00:28 , Mar 15, 2019 |  BC Week In Review  |  Clinical News

Galderma planning Phase III program for atopic dermatitis therapy

Galderma said nemolizumab met the primary endpoint in a Phase IIb trial to treat adults with moderate-to-severe atopic dermatitis not adequately controlled by topical corticosteroids. The company plans to start a Phase III program of...
18:24 , Mar 7, 2019 |  BC Innovations  |  Distillery Therapeutics

mir-515 inhibitor sensitizes HER2-negative breast and liver cancers to Kadcyla, Herceptin

DISEASE CATEGORY: Cancer INDICATION: Breast cancer; liver cancer In vitro and cell culture studies suggest an inhibitor of miR-515 could sensitize HER2-negative breast and liver cancers to anti-HER2 therapies. Chemical synthesis and in vitro testing...
03:20 , Feb 16, 2019 |  BioCentury  |  Product Development

ADCs’ inflection point

Industry is writing a new rule book for antibody-drug conjugates that could take the modality beyond the one-size-fits-all approach that has limited its success. By 2Q20, late-stage data from at least four ADCs testing new...
00:41 , Feb 9, 2019 |  BioCentury  |  Product Development

Genentech takes the wheel

Roche has good cause to call on Genentech to prevent it from losing its long-standing dominance in cancer. While the pharma is late to the party in immuno-oncology, its former biotech unit is behind at...
00:23 , Jan 12, 2019 |  BioCentury  |  Finance

We all fall down

After an exuberant third quarter that put biotech indexes near their 2015 highs, all market cap tiers fell in 4Q18, eliminating the first nine month’s gains and losing $291.2 billion in aggregate value. Median losses...
02:49 , Jan 5, 2019 |  BioCentury  |  Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
19:07 , Jan 4, 2019 |  BC Week In Review  |  Clinical News

Viela planning BLA submission for inebilizumab in rare CNS disorder

Viela Bio Inc. (Gaithersburg, Md.) said it will submit a BLA to FDA this half for inebilizumab (MEDI-551) to treat neuromyelitis optica spectrum disorder (NMOSD) after the compound met the primary endpoint in the Phase...
01:42 , Jan 4, 2019 |  BC Week In Review  |  Clinical News

Japan approves Foundation Medicine's genomic profiling and companion diagnostic cancer test

Japan's Ministry of Health, Labour and Welfare (MHLW) approved FoundationOne CDx from Foundation Medicine Inc. and Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) as a comprehensive genomic profiling test for all solid tumors and as a companion...
12:06 , Jan 3, 2019 |  BC Extra  |  Clinical News

Viela planning BLA submission for inebilizumab in rare CNS disorder

Viela Bio Inc. (Gaithersburg, Md.) said it will submit a BLA to FDA this half for inebilizumab (MEDI-551) to treat neuromyelitis optica spectrum disorder (NMOSD) after the compound met the primary endpoint in the Phase...
19:26 , Dec 21, 2018 |  BC Week In Review  |  Clinical News

Chugai's IL-6 receptor mAb meets in Phase III for rare CNS disorder

Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) said satralizumab (SA237, RG6168) as monotherapy met the primary endpoint in the Phase III SAkuraStar trial to treat neuromyelitis optica spectrum disorder (NMOSD). The company plans to submit regulatory applications...