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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. This often leaves the task to institutions to ensure that licensed drugs are used in their best formulation.

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How to Identify Branded Drugs with a Low Likelihood of Generic Entry as Targets for In-Licensing

Drug Patent Watch

Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. This approach not only helps maintain market exclusivity but also ensures a steady revenue stream for pharmaceutical companies.

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Centralisation of drug licensing may not be the right path to improve quality of drugs: SPIC

AuroBlog - Aurous Healthcare Clinical Trials blog

Empowering of the Central Drugs Standard Control Organisation (CDSCO) through centralisation of drug licensing may not be the path to improve the quality of drugs manufactured in the country both for domestic and international markets, says SME Pharma Industries Confederation (SPIC), the apex organisation of small and medium pharma industries in the (..)

Licensing 189
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EC announces EU pharma reform that cuts market exclusivity

Pharmaceutical Technology

The European Commission’s (EC) long-anticipated pharma reform plans in the European Union have finally been unveiled , indicating a focus on improving access to medicines across the bloc while cutting down on market exclusivity. Along with the patent-related changes, the EC is seeking to ease some of the regulatory steps.

Marketing 264
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Untapped opportunity: the growing potential of clinical trials in Georgia

Pharmaceutical Technology

In the wake of Russia’s invasion of Ukraine, sponsors are increasingly evaluating other European countries to conduct their clinical trials. Among them, the Eastern European nation of Georgia has emerged as a key rescue country for multinational clinical trials that were put on hold due to the war. Room to grow.

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Jupiter Neurosciences Makes Way in CNS Treatments with $11M IPO

XTalks

Jupiter Neurosciences, a clinical-stage pharma company specializing in neuroinflammation, made its public market debut with an initial public offering (IPO) on the Nasdaq Capital Market under the symbol “JUNS.” ” The company priced 2,750,000 shares of common stock at $4.00

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Melinta and Cidara sign licensing deal for rezafungin

Pharmaceutical Technology

Melinta Therapeutics has signed a licence agreement with Cidara Therapeutics to facilitate a strategic collaboration for marketing the latter’s rezafungin in the US. According to the deal, Cidara will continue to oversee the international Phase III ReSPECT prophylaxis clinical trial underway.

Licensing 147