Archives

Use the basic search or click on advanced for more search options.

Advanced Search Basic Search Advanced Search

Publications

Section

Select publication to see the relevant sections.

Publication Date

    E.g., 2018-10-21
    E.g., 2018-10-21

Archive Search

259517 items
10:53 AM, Oct 19, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Priority review for Imbruvica-Gazyva combo to treat CLL, SLL

AbbVie Inc. (NYSE:ABBV) said FDA accepted and granted Priority Review to an sNDA for Imbruvica ibrutinib plus Gazyva obinutuzumab to treat chronic lymphocytic leukemia or small lymphocytic leukemia in the first-line setting. AbbVie said the...
10:50 AM, Oct 19, 2018  |  BC Week In Review | Financial News  |  Completed Offerings

Equillium prices $65.4M IPO

Autoimmune and inflammatory disease company Equillium Inc. (NASDAQ:EQ) raised $65.4 million in an IPO on Oct. 12 through the sale of 4.7 million shares at $14. Jefferies, Leerink and Stifel underwrote the offering. The company has...
10:49 AM, Oct 19, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

FDA OKs U.S. trial for Alphamab Oncology's HER2 bispecific antibody

Alphamab Oncology (Suzhou, China) said it received clearance from FDA to begin a U.S. Phase I trial of KN026, a HER2 bispecific antibody. Alphamab Oncology Chairman and CEO Ting Xu said in a statement that this...
10:47 AM, Oct 19, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Acacia provides update on plan to address PONV complete response letter

Acacia Pharma Group plc (Euronext:ACPH) said Oct. 15 that it will complete within one month a plan to address an undisclosed manufacturing deficiency identified by FDA that caused the agency to issue a complete response...
10:46 AM, Oct 19, 2018  |  BC Week In Review | Company News  |  Other News

Trump signs law intended to deter 'pay-for-delay' deals for biosimilars

President Donald Trump signed the Patient Right to Know Drug Prices Act (S.2554) into law on Oct. 10, which includes a provision to make it more difficult for branded drugmakers to strike “pay-for-delay” deals with...
10:46 AM, Oct 19, 2018  |  BC Week In Review | Financial News  |  Completed Offerings

Krystal raises $60M following Phase I/II gene therapy readout

On the heels of reporting data for its topical gene therapy, Krystal Biotech Inc. (NASDAQ:KRYS) raised $60 million late Oct. 18 through the sale 3 million shares at $20 in a follow-on underwritten by Cowen,...
10:41 AM, Oct 19, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA accepts resubmitted BLA for ADMA's RI-002

FDA accepted for review a resubmitted BLA from ADMA Biologics Inc. (NASDAQ:ADMA) for RI-002 to treat primary immune deficiency disease. The PDUFA date is April 2, 2019. In 2016, FDA issued a complete response letter to...
10:40 AM, Oct 19, 2018  |  BC Week In Review | Company News  |  Deals

Revolution acquiring Warp Drive

Revolution Medicines Inc. (Redwood City, Calif.) is expanding its cancer pipeline with the acquisition of another Third Rock Ventures portfolio company, Warp Drive Bio Inc. (Cambridge, Mass.). The financial terms of the deal are undisclosed...
10:38 AM, Oct 19, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Eisai, Purdue insomnia candidate meets in second Phase III

Eisai Co. Ltd. (Tokyo:4523) and Purdue Pharma L.P. (Stamford, Conn.) said lemborexant met the primary and secondary endpoints in the Phase III SUNRISE 2 trial to treat insomnia. The trial is the second Phase III...
10:35 AM, Oct 19, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Transgene brings IV oncolytic virus into the clinic for GI tumors

Transgene S.A. (Euronext:TNG) started a European Phase I/II trial to evaluate its IV-administered oncolytic virus TG6002 in combination with oral 5-fluorouracil (5-FU) chemotherapy prodrug in patients with gastrointestinal tumors. TG6002's viral vector expresses the Saccharomyces...

Pages