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Sweeping changes in leaked EU pharma law draft reignite profit vs access conflict

Pharmaceutical Technology

The EU is planning a sweeping revision of its pharma legislation in March, the largest change in 20 years. The overhaul will address drug marketing exclusivity length, pricing, patient access, innovation incentives, antimicrobial resistance, clinical trials, supply chain security and shortages, and environmental impact.

Pharma 64
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Interchangeability of biosimilars in the EU – the industry impact

European Pharmaceutical Review

Nonetheless, some stakeholders remain concerned with this new approach given the complexity of biological medicines and the need for patients to be treated individually and have called for further discussions with regulators and all stakeholders. Directive 2001/83 (as amended). EMA Biosimilars Q&A.

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Pharma Sales To Med Device CEO: The Jeff Smith Story Part 1

Evolve Your Success

Pharma Sales To Med Device CEO: The Jeff Smith Story Part 1. Our company is a commercial-stage venture-backed spinal implant business, and we’re on a mission to establish circumferential cervical fusion as the standard of care for high-risk patients. You started in pharma. — Watch the episode here. I have four sons.

Sales 52
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PROTAC development gains momentum, but clinical performance is poor

Pharmaceutical Technology

The first concept for a PROTAC was published in 2001, and recently these protein degraders have gained rapid momentum as a promising novel modality. By this same virtue, PROTACs are able to degrade previously undruggable targets, which provides a major competitive advantage for this modality if shown to be true.

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Achieving scale up success under economic uncertainty

European Pharmaceutical Review

For both small biotechs and large pharma, economic uncertainty is rising, intensifying decision-making risks associated with early drug discovery efforts, clinical trials, quality and manufacturing process execution, and navigating the approval process. In 2001 and 2007, through 2009, the economy was hit hard.

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Reality Bites: Disappointment in the R&D Sector

Pharmaceutical Technology

“To remain at the forefront of medical research, pharma needs a faster, more predictive way of testing molecules before they go into humans,” says Steve Arlington, global life sciences industry advisor leader at PwC. “There is a real threat the pharmaceutical R&D industry could move offshore.”