国际新闻精选周四（2017年3月2日）

Would Trump's FDA Deregulation Create An Age Of Miracles? Don't Bet On It

In his first address to a joint session of Congress, President Donald Trump made a dramatic appeal for lowering the hurdles new medicines face in gaining approval from the Food and Drug Administration. But Trump’s promises – that reduced regulatory standards would result in more cures reaching the market and lower drug prices – may be hard to keep.【阅读全文】

A Safe “BET” on Epigenetic Drugs

Epigenetic therapies, small-molecule drugs named for their ability to alter gene expression by targeting epigenetic regulators, could enable powerful new strategies to combat diseases marked by aberrant gene expression, like cancer.

Epigenetic regulators fall into three main categories: writers, erasers, and readers. Writers modify histones by adding chemical groups that result in acetylation, phosphorylation, methylation, or other modification types, while erasers remove these groups. The important task of recognizing these modifications falls to reader proteins.【阅读全文】

Priority review for Merck, Pfizer’s avelumab in urothelial cancer

US regulators have agreed to undertake a priority review Merck and Pfizer's avelumab as a potential treatment for metastatic urothelial carcinoma (mUC).

The companies are targeting the treatment towards patients with locally advanced or mUC with disease progression on or after platinum-based therapy.【阅读全文】

Genentech to launch second PhIII trial of Alzheimer’s drug

Roche's Genentech is launching a second Phase III trial of anti-Abeta antibody crenezumab in patients with early forms of Alzheimer's disease (AD), on the back of promising data on the drug's "unique" binding properties and in support of increased dosing.

The new trial - CREAD2 - intends to recruit 750 patients with prodromal or mild AD, complementing the ongoing Phase III CREAD1 trial, which is assessing the drug in the same patient target group and is expected to read out in 2020.【阅读全文】

Lilly Completes Acquisition of CoLucid Pharmaceuticals

Eli Lilly and Company (NYSE: LLY) today announced the successful completion of its acquisition of CoLucid Pharmaceuticals, Inc. (NASD:CLCD). The tender offer for all outstanding shares of common stock of CoLucid, at a price of $46.50 per share, expired as scheduled on Tuesday, February 28, 2017.【阅读全文】

SELLAS Life Sciences Announces Updated Positive Phase 2 Data Reinforcing Meaningful Clinical Benefit of its WT1 Immunotherapeutic Anti-cancer Treatment in Multiple Myeloma Patients

SELLAS Life Sciences Group (SELLAS or the Company), a late-stage biopharmaceutical company developing novel cancer immunotherapies for an extensive list of cancer indications, today reported updated positive Phase II data from its WT1 immunotherapeutic anti-cancer treatment, galinpepimut-S, in multiple myeloma (MM) patients. Consistent with preliminary data, the updated results indicate a meaningful clinical benefit among high-risk MM patients, positioning galinpepimut-S as a potential first-in-class immunotherapeutic cancer treatment. MM patients typically relapse within 12 months after frontline induction therapy, followed by successful autologous stem cell transplantation (ASCT). 【阅读全文】

Months after another lethal setback, Juno finally opts to kill lead CAR-T

Months after one of the worst setbacks in the recent history of drug development left a string of patients dead, Juno has finally decided that it will terminate its lead drug program, hoping for a better outcome with another CAR-T therapy in its pipeline.【阅读全文】

Investigational drug shows promise for hard-to-treat renal cancer

The investigational compound savolitinib appears to have antitumor activity in patients with c-MET-driven papillary renal cell carcinoma, according to the results of a phase II study released at the 2017 Genitourinary Cancers Symposium in Orlando, FL.

Savolitinib is an oral, highly selective inhibitor of the c-MET receptor tyrosine kinase.【阅读全文】

After 22 years Lexicon has an approved drug

Lexicon Pharmaceuticals has been through its share of makeovers. Still, no one who remembers its birth as a genetic engineering company before the 2000 biotech boom and bust could have predicted that it would end up a rare disease player.【阅读全文】

Enasidenib in Relapsed or Refractory AML with an IDH2 Mutation

Celgene Corporation (NASDAQ:CELG) and Agios Pharmaceuticals (NASDAQ:AGIO) today announced that the U.S. Food and Drug Administration (FDA) has accepted Celgene’s New Drug Application (NDA) for enasidenib (AG-221/CC-90007) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation. The NDA was granted Priority Review and has been given a Prescription Drug User Fee Act (PDUFA) action date of Aug. 30, 2017. Celgene completed the NDA submission in late December 2016.【阅读全文】

Battered over safety questions in ’16, Aurinia comes back with more positive data on lupus drug

Last summer, Aurinia $AUPH found itself between a rock and a hard place as it sought to explain a troubling cluster of deaths in the two dosing cohorts — as well as an odd flip-flop in results you might expect to see from the low and high doses — used to test their drug voclosporin for lupus nephritis. Unsatisfied by the case Aurinia made for efficacy and safety at 24 weeks, investors pulled out after looking over the fallout, cratering the stock.【阅读全文】

EMA adds Alnylam RNAi drug to PRIME fast-track scheme

The European Medicines Agency (EMA) has added Alnylam’s acute hepatic porphyria candidate to its priority medicine (PRIME) scheme. Securing the status positions Alnylam to benefit from a close relationship with the EMA as it works to move the drug prospect into phase 3 by the end of the year.【阅读全文】

Accera fails phase 3 Alzheimer’s trial, denting energy theory

A phase 3 trial of Accera’s Alzheimer’s disease candidate has missed its primary endpoint. The trial aimed to show Accera’s brain metabolism-focused approach to improving outcomes in Alzheimer’s could succeed where beta-amyloid drugs have failed, but instead ended up becoming yet another late-phase failure.【阅读全文】

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