Here are the latest stories being discussed in biopharma today:
J&J Achieves Full Approval for Bladder Cancer Drug Balversa
Johnson & Johnson’s bladder cancer drug Balversa has gained full FDA approval. Easing the path of tumor reduction, Balversa, or erdafitinib, is now being recommended for patients having a certain FGFR3 mutation and who have unsuccessful prior systemic therapy. Triumphing over chemotherapy, Balversa demonstrated a median overall survival of 12.1 months in patients, as compared to 7.8 months for those who received chemotherapy alone.
AstraZeneca’s Blood Disorder Pill Cleared in Japan
AstraZeneca’s add-on pill for the rare blood disorder, known as paroxysmal nocturnal haemoglobinuria (PNH), has attained its initial approval in Japan. Sold as Voydeya, the pill aims to alleviate anemia symptoms in patients experiencing insufficient results from C5 inhibitors. Heralding a potential outcome improvement for those dealing with EVH manifestations, Voydeya is still under review by various international health authorities.
AstraZeneca’s Imfinzi Combo Delays Progression in Liver Cancer
AstraZeneca’s Imfinzi combined with bevacizumab (also known as Avastin) and standard care chemotherapy treatment TACE for liver cancer has shown longer staving off cancer progression than chemotherapy treatment alone. This result emerges from the Phase II EMERALD-1 study conducted on over 600 patients with hepatocellular carcinoma, the most common form of liver cancer.
AstraZeneca, Boehringer Ingelheim, GSK Rally Against Pressure on Patent Listings
In response to Sen. Amy Klobuchar’s pressure on six pharma companies to rectify improperly listed patents on the FDA’s Orange Book, companies like AstraZeneca, Boehringer Ingelheim, and GSK are defending their patent listings. Klobuchar insists that such incorrect listings prevent generics from coming to market, consequently hurting patients, and demands either their removal from the Orange Book or appropriate clarification.
J&J Scores Full Approval for Balversa
Johnson & Johnson recently received full FDA approval for its bladder cancer drug Balversa. Now recommended for patients with specific FGFR3 mutations, Balversa has been lauded for its proficiency in shrinking tumors. This treatment managed to outperform chemotherapy, revealing a median overall survival of 12.1 months in patients, as contrasted with 7.8 months for those receiving only chemotherapy.
