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China accepts 17 cancer drugs for coverage; FDA flags Trevena opioid for safety

Top news

* Chinese regulators approved the inclusion of 17 anti-cancer drugs under the national medical insurance coverage following price negotiations with drugmakers. Inclusion in the reimbursement list is seen as key to a drug's commercial success in China as without the state reimbursement, patent-protected brand medicines become out of reach for most patients.

The reimbursed medicines include Celgene Corp.'s blood cancer chemotherapy Vidaza, and non-small cell lung cancer treatments including Pfizer Inc.'s Xalkori, Roche Holding AG's Tarceva and Novartis AG's Zykadia. The additions will be implemented by the end of November and will remain valid until Nov. 30, 2020.

Prices of the 17 anti-cancer drugs will be 57% lower on average following the price negotiations, deeper than the 44% average price cut in 2017 when regulators added 36 high-priced innovative drugs to the national reimbursement list, Hong Kong-based senior research analyst at ICBC, Zhang Jialin, told S&P Global Market Intelligence in an email. Novartis had the most number of cancer treatments added to the list this year at four, followed by Pfizer with three, Zhang said.

* Scientists from the U.S. Food and Drug Administration raised concerns about the safety and efficacy of Trevena Inc.'s intravenous opioid oliceridine, particularly its high potential for abuse. Trevena's plea to the FDA to market oliceridine to manage moderate to severe acute pain in adults for whom an intravenous opioid is warranted comes at the height of the U.S. addiction crisis — an epidemic that killed 72,000 Americans in 2017.

Last week, the Senate agreed with the House on a massive package of legislation to address the crisis, a bill that is awaiting enactment by the White House.

On the policy front

* The U.S. FDA is planning a series of guidance documents to ease the regulatory burden that generic companies have to go through to develop copies of complex drugs — medicines that are harder to "genericize" under traditional means and therefore face less competition.

M&A and capital markets

* LogicBio Therapeutics Inc. expects to price its IPO of 5,770,000 common shares on the Nasdaq Global Market between $12 and $14 per share.

* Guardant Health Inc., a precision oncology company, has closed its IPO of 14,375,000 common shares at $19 each for gross proceeds of about $273.1 million. The healthcare equipment company's shares began trading on the Nasdaq Global Select Market on Oct. 4 under the ticker symbol GH.

* Breathtec Biomedical Inc. has signed a share exchange agreement to acquire Nash Pharmaceuticals Inc., a privately held clinical-stage pharmaceutical development company focused on drug re-purposing. Vancouver, British Columbia-based Nash Pharma specifically focuses on chronic kidney disease, inflammatory bowel disease and non-alcoholic steatohepatitis, an inflammation of the liver.

* Chengdu Rongsheng Pharmaceutical Co. Ltd. has reached an agreement with Sinopharm Group Guangdong Medi-World Pharmaceutical Co. to acquire the remaining 20% equity interest in Sinopharm Group Guizhou Blood Products Co. Ltd. for HK$102.4 million. Chengdu Rongsheng Pharmaceutical is an indirect subsidiary of China National Pharmaceutical Group Corp., which is also the holding company of Sinopharm Hong Kong and related units.

Drug and product pipeline

* Johnson & Johnson said its blockbuster drug Stelara was effective in treating moderate to severe ulcerative colitis in a late-stage trial evaluating patients who did not respond to other therapies. The phase 3 study, called Unifi, compared two intravenous doses of the drug against placebo.

Of the 961 patients that were evaluated after eight weeks, 15.6% of those that received a standard 130-milligram dose and 15.5% of those that received a dose tied to their weight had clinical remission and showed no sign of the disease. This compares to 5.3% of those who took a placebo.

* Roche Holding AG said Ocrevus, given early to patients with multiple sclerosis, delivered greater clinical benefit in late-stage studies. Data from phase 3 extension trials compared outcomes in MS patients who received Ocrevus continuously for five years to MS patients who switched over only after two years of alternative therapy.

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* Novartis AG said data from a mid-stage study showed that its investigational drug crizanlizumab prevented pain in more sickle cell disease patients than placebo. A 52-week post hoc analysis of results from a phase 2 study, called Sustain, counted patients who experienced vaso-occlusive crises, a common, painful complication of sickle cell disease that is linked to increased morbidity and mortality.

* Nymox Pharmaceutical Corp. said its fexapotide triflutate injection helped reduce the risk of disease progression among patients with prostate cancer in a mid-stage study. The phase 2b study evaluated fexapotide triflutate in 2.5-milligram and 15-milligram doses to treat 146 patients with low grade localized prostate cancer.

* Aerie Pharmaceuticals Inc. said the European Medicines Agency has accepted the application of its eye therapy Rhokiinsa for review and expects to make a decision during the second half of 2019. The therapy, marketed in the U.S. as Rhopressa, is used to lower fluid pressure within the eyes of patients with open-angle glaucoma, a condition that leads to irreversible blindness and ocular hypertension.

Operational activity

* Pfizer Inc. said its global president of worldwide research and development and medical, Mikael Dolsten, will also be the U.S. drugmaker's chief medical officer. The New York-based pharmaceutical giant also appointed Lidia Fonseca as executive vice president and chief digital and technology officer.

Fonseca, who will take up the role at Pfizer in January 2019, is the chief information officer and senior vice president at testing services provider Quest Diagnostics Inc.

Our features

A CRISPR primer: Gene editing company leaders talk tech's potential in humans: What's all the fuss about with Clustered Regularly Interspaced Short Palindromic Repeats? The major CRISPR companies' executives explain how the tool works and what it is being leveraged for ahead of the first company-sponsored human trial.

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Other features

* Reuters has features about the financial cost of mental health disorders on the global economy and about the difficulty and costliness of securing medical records in the U.S.

Reuters also writes about how improved insurance coverage of non-drug therapies could help alleviate the U.S. opioid crisis and how the number of clinical trials in the U.K. is falling due to Brexit.

The day ahead

Early morning futures indicators pointed to a lower opening for the U.S. market.

In Asia, Hang Seng increased 0.08% to 26,193.07, while the Nikkei 225 rose 0.16% to 23,506.04.

In Europe, around midday, the FTSE 100 increased 0.01% to 7,238.30, and the Euronext 100 decreased 0.56% to
1,025.23.

Click here to read about today's financial markets, setting out the factors driving stocks, bonds and currencies around the world ahead of the New York open.

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