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Lilly, Innovent's Tyvyt approved in China; Sanofi, Merck vaccine wins US nod


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Lilly, Innovent's Tyvyt approved in China; Sanofi, Merck vaccine wins US nod

Top news

* Eli Lilly and Co. and Innovent Biologics Inc. said their drug Tyvyt received approval from China's National Medical Products Administration for treating certain patients with classical Hodgkin's lymphoma, a type of blood cancer. Anti-PD-1 therapy Tyvyt, or sintilimab, is being tested in over 20 clinical trials, including studies in lung, gastric, liver and esophageal cancers.

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* The U.S. Food and Drug Administration approved Sanofi and Merck & Co. Inc.'s Vaxelis as a vaccine to prevent diphtheria, tetanus, whooping cough, polio, hepatitis B and invasive disease due to Haemophilus influenzae type b in children from 6 weeks through 4 years of age. Commercial supply of Vaxelis will not be available in the U.S. before 2020.

Drug and product pipeline

* Capricor Therapeutics Inc. voluntarily halted testing of its Duchenne muscular dystrophy treatment after a patient had a severe allergic reaction during the trial, dubbed Hope-2, which was evaluating young men and boys. Capricor said the patient responded well to medical treatment and is now showing no symptoms.

Operational activity

* Former Insys Therapeutics Inc. CEO Michael Babich agreed to plead guilty to being involved in a scheme that bribed doctors to prescribe Subsys, the company's addictive opioid painkiller, Reuters reported, citing U.S. prosecutors. Babich, who left Insys in 2015, will plead guilty to conspiracy and mail fraud when he goes on trial in January.

* Neos Therapeutics Inc. agreed to settle its patent infringement case filed against a unit of Teva Pharmaceutical Industries Ltd. Neos was claiming that an abbreviated new drug application for the generic version of Cotempla XR-ODT, or methylphenidate, filed with the U.S. Food and Drug Administration by Teva unit Teva Pharmaceuticals USA Inc. infringed its patents.

* Chinese authorities are probing Quanjian Group, a traditional Chinese medicine company, in connection with a young girl with cancer who died in late 2015 after using one of Quanjian's therapies, Reuters reported.

Other features

* The U.K. biotech sector received nearly £1.6 billion in investments during the first eight months of 2018, higher than the £1.2 billion for the whole of 2017, despite uncertainty surrounding Britain's exit from the EU, The Guardian reported.

* Between 2006 and 2016, at least 12 patients at the National Institute of Health's hospital in Bethesda, Md., were infected with an antibiotic-resistant bacteria known as Sphingomonas koreensis, leading to at least three deaths in 2016 alone, STAT News wrote, citing a study published in the New England Journal of Medicine. In 2011, a deadly superbug outbreak happened at the NIH Clinical Center, while certain drug vials were found to have fungal contamination in 2015.

* The New York Times highlighted how the war between government forces and a militia group is making it harder for health workers to end an Ebola outbreak at the Democratic Republic of the Congo.

The day ahead

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

In Asia, the Nikkei 225 increased 3.88% to 20,077.62, while the Hang Seng fell 0.67% to 25,478.88.

In Europe as of midday, the FTSE 100 was down 0.92% to 6,624.73 and the Euronext 100 fell 0.15% to 896.32.

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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