20:51 , Mar 26, 2019 |  BC Extra  |  Company News

Japan approvals include Kymriah as Japan's first CAR T therapy

Japanese regulators approved a basket of drugs on Tuesday, including the first CAR T cell therapy in Japan. Novartis AG (NYSE:NVS; SIX:NOVN) said Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Kymriah tisagenlecleucel to...
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...
23:21 , Mar 7, 2019 |  BC Extra  |  Company News

Moderna announces pipeline updates in first financial results

In its first quarterly financial results as a public company, Moderna announced its first rare disease mRNA program is heading to the clinic. Moderna Inc. (NASDAQ:MRNA) said Wednesday that it has submitted an IND for...
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...
19:01 , Feb 21, 2019 |  BC Innovations  |  Translation in Brief

Bugging inflammation in lung cancer

An MIT study linking the lung microbiome to inflammation offers new therapeutic strategies for treating lung cancer and a mechanistic rationale for testing cytokine inhibitors in the disease, a tack Novartis AG (NYSE:NVS; SIX:NOVN) has...
16:04 , Feb 5, 2019 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Colorectal cancer; melanoma; cancer Mouse studies suggest an mRNA immunotherapy based on IL-36γ, IL-23 and OX40L could help treat colorectal cancer, melanoma and other cancers, including those resistant to checkpoint inhibitors. The therapy consists...
00:04 , Jan 31, 2019 |  BC Extra  |  Preclinical News

Moderna's triplet mRNA therapy treats checkpoint inhibitor-resistant tumors in mice

Moderna Inc. (NASDAQ:MRNA) published preclinical data Wednesday showing a triple mRNA combination product has efficacy against solid tumors, including those resistant to checkpoint inhibitors. The company's mRNA-2752 contains mRNAs encoding IL-23, IL-36γ and OX40L encapsulated...
03:03 , Jan 26, 2019 |  BioCentury  |  Product Development

Target wide, test narrow in lupus

While last year’s spate of clinical misses in lupus leave the field still in search of optimal targets, the 2019 outlook isn’t all doom. Companies with shots on goal are using sharper endpoints and aiming...
21:19 , Dec 14, 2018 |  BC Week In Review  |  Clinical News

Tremfya superior to Cosentyx in head-to-head Phase III trial

Janssen Biotech Inc. said Tremfya guselkumab met the primary endpoint of improving PASI 90 response rate vs. Cosentyx secukinumab from Novartis AG (NYSE:NVS; SIX:NOVN) in the Phase III ECLIPSE trial to treat moderate to severe...
23:31 , Dec 12, 2018 |  BC Extra  |  Clinical News

Tremfya superior to Cosentyx in head-to-head Phase III trial

Janssen Biotech Inc. said Tremfya guselkumab met the primary endpoint of improving PASI 90 response rate vs. Cosentyx secukinumab from Novartis AG (NYSE:NVS; SIX:NOVN) in the Phase III ECLIPSE trial to treat moderate to severe...