
20:02 , Feb 15, 2019 |  BC Week In Review  |  Clinical News

Allakos reports Phase II data of AK002 for refractory chronic urticaria

Allakos Inc. (NASDAQ:ALLK) said AK002 improved urticaria control test scores in six of 11 Xolair omalizumab-refractory chronic spontaneous urticaria patients in a Phase II trial. In the open-label, U.S. trial, patients received an initial AK002...
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...