BioCentury | Aug 1, 2020
Product Development

July 31 Quick Takes: FDA approves MorphoSys’ tafasitamab; Truvian, AbbVie, Boehringer, Lilly, Alector, Henlius-Accord, Ascletis, Roche, Merck

MorphoSys follows Kress’ first big deal with U.S. approval FDA granted accelerated approval to Monjuvi tafasitamab-cxix from MorphoSys AG (Xetra:MOR; NASDAQ:MOR) and Incyte Corp. (NASDAQ:INCY) in combination with lenalidomide to treat patients with relapsed or...
BioCentury | Jul 3, 2020

July 2 Quick Takes: Novartis to ante up $678M in settlement; plus Zai, Neoleukin, Base Genomics, Sarepta-Hansa, Dr. Reddy-Fujifilm

Novartis to pay $678M in kickbacks settlement  Novartis AG (NYSE:NVS; SIX:NOVN) will pay $678 million and, under a corporate integrity agreement, conduct its speaker programs virtually for the next five years after the pharma reached...
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...
BioCentury | Jun 19, 2020
Product Development

InflaRx, Kiniksa anti-inflammatory mAbs yield trend toward lower COVID-19 mortality, plus Sinopharm reports antibody readout from vaccine trial

After dexamethasone set a new bar for mortality reduction in COVID-19 patients this week, InflaRx and Kiniksa reported data from their anti-inflammatory mAbs showing trends toward a survival benefit. InflaRx N.V. (NASDAQ:IFRX) announced on Wednesday...
BioCentury | Jun 11, 2020
Product Development

Emerging COVID-19 serology tests aim for neutralizing antibodies

The next wave of serology tests from big diagnostic players could get closer to telling people whether they are protected from COVID-19 by homing in on the antibodies most likely to block viral entry into...
BioCentury | Jun 5, 2020
Emerging Company Profile

Epsilogen: co-opting IgE antibodies against cancer

Epsilogen is taking a long overlooked isotype of human antibodies -- the IgE class -- and leveraging their high affinity for immune effector cells to seek out and destroy solid tumors. “What we are doing...
BioCentury | Jun 2, 2020
Tools & Techniques

Spark’s approach to the problem of redosing AAV gene therapies

Spark aims to solve one of the big problems plaguing gene therapy -- immune responses against viral vectors -- by adapting a strategy Hansa has been developing for transplant rejection. Past infections with adenoviruses or...
BioCentury | May 9, 2020
Targets & Mechanisms

Connecting COVID-19 antibody responses to disease protection, one data set at a time

Reports that most if not all COVID-19 survivors have antiviral antibodies are beginning to set benchmarks for immunity, but understanding how much protection different levels and types of antibodies provide will be critical for determining...
BioCentury | May 2, 2020
Product Development

Good test hunting: FDA authorizations point to benchmarks for COVID-19 serology

The critical role of COVID-19 antibody testing in reopening society -- combined with controversy around the regulatory flexibility these tests have received and reports that some are performing poorly -- have put all eyes on...
BioCentury | Apr 30, 2020
Product Development

NIH competition to encourage COVID-19 diagnostic innovation, pad U.S. testing capacity

As dozens of leading biopharmas, research institutes and health agencies embrace precompetitive coalitions and master protocols to speed development of COVID-19 therapies and vaccines, NIH has created a competition to accelerate diagnostics. The organization today...
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