16:25 , Apr 19, 2019 |  BioCentury  |  Finance

Earnings on deck

Earnings on deck At least 12 profitable biotechs and pharmas are slated to report earnings this week. (A) During trading hours in Europe; premarket on U.S. exchange; (B) Full-year EPS for fiscal year ended March...
01:56 , Mar 8, 2019 |  BC Innovations  |  Targets & Mechanisms

Oral insulin innovation

While clinical data suggest an oral insulin product may finally be within reach, the technology struggles to compete with injectables on price and efficacy. A handful of academics and companies are pushing preclinical innovation in...
00:38 , Jan 25, 2019 |  BC Week In Review  |  Clinical News

Samsung's Herceptin biosimilar gains U.S. approval

FDA approved a BLA for Ontruzant trastuzumab-dttb from Samsung Bioepis Co. Ltd. (Incheon, Korea), a biosimilar of Herceptin. The biosimilar is Samsung Bioepis' first approved in the U.S. to treat cancer. Ontruzant received approval for...
16:55 , Jan 22, 2019 |  BC Extra  |  Company News

Samsung's Herceptin biosimilar gains U.S. approval

FDA approved a BLA for Ontruzant trastuzumab-dttb from Samsung Bioepis Co. Ltd. (Incheon, Korea), a biosimilar of Herceptin. The biosimilar is Samsung Bioepis' first approved in the U.S. to treat cancer. Ontruzant received approval for...
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...
14:30 , Dec 11, 2018 |  BC Extra  |  Politics & Policy

FDA biosimilars policies will bring interchangeable insulin to market

New FDA policies will lead to approvals of interchangeable insulin products that can be automatically substituted for branded insulin, FDA Commissioner Scott Gottlieb said Tuesday. Gottlieb made the prediction in a statement about new guidance...
19:29 , Oct 26, 2018 |  BC Week In Review  |  Clinical News

CHMP backs Takhzyro, Dengue vaccine, biosimilar Herceptin

EMA’s CHMP on Oct. 19 recommended several approvals, including hereditary angioedema (HAE) mAb Takhzyro lanadelumab, dengue vaccine Dengvaxia and Herceptin trastuzumab biosimilar Ogivri. CHMP backed Takhzyro from Shire plc (LSE:SHP; NASDAQ:SHPG) to prevent recurrent attacks...
23:38 , Oct 19, 2018 |  BC Extra  |  Company News

CHMP backs Takhzyro, Dengue vaccine, biosimilar Herceptin

EMA’s CHMP recommended several approvals Friday, including hereditary angioedema (HAE) mAb Takhzyro lanadelumab, dengue vaccine Dengvaxia and Herceptin trastuzumab biosimilar Ogivri. CHMP backed Takhzyro from Shire plc (LSE:SHP; NASDAQ:SHPG) to prevent recurrent attacks of HAE....
23:30 , Oct 19, 2018 |  BioCentury  |  Finance

Earnings on deck

Earnings on deck At least 11 profitable biotechs and pharmas are slated to report earnings this week. (A) Fiscal 2Q Company Date Pre/post mkt 3Q18 EPS est 3Q17 EPS Expected chg Biogen Inc. (NASDAQ:BIIB) 10/23...