Jul 2 Recent Pharma News

Pharma Market | FDA’s approval to Pfizer’s Zirabev; Launch of Century Therapeutics; Imbruvica’s recommendation from CHMP

Pfizer’s Zirabev gets FDA nod for the treatment of five types of cancer

The US FDA has approved Zirabev (bevacizumab-bvzr), a drug developed by Pfizer, for the treatment of five different types of cancer namely metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer. Zirabev, which is a biosimilar to Roche’s Avastin (bevacizumab), secured regulatory approval in Europe for the same in earlier this month. The drug works by inhibiting the formation of new blood cells by targeting and thereafter binding to vascular endothelial growth factor (VEGF) protein. Zirabev, after Trazimera, is the second drug by Pfizer which got FDA-approved.

Century Therapeutics launches with USD 250 M for iPSC Allogenic cell therapy

A new startup Century Therapeutics came to life with an investment of USD 250 Million financed jointly by Bayer, Versant and Fujifilm Cellular Dynamics Inc. Founded by Versant Venture, Century Therapeutics is focusing on developing induced pluripotent stem cell- (iPSC) based therapies for the treatment of hematologic and solid malignancies.
iPSC have an unlimited self-renewing capacity, enabling multiple rounds of cellular engineering. This will help produce a master cell bank of modified cells, in the end supplying vast amounts of allogeneic and homogeneous therapeutic products. The consortium will help Philadelphia-based Century Therapeutics to realize its potential as iPSC cell therapy platform and addressing high unmet needs in cancer treatment market.

A positive opinion for Janssen’s IMBRUVICA from CHMP

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the expanding of existing market authorization (MA) for Janssen’s Imbruvica (ibrutinib). The drug, Imbruvica, at present, is administered to adult patients suffering from, once treated, relapsed or refractory mantle cell lymphoma (MCL), or chronic lymphocytic leukaemia (CLL). After the CHMP recommendation, it will be used for treating chronic lymphocytic leukaemia (CLL) and Waldenström’s macroglobulinemia (WM) in combination with obinutuzumab and andrituximab respectively.

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