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FDA grants swift review to Lynparza in first-line prostate cancer

pharmaphorum

AstraZeneca and Merck & Co’s PARP inhibitor Lynparza is already used to treat prostate cancer associated with a specific genetic mutation, but could see its use broadened if a new marketing application is approved by the FDA. The post FDA grants swift review to Lynparza in first-line prostate cancer appeared first on.

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Pharma is in acquisition mode but small biotechs hurting for money

World of DTC Marketing

Data were mainly accessible for smaller firms, effects in some therapeutic regions, orphan drugs, first-in-class drugs, therapeutic agents that received accelerated approval, and products approved between 2014 and 2018. According to the study in JAMA “the FDA approved 355 new drugs and biologics over the study period.

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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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Oncology biosimilar case studies: rituximab biosimilars

Pharmaceutical Technology

Rituxan received its first FDA approval in 1997 for the treatment of B-cell non-Hodgkin’s lymphoma (B-NHL) and reached peak global sales of $7.5bn in 2014. Rituximab biosimilars have since achieved notable commercial success, with global sales surpassing $900m collectively.

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Medtechs that book the most sales per employee face the greatest losses

Rep-Lite

The medtechs that enjoy the highest sales for their headcount tend to be those making large, expensive machines or largely genericized orthopedic implants – the types of product that tend to require relatively little in the way of R&D expenditure. Welcome to the calm before the Covid-19 storm.

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Catalyst Receives FDA 510(k) Clearance for its Convertible Stemmed Total Shoulder Arthroplasty System

Legacy MEDSearch

Food and Drug Administration (FDA) to market its fully convertible stemmed total shoulder arthroplasty system with an ellipsoid anatomic head. Catalyst OrthoScience was founded in 2014 by orthopedic surgeon Steven Goldberg, M.D., Catalyst OrthoScience Inc. About Catalyst OrthoScience Inc. Headquartered in Naples, Fla., Are you hiring?

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The current pharma business model is unsustainable

World of DTC Marketing

Although COVID-19 has slowed the growth of drug sales, the oncology market’s total growth is driven by the targeted drugs in oncology. While that sounds encouraging, most cancer drugs launched between 2009 and 2014 cost more than USD 100,000 annually. . ” Why are the costs so high?

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