FDA Asks Eli Lilly, Pfizer, and AbbVie to List JAK Warnings
The US FDA (Food and Drug Administration) has asked Eli Lilly & Co, Pfizer, and AbbVie, to inform consumers about potential risks relating to their high-profile Janus kinase (JAK) inhibitor medications. The FDA has ordered label warnings that list a heightened...
78 Million People With Dementia by 2030, WHO Predicts
Dubbed a global health concern, The WHO (World Health Organization) has projected that the number of people living with dementia will increase to 78 million by the year 2030 and will cost the global economy $1.3 trillion p/a. Currently, there are over 55 million...
EU Vaccinated 70% of Adult Population Against COVID-19
The European Commission announced that 70% of adults in the European Union (EU) are fully vaccinated against COVID-19, meeting the target that was initially set in January 2021, at the start of the vaccine rollout. This milestone marks a success for the EU's...
Eagle Receives USPTO Additional Patent for Bendamustine
Eagle Pharmaceuticals have been granted their U.S. Patent No. 11,103,483 titled, “Formulations of Bendamustine”, by the U.S. Patent and Trademark Office (USPTO). Eagle plans to submit this patent to be included in the FDA’s (Food and Drug Administration’s) Orange Book...
Seizures in Children: FDA Expands Approval for UCB Briviact
The US FDA (Food and Drug Administration) has expanded their approval of brivaracetam (Briviact, UCB) to now be used as both a monotherapy or adjunctive therapy for pediatric patients, as young as 1 month old, who suffer with partial-onset seizures, meaning that all...
BioCryst ORLADEYO Reviewed by Health Canada and Swissmedic
BioCryst Pharmaceuticals have announced that Health Canada accepted their new drug submission for ORLADEYO® (berotralstat) for review for the prevention of recurring attacks in patients aged 12 years and older who have hereditary angioedema (HAE). Similarly,...
FDA Will Not Resume Onsite GMP Foreign Inspections Amidst COVID-19
A spokesperson from the U.S. Food and Drug Administration (FDA) reported that the FDA has no intentions of resuming onsite GMP foreign inspections for non-"mission critical" operations during the COVID-19 pandemic. Further, the agency intends on continuing to use...
LATAM Series: Colombia’s Medical Device Regulatory Pathway
Following our last LATAM series blog post which focused on Venezuela, this week we are focusing on Colombia’s medical device regulatory pathway. In 2018, over 80% of Colombia’s medical device market relied on imported devices; from a monetary perspective, this equals...
FDA Updates RAS Devices Safety Communication for Mastectomies
In their updated safety communication, the US FDA (Food and Drug Administration) states that the safety and efficacy of robotically assisted surgical (RAS) devices is still to be determined in the prevention and treatment of breast cancer. While the use of RAS devices...
Pfizer COVID-19 Vaccine Received Full FDA Approval
Marketed under the name, Comirnaty, The US FDA (Food and Drug Administration) granted the Pfizer-BioNTech COVID-19 vaccine full approval yesterday, the first COVID-19 vaccine to become fully licensed in the US. In the US, the vaccine is now approved for people aged 16...
COVID-19 Shots in Pregnant Women Lead to Antibody Transfer
A study has found that pregnant women who receive their first messenger RNA–based COVID-19 vaccine during their pregnancy, produce antibodies for COVID-19 as early as five days following inoculation. The study also found that within 16 days following the first...
AstraZeneca Therapy Shows Strong Prevention Against COVID-19
British drug maker, AstraZeneca, announced their late-stage clinical trial data shows their new antibody treatment, AZD7442, reduces the risk of developing COVID-19 symptoms by 77%. The study gives hope to sufferers whose immune system did not generate a strong...
Rentschler Begins Commercial Production of CureVac Covid-19 Shot
Rentschler Biopharma is in the final stages of preparations to begin commercial production of CureVac’s COVID-19 Shot. The German contract drug manufacturer built a production site for CureVac’s Vaccine and intends to deliver at least 100 million doses per year....
Brain Cancer – Researchers Testing Drugs Using 3D Printing
Researchers from the Tel Aviv University are testing the efficacy of potential treatments by using patients’ own brain cancer cells to make a 3D model of their tumors. The process includes the extraction of the tumor from a patient diagnosed with glioblastoma, one of...
FDA Approves Abbott’s Amplatzer Amulet Fibrillation
The US FDA (Food and Drug Administration) has approved Abbott’s Amplatzer Amulet left atrial appendage occlude for the treatment of nonvalvular atrial fibrillation in people with a higher risk of stroke and systemic embolism. Abbott's Amulet is characterized by its...
Rocket to Resume Clinical Trial following FDA Hold Lift
The US FDA (Food and Drug Administration) has lifted their clinical hold on Rocket Pharmaceuticals for their experimental gene therapy program for the treatment of Danon disease. Following the decision, Rocket announced it will resume patient enrollment later this...
CytoDyn HIV Justification Report: Guidance From FDA
The U.S FDA (Food and Drug Administration) has provided CytoDyn with guidance on its recent HIV BLA dose justification report, a crucial part of the company’s resubmission for its Biologics License Application (BLA) for HIV. CytoDyn is known for specializing in...
LATAM Series: Venezuela’s Medical Device Regulatory Pathway
Venezuela is the third largest medical device market in Latin America, following Brazil and Mexico, which makes understanding Venezuela’s medical device regulatory pathway crucial for MedTech companies expanding into Latin America (LATAM). Somewhat similar...
FDA Clearance: Syntr Health Technologies SyntrFuge System
Syntr Health Technologies has been granted clearance from the US FDA (Food and Drug Administration) for their SyntrFuge System for surgical use when transferring a patient’s adipose (fat) tissue. Syntr Health Technologies, a medical device company that focuses on the...
Akouos AK-OTOF Receives Positive Statement From EMA For ODD
The European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has given a positive opinion on Akousos application for orphan drug designation for AK-OTOF. Akouos, a precision genetic medicine company which aims to produce gene therapies for people...