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ICER may make room for CAR-T; Softbank bets big

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ICER may make room for CAR-T; Softbank bets big

* In an upcoming review of experimental CAR-T therapies from Novartis AG and Kite Pharma Inc., U.S. price watchdog the Institute for Clinical and Economic Review will for the first time consider whether there are "low-value services" that can be cut to make way for innovative, yet potentially high-priced options such as the new class of gene-modifying cancer drugs.

* Japan's SoftBank Group Corp. is leading a $1.1 billion investment in privately held biotech Roivant Sciences, the Financial Times reported. Basel, Switzerland-headquartered Roivant focuses on acquiring medicines abandoned by big pharma due to cost cutting or corporate restructurings. The company owns a number of subsidiaries with the -vant suffix, including Axovant Sciences Ltd., which is developing a drug for Alzheimer's disease.

The FT called the investment the "largest private financing in the healthcare industry and one of the biggest in any industry."

Drug and product pipeline

* Mylan NV said U.S. approvals of the first generics to market have slowed amid an ongoing reorganization at the U.S. Food and Drug Administration, even as the agency tries to spur greater competition to lower medicine costs. Citing the regulatory environment, Mylan announced that it would push back all its planned drug launches in the country until next year.

* Mexico's antitrust regulator raised concerns about uncompetitive practices in the pharmaceutical sector that benefit companies such as GlaxoSmithKline plc and Pfizer Inc., Reuters reported.

Operational activity

* Novo Nordisk A/S said pricing pressures in the U.S. insulin market will persist into 2018 as the pharmaceutical company announced strong second-quarter sales and lifted estimates for the full year. Pricing pressure in the U.S. market has intensified due to political pressure and increased competition in a country where 29.1 million people are diagnosed with the disease, or 9.1% of the population, according to the Centers for Disease Control and Prevention.

* Bristol-Myers Squibb Co. is laying off 58 marketing positions that support its HIV line up, effective Oct. 6, as the company nears patent expiry for its HIV drugs Reyataz and Sustiva, FiercePharma wrote, citing an email from a company spokeswoman.

The day ahead

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

In Asia, the Hang Seng fell 1.13% to 27,444.00, while the Nikkei 225 was down 0.05% to 19,729.74.

In Europe, around midday, the FTSE 100 was down 1.15% to 7,411.83, and the Euronext 100 fell 0.43% to 999.12.

Now featured on S&P Global Market Intelligence:

* China FDA aims to improve medical device regulations: The China Food and Drug Administration is seeking to strengthen regulations around the groups that conduct trials for medical devices, according to a ministry notice seeking public opinion.

The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.