Tags : the US

The US FDA Rejects Gilead’s Filgotinib Due to Toxicity Issues

Shots: The US FDA has issued a complete response letter for the NDA of filgotinib to treat moderately to severely active RA. FDA has requested data from two ongoing clinical trials, MANTA and MANTA-Ray assessing the effect of filgotinib (200mg) on sperm parameter The authority has expressed concerns regarding the overall benefit/risk profile of the […]Read More

CytoDyn Signs an Agreement with American Regent for Leronlimab to

Shots: CytoDyn to receive quarterly payments based on the profit-sharing arrangement and will supply Leronlimab to American Regent. American Regent will be responsible for the distribution of Leronlimab post completion of CytoDyn’s ongoing clinical trials including the FDA’s approval in the US CytoDyn’s P-IIb/III trial is enrolling patients which will be evaluating leronlimab vs PBO […]Read More

Mylan and Biocon Launch Ogivri (biosimilar, trastuzumab) in the US

Shots: The FDA’s approval is based on study assessing Ogivri vs Herceptin with docetaxel or paclitaxel in 456 patients with measurable HER2+ mBC without prior chemotherapy or trastuzumab for metastatic disease The study demonstrated equivalence in overall response @24wks. with equivalence margin (0.81, 1.24) showing no clinically meaningful differences in terms of safety, purity and […]Read More

Pfizer to Launch its Zirabev (biosimilar, bevacizumab) in the US

Shots: The biosimilar launch in the US on Dec 31, 2019 following the settlement between Genentech and Pfizer granting all global rights of the product to the Pfizer. In Sept 2019, Genentech and Pfizer signed a joint stipulation of dismissal in their patent litigation case and voluntarily dismissed all the claims and counterclaims of April […]Read More

FDA Orders Immediate Stop on Commercialization of Surgical Mesh for

Shots: The US FDA has ordered all medical device manufacturers including Boston Scientific and Coloplast to stop sales & distribution of surgical mesh for the transvaginal repair of pelvic organ prolapse (POP) for the protection of women’s health The PMA submitted failed to provide long term assessment of safety & benefits compared to transvaginal surgical […]Read More

Baxter’s Eptifibatide Receives the US FDA’s Approval for Cardiovascular Diseases

Shots: Baxter’s ready to use Eptifibatide is approved and launched for patients with acute coronary syndrome (ACS) & percutaneous coronary intervention (PCI) The FDA approval strengthens Baxter’s premix portfolio, enhance patient’s safety by avoiding dosing error and reduces the burden on hospital pharmacist Eptifibatide (75mg/100ml) is a platelet aggregation inhibitor, based on Baxter’s galaxy container […]Read More