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Home » Newsletters » BioWorld

BioWorld

Sep. 7, 2018

View Archived Issues

Clinical data for Sept. 6, 2018

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Regulatory front

Delivering on a promise made last year, the American Hospital Association and other hospital groups filed suit Wednesday in a federal district court against U.S. Health and Human Services (HHS) Secretary Alex Azar over a change in Medicare reimbursement for 340B drugs.  Read More

Other news to note

Civica Rx, of Salt Lake City, previously known as Project Rx, is a new, not-for-profit generic drug company aimed at helping patients by addressing shortages and high prices of lifesaving medications. (See BioWorld, Jan. 29, 2018.) Read More

Financings

Nicox SA, of Sophia Antipolis, France, said it confidentially submitted a draft registration statement on form F-1 to the SEC relating to a proposed offering of American Depository Shares representing the company's ordinary shares in the U.S. The offering has not yet been priced. Read More

New heart disease lipid biomarkers, targets identified

An Australian study has discovered several new lipid molecules that may represent new biomarkers and/or potential therapeutic targets for atrial fibrillation (AF) and heart failure (HF). Read More

More than a best friend, dogs could sniff out the path to developing cancer therapies

With immunotherapies inspiring reason for hope against what have been hopeless cancers, researchers are looking for ways to make preclinical development more predictive of how a potential treatment will work in people. Read More

In the 28-7 world, $65M series A moves the needle on ncRNA biology

Not to be confused with a round-the-clock operation, Twentyeight-Seven Therapeutics Inc. (28-7) managed its time over the past two years by quietly assembling a team of scientific luminaries focused on the task of modulating non-coding RNA (ncRNA) as the platform to discover and develop small molecules that increase levels of the tumor suppressor microRNA (miRNA), Let-7, in cancer indications. Those efforts resonated with a stable of investors, including seed investor MPM Capital, which co-led with Novartis Venture Fund 28-7's $65 million series A. Others in the syndicate included JJDC Inc., Vertex Ventures HC, Longwood Fund, and Astellas Venture Management. Read More

Rare-ing to go, companies gain FDA's favor but hard road ahead as payers balk

BOSTON – The intersection of gene therapy with rare disease drug development was one topic explored by panelists at Biopharm America, who surveyed new business models, fretted over reimbursement, and took stock of the favorable (so far) regulatory climate. Read More

Aurobindo Pharma strikes $1B deal for parts of Sandoz generics portfolio

Aurobindo Pharma USA Inc. has agreed to pay Novartis AG's generics division, Sandoz Inc., up to $1 billion for a basket of dermatology and generic oral medicines that the Swiss drugmaker is divesting as it pursues growth amid increasingly challenging forces in the generics space. With an up-front purchase price of $900 million plus up to $100 million in potential earn-outs, the deal will add about 300 products to Aurobindo's portfolio, including projects in development, as well as new U.S.-based commercial and manufacturing capabilities. Read More

Regulatory actions for Sept. 6, 2018

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