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...
01:36 , Jan 4, 2019 |  BC Week In Review  |  Clinical News

FDA needs more information to approve manufacturing changes to ADMA's Bivigam

ADMA Biologics Inc. (NASDAQ:ADMA) said FDA has issued a complete response letter to a prior approval supplement (PAS) reporting CMC changes to an approved BLA for Bivigam. The company dropped $1.92 (46%) to $2.29 on...
17:41 , Oct 19, 2018 |  BC Week In Review  |  Clinical News

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...
00:48 , Oct 6, 2018 |  BioCentury  |  Finance

Seeking validation

The final stretch of the year offers clinical catalysts and early launch data that could validate investments in hot immuno-oncology targets and large untapped markets. Late-stage readouts from Vertex Pharmaceuticals Inc. in cystic fibrosis and...
00:43 , Jan 13, 2018 |  BioCentury  |  Finance

Choosy investors

  Despite losing steam in 4Q17, the broad-based recovery in biotech stocks last year has left investors generally comfortable with current valuations, and hence less optimistic that the sector indexes will outpace the broader market...
22:18 , Nov 17, 2017 |  BioCentury  |  Emerging Company Profile

New shot at sepsis

Critical Pressure Ltd. is developing a therapy for septic shock to combat hypotension more effectively than marketed vasopressors, and without their side effects. Sepsis is a systemic inflammatory response triggered by severe bacterial infection. Over...
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

Ground up

Steve Edelson, Senior Editor   As the third quarter gets under way, biotech is shaking off the hangover of the Brexit vote while facing the overhang of the November election in the U.S. Fifteen bankers...
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...