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Navigating Regulatory Hurdles in Drug Development

DrugBank

A well-known example is Merck’s rofecoxib , approved for pain relief in 1999 but withdrawn from the market in 2004 due to cardiovascular risks that were not sufficiently monitored during post-market surveillance. One of the most significant challenges in drug development is global regulatory variability.

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FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche

BioPharma Drive: Drug Pricing

In a research note on Wednesday, RBC Capital Markets analyst Leonid Timashev estimated peak yearly sales of the drug could reach nearly $640 million. Published June 11, 2025 Ben Fidler Senior Editor post share post print email license The FDA on June 11, 2025 approved Nuvation's Ibtrozi for ROS1-positive non-small cell lung cancer.

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Tackling complex manufacturing challenges in modern drug development

Drug Target Review

With a particular focus on biologics, cell, and gene therapies, Galbraiths work is centred on equipping drug developers with the tools, insights, and support needed to advance their therapies from concept to clinic. This global role allowed him to develop the application of innovative technologies to bring new ATMPs to the clinic.

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Building the requisite clinical development infrastructure for medical innovation to thrive

Drug Target Review

We have seen how quickly vaccines and treatments can be developed when innovation is prioritised and stakeholders work together against the backdrop of imminent societal needs. Converting these challenges into opportunities, we must embrace new clinical development strategies that promote agility, efficiency and effectiveness.

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Soleno sales of new Prader-Willi drug rise faster than expected

BioPharma Drive: Drug Pricing

Spencer Platt via Getty Images The first marketed treatment for the insatiable hunger associated with Prader-Willi disease is selling more quickly than Wall Street analysts expected, an early, but encouraging sign of demand. Condulis, for instance, predicts Vykat could reach $2.5 billion in worldwide yearly sales at its peak.

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Seven Strategies to Avoid Common Pitfalls in Vaccine Development

PPD

Clinical trials for COVID-19 vaccines changed how all vaccine trials are conducted. The success of the COVID-19 vaccines has brought renewed interest to vaccine development across indications and therapeutic areas. Working with a vertically integrated organization can further accelerate market entry.

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Novavax inks deal to deliver one billion COVID-19 vaccine doses in India and other regions

The Pharma Data

Novavax is partnering up with the Serum Institute of India Private Limited (SIIPL) in a licensing deal to development and marketing of up to one billion doses of its potential recombinant COVID-19 vaccine candidate, NVX?CoV2373. Negotiations are currently ongoing to have SIIPL manufacture the candidate within India. M adjuvant.

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