03:05 , Jun 30, 2018 |  BioCentury  |  Finance

Hidden in the rough

Judicious stock picking was especially important in the second quarter, as 57% of global biotech stocks saw their equity values decline. Volatility continued to roil global markets during the period and additional uncertainty looms with the...
18:26 , Jun 22, 2018 |  BC Week In Review  |  Clinical News

Teva discontinues Phase III chronic cluster headache trial of fremanezumab

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) discontinued a Phase III trial of fremanezumab (TEV-48125) to prevent chronic cluster headache based on a prespecified futility analysis. The company said a Phase III trial of the...
19:07 , Jun 15, 2018 |  BC Extra  |  Clinical News

Teva discontinues chronic cluster headache trial of fremanezumab

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) discontinued a Phase III trial of fremanezumab (TEV-48125) to prevent chronic cluster headache based on a prespecified futility analysis. The company said a Phase III trial of the...
18:23 , Jun 8, 2018 |  BC Week In Review  |  Clinical News

FDA rebuffs third biosimilar Herceptin

Amgen Inc. (NASDAQ:AMGN) received a complete response letter from FDA for ABP 980. This marks the third CRL the agency has issued for a biosimilar of Herceptin trastuzumab. Amgen declined to disclose details of the...
20:53 , Jun 1, 2018 |  BC Extra  |  Company News

FDA rebuffs third biosimilar Herceptin

Amgen Inc. (NASDAQ:AMGN) said Friday it received a complete response letter from FDA for ABP 980. This marks the third CRL the agency has issued for a biosimilar of Herceptin trastuzumab. Amgen declined to disclose...
19:26 , May 3, 2018 |  BC Extra  |  Company News

Teva reveals delay in migraine timeline, reports earnings

Teva Pharmaceuticals Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) said in its 1Q18 earnings that it does not expect FDA to approve its BLA for migraine prophylactic candidate fremanezumab (TEV-48125) on its mid-June PDUFA date. The company...
19:31 , Apr 27, 2018 |  BC Week In Review  |  Clinical News

Pfizer receives CRL for Herceptin biosimilar

Pfizer Inc. (NYSE:PFE) received a complete response letter from FDA for a BLA for PF-05280014, the company’s biosimilar of Herceptin trastuzumab. Pfizer said FDA requested additional technical information unrelated to safety or clinical data, but...
16:45 , Apr 23, 2018 |  BC Extra  |  Company News

Pfizer receives CRL for Herceptin biosimilar

Pfizer Inc. (NYSE:PFE) received a complete response letter from FDA for a BLA for PF-05280014, the company’s biosimilar of Herceptin trastuzumab. Pfizer said FDA requested additional technical information unrelated to safety or clinical data, but...
23:09 , Apr 6, 2018 |  BioCentury  |  Finance

Fundamentally driven

Continued struggles by the mega-cap bellwethers and the resurgence of volatility in global equity markets were the major themes of 1Q18, whipsawing biotech stocks throughout the quarter but leaving index values little changed on the...
17:09 , Apr 6, 2018 |  BC Week In Review  |  Clinical News

FDA issues CRLs for Celltrion biosimilars

Celltrion Inc. (KOSDAQ:068270) received complete response letters from FDA for BLAs for Herzuma biosimilar trastuzumab (CT-P6) and Truxima biosimilar rituximab (CT-P10). Celltrion told BioCentury the letters are directly related to FDA's January warning letter describing GMP...