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AstraZeneca acquires TeneoTwo in $1.3bn deal to broaden haematology portfolio

Pharmaceutical Technology

In December 2014, Amgen’s landmark FDA approval saw Blincyto (blinatumomab) approved for relapsed/refractory (R/R) B-cell progenitor acute lymphoblastic leukaemia (B-ALL), at the time being the only marketed BiTE. Currently, there are 110 BiTEs in oncology clinical trials, with seven in Phase III and three in pre-registration.

Safety 59
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BMS scores first approval for psoriasis therapy Sotyktu

pharmaphorum

The US FDA has cleared the first-in-class tyrosine kinase 2 (Tyk2) inhibitor as Sotyktu , and BMS says it now plans to launch the new drug later this month, aiming to mount a challenge to Amgen’s $2.3 It had been approved since 2014 for moderate to severe cases only. billion oral psoriasis therapy Otezla (apremilast).

FDA 52
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Centerline Biomedical Raises $33 Million in Series B Financing

Legacy MEDSearch

This funding will help propel the company into new surgical applications, accelerate its commercial sales and add to its growing clinical evidence repository. IOPS® is FDA 510(k) cleared and currently launching in the US at select sites. Founded in 2014, Centerline Biomedical is headquartered in Cleveland, Ohio.

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Securing every dose with an edible security technology for safe medicines

European Pharmaceutical Review

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. The US Food and Drug Administration (FDA) further estimates that 97 percent of online pharmacies are operating illegally. Available from: [link]. Leem JW, Jeon HJ, Ji Y, et al.

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ASH roundup: late breakers take the stage

pharmaphorum

Researchers cautioned that these are early results, and more follow-up is needed to determine the long-term safety and efficacy, but the data could spell trouble for AZ and Alexion’s C5 franchise, which brought in more than $4 billion in sales in the first nine months of this year.

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New quality requirements for tobacco products

European Pharmaceutical Review

1 In the EU, the Tobacco Products Directive (2014/40/EU) governs “the manufacture, presentation and sale of tobacco and related products”. 1 In the EU, the Tobacco Products Directive (2014/40/EU) governs “the manufacture, presentation and sale of tobacco and related products”. The AIs for NNN and NNK are 96.0

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Moving towards oral delivery of biologics

European Pharmaceutical Review

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Importantly, we believe the safety, reliability, and pharmacokinetic data that we collected through both parts of the Phase I study support the initiation of a Phase II trial of RT-102 in osteoporosis,” Hashim said.