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FDA grants fast track status to Zai Lab’s lung cancer treatment

Pharmaceutical Business Review

This designation reinforces the clinical progress we have achieved for ZL-1310 to-date, and we remain on track to initiate a pivotal study in small cell lung cancer later this year, positioning us for a potential accelerated approval in 2027.

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NHC Submits Comments on CMS Draft Guidance for IPAY 2028

Putting Patients First Blog

Even well-intentioned policies can create access disparities if communication and operational support are lacking. The process by which CMS will determine that a drug qualifies for renegotiation should be more transparent. Nor are refund processes standardized or consistently communicated across payers and providers.

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Vor Bio back from brink with autoimmune drug deal rising to $4bn

Pharmaceutical Technology

A month and a half after winding operations and laying off almost all its staff, Vor Bio has emerged from the brink with a licensing deal potentially rising to $4bn for an autoimmune drug developed by Chinese biotech RemeGen. The deal signals an abrupt turnaround for Vor Bio.

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EHDS regulation will depend on strong patient confidence

Pharmaceutical Technology

Communication between European Union (EU) member states is ongoing to finalise the details of the legislation, but at its core, the EHDS will provide a single registry of patient data from across the continent. Trust is something that you earn, so how we communicate what’s coming out of this directive is very important.

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BioOrbit eyes 2026 for pre-clinical trials of space manufactured protein crystals

Pharmaceutical Technology

Then, we will need to run pre-clinical trials of these crystals, which will be in 2026 or 2027. Then the next step is to produce meaningful quantities of these crystals, which will be next year.” After that, it will be about compliance and regulation, as we must ensure that all our processes adhere to pharma regulations.

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The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. According to GlobalData, as of November 28, there were 316 generic and novel drugs marketed to treat obesity. Anti-obesity therapeutic landscape.

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The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. According to GlobalData, as of November 28, there were 316 generic and novel drugs marketed to treat obesity. Anti-obesity therapeutic landscape.