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...
ACC Finds Women Still Under-represented in Cardiology Trials
The American College of Cardiology (ACC) Cardiovascular Disease in Women Committee released a new report concluding that women, particularly women of color and minority women are still under-represented in a large majority of clinical cardiology (CVD) trials, in spite...
ICMRA Issues Guidelines for Global Track and Trace Systems
The International Coalition of Medicines Regulatory Authorities (ICMRA) has released comprehensive guidelines recommending how regulatory bodies can introduce aligned track and trace systems around the world to combat counterfeit or falsified products in global supply...
FDA Approves Sanofi’s Nexviazymefor to Treat Pompe Disease
The US FDA (Food and Drug Administration) has approved Sanofi’s Nexviazymefor to treat patients with rare but potentially fatal muscle disorder, Pompe disease. Pompe disease affects 1 in 40,000 Americans and weakens the heart and skeletal muscles caused by an...
Ardelyx Tenapanor Approval Requires Further Clinical Study
The US Food and Drug Administration (FDA) has rejected Tenapanor for Control of Phosphorus in Kidney Disease, asking for another clinical trial that indicates the drug’s greater benefits before approval. Ardelyx devleoped Tenapanor, an oral inhibitor of the...
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...