国际新闻精选周四（2017年3月23日）

Not All Cardiologists Trust Amgen's Cholesterol Drug Study

There were high hopes for the FOURIER trial. Current dogma is that the more you can lower your LDL cholesterol (LDL-c), the lower the risk of a heart attack or stroke. Repatha did, in fact, produce unprecedented LDL-c lowering in FOURIER. Those patients taking optimal doses of statins had on average LDL-c levels of 92mg/dL, whereas those who were also dosed with Repatha had average LDL-c levels of 30mg/dL. The latter patients did have fewer CV events, but of a smaller magnitude than hoped. The PCSK9 had only a 15% decrease in CV events, only half of what had been hoped.【阅读全文】

BioClin raises $30M Series B round for bladder cancer candidate

Quiet upstart BioClin Therapeutics has raised $30 million in a Series B funding round, taking its total to $59 million since its founding, as it aims to push on with clinical work on its bladder cancer candidate B-701 that includes a combo test with Roche’s new PD-L1 med.【阅读全文】

Novartis’ heart drug serelaxin fails in key trial

Novartis is considering the future of serelaxin after the drug hit another setback failing to meet key goals in a late-stage study involving patients with acute heart failure.

The Phase III RELAX-AHF-2 study failed to hit its primary endpoints of showing that serelaxin (also known as RLX030) reduced the risk of cardiovascular death or reduced worsening heart failure when added to standard therapy.【阅读全文】

Aprea Therapeutics Announces Research Collaboration with Memorial Sloan Kettering Cancer Center

Aprea Therapeutics, a privately held, clinical stage biopharmaceutical company developing novel anticancer therapies targeting the tumor suppressor protein p53, today announced a collaboration with Memorial Sloan Kettering Cancer Center to study the effects of reactivation of tumor suppressor protein p53 by APR-246.【阅读全文】

AVEO Announces First Patient Dosed in Phase 1/2 TiNivo Trial of Tivozanib and Opdivo (nivolumab) in Advanced RCC

AVEO Oncology (NASDAQ:AVEO) today announced that the first patient has been dosed in the Phase 1/2 AVEO-sponsored TiNivo trial evaluating tivozanib in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, Opdivo® (nivolumab), in advanced renal cell carcinoma (RCC). The study, which will be led by the Institut Gustave Roussy in Paris, is under the direction of Professor Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee. The Phase 1 trial will evaluate the safety of tivozanib in combination with nivolumab at escalating doses of tivozanib and, assuming favorable results, is expected to be followed by an expansion Phase 2 cohort at the established combination dose.【阅读全文】

Serelaxin setback puts focus on Entresto

The prospects for Novartis’s heart failure franchise have taken a major blow with the phase III failure of serelaxin. Not only has the company lost a potential blockbuster, it is now even more reliant on Entresto, which has so far struggled to live up to expectations.【阅读全文】

Erytech looks to pancreatic cancer data for uplift

The French company Erytech is offering a novel approach to cancer treatment with Graspa, a red blood cell-encapsulated version of the chemotherapy drug L-asparaginase. The aim is to avoid the allergic reactions seen with older forms of the drug that are not encapsulated, with data in second-line pancreatic cancer due by the end of the first quarter.【阅读全文】

A year after a patient's death, Akashi gets FDA all-clear to resume DMD trial

kashi Therapeutics has been given the FDA go-ahead to restart tests for its Duchenne Muscular Dystrophy (DMD) candidate HT-100 (delayed-release halofuginone), just over a year after the test was suspended after a death.

The Cambridge, MA-based biotech at the start of last year suspended its study after a patient was sent to the hospital, and then a week later the biotech reported that the trial subject has died.【阅读全文】

Neurocrine posts full phase 3 Ingrezza data as PDUFA date, showdown with Teva in tardive dyskinesia near

Neurocrine Biosciences has published a journal paper about its phase 3 trial of tardive dyskinesia candidate Ingrezza. Publication of the paper comes weeks before a PDUFA date that could result in Neurocrine and Teva going head to head for the neurological disorder market in the years to come.

San Diego, CA-based Neurocrine published top-line results from the phase 3 trial of its vesicular monoamine transporter 2 inhibitor late in 2015. This week’s publication in The American Journal of Psychiatry fleshes out the dataset by providing additional details of the safety and efficacy of the candidate.【阅读全文】

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