Partnerships/Licensing

• Existing MS-DRG system unable to handle potential USD 300k-USD 1m support costs
• Risk of financial losses may prompt hospitals not to offer CAR-T therapies
• Therapies may be steered to PPS-exempt hospitals, but limited number in US

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Pfizer’s (NYSE:PFE) Sutent (sunitinib) will find low uptake in adjuvant renal cell carcinoma (RCC) setting, but approval could still come through despite a split Oncologic Drug Advisory Committee (ODAC) vote, experts said.

On 19 September, the FDA’s ODAC voted 6-6 for the use of Sutent as an adjuvant RCC treatment following a nephrectomy.

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AstraZeneca’s (LON:AZN) PACIFIC Phase III of Imfinzi (durvalumab) results in unresectable Stage III non-small-cell lung cancer (NSCLC) following concurrent chemoradiotherapy will trigger immediate practice changes, oncologists said. They added the results should likely lead to regulatory approvals, despite the full overall survival (OS) data not yet being available.

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Allergan’s (NASDAQ:AGN) efforts to have inter partes review (IPR) disputes dismissed through transferring Restasis (cyclosporine ophthalmic emulsion) patents to a Native American tribe may uncover alternative nonlitigious patent-invalidation procedures for generic companies, experts said.

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CRISPR development race has “no clear winner” despite China trial approval, steep hills en route to market – experts

The quest to develop and commercialise a CRISPR therapy will likely involve numerous stages of scientific and regulatory hurdles for developers as they race to dose the first human, agreed industry experts. Sichuan University’s West China Hospital’s recent milestone of achieving the world’s first CRISPR trial approval in lung cancer last month is merely one short leg of a tough R&D marathon, and does not necessarily guarantee any solid lead, said CRISPR experts.

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Roswell Park Cancer Institute seeks partner, CRO for Cuban lung cancer vaccine Phase II study – immunology chairman

The Roswell Park Cancer Institute, based in Buffalo, New York, hopes to facilitate a partnership to develop Centro de Inmunologia Molecular’s (CIM’s) Cimavax lung cancer vaccine in the next 12-18 months, said Roswell Park’s Dr Kelvin Lee, chair, Department of Immunology. The institute would largely play a facilitating role, while commercialization and further details such as deal structure would be up to a Havana-based CIM, he said.

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