07:00 , Aug 8, 2016 |  BC Week In Review  |  Clinical News

RI-002 regulatory update

FDA issued a complete response letter to a BLA from ADMA for R1-002, an IV immunoglobulin (IVIG), to treat primary immunodeficiency disease (PIDD). According to ADMA, the agency cited no safety or efficacy concerns and...
07:00 , Jul 11, 2016 |  BioCentury  |  Finance

Rethinking risk

Steve Edelson, Senior Editor   The second half does not contain the high-impact, sector-moving milestones seen in the first six months of the year, but investors still have at least 90 late-stage milestones from which to...
07:00 , May 23, 2016 |  BC Week In Review  |  Financial News

ADMA completes debt financing

ADMA Biologics Inc. (NASDAQ:ADMA), Ramsey, N.J.   Business: Hematology, Infectious   Date completed: 2016-05-13   Type: Debt financing   Raised: $4 million   Investor: Oxford Finance   Note: ADMA drew down an additional $4 million under an amended June 2015 loan...
08:00 , Jan 11, 2016 |  BioCentury  |  Finance

Sowing season

Stephen Hansen, Associate Editor   BUYSIDE VIEW XXIV While the biotech sector's three-year rocket ride isn't likely to continue in 2016, fund managers are still anticipating a slew of high-profile milestones in the New Year. This year...
07:00 , Sep 28, 2015 |  BC Week In Review  |  Clinical News

Subgam-VF: Phase III started

Bio Products began the open-label, U.S. Phase III SCIG03 trial to evaluate weekly subcutaneous Subgam-VF for up to 26 weeks in about 35 patients. Bio Products Laboratory Ltd., Elstree, U.K.   Product: Subgam-VF   Business: Autoimmune...
07:00 , Jun 29, 2015 |  BC Week In Review  |  Financial News

ADMA completes debt financing

ADMA Biologics Inc. (NASDAQ:ADMA), Ramsey, N.J.   Business: Hematology, Infectious   Date completed: 2015-06-22   Type: Debt financing   Raised: $16 million   Investor: Oxford Finance   Note: ADMA drew down $16 million in the first tranche of a new $21...
07:00 , Apr 6, 2015 |  BioCentury  |  Finance

Q is for quiet

Investors expect 2Q15 to be fairly quiet in terms of news flow until the deluge of data for cancer immunotherapy combinations come out in June at the American Society of Clinical Oncology meeting. The problem...
08:00 , Mar 2, 2015 |  BC Week In Review  |  Clinical News

RI-002: Additional Phase III data

Additional data from the open-label, U.S. Phase III ADMA-003 trial in 59 patients with PIDD who received 300-800 mg/kg IV RI-002 for 12 months showed that a total of 93 days of work/school/daycare were lost...
08:00 , Dec 22, 2014 |  BC Week In Review  |  Clinical News

RI-002: Phase III data

Top-line data from the open-label, U.S. Phase III ADMA-003 trial in 59 patients with PIDD showed that 300-800 mg/kg IV RI-002 for 12 months met the primary endpoint of preventing serious bacterial infections. Specifically, there...
08:00 , Nov 11, 2013 |  BC Week In Review  |  Clinical News

RI-002: Completed Phase III enrollment

ADMA completed enrollment of about 60 patients in an open-label, U.S. Phase III trial evaluating 300-800 mg/kg IV RI-002 every 21 or 28 days for 12 months. ADMA said RI-002 demonstrated improved production yields, an...