FDA Grants Fast Track Designation for Gemini Therapeutics’ Treatment GEM103
Today (1/7) Gemini Therapeutics announced that the U.S. Food and Drug Administration (FDA) granted GEM103 treatment of dry age-related macular degeneration (AMD) for Fast Track designation. Gemini Therapeutics is a clinical stage precision medicine company based in...
The Diversity of India and Its Impact on the Global Clinical Trial Landscape
With a population of more than 1.3 billion people, India is one of the fastest growing economies in the world. As their global economy continues to expand, and as clinical trials are continuing to be conducted overseas, India remains unique in both the opportunities...
FDA Releases Statement Urging Healthcare Providers to Follow Proper Dosing Schedules
The U.S. Food and Drug Administration (FDA) released a statement on Monday (1/4) urging healthcare providers to follow the approved dosing schedules for COVID-19 vaccinations, after discussions of changing doses, limiting doses, and extending length of time in between...
FDA Clears BioSerenity’s Electroencephalography (EEG) Wearable Device
Today (1/5) BioSerenity announced that the U.S. Food and Drug Administration (FDA) cleared the Neuronaute® EEG System and IceCap® EEG wearable device. The device is designated for patients diagnosed with epilepsy, and will enable physicians to remotely monitor and...
NDA Submitted by Antengene in South Korea
Antengene submitted yesterday (1/3) a New Drug Application (NDA) with Orphan Drug Designation (ODD) to South Korea’s regulatory body, the Ministry of Food and Drug Safety (MFDS), for ATG-010 (selinexor). The NDA is specifically for the approval of ATG-010 (selinexor)...
AstraZeneca Unlikely to Receive EUA Approval Until April
According to Operation Warp Speed Chief, Moncef Slaoui, the AstraZeneca and Oxford University vaccine may not receive the U.S. Food and Drug Administration’s Emergency Use Approval (EUA) until April, despite the UK's approval yesterday (12/30). Questions surrounding...
NeuroRx and Relief Therapeutics Approved to Commence Phase 2b/3 Trial for ZYESAMI
NeuroRx and Relief Therapeutics have completed enrollment for their phase 2b/3 clinical trial for their treatment of respiratory failure in patients with severe cases of COVID-19. The trial, who’s top-line data is expected in one month, has...
FDA Risk Evaluation and Mitigation Strategy (REMS) for Fentanyl Products
The U.S. Food and Drug Administration (FDA) has made their REMS requirements for transmucosal immediate-release fentanyl (TIRF) products more rigorous to minimize inappropriate prescriptions for the strong and highly addictive opioid. The REMS guidelines serve as a...
InnoCare Pharma of Beijing Receives China’s National Medical Products Association Approval
The Chinese company InnoCare Pharma announced today (12/28) that its BTK inhibitor orelabrutinib received approval for the treatment of cancer and autoimmune diseases, specifically relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma...
Walmart Sued for Prescription Opioid Sales
The Department of Justice sued Walmart yesterday (12/22) for inadequately screening for questionable prescriptions, ultimately fueling the nation’s opioid crisis. According to the lawsuit, Walmart’s understaffed pharmacies pressured employees to fill prescriptions...
FDA Approves First Prostate Cancer Hormone Treatment
Today (12/21) the U.S. Food and Drug Administration (FDA) approved the first oral treatment for prostate cancer, a disease that affects on average one in every nine men. Orgovyx, created by Myovant, was created to treat advanced prostate cancer cases by blocking the...
Moderna COVID-19 Vaccine Receives FDA Emergency Use Authorization
On Friday (12/18) The U.S Food and Drug Administration granted Moderna Emergency Use Authorization for their COVID-19 vaccine in adults over 18 years old. In addition to Pfizer’s vaccine, the U.S government agreed to purchase 200 million doses from Moderna which will...
GlaxoSmithKline, MacroGenics Inc. and More Receive FDA Approvals
The U.S. Food and Drug Administration (FDA) had many approvals this week including a treatment created by GlaxSmithKline for Lupus Nephritis in adults, one of the most common autoimmune diseases. The FDA approval for GlaxoSmithKline was historic, as Benlysta is the...
Jet 7 Xtra Flex Catheter for Stroke Patients Recalled by Penumbra
Following the close of the market on Tuesday, Penumbra announced the U.S. Food and Drug Administration (FDA) advised recall of their catheter device resulting from 14 reported patient deaths, among other patient hemorrhages,...
Emergency Use Authorization Given to Ellume’s At-Home COVID-19 Test
On December 15, 2020, the U.S. Food and Drug Administration (FDA) approved the first over the counter fully at-home COVID-19 Test. The test delivers results in approximately 20 minutes and diagnoses individuals as young as two years old and is expected to be delivered...
Pre-Market Review Option Rolled Out by FDA for 510k Clearance
Under its Abbreviated 510k Program, the U.S. Food and Drug Administration (FDA) outlined guidelines for the Safety and Performance Based Pathway, a fast track for medical devices in well established categories to gain market...
Pfizer and BioNTech Receive Premier COVID-19 Vaccine Authorization
Pfizer and BioNTech have made history with their COVID-19 vaccine, as it is the first to enter the U.S. market after Phase 3 clinical trial results showing 95% efficacy. The mRNA vaccine is being allocated for emergency use to hospitals nationwide,...
AstraZeneca Partners with Sputnik to Boost COVID-19 Vaccine Efficacy
Russia’s Sovereign Health Plan disclosed today (12/11) that Sputnik-V will be joining AstraZeneca in their pursuit for a COVID-19 vaccine. The joint vaccine production will enter clinical trial phases on adults 18 years and older by the...
The European Medicines Agency (EMA) Suffers Cyber Attack
BioNTech released a statement on December 9, 2020 that Pfizer and their COVID-19 vaccine documents was “unlawfully accessed” in a breach on the European Medical Agency's (EMA) system. The severity of the attack was not divulged, however the EMA disclosed that they...
FDA Breakthrough Designation Given to ReGelTec
ReGelTec, a medical device company out of Baltimore’s leading medical device HYDRAFIL, has received Breakthrough Designation from the U.S. Food and Drug Administration (FDA). The Breakthrough Device Program was created with intentions to expedite the...