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With positive top-line data reported for Axsome Therapeutics Inc.’s oral migraine candidate, AXS-07, in its INTERCEPT trial, the company and the candidate have notched two successful phase III trials in little more than three months.
Fate Therapeutics Inc. inked a multiyear, global collaboration worth up to $3 billion with Janssen Biotech Inc., which calls for the latter to contribute antigen binding domains for up to four tumor-associated targets.
In an uncertain time that’s dominated by COVID-19, Flagship Pioneering Inc. and Arch Venture Partners collectively raised a massive $2.56 billion to fund new company creation and growth.
Kendall Square was a great jumping-off point for Cambridge, Mass.’s Pandion Therapeutics Inc. but with an $80 million series B in its pocket, the time has come to pick up sticks to accommodate its growth.
A U.S. district court in Nevada ruled in favor of two ANDA filers in Amarin Corp. plc.’s patent litigation case regarding its fish oil cardiovascular therapy franchise, Vascepa (icosapent ethyl), increasing the possibility of generics crowding Amarin’s U.S. sales.
The newest angle in the partnership between Johnson & Johnson and the U.S. federal government, part of the company’s $1 billion commitment to COVID-19 R&D, is designed to drive its lead candidate into the clinic by year-end and to increase its vaccine manufacturing worldwide.
Now that Rockwell Medical Inc.’s intravenous formulation of Triferic, Triferic AVNU (ferric pyrophosphate citrate) is FDA-approved, the nod coming a day before its PDUFA date of March 28, the company plans putting evaluation programs into action during the third quarter of this year. Only after those programs’ completion will the formulation be available commercially.
Privately held Recode Therapeutics Inc. brought in $80 million through an oversubscribed series A financing with plans to continue its preclinical work in primary ciliary dyskinesia (PCD) and cystic fibrosis (CF).
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) recently granted the first urgent-use licenses to four COVID-19 novel coronavirus diagnostic...
HONG KONG – As the number of COVID-19 confirmed cases and deaths continue to rise globally, South Korea’s focus on testing has attracted international attention....
Like so many other ventilator providers in recent days, Resmed Inc. has committed to ramping up production. It aims to triple its ventilator output and multiply...
DUBLIN—Can high-dose inhaled nitric oxide (NO) make a meaningful contribution to patients with COVID-19 infection? The FDA was sufficiently persuaded by the data...
Randomized trials of the broad-spectrum antiviral favipiravir, marketed as an anti-influenza treatment by Fujifilm Holdings Corp., have shown "obvious efficacy"...
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