The FDA has approved Novartis AG’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan, formerly referred to as 177Lu-PSMA-617) for treating adults with metastatic prostate-specific membrane antigen (PMSA)–positive metastatic castration-resistant prostate cancer (mCRPC). The treatment is the indication’s first FDA-approved targeted radioligand therapy that contains a radioisotope. In tandem, the FDA also approved Locametz, an imaging agent for using after radiolabeling. It may be used to identify PSMA-positive lesions in adult patients with mCRPC through a PET scan. The approval was based on a phase III study showing participants treated with Pluvicto plus standard of care had a 38% lower risk of death and a statistically significant reduction in the risk of radiographic disease progression or death compared to SOC alone.

Innovent, Lilly receive CRL for NSCLC candidate sintilimab

Innovent Biologics Co. Ltd. and Eli Lilly and Co. are "assessing next steps" for their jointly developed PD-1 inhibitor, sintilimab, following receipt of a complete response letter (CRL) from the U.S. FDA. The pair sought approval of a BLA for sintilimab plus pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small-cell lung cancer (NSCLC) but found near-unanimous opposition from FDA advisers dissatisfied with China-only trial data submitted in support of the application. The medicine is already approved for multiple indications in China, where it’s marketed as Tyvyt.

Zai Lab hits primary endpoint in phase III Zejula study for ovarian cancer

Zai Lab Ltd. has shared positive data from its phase III study for PARP inhibitor Zejula (niraparib) in the treatment of newly diagnosed ovarian cancer following a response to platinum-based chemotherapy. The study, called Prime, involved 384 advanced ovarian cancer patients in China and met its primary endpoint. Patients treated with Zejula had a significantly longer median progression-free survival of 24.8 months, regardless of biomarker status, compared to 8.3 months for patients taking a placebo. Zai has developed the drug in partnership with Glaxosmithkline plc.

China’s Nuance Pharma in-licenses Asian rights to Bavarian Nordic’s RSV vaccine in $225M deal

Nuance Pharma Co. Ltd. signed a licensing deal with Denmark’s Bavarian Nordic A/S for rights to its MVA-BN RSV vaccine for respiratory syncytial virus (RSV) in the Chinese mainland, Hong Kong, Macau, Taiwan, South Korea and certain Southeast Asian countries. Shanghai-based Nuance plans to run its own phase I and phase III trials in China to support regulatory approval of MVA-BN RSV in China, which will be conducted separately from Bavarian Nordic's own phase III trial planned to begin in the first half of 2022. Under the terms, Bavarian Nordic will receive an up-front payment of $12.5 million and is eligible to receive future clinical, regulatory and commercial milestone payments up to $212.5 million plus tiered, double-digit sales royalties.

UK Chancellor pledges life sciences R&D relief as inflation squeezes economy

While the focus of much U.K. Chancellor Rishi Sunak’s spring statement 2022 was on the rising cost of living, there was welcome relief for life sciences and research-based industries as part of a drive to restore economic growth. Against a backdrop of high inflation – a hangover from the COVID-19 pandemic made worse by the economic shock from the Ukraine war – Sunak was under pressure to help families and businesses negotiate a testing economic environment in this mini-budget. But there were welcome inclusions for industry. The country’s pharma trade body, the Association of the British Pharmaceutical Industry, for instance, welcomed a proposed tax plan, which aims to cut and reform business taxes to create an enterprise culture and create the conditions for private sector-led growth.

EU, WHO expand African partnership

Building on its partnership with the World Health Organization (WHO) to improve access in Sub-Saharan Africa to vaccines, drugs and medical technologies, the EU on March 23 committed at least €24.5 million (nearly US$27 million) to fund projects aimed at tackling some of the barriers to that access. “The European Union and WHO share a common ambition to boost local production capacity and access to quality, safe, effective and – importantly – affordable medicines and vaccines,” EU Commissioner Jutta Urpilainen said. The biggest share of the new funding, €12 million, will be used to support technology transfer, especially for mRNA technologies, to the region and to help develop the necessary workforce.

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