Novartis’s Pluvicto (radioligand therapy) is now FDA Approved for mCRPC treatment
The Swiss based Pharma Major scores yet another FDA approval for its new radioligand therapy. This much anticipated regulatory nod was received this week, enabling the global innovator to offer a new treatment paradigm. mCRPC is the short form for metastatic castration resistant prostate cancer. Prostate cancer is the most common cancer type in men….
News ViewsPfizer’s RSV vaccine granted FDA Breakthrough Therapy Status
Pfizer has secured the Breakthrough designation for its RSV vaccine RSVpreF this week. The US FDA has granted RSVpreF this coveted status base on a phase 2b proof of concept study. This also comes at a time when GSK, another player in this segment has faced a setback after the safety assessment of its vaccine….
Livtencity (maribavir) by Takeda – FDA Approved Drug for Cytomegalovirus treatment
Livtencity is the first drug to be approved by US FDA for the treatment of Cytomegalovirus. This approval is specifically for the use in patients with post-transplant cytomegalovirus (CMV) infection or disease, failing to respond to the available antiviral treatments. Livtencity’s FDA approval is awarded with Breakthrough Therapy and Priority Review Designations. Livtencity works by…
Mirum Pharma’s Livmarli (maralixibat) gets FDA nod to treat cholestatic pruritus
Livmarli is the first drug to be approved by the US FDA for the treatment of cholestatic pruritus in young patients with the super rare Alagille syndrome (ALGS). Developed by California based Mirum Pharmaceuticals, Maralixibat is an IBAT inhibitor that reduces the absorption of circulating bile acid levels. Its mechanism of action would ultimately lower…
Genzyme’s Nexviazyme gets US FDA Approval for Pompe disease treatment
Sanofi’s Genzyme has recently secured the FDA approval for Nexviazyme (avalglucosidasalfa-ngpt). It has received Breakthrough Therapy and Orphan Drug Designations. This willadd more scope for treating patients with late-onset Pompe disease, a rare genetic condition. Nexviazyme is the third innovative drug to be launched by Sanofi for the Pompe disease management. Myozyme and Lumizyme are…
AstraZeneca’s mAb Saphnelo scores FDA Approval for the treatment of Lupus
Systemic lupus erythematosus (SLE) is the most common type of Lupus, which is an autoimmune disease. Autoimmune disorders are not so rare, which are characterized by the immune system attacking own body tissues, affecting the vital organs. SLE can affect brain, lungs and kidneys along with joints, skin and blood vessels. The Lupus Foundation of…
AstraZeneca’s Tezepelumab found to significantly reduce Asthma Exacerbations
One of the global Biopharma Majors, AstraZeneca has recently announced that their Biologics License Application (BLA) for Tezepelumab has been granted Priority Review by the US FDA. This acceptance of Priority Review is for the treatment of Asthma. As per the company’s recent press release, Tezepelumab which is developed in collaboration with Amgen is the…
Biosimilar Drugs – Improved Access and Health Economics with New Age Adaptations
What are Biosimilar Drugs? Filgrastim-sndz was the first Biosimilar to be approved by the US FDA in 2015. There has been active participation by the Pharmaceutical majors in the US and other parts of the world since this first approval. It was even estimated that six out of ten top drugs or products could be…
News ViewsPatent Waiver for Vaccines and how does it impact access to COVID-19 Vaccines?
The proposed Patent or IP waiver for the COVID-19 Vaccines appears to be a closer reality now. The Biden Administration in the US is convinced that waiving off the IP restrictions for Coronavirus vaccines is a fair thing to do. The European Union may also incline to this narrative which is to be confirmed in…