A new method, based on gene editing with oligonucleotides and functional analyses, identifies which variants of DNA repair genes associated with Lynch syndrome are truly harmful and which are not. Scientists at The Netherlands Cancer Institute have developed this technique and classified these gene variants in both coding and noncoding regions, distinguishing those that are pathogenic from those that are benign.
After passing on one skinny label case a few years ago, the U.S. Supreme Court agreed to delve into the dark hole the Federal Circuit has dug for drug label carveouts that allow generic drugs and biosimilars to come to market even though some indications of the reference drug may still be protected by exclusivities or patents. The high court granted cert Jan. 16 to Hikma Pharmaceuticals v. Amarin Pharma Inc., which revolves around Hikma’s marketing of its generic version of Amarin’s blockbuster drug, Vascepa (icosapent ethyl).
China’s National Medical Products Administration has accepted for review Grand Pharmaceutical Group Ltd./Telix Pharmaceuticals Ltd.’s NDA for TLX-591-CDx (Illuccix, gallium Ga 68 PSMA-11), a radionuclide-drug conjugate for diagnosing prostate cancer.
Astrazeneca plc is paying up to $630 million to acquire China rights to Abelzeta's Pharma Inc.’s C-CAR031 (AZD5851), an autologous glypican 3-targeting CAR T, securing global rights to develop, manufacture and commercialize the CAR T for liver cancer.
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