BioCentury | Jun 23, 2020
Product Development

June 22 Quick Takes: Invitae acquiring ArcherDX; plus lymphoma approval for Karyopharm, Merck, Nabriva, Myovant, Assembly-AbbVie, Genentech and more

ArcherDX picks deal with Invitae over IPO  Genetic testing company Invitae (NYSE:NVTA) is acquiring ArcherDX Inc., adding a cancer diagnostics platform to its precision oncology business. ArcherDX’s shareholders will receive $325 million in cash plus...
BC Extra | Aug 19, 2019
Company News

Nabriva gets first approval in novel antibiotic class

Nabriva plans to launch its first approved antibiotic, Xenleta lefamulin, in mid-September to treat community-acquired bacterial pneumonia, and the company has taken steps to facilitate Xenleta's adoption through negotiations with healthcare providers, payers and pharmacies....
BC Extra | Aug 16, 2019
Company News

Ahead of FDA decisions on one antibiotic, Nabriva plans resubmission of another

As it awaits FDA's decisions on twin NDAs for lefamulin, Nabriva said it plans to resubmit an NDA early next quarter for another one of its antibiotics following a complete response letter this year. Nabriva...
BioCentury | Jun 29, 2019

Biotech backs down in 2Q19

In a reversal from 1Q19, biotech stocks across all market cap tiers fell in the second quarter, leading to a total loss of $22.3 billion. However, the year-to-date change in market cap remains well in...
BC Extra | May 1, 2019
Company News

May 1 Company Quick Takes: Heron, Nabriva, Allergan, GSK, Merck, Alnylam

Complete response letter for Heron’s non-opioid pain therapy  Heron Therapeutics Inc. (NASDAQ:HRTX) was off $3.93 (18%) to $17.75 on Wednesday after FDA issued a complete response letter for an NDA for HTX-011 to manage postoperative...
BioCentury | Apr 6, 2019

Big caps under pressure

Biogen’s fall in the wake of its decision to discontinue late-stage trials of Alzheimer’s therapy aducanumab is yet another reminder that large caps are in dire need of new pipeline products, and could serve as...
BC Week In Review | Jan 18, 2019
Clinical News

FDA moves up PDUFA for Nabriva's Contepo by two months

Nabriva Therapeutics plc (NASDAQ:NBRV) said FDA accelerated its review timeline for Nabriva's broad-spectrum antibiotic Contepo fosfomycin, moving the NDA's PDUFA date to April 30 from June 30. Nabriva said the accelerated timeline is "due to...
BioCentury | Oct 6, 2018

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...
BC Week In Review | Jul 27, 2018
Company News

Nabriva acquires Zavante

Nabriva Therapeutics plc (NASDAQ:NBRV) acquired Zavante Therapeutics Inc. (San Diego, Calif.) for 8.2 million Nabriva shares, or $27.1 million based on the company’s close of $3.30 on July 24, before the acquisition was announced after...
BC Week In Review | Apr 7, 2017
Clinical News

Zolyd: Ph II/III ZEUS data

The double-blind, international Phase II/III ZEUS trial in 465 patients showed that thrice-daily 6 g IV Zolyd met the primary endpoint of non-inferiority to thrice-daily 4.5 g piperacillin/tazobactam in the proportion of patients who achieved...
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