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Home » Newsletters » BioWorld

BioWorld

July 11, 2019

View Archived Issues

Jazz deal seeks to move Redx out of red, into black

Jazz Pharmaceuticals plc's acquisition of Redx Pharma plc's pan-RAF inhibitor program for treating RAF- and RAS-mutant tumors was rocket fuel for Redx's stock (AIM:REDX), which closed 108% higher than it opened, offering some relief for the struggling company. Read More

Osivax advancing universal flu vaccine with $9M series A

DUBLIN – Early stage vaccine developer Osivax SAS raised €8 million (U$9 million) in series A funding to continue development of a clinical-stage universal influenza vaccine, based on what it believes is a highly immunogenic method of presenting the viral nucleoprotein to the immune system. Read More

First soft tissue sarcoma drug cleared in China as NMPA approves Focus V

HONG KONG – China biopharma pioneer Chia Tai Tianqing Pharmaceutical Holdings Co. Ltd. said its self-developed chemical oncology, Focus V (anlotinib hydrochloride capsules), is now approved for a second indication to treat soft tissue sarcoma, becoming the only approved therapy for this rare cancer in China. Read More

Even in mutated oncogenes, tissue of origin matters

Despite the arrival of FDA-approved tissue-agnostic targeted cancer therapies, there is increasing recognition that the response of tumors that are driven by the same oncogene differs according to their location. Read More

TGA receives mixed response from industry on proposal to begin formal GCP inspections

PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) received mixed comments from stakeholders on whether it was necessary to implement a formal good clinical practices inspections program in Australia. Many comments questioned how inspectional findings from a proposed pilot program would be released, but most agreed that a formal inspections program would raise compliance and enhance international competitiveness. Read More

Short supply of GSK's Menveo spurs Argentina vaccine debate

BOGOTA, Colombia – Argentina, hit by a challenging economic crisis, is struggling to supply vaccines to its population. The most recent shortages affect Menveo, a vaccine produced by Glaxosmithkline plc for preventing meningococcal disease. Read More

Fed Circuit leaves biopharma IPR concerns unanswered

The U.S. Court of Appeals for the Federal Circuit this week sidestepped some of the concerns raised by the biopharma industry, choosing instead to simply vacate and remand two Patent Trial and Appeal Board's (PTAB) decisions that invalidated patent claims involving the securing of communications over the Internet. Read More

Appointments and advancements

Ideaya Biosciences Inc., of South San Francisco, appointed Paul A. Stone chief financial officer, Andres Briseno, vice president, finance and Mick O'Quigley vice president, development operations. Read More

Financings

Hummingbird Bioscience Pte. Ltd., of Singapore, said it completed an extended series A financing round led by Heritas Capital Management and SEEDS Capital, the investment arm of Enterprise Singapore. Read More

Other news to note

Volitionrx Ltd., of Austin, Texas, was awarded a $1.4 million grant from the Walloon Region in Belgium to support a collaboration with Giga at the University of Liege, Belgium. The project will study the use of telomere maintenance as a cancer diagnostic using Volitionrx's Nucleosomics platform. Read More

Regulatory front

The Institute for Clinical and Economic Review (ICER) unveiled its preliminary list of potential assessment topics for next year. The list is based on the projected timing and likelihood of FDA approval, and whether an evidence review would suggest specific actions for payers, physicians, patients and policymakers to improve clinical practice.  Read More

Clinical data for July 10, 2019

Read More

Regulatory actions for July 10, 2019

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