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Home » Newsletters » BioWorld

BioWorld

Nov. 2, 2018

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Clinical data for Nov. 1, 2018

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Regulatory actions for Nov. 1, 2018

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Analysis: Divided 116th Congress would maintain status quo for biopharma

Tuesday's midterm elections in the U.S. aren't expected to create huge shifts in the makeup of the congressional committees most involved with health issues, but who wields the gavel on those committees will dictate health care priorities for the next two years. Read More

ASH drop: Argenx, Affimed, Morphosys shares climb on release of 2018 abstracts

DUBLIN – Shares in several European antibody developers, including Affimed NV, Argenx SE and Morphosys AG, posted healthy gains Thursday on the release of abstracts in advance of the 60th annual meeting of the American Society of Hematology (ASH), which kicks off on Dec. 1 in San Diego. Read More

Scientists launch 10-year EBP program to sequence all 1.5M known genomes

LONDON – A global $4.7 billion, 10-year effort to sequence the genomes of all 1.5 million known animal, plant, protozoan and fungal species on earth was launched in London on Thursday. The Earth Biogenome Project (EBP) will build the infrastructure for a new biology and provide insights for a broad range of research, said Harris Lewin, chair of the EBP working group. Read More

Financings

Eton Pharmaceuticals Inc., of Deer Park, Ill., is selling 3 million shares at $6 per share in its IPO. The specialty pharmaceutical company is focused on developing and commercializing pharmaceutical products utilizing the FDA's 505(b)(2) regulatory pathway. The company will list its shares on Nasdaq under the symbol ETON. Read More

Regulatory front

A direct-to-consumer test designed to provide information about genetic variants that may be linked with a patient's ability to metabolize some medications has been given the green light from the FDA. The 23andme Personal Genome Service Pharmacogenetic Reports test has been authorized to detect 33 variants for multiple genes.  Read More

Sanofi taps Denali to help tackle neurodegenerative, inflammatory diseases in $1B-plus collaboration

Sanofi SA's Genzyme Corp. has agreed to pay Denali Therapeutics Inc. $125 million to kickstart development of multiple small-molecule inhibitors of receptor-interacting serine/threonine-protein kinase 1 (RIPK1), a signaling protein that regulates inflammation and cell death in a variety of diseases. The candidates could potentially benefit people with Alzheimer's disease (AD), amyotrophic lateral sclerosis (ALS) and multiple sclerosis. Should all succeed, Denali could earn nearly $1.1 billion in milestone payments from Sanofi. Read More

FDA panel not swayed by Alkermes' MDD pitch; cites trial changes, more

As expected, Dublin-based Alkermes plc encountered rough waters in the joint meeting of the FDA's Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, which deliberated over ALKS-5461 sublingual tablets for the adjunctive treatment of major depressive disorder (MDD). Read More

Fiber-based microfluidics developed for large-volume analysis, manipulation

Traditional microfluidics undergirds advances in genomics, proteomics and point-of-care diagnostics. It allows the manipulation and analysis of tiny amounts of liquids on a microchip-like structure. But now microfluidics may be ready to go macro, as Massachusetts Institute of Technology (MIT) researchers have developed a new technological metaphor as a model – moving from a chip to fiber. Read More

Other news to note

Navidea Biopharmaceuticals Inc., of Dublin, Ohio, said the U.S. District Court for the Southern District of New York dismissed all claims raised by Platinum-Montaur Life Sciences LLC over a 2012 note and loan agreement between the two parties. Read More

Earnings

Radius Health Inc., of Waltham, Mass., reported its third-quarter U.S. net sales of Tymlos (abaloparatide) injection for postmenopausal women with osteoporosis were $27.6 million, compared to approximately $3.5 million for the three months ended Sept. 30. The company recorded a net loss of $49.8 million, or $1.09 per share, compared to a net loss of $57.8 million, or $1.31 per share, for the three months ended Sept. 30.  Read More

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