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Do patients care about accelerated approval drugs?

World of DTC Marketing

Accelerated Approval allows for early access to drugs and biologics based on initial evidence of safety and effectiveness, while confirmatory studies required to verify clinical benefits are ongoing. The program was codified into law under the Food and Drug Safety and Innovation Act (FDASIA) in 2012. Do patients care?

Patients 200
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Could acoziborole eliminate sleeping sickness in Africa?

European Pharmaceutical Review

Between 2016 and 2019, DNDi and its partners led an open-label, Phase II/III study to assess the safety and efficacy of acoziborole in patients with early- and late-stage g-HAT. The study demonstrated acoziborole has a favourable safety profile, with no significant drug-related safety signals reported.

Safety 89
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Updates on Salesforce Safety and Wellbeing Actions

Salesforce

Salesforce will be making a $1 million USD donation to local partners focused on medical equipment and supply sourcing, vaccine awareness and distribution, community isolation centers, and food security for the most vulnerable populations. In addition, we’ve launched a global employee giving and matching campaign to further our impact.

Safety 52
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New ethical guidance for paediatric clinical trials

European Pharmaceutical Review

The US Food and Drug Administration (FDA) have published initial guidance deliberating how ethical it is for children to take part in research trials. Instead, doctors have had no choice but to use and prescribe suitable products which unfortunately, have not been assessed for safety or efficacy by the FDA.

Ethics 87
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US FDA approves Amgen-AstraZeneca’s Tezspire for asthma treatment

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval to Amgen and AstraZeneca ’s Tezspire (tezepelumab-ekko) for self-administration using a single-use, pre-filled pen for severe asthma patients aged 12 years and above. Asthma control improvement and safety profile were consistent with previous clinical trials.

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FDA approves Coherus’ Cimerli for DME, with year-long interchangeability exclusivity

Pharmaceutical Technology

The diabetic macular oedema (DME) space recently witnessed a new approval; the US Food and Drug Administration (FDA) announced the approval of Coherus’ Cimerli (ranibizumab-eqrn; FYB201), a vascular endothelial growth factor (VEGF) inhibitor therapy. Thus, the biosimilar presented a similar efficacy to the reference product.

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Delivery systems for biologics

European Pharmaceutical Review

Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5 Advancement of these oral medical devices is still in its infancy and further investigation is needed to ensure their effectiveness and safety in use for humans.