Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.
The EU Approves 200 Million Novavax Covid-19 Vaccines Supply
The European Commission (EC) has granted approval of a supply contract with Novavax to purchase more than 200 million COVID-19 vaccines. The deal is an attempt to further diversity the EU’s vaccine strategy after betting heavily on their Pfizer and Moderna vaccine...
Novartis begins Zolgensma study after FDA’s hold lifts
Aiming to expand the use of Zolgensma, Novartis has announced the launch of a new phase three study following the FDA’s decision to remove restrictions and partial clinical trial hold. Novartis plans to evaluate the use of Zolgensma to treat patients (aged 2-18) for...
FDA Grants Alkermes Fast Tracked Designation for Nemvaleukin
The FDA has granted Alkermes fast-tracked designation for Nemvaleukin Alfa (nemvaleukin) to treat patients with mucosal melanoma, following nemvaleukin's orphan drug designation earlier in the year. Nemvaleukin alfa is Alkermes’ first investigational engineered...
Bristol Myers Opdivo Wins The EC Approval for GEJ Cancer
The European Commmision (EC) has granted Bristol Myers approval for Opdivo (nivolumab) to treat adult esophageal or gastroesophageal junction (GEJ) cancer who have pathologic disease after previous neoadjuvant chemoradiotherapy (CRT). With the approval based on the...
FDA Approves Eli Lilly COVID-19 Drug Without Remdesivir
Expanding on their emergency authorization from November, the FDA has granted Eli Lilly approval for the use of their COVID-19 drug baricitinib to be taken on its own and not in combination with Gilead's drug remdesivir for patients with COVID-19. With the approval...
Singapore HSA: SaMD Regulation Guidelines Feedback
Singapore’s Health Sciences Authority (HSA) is seeking feedback on draft guidelines released on standalone medical mobile applications and qualification of clinical decision support software (CDSS). Based on the International Medical Device Regulators Forum’s (IMDRF)...
FDA Grants LifeSignals Approval for Remote Monitoring Program
LifeSignals’ LX1550 Multiparameter Remote Monitoring Platform has been granted FDA Class II 510 (K) approval, following recent CE marketing. With the Remote Monitoring Platform, healthtech companies can improve their product and service portfolios and provide...
Canada Approves BeiGene BRUKINSA for Mantle Cell Lymphoma
Health Canada has granted BeiGene approval for BRUKINSA (Zanubrutinib) to treat mantle cell lymphoma (MCL) in adults who have already received at least one other prior treatment. As global, science-driven biotechnology company, BeiGene focuses on improving treatment...
AstraZeneca Diabetes Drug Given FDA Approval for Children
AstraZeneca has been granted FDA approval for its once-weekly diabetes medicine Bydureon (exenatide) to treat children (aged 10-18) with type-2 diabetes. The drug, an injectable suspension, aims to lower blood sugar rates. The approval is based on a late-stage study...
LATAM Series: Mexico’s Medical Device Regulatory Pathway
Our LATAM series continues this week with Mexico’s medical device regulatory pathway. In 2019, Mexico’s import medical device market was estimated to be approximately $5.7 billion USD. In 2020, that number increased to $6.5 billion USD. With demand for medical devices...
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