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Home » Newsletters » BioWorld

BioWorld

May 23, 2019

View Archived Issues

COX and LOX: For immune response, tolerance beats scorched-earth

For the immune system, the self and non-self are something like the proverbial rock and a hard place. In order to be effective, the system as a whole needs to react vigorously to pathogens. But that vigorous reaction can also damage the organism it is meant to protect. The conundrum is on display in influenza infections. Read More

Nuevolution stock rockets on $167M offer from Amgen

DUBLIN – Shares in Nuevolution AB skyrocketed by 166% Wednesday on news of a $167 million cash offer from Amgen Inc., which values the company a whole lot more than the market ever did. Read More

Elevatebio portfolio company Allovir launches with $120M series B round

Little more than a week after corralling $150 million to create and build a portfolio of cell and gene therapy companies, Elevatebio Inc. is revealing its first play, backing a Houston-based startup making allogeneic cell therapies to battle viral pathogens. The Baylor College of Medicine spinout, Allovir, will use a new $120 million series B financing to initiate multiple pivotal studies for its lead product, Viralym-M, in the next 12 months, while also advancing a second candidate to the clinic. Read More

Locana closes $55M series A to advance RNA-targeting gene therapy approaches

It was time for Locana Inc., a San Diego-based biopharma, to grow itself, its science and its profile, according to newly installed director and CEO Jeffrey Ostrove, so the company sought out and just closed on an oversubscribed $55 million series A deal. Read More

Mixed reaction to glioma trial continuation sends Tocagen falling; data expected year-end

Tocagen Inc.'s disclosure that the independent data monitoring board for its ongoing phase III trial in recurrent high-grade glioma (HGG) recommended the study continue without modification following a planned interim analysis drew mixed reactions from analysts and sent shares of the San Diego-based company (NASDAQ:TOCA) falling 38% Wednesday. Read More

Supreme Court adds three years to whistleblowers' statute of limitations

The statute of limitations for qui tam lawsuits was fairly simple until 1986, and they just became even more complicated thanks to the U.S. Supreme Court's recent decision in a whistleblower case. The Court determined that whistleblowers are entitled to a three-year extension on the six-year statute of limitations even when the government decides not to intervene, a ruling that will expose drug- and device makers to greater liability under the False Claims Act (FCA). Read More

Regulatory front

Japan's Pharmaceuticals and Medical Devices Agency (PMDA) issued a Blue Letter warning to health care professionals about the possibility of interstitial lung disease in patients treated with Indianapolis-based Eli Lilly and Co.'s breast cancer drug, Verzenio (abemaciclib).  Read More

Financings

Bioasis Technologies Inc., of Guilford, Conn., said it closed its private placement, issuing 4.58 million units, consisting of one common share and one common share purchase warrant, at CA28 cents each, for gross proceeds of CA$1.28 million ($US953,168).  Read More

Appointments and advancements

Voyager Therapeutics Inc., of Cambridge, Mass., appointed Omar Khwaja chief medical officer and head of research and development, effective June 28. Read More

Other news to note

Medigene AG, of Martinsried, Germany, established a clinical trial agreement with Leiden University Medical Center to conduct a phase I study of MDG-1021, a T-cell receptor modified T-cell therapy targeting the HA-1 antigen. The study is scheduled to start in 2020. Read More

Clinical data for May 22, 2019

Read More

Regulatory actions for May 22, 2019

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