Remove 2007 Remove Patients Remove Safety
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Competition is on the horizon for costly narcolepsy treatments

pharmaphorum

When patients experience intense emotion, either positive or negative, they are rendered unconscious. In order to bring it to market, a special program called Risk Evaluation and Mitigation Strategy (REMS) had to be put in place, where only eligible patients could access the drug through a very strict process.

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Company profile: NeoImmuneTech

pharmaphorum

NT-I7 amplifies and reinvigorates persistent T cell immunity in the treatment of patients with cancer and lymphopenia, thus providing unique opportunities for immuno-oncology (IO) combination therapy strategies. It is worth noting that patients with r/r PaC or r/r MSS-CRC have very limited treatment options.

Safety 105
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Innovating allergy drug delivery with a needle-free alternative

European Pharmaceutical Review

These factors may increase the likelihood that patients and caregivers carry it regularly. 8 An additional study in patients experiencing anaphylaxis symptoms following an oral food challenge demonstrated that neffy reversed anaphylaxis symptoms within the same timeframe typically observed for injection products. 2007; 2(1):5-11.

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Pressure rises on Lucentis, as Coherus biosimilar gets FDA nod

pharmaphorum

It is, however, the first that can be substituted across all Lucentis’ five indications and to be fully interchangeable – which means it is considered to have no clinically meaningful difference compared to the reference drug in safety, purity, or potency and can be substituted for it without any prescriber intervention.

FDA 59
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The evolution of AAVs in cell and gene therapy

European Pharmaceutical Review

Dr Baghirzade continued, highlighting that since a particular defining moment for the industry in the late 90s, which resulted in an unfortunate patient fatality, “there is a lot more focus on safety” in gene therapy clinical trials today. She also touched on production costs being irrecoverable—there is a high cost per patient.

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

Pharmaceutical Technology

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. The EU is planning a sweeping revision of its pharma legislation in March, the largest change in 20 years.

Pharma 64
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Veeva Systems Summit, Madrid – pharmaphorum reflects

pharmaphorum

Founded in 2007 by Peter Gassner, a luminary of Silicon Valley with a net worth of circa $5.25 With an eye on launch and commercialisation, the key is gaining access to patients for studies. When we think about the problems, Shawah said, it’s about getting the right medicine to the right patient.

Pharma 98