National Cancer Center of Japan sets up a new drug development system
24 August 2017
Japan’s National Cancer Center will establish a system for cooperating on the development of cancer drugs with four medical institutions in South Korea, Taiwan, Singapore and Hong Kong. The scheme aims to expedite the approval of new drugs.
After two years of negotiations, FDA gets its user fee programs authorized through 2022
23 August 2017
President Donald Trump signed the FDA Reauthorization Act of 2017 into law late Friday, quietly ending a two-year long process that until several weeks ago threatened to disrupt agency operations.
St. Petersburg start-up makes inroads into Bavarian market
23 August 2017
Data MATRIX, a St. Petersburg start-up developing clinical data processing solutions, has opened a rep office in Munich, in southern Germany, and joined the Bavarian biotech cluster, Russian portal Firrma.ru reported , citing a source in the start-up.
Biotech deals down by half and could be lowest since 2013: report
22 August 2017
We all know that biotech M&A activity has been pretty sluggish in 2017, but new stats out from Bloomberg show just how quiet things have been. In a new report, the financial news service found that biotech deals this year “are on pace for almost half the yearly totals of the past two years,” with just $11.5 billion in takeovers made thus far in 2017, half the total over the 24 months prior.
Pfizer wins approval for blood cancer drug Besponsa
22 August 2017
Pfizer today won FDA approval for a new targeted drug for the treatment of relapsed or refractory acute lymphoblastic leukemia (ALL). The approval comes at a watershed moment for treating the disease as next-gen treatment options appear on the horizon.
Scientists give star treatment to lesser-known cells crucial for brain development
21 August 2017
After decades of relative neglect, star-shaped brain cells called astrocytes are finally getting their due. To gather insight into a critical aspect of brain development, a team of scientists examined the maturation of astrocytes in 3-D structures grown in culture dishes to resemble human brain tissue. The study, which confirms the lab-grown cells develop at the same rate as those found in human brains, was published in Neuron and funded in part by the National Institutes of Health’s National Institute of Neurological Disorders and Stroke (NINDS).
Surprise: A short list of TV-ad drug risks is easier to recall, FDA study finds
21 August 2017
Ready to say goodbye to the laundry list of risks in pharma TV ads? Don't hold your breath, but one newly published FDA study found shorter risk statements in DTC commercials led to better recognition and recall.
FDA under fire over accelerated approval data demands
18 August 2017
Researchers have raised concerns with the level of evidence needed to win accelerated approval from the FDA. Regulators stand accused of waving through drugs on the basis of slight data and then failing to ensure confirmatory postapproval trials validate the decision.
What’s worth $500M-plus? The Big 6 deals of Q2 show you where the money is — and isn’t
17 August 2017
You thought it was getting quiet on the deal front? You’re right. Those big licensing deals biopharma loves to boast about were on the wane in Q2. Analysts for Cortellis tracked the big licensing game potentially worth a half billion dollars or more, and came up with only 7 in Q2, way down from the 17 seen in Q1. Altogether, they recorded 967 new deals of all sizes, down 8% from the 1,050 seen in the first three months of the year.
Drug developers face increasingly risky tightrope walk between top-line results and hard data
16 August 2017
Even the biggest pharma companies can hype the results of a big drug study, given the curious dance-of-the-seven-veils choreography provided to late-stage data. And the Wall Street Journal is offering up an example to underscore just how perilous this dance can be for all players.
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NovaMedica team wishes you a Merry Christmas and a Happy New Year!
26 December 2023
Putin has stated that Russia will support Africa in the struggle against epidemics
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The Russian government has expanded the list of vital and essential drugs
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Achieving FAIR bacterial identification
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Unique testing regimen could prevent nuclease contamination
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