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Home » Newsletters » BioWorld

BioWorld

June 18, 2018

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Conference data: European Hematology Association (Stockholm)

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Regulatory actions for June 15, 2018

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Clinical data for June 15, 2018

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Tumor mutations can aid variant calling for germline

Researchers at the University of Washington have used information from acquired mutations in mismatch repair genes to assess whether the same mutations, when they occurred in the germline, put those that harbored them at risk of Lynch syndrome. Read More

Calliditas prices $74M IPO in Stockholm

DUBLIN – Calliditas Therapeutics AB is raising SEK650 million (US$74 million) in an IPO on the Nasdaq Stockholm exchange, which it priced Friday at SEK45 per share. An overallotment option, if exercised, would push the gross to SEK747 million. Commitments from current shareholders cover about half of the fundraising target. The book-building process kicks off today, and the shares are expected to start trading – under the stock symbol CALTX – on June 29. Read More

Giant strides in breast cancer treatment, but mechanisms of relapse still baffle

For the treatment of breast cancer, the biggest newsmaker at the 2018 American Society of Clinical Oncology (ASCO) annual meeting in Chicago had nothing to do with drug development. Instead, the findings came from a National Cancer Institute (NCI)-sponsored study directing physicians to use less treatment, not more, in most women with a common form of early stage disease. Read More

Sandpiper grounded, MEI to float PI3K pivotal effort; 'top-of-heap' FL candidate

At the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Roche Holding AG reported disappointing news from the phase III Sandpiper study testing the phosphoinositide 3-kinase (PI3K) inhibitor taselisib in breast cancer, news that rocked the beleaguered drug class yet again. MEI Pharma Inc., however, is keeping faith with its PI3K prospect, which also yielded results at ASCO – and impressive ones. Read More

Daiichi looks for Ambit gambit payoff with quizartinib answers in AML

Earlier this month, during the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Daiichi Sankyo Co. Ltd. provided a sneak peek at data from the pivotal phase III QUANTUM-R study of single-agent quizartinib in patients with relapsed/refractory acute myeloid leukemia (r/rAML) with FLT3-ITD mutations. But the Tokyo-based company saved details for the 23rd Congress of the European Hematology Association (EHA) in Stockholm, where the data on the oral selective FLT3 inhibitor were presented as a late-breaking oral presentation during the plenary program. Read More

Ascletis wins nod for first China-developed DAA, aims for HCV blockbuster

HONG KONG – Hangzhou, China-based Ascletis Pharma Inc. said its core product, Ganovo (danoprevir) for the treatment of viral hepatitis C, recently approved by the China Drug Administration (CDA), is poised to be a blockbuster for the startup. Read More

Financings

Noxxon Pharma NV, of Berlin, said it secured €380,000 (US$441,451) of additional financing from existing investors in the form of a convertible bond, which will convert to shares at the terms of a future equity financing round, or starting on Oct. 1, 2018, at the investors option at the market price, which will be reset quarterly to the 10-day volume-weighted average price.  Read More

Regulatory front

The American Medical Association, in a statement published Friday, urged the Federal Trade Commission and the Justice Department to monitor "spiking" insulin pricing and market competition and take enforcement actions as appropriate.  Read More

Other news to note

ERS Genomics Ltd., of Dublin, said the Japanese Patent Office has granted Emmanuelle Charpentier, ERS' co-founder, together with the University of California and University of Vienna, its first Japanese patent, with broad claims covering the single-guide format of CRISPR/Cas9 technology and uses for gene editing.  Read More

Bench Press: BioWorld looks at translational medicine

Researchers from the RV411 study group have reported that even when HIV-infected individuals started antiretroviral treatment (ART) within two weeks of infection, it could not prevent the establishment of a viral reservoir nor the occurrence of viral rebound if treatment was interrupted.  Read More

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