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...
Endometrial Carcinoma: FDA Approved KEYTRUDA and LENVIMA Treatment
Merck (also known as MSD outside of North America) and Eisai Inc. announced that the FDA (Food and Drug Administration) has given approval for the combined treatment of Merck’s KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, and Elsai’s LENVIMA (lenvatinib), a...
FDA Approved Octapharma Immunoglobulin for Dermatomyositis
The FDA (Food and Drug Administration) has given Octapharma USA approval for the first-ever intravenous immunoglobulin, called Octagam 10%, to treat adult dermatomyositis. 10 out of every million people in the US live with Dermatomyositis, a rare, idiopathic...
FDA to Update Labelling on All Statins for Pregnant Patients
The US FDA (Food and Drug Administration) plans to modify labelling on all statins to change the blanketed contraindication on the drugs in all pregnant patients. Statins, a group of lipid-lowering drugs, are used to help reduce illness and mortality of patients who...
Neutrogena Beach Defense and Ultra Sheer Sunscreens Recalled
Johnson & Johnson is recalling Neutrogena Beach Defense and Ultra Sheer sunscreens after elevated levels of benzene were detected. Benzene is a chemical compound that, over long term and frequent exposure via skin contact or inhalation, can cause serious health...
IRLAB and Ipsen Form Global Exclusive Licensing Agreement for Parkinson’s Disease
Ipsen, a global pharma company, and IRLAB, a Swedish research and development business, have entered an exclusive licensing agreement for Ipsen to commercialize mesdopetam, a dopamine D-3 receptor antagonist taken orally to improve the quality of life for patients...
FDA Grants Approval to iSTAR Medical for Clinical Trial for MINIject
The U.S. Food and Drug Administration (FDA) has granted iSTAR Investigational Device Exemption (IDE) approval for to begin a trial with MINIject, a revolutionary MIGS device for patients with primary open-angle glaucoma. The study will test the safety and efficacy of...
European Commission Provides Guidance on Codes Under IVDR
The Medical Device Coordination Group (MDCG), part of the European Commission, has provided a guidance document navigating the use of codes under the In Vitro Diagnostic Regulation (IVDR). The codes are used to describe the qualifications of both the notified body...
FDA Clears First Biodegradable Subacromial Balloon Spacer
The U.S. Food and Drug Administration (FDA) has cleared the first ever biodegradable subacromial balloon spacer developed by OrthoSpace Inc. and acquired by Stryker. The balloon, called InSpace, is the first implant for arthroscopic treatment of MIRCTs (massive...
FDA Accepts Pre-IND Request for Potential Cure for Hepatitis B
The U.S. Food and Drug Administration (FDA) has accepted Enochian BioSciences Pre-IND (Investigational New Drug) request for a potential cure of Hepatitis B (HBV). HBV is a viral infection that affects the liver. The request comes after promising results from a...
Anivive Awarded FDA Grant for Canine Cancer Research
The U.S. Food and Drug Administration (FDA) has awarded Anivive, a pet health tech company, a $500,000 USD grant to continue research on LAVERDIA™ -CA1 (verdinexor) and its effect on treating canine cancer. As one of four companies selected for the MUMS grant,...
Global Medical Affairs – The Next Generation of Innovation
On our most recent Coffee & Conversations podcast episode, podcast hosts Brigid and Shelby joined CSOFT’s President and CEO Shunee Yee and Professor Victoria Elegant, who serves as Vice-President of JAPAC Regional Medical Head of Amgen to discuss The Next...
AstraZeneca-Amgen Asthma Treatment Granted FDA Speedy Review
A drug by AstraZeneca and Amgen designed to treat asthma has been granted a speedy review by the Food and Drug Administration (FDA). The experimental drug tezepelumab aims to reduce asthma attacks for patients with severe and uncontrolled forms of asthma. Both...
UDI Guidance Finalized by FDA
The U.S. Food and Drug Administration (FDA) has finalized UDI guidance content requirements and form for unique device identifiers (UDIs), after five years from its first drafted release. The guidance covers two types of UDIs, including automatic identification and...
ANSEM Grants Cohort Temporary Authorization for Use to GenSight Biologics
ANSEM (the National Agency for Medicines and Health Products Safety), France's Competent Authority, has granted Cohort Temporary Authorization for Use (ATUc) to GenSight Biologic's LUMEVOQ®. LUMEVOQ® is a drug therapy designed to treat Leber Hereditary Optic...
Delta Variant: J&J COVID-19 Vaccine Shows Promising Results
Johnson & Johnson have announced that findings from a laboratory study have shown promising results for it its single-dose COVID-19 vaccine against the Delta variant. Blood analysis drawn from eight patients revealed that immune responses to the Delta variant were...
FDA Approves HDT Bio COVID-19 Vaccine Phase 1 Clinical Trial
The FDA (Food and Drug Administration) has evaluated HDT Bio Corp’s Investigational New Drug (IND) Application and given the company the green light for a Phase 1 clinical trial of its HDT-301 COVID-19 RNA vaccine. HDT Bio, a developer of immunotherapies for oncology...
NuVasive Pulse Receives CE Mark, Begins Clinical Evaluations
With an aim to transform disruptive spine surgery, NuVasive (NASDAQ: NUVA), a leader in spine technology innovation, announced that clinical evaluations have started for its Pulse® platform which recently received CE Mark (Conformitè Europëenne) approval. The Pulse...
Yiling Pharmaceutical Gains Market Access in the Ukraine
Yiling Pharmaceutical has received medicine registration document from the Ministry of Health of Ukraine for its drug therapy Lianhua Qingwen Capsules. Lianhua Qingwen Capsules are designed to treat COVID-19, as well as other viruses like the flu or cold. The medicine...