国际新闻精选周五（2017年1月13日）

JP Morgan day three roundup – Trump reminds the sector who’s in charge

Biotech investors should have been pleased with the chunky research deal delivered by Vertex on day three of the JP Morgan conference, but instead the US president-elect spoiled the party. Donald Trump’s vigorous pledge to act on drug prices ended the Nasdaq Biotechnology Index’s 2017 rally and hit pharma stocks elsewhere, reminding the sector what the real story is going to be this year. News from elsewhere did manage to filter through, however, and Mylan’s embattled chief executive uttered what could become a profound prediction for the coming year. A development setback with mRNA from Curevac served as a reminder of likely slow progress in this hot space, while other stock market darlings, Bluebird Bio, Kite Pharma and Editas, all highlighted approaching crucial clinical milestones.【阅读全文】

EU approves Gilead’s hepatitis B therapy Vemlidy

Patients with chronic hepatitis B in Europe have gained the firm new treatment option in nearly 10 years following the approval of Gilead's Vemlidy. The active substance of Vemlidy is tenofovir alafenamide (TAF), a novel, targeted prodrug of tenofovir with high antiviral efficacy similar to Gilead's Viread (tenofovir disoproxil fumarate; TDF) at one-tenth of the dose. Because TAF enters cells more efficiently than TDF it can be given at a lower dose, massively reducing the amount of tenofovir present in the bloodstream.【阅读全文】

Failed Nivalis pares down to a skeletal crew as it launches a salvage operation

Back at the end of November, little Boulder, CO-based Nivalis Therapeutics hit a clinical land mine and saw its shares explode, in a bad way, as its lead drug flopped in an effort to see if it could help cystic fibrosis patients. Now, with its back up against a wall and Wall Street in a black mood regarding clinical failure, CEO Jon Congleton and some two dozen staffers are being dismissed as the 5 survivors go out in search for a viable “strategic alternative.”【阅读全文】

Ionis to get volanesorsen in front of the FDA ‘ASAP’: CEO

Ionis, fresh from its approval of Spinraza with Biogen, says it is seeking to get its heart drug volanesorsen in front of the FDA as soon as possible, as it also looks to work on a new alternative med with Biogen after dropping development of IONIS-DMPK-2.5-R. Speaking to FierceBiotech from this year’s J.P. Morgan event in San Francisco, Ionis’ CEO Dr. Stanley Crooke wouldn’t give an exact timeline, but said the biotech is “gearing up to file the NDA in a very short time after we get our latest phase 3 results.”【阅读全文】

A Nevada woman dies of a superbug resistant to every available antibiotic in the US

If it sometimes seems like the idea of antibiotic resistance, though unsettling, is more theoretical than real, please read on. Public health officials from Nevada are reporting on a case of a woman who died in Reno in September from an incurable infection. Testing showed the superbug that had spread throughout her system could fend off 26 different antibiotics.【阅读全文】

FDA rejects Tesaro’s IV version of rolapitant, citing manufacturing issues

Tesaro’s plans for building up sales of Varubi — or rolapitant — through a new intravenous formulation of the drug will have to wait. The FDA shot down the biotech’s marketing application, which the biotech says is solely during to some outstanding manufacturing issues. The pill version of the drug — used to treat chemo induced nausea and vomiting — was OK’d back in 2015, triggering a blockbuster projection from the company. Analysts, though, have been less than impressed with the rollout, with Leerink pulling back its forecast on sales.【阅读全文】

CureVac’s lead mRNA program flunks a critical PhIIb study, raising questions for high-profile biotech unicorns

CureVac’s leading mRNA program CV9104, a prostate cancer vaccine, has failed a critical Phase IIb study. And that stinging setback for the most advanced clinical study in the field will raise fresh questions about a complex new technology that has attracted billions of dollars in investment cash. The German biotech reported that not only did CV9104 fail the primary endpoint on improving overall survival, there was also no improvement on progression- free survival over a placebo.【阅读全文】

Medtech M&A regresses to the mean in 2016

When it comes to the consolidation of medtech companies 2016 is the new 2014. The two years saw the same number of M&A deals closed – 217 – and a very similar figure for their total value – $41.8bn last year, versus $40.8bn two years earlier. This has the effect of making 2015 stand out all the more starkly, its total looking truly extraordinary at nearly $130bn (see graph below). Several billion-dollar deals were closed last year, but all were relatively modestly priced: the largest was Canon’s purchase of Toshiba’s medtech division, at $6bn.【阅读全文】

JP Morgan day two roundup – all talk, very little action

Day two of the JP Morgan conference contained lots more talk but very little action, on the deal front at least. Valeant's asset sales were the biggest transactions timed to hit the headlines, while Sanofi’s comments on a deal that did not happen, Actelion, essentially amounted to criticism of media reports at the time. Executives notably did not go so far as to deny that talks actually happened. Elsewhere, Merck stole the immuno-oncology limelight with the surprise announcement of a filing for a Keytruda combination in first-line lung cancer, progress that knocked Bristol-Myers Squibb shares and prompted a robust defence of its own I-O strategy. And among the small caps, Sarepta provided relief with some sales figures for Exondys 51. The confab’s news front has noticeably quietened versus day one, however.【阅读全文】

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