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Home » Newsletters » BioWorld

BioWorld

July 10, 2018

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Clinical data for July 9, 2018

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Other news to note

Txcell SA, of Valbonne, France, said it exercised its exclusive option to in-license the intellectual property rights of one of its academic partners, the University of British Columbia, onto the HLA-A2 CAR-Treg program.  Read More

Financings

Constellation Pharmaceuticals Inc., of Cambridge, Mass., set terms for its IPO, planning to offer 5.34 million shares priced in the range of $14 to $16 each.  Read More

Regulatory front

The U.S. SEC is amending its definition of "smaller reporting company," expanding the number of registrants that will qualify for the designation.  Read More

Lack of access to therapy adding to burden of patients living in chronic pain

Billed as a public meeting on patient-focused drug development for chronic pain, the FDA held a listening session Monday that turned into a grass roots rally against government restrictions that are keeping patients from getting the pain treatment they need to get through the day. Read More

Scientists identify new PARP traps, synthetic lethal target

In the course of screening for synthetic lethal interactions, researchers have identified a new mechanism for the formation of DNA lesions that trap the enzyme poly(ADP-ribose) polymerase (PARP) as well as dozens of previously unknown genetic changes that could sensitize cells to PARP inhibition. Read More

Compugen gets green light for two INDs based on computer prediction tech

HONG KONG – Compugen Inc. has two investigational new drug applications (INDs) recently approved by the FDA, as the Israeli company is set to transform from a predictive drug discovery and development company into a clinical-stage venture. Read More

Spero advances lead carbapenem toward phase III cUTI trial

Spero Therapeutics Inc. is laying the groundwork to move its lead candidate, the carbapenem SPR-994, into a phase III trial for people with complicated urinary tract infections (cUTI) around year-end, encouraged by interim phase I data suggesting the candidate can be just as safe and effective as its progenitor, Meiji Seika Pharma Co. Ltd.'s Asia-marketed Orapenem (tebipenem pivoxil). Spero's phase III trial, subject to FDA review, would be a noninferiority study pitting oral SPR-994 against I.V. Merck & Co. Inc.-marketed Invanz (ertapenem), the most commonly prescribed carbapenem for cUTI. Read More

Abingworth adds new investors in $315M Bioventure VII fund

LONDON – Abingworth has closed its latest fund, Bioventure VII, at $315 million, $15 million ahead of target and with the support of 28 new investors, including, for the first time, backers from Asia, for what is the veteran VC firm's 12th life sciences fund. Read More

Pixuvri flunks postmarketing exam in B-cell NHL, jeopardizing conditional EU approval

CTI Biopharma Corp. provided no details but faces limited options for Pixuvri (pixantrone) after a postmarketing phase III trial missed the primary endpoint of progression-free survival (PFS). The study was evaluating the small molecule in combination with Rituxan (rituximab, Roche Holding AG/Biogen Inc.) compared to gemcitabine plus rituximab in patients with aggressive B-cell non-Hodgkin lymphoma (NHL). Read More

Regulatory actions for July 9, 2018

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