国际新闻精选周五（2017年2月3日）

AstraZeneca CEO: We want a ‘strong, science-led FDA’

The chief of AstraZeneca, Pascal Soriot, said during the Big Pharma’s financials this morning that he wants a “science-led FDA” as President Donald Trump's administration looks to slash regulations, and potentially staff, from across the agency.

In the Q4 update call to journalists and analysts, Soriot said: “We actually believe in a strong, science-led FDA. We are a science-led organization that thrives to hit high scientific standards and so we would expect the FDA to be well staffed and focused also on those standards.”【阅读原文】

IPO bumps slow, but no need to panic yet

In spite of the recent volatility in the public markets, venture investors in biopharma companies are still reaping the rewards when these groups float. However, the rate of returns has dipped since this analysis was last carried out in 2015, and if the IPO scene continues to stagnate it could fall further still.

Nevertheless, there is still a profit to be made, and the latest numbers could reassure any jittery VCs; on average, investors more than doubled their money in the 2013-16 period, and those willing to take a risk on early-stage assets did particularly well, with the biggest bump-ups coming in phase II (see tables below).【阅读原文】

Amgen scores positive PhIII cardio outcomes for its PCSK9 franchise drug Repatha

Amgen got another round of good news for its PCSK9 franchise drug Repatha. Hot on the heels of a major patent fight victory over Sanofi and Regeneron, the big pharma company says investigators garnered positive top-line cardio outcomes data from their critical FOURIER trial.【阅读原文】

Big data study finds new targets for breast cancer treatment

A study using big data has fast-forwarded progress in breast cancer research "by decades", discovering a cell shape/gene network that sheds new light on the development of the disease, potentially forming the basis for better treatment selection in the future.【阅读原文】

Meridian Lab and Apobiologix Enter into a Definitive Agreement for Development of Docetaxel Injection

Meridian Laboratories, Inc., a Buffalo, IL based specialty-oncology drug development company, announced today that it has entered into a definitive agreement with Apobiologix, a part of the Apotex Inc. group, to develop and market a one-vial liquid improved formulation of docetaxel injection for the treatment of multiple forms of cancer. The agreement includes the possibility for co-development and marketing of future products between Meridian and Apobiologix, which has a strong oncology pipeline.【阅读原文】

Trial Patient Dies From a Stemline SL-401 Side Effect

A trial patient died from a Stemline Therapeutics' SL-401 cancer drug side effect, the family confirmed. Not reported by Stemline (STML) , the death came a day prior to a $45 million stock offering on Jan. 19. The patient's family confirmed that the BPDCN cancer patient died due to capillary leak syndrome. Despite increased safety monitoring and new dosing rules, this is the third death from the same side effect. Hoping to use the phase II study as the basis for its marketing application to the FDA, Stemline cannot afford a serious setback.【阅读原文】

Targovax announces encouraging top line two-year survival data from TG01 clinical trial in resected pancreatic cancer patients

Targovax ASA ("Targovax" or "the Company"; OSE: TRVX), a clinical stage company focused on developing immuno-oncology therapies to target solid tumors, today announces encouraging overall survival data from an analysis of the first cohort of patients in its ongoing, phase I/II clinical trial evaluating TG01 (co-administered with GM-CSF[1]) in resected pancreatic cancer given in combination with chemotherapy, gemcitabine, the current standard of care, study CTTG01-01.【阅读原文】

Roche powers up for first-line lung duel

Roche could not afford to fall behind its immuno-oncology peers, most of whom have been frantically amending study designs in a race for the moving target of first-line lung cancer. Sure enough, the Swiss firm yesterday upped the ante, revealing that all trials of Tecentriq in this setting were now looking at overall as well as progression-free survival as co-primary endpoints.【阅读原文】

Moving From Big Pharma To Biotech: A Conversation With Achillion's Joel Barrish

It’s becoming more and more common for senior scientific executives to leave big drug companies either for small biotech companies or startup initiatives. At times, of their own volition, these leaders make this transition despite enjoying a key leadership position with major responsibilities in a big company setting. A year ago, Dr. Joel Barrish, now the Chief Scientific Officer of Achillion, made such a move.【阅读原文】

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