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Thursday pharma headlines

World of DTC Marketing

million, his first big raise since 2015, thanks to incentive pay that jumped by about $1.2 million in 2020, more than double the number in 2015, according to health data company IQVIA. The national vaccine safety surveillance program run by the Centers for Disease Control and Prevention (CDC) and the U.S. ” Ouch.

Pharma 180
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Senju Pharmaceutical and Novaliq close agreement for dry eye disease therapy

Pharmaceutical Technology

The therapy has shown efficacy and safety in trials for patients with a history of dry eye disease and clinical Meibomian gland dysfunction. Its safety and efficacy have been demonstrated in numerous studies in Europe, the United States and China. to treat dry eye disease.

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FDA AdCom votes in favour of Lundbeck’s/Otsuka’s Rexulti in AAD

Pharmaceutical Technology

The current unmet need, the benefit of treatment with Rexulti, and a reasonable safety profile persuaded Dr. Merit Cudkowicz, Julieanne Dorn professor of neurology at Harvard University’s Medical School, to give a positive vote.

FDA 96
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Citrate-free HCF of adalimumab biosimilar gets positive opinion

European Pharmaceutical Review

The study met all its primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity between the two concentrations. In 2015, the EMA and US Food and Drug Administration (FDA) approved Humira ® HCF, which contains adalimumab at a concentration of 100mg/ml.

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FDA starts speedy review of Takeda’s dengue vaccine

pharmaphorum

Qdenga isn’t the first dengue vaccine to reach the market, but is free of the severe restrictions that have held back its only predecessor, Sanofi’s Dengvaxia, which was first approved for marketing in 2015, but was found to have a serious safety issue.

FDA 117
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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve. EMA/95098/2010. Internet] European Medicines Agency.

Safety 112
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Fentanyl: a horrifyingly disruptive drug

Pharmaceutical Technology

Increased trafficking of illegal fentanyl represents a new threat to public health and safety. According to the National Institute of Drug Abuse, the total number of drug-involved overdose deaths in the US increased from 52,404 in 2015 to 91,799 in 2020. A lethal drug that creates its own demand.

Safety 105