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Home » Newsletters » BioWorld

BioWorld

Aug. 3, 2018

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Other news to note

Decibel Therapeutics Inc., of Boston, said data published in Cell showed how researchers used massively parallel single-cell RNA-sequencing to profile the transcriptomes of thousands of individual cochlear neurons and identified groups of genes (ion channels, adhesion molecules, transcription factors) that are enriched within each subtype of neuron and which may regulate their unique functional properties. Read More

Earnings

Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y, reported second-quarter U.S. sales of ophthalmology drug Eylea (aflibercept) totaling $992 million, up 8 percent over the same period last year. Read More

Financings

Therapeuticsmd Inc., of Boca Raton, Fla., said it priced its $65 million underwritten public offering of common stock at $5.10 per share. That price per share will also be paid by a strategic investor in a previously announced concurrent $20 million registered direct offering. Read More

Regulatory actions for Aug. 2, 2018

Read More

Regulatory front

Auromedics Pharma LLC, of East Windsor, N.J., is voluntarily recalling two lots of piperacillin and tazobactam for injection in single-dose vials to the hospital level. The recall was prompted by complaints of glass in one vial and a silicone particle in another. The generic combination drug is used to treat moderate to severe bacterial infections. Read More

BMS dogged by six-year history at New Jersey superfund site

It's a legacy that keeps on "giving" – and one that Bristol-Myers Squibb Co. (BMS) likely wishes it could undo. Read More

Korea's Samyang Biopharma to establish U.S. office for biologics development

HONG KONG – South Korea's Samyang Biopharmaceutical Corp. is set to expand to the U.S. with a new office in Boston, scheduled to open this month. The new location will focus on biologics product development as well as leveraging the local network for M&A opportunities. Read More

Celtaxsys 'ace's phase II CF effort, makes designs on pivotal program

Celtaxsys Inc. is already prepping the design of a phase III program for acebilustat after the oral leukotriene A4 hydrolase (LTA4H) inhibitor met with success in a phase II effort targeting treatment of cystic fibrosis (CF), irrespective of the causative genotype. Read More

Lilly of the valley? Karuna flowers with $42M round, schizophrenia first target

Readying for a phase II in the third quarter with Karxt, its combo drug for schizophrenia, Karuna Pharmaceuticals Inc. aims to capitalize on data gained previously by licensor Eli Lilly and Co. with the muscarinic acetylcholine receptor agonist xanomeline as well as historic findings with trospium chloride, a muscarinic receptor antagonist approved by the FDA in 2004 for overactive bladder. Read More

Epizyme recalibration spooks investors as work to resolve clinical hold continues

Shares of Epizyme Inc. (NASDAQ:EPZM) fell 23.9 percent to $9.90 on Thursday after the company said it would delay submitting a new drug application for its lead candidate, tazemetostat, in epithelioid sarcoma (ES) until mid-2019 and quit testing the drug as a monotherapy in diffuse large B-cell lymphoma (DLBCL) after an interim assessment suggested the phase II study wasn't worth continuing. Read More

Clinical data for Aug. 2, 2018

Read More

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