国际新闻精选周二（2017年2月7日）

BMS, Innate checkpoint inhibitor flunks AML phase 2

A phase 2 trial of Innate Pharma’s lirilumab in elderly patients with acute myeloid leukemia (AML) has missed its primary endpoint. The Bristol-Myers Squibb-partnered checkpoint inhibitor failed to improve leukemia-free survival by more than placebo.

Innate enrolled 150 people in the trial and randomized them to receive one of two doses of the anti-KIR monoclonal antibody or a placebo. The clinical trial failed to find a statistically significant difference between either treatment arm and the placebo in terms of leukemia-free survival or any other efficacy endpoint. The across-the-board failure is a stumble at the first major clinical efficacy hurdle faced by lirilumab.【阅读全文】

NW Bio Announces Lifting of Clinical Hold on DCVax-L Phase III Trial By FDA; Progression-Free Survival Events Reached; Overall Survival Events Not Yet Reached

Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio" or the "Company"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today provided a further update about the Company's Phase III trial of DCVax®-L for Glioblastoma multiforme ("GBM") brain cancer (the "Trial"). The Company announced that the partial clinical hold on the Trial has been lifted by the FDA, and that the Trial has accumulated a sufficient number of events toward the progression-free survival ("PFS") endpoint, but not yet for the overall survival ("OS") endpoint.【阅读全文】

Merck submits Keytruda for bladder cancer

Merck & Co is continuing on its quest to expand the approved uses of its immunotherapy Keytruda, filing the drug in the US for both first- and second-line use in bladder cancer.

In the first-line setting approval is being sought for the drug's use in patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing therapy, while second-line use is being targeted towards these patients with disease progression on or after platinum-containing chemotherapy.【阅读全文】

Ablynx files caplacizumab for ultra rare blood disorder

Patients in Europe with the ultra rare blood clotting disorder acquired thrombotic thrombocytopenic purpura (aTTP) are a step closer to getting the first therapeutic specifically indicated for treating the disease, after Ablynx filed for approval of caplacizumab.

The life-threatening disorder has a sudden onset caused by impaired activity of the ADAMTS13 enzyme, resulting in severe thrombocytopenia (very low platelet count) and micro-clot formation in small blood vessels throughout the body which cause thrombotic complications and widespread organ damage.【阅读全文】

With Trump’s new FDA commish nominee looming, industry execs are keeping their fingers crossed for Scott Gottlieb

Last week President Trump said he was just days away from announcing an absolutely “fantastic” new FDA commissioner. One who would cut up to 80% of the regulations around drug development, blazing a shorter path to an approval. One who would get experimental meds to dying patients, overhauling timelines and slashing development budgets.【阅读全文】

Gene therapy helps deaf mice hear sounds as soft as whispers

Scientists at Harvard Medical School are reporting today that they’ve perfected a form of gene therapy originally developed to restore hearing, and as a result, genetically deaf mice are able to hear down to 25 decibels. That’s the equivalent of a whisper.【阅读全文】

Lilly to ax 200 R&D positions globally

Eli Lilly is working to cut 200 R&D positions. The Big Pharma is framing the action as a “voluntary reallocation program” that will see it reduce its global R&D headcount by nearly 3% while it ups its investment in other areas.

The cuts, news of which was first reported by Stat, follow shortly after Lilly detailed plans to ax 485 employees in response to the failure of its Alzheimer’s trial. But, according to the company, the aim this time is different. Lilly is looking for 200 staffers from multiple R&D sites around the world to voluntarily sign up to leave the company.【阅读全文】

Cellectis preps for groundbreaking US trials for an off-the-shelf CAR-T therapy

Cellectis is ramping up the first-ever US trial launches for an off-the-shelf CAR-T therapy.

The Paris-based biotech $CLLS, which has a sizable R&D group in Manhattan, says the FDA has signed off on their IND for a Phase I study of UCART123 in acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm.【阅读全文】

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