WHO-Backed African Hub to Replicate Moderna COVID-19 Vaccine
The World Health Organization (WHO) has announced that they plan on replicating Moderna’s COVID-19 vaccine to boost COVID-19 vaccination rates and production in Africa. Although efforts have yet to yield results, the plans will allow for more developing countries to...
FDA Accepts Axsome Therapeutics NDA for AXS-07
Biopharmaceutical company Axsome Therapeutics, known for developing innovative therapies for central nervous system (CNS) disorders, announced that the FDA (Food and Drug Administration) has accepted their New Drug Application (NDA) for AXS-07 for acute migraine...
BeiGene’s BLA for Tislelizumab Accepted for Review by FDA
The US FDA (Food and Drug Administration) has accepted for review BeiGene’s Biologics License Application (BLA) for its anti-PD-1 antibody tislelizumab to treat patients with reoccurring locally advanced or metastatic esophageal squamous cell carcinoma (ESCC)...
MENA: BioCryst Partners with NewBridge Pharma to Market ORLADEYO
The Ministry of Health and Prevention (MOHAP) in the United Arab Emirates (UAE) has granted BioCryst Pharmaceuticals marketing authorization for their oral medication ORLADEYO® (berotralstat) to help prevent frequent hereditary angioedema (HAE) attacks in patients 12...
Soin Therapeutics receives FDA Orphan Drug Status Grant
The US FDA (Food and Drug Administration) has granted Ohio-based pharmaceutical company Soin Therapeutics orphan drug status for low dose naltrexone (LDN) for the treatment of complex regional pain syndrome (CRPS). Complex Regional Pain Syndrome is characterized by...
Novavax Begins Australian Influenza/COVID-19 Vaccine Trial
American biotech company Novavax announced that it will begin an early-staged trial for a combined influenza/COVID-19 vaccine. The trial will be conducted in Australia and will include 640 adults (between 50 and 70 years of age) and who have either been previously...
2% of Patients With IBD Will Develop PSC, Study Says
A new study has found that approximately 2% of patients with inflammatory bowel diseases (IBD) will develop primary sclerosing cholangitis (PSC), with more men developing the condition compared to women. The analysis, published in Gastroenterology, also states that...
UK Study Shows COVID-19 Vaccines Reduce Risk of Long COVID
A UK study has shown that the risk of developing long COVID, as well as severe illness caused by COVID-19, is greatly reduced in a person who is fully vaccinated. Published by the Lancet Infectious Diseases Journal, the study indicates that those who have received...
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...