EyewireTV – FDA Approves Raindrop Inlay; Humira for Uveitis Treatment
08 July 2016
In this week’s EyewireTV, ReVision Optics receives FDA approval for the Raindrop Near Vision Inlay, the first implantable device that changes the shape of the cornea to achieve improved vision; and the FDA approves Humira (adalimumab) for the treatment of noninfectious intermediate and posterior uveitis and panuveitis. Also, Bausch + Lomb and Nicox announce that the results of a phase 3 study of glaucoma drug candidate latanoprostene bunod have been published in the American Journal of Ophthalmology.
Test Aids Prostate Cancer Treatment
07 July 2016
Genomic Health Inc. has struck a deal to commercialize a new blood test that can help advanced prostate cancer patients decide whether to try costly new-generation drugs or rely on much cheaper traditional chemotherapy to improve their chances for survival. The test, developed by closely held Epic Sciences Inc., San Diego, detects a mutation associated with a poor response to two new drugs, Xtandi from Medivation Inc. and Astellas Pharma Inc. of Japan, and Zytiga from Johnson & Johnson.
New blood test from Epic Sciences matches patients with PARP inhibitors
30 June 2016
San Diego-based liquid biopsy company Epic Sciences has announced a new blood test that may quickly identify cancer patients who respond to a promising class of drugs called poly ADP ribose polymerase (PARP) inhibitors. The test works by identifying circulating tumor cells (CTCs) affected by homologous recombination deficiency (HRD), a damaged DNA repair mechanism.
Epic Sciences unveils new, more sensitive biopsy test to detect a range of cancers
28 June 2016
San Diego's Epic Sciences has added a new liquid biopsy test to its arsenal of biopharma cancer detection tools that targets homologous recombination deficiencies (HRDs) in individual circulating tumor cells.
Treatment for age related loss of near vision: Raindrop near vision inlay one-year clinical results
09 June 2016
Presbyopia is an ocular condition associated with age related loss of near vision. The eye loses the ability to focus well on near objects due to the hardening of the natural lens. It affects billions of people worldwide with the onset occurring around age 45. The most common treatment for presbyopia is the use of reading glasses. Recently, surgical correction of presbyopia has been tested as part of a clinical study by implanting a small device into the cornea, the clear front part of the eye. The Raindrop Near Vision Inlay is an investigational device that is being evaluated to treat this condition so that dependence upon reading glasses may be reduced in order to see objects up close.
18 April 2016
Marinus Pharmaceuticals (NASDAQ:MRNS) has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for ganaxolone for the treatment of status epilepticus, according to the agency’s website. Status epilepticus is a dangerous condition in which epileptic seizures follow one another without recovery of consciousness between them.
Multiple STIs could be detected with researchers developing a single 30 minute test
16 March 2016
One test that could detect four of the most common sexually transmitted infections in 30 minutes and allow them to be rapidly treated, will be developed by St George’s, University of London and diagnostics company Atlas Genetics.
Despite Turbulence, Russia’s Pharma Market Holds Promise
15 March 2016
The world’s largest nation, Russia remains an attractive market for most industries. Nevertheless, the country has struggled through a rough economic period, rocked by a drop in the value of the currency and turbulence in the oil market. Geopolitical pressures have raised challenges, including sanctions imposed on the country.
Syndax braves a market tempest in second IPO try, scores a $53M raise
04 March 2016
Syndax ($SNDX) has joined a small group of biotechs that has managed to price an IPO in the face of gale force market headwinds. The biotech had to go well under its projected range, though, and settle for $12.
Syndax Cuts Price But Bags $53M in Second IPO Try
03 March 2016
Over the past year, Syndax Pharmaceuticals has altered its strategic course and hired new management to implement it. And it looks like that change was big enough to propel Waltham, MA-based Syndax through the IPO queue on its second attempt since late 2014—albeit not on the terms the company had hoped for.
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Children visited the NovaMedica Innotech pharmaceutical manufacturing facility
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Optimising wet granulation manufacturing with advanced technologies
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First-in-class therapy approved for schizophrenia
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The Russian Ministry of Health proposed changes to essential drug lists
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WHO guidance aims to strengthen clinical trial ecosystem
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