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Sanofi's Cablivi gets EU nod; Novartis streamlining production amid price drops

Top news

* Sanofi said the European Commission approved its drug Cablivi for treating acquired thrombotic thrombocytopenic purpura, or aTTP, a rare blood clotting disease causing extensive clots in a patient's small blood vessels, resulting in low platelet count, loss of red blood cells, restricted blood supply and organ damage. Cablivi was developed by Ablynx NV — a company Sanofi acquired in January.

The U.S. Food and Drug Administration also granted priority review to Cablivi for treating patients 18 years and older experiencing an episode of aTTP. The U.S. regulator is expected to make a decision by Feb. 6, 2019.

* Novartis AG chairman Joerg Reinhardt said the company is planning to streamline its global production to counter the falling prices of its medicines in the U.S., Reuters reported, citing an interview from Swiss newspaper NZZ am Sonntag. U.S. revenues from the drugmaker's key drugs fell between 1% and 2% in 2017, Reinhardt said.

On the policy front

* The Centers for Medicare and Medicaid Services have previously criticized the accountable care organization, or ACO, shared savings program for not providing enough value, but new data shows that the current model generated over $1 billion of savings in 2017. The data released by the agency Aug. 30 shows that 472 ACOs participating in the program saved $1.09 billion in 2017.

Even after the agency shared savings with providers, which is an aspect of the program, CMS saved a net total of $313.7 million. Allison Brennan, vice president of policy for the National Association of ACOs, said that after six years the program is beginning to show positive results because provider groups have had the time and experience to figure out the intricacies of the model and make adjustments.

* Drug assessment contracts between the European Medicines Agency and the U.K.'s Medicines & Healthcare products Regulatory Agency, or MHRA, are being reallocated to members of the EU as a result of Brexit, U.K.'s The Guardian reported. The MHRA previously handled 20% to 30% of all assessments in the EU — a process that all drugs in Europe need to go through before they could be used by health services.

* The American Academy of Pediatrics is urging parents to get their children vaccinated with the injectable flu vaccine instead of the nasal spray vaccine FluMist for the upcoming flu season, STAT reported.

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Drug and product pipeline

* CRISPR Therapeutics AG and Vertex Pharmaceuticals Inc. are sponsoring a human trial of CTX001, a gene therapy for treating patients with beta-thalassemia — a blood disorder that reduces the production of hemoglobin, FierceBiotech reported. The companies are one of the first to conduct testing of CRISPR technology in humans.

Operational activity

* The Dutch Pharmaceutical Accountability Foundation, a group of doctors and health advocates, is planning to file a claim with the Netherlands' Authority for Consumers and Markets to probe Leadiant Biosciences for allegedly abusing market power by increasing the price of its drug chenodeoxycholic acid, or CDCA, by 500 times, the Financial Times reported. CDCA is a treatment for cerebrotendinous xanthomatosis, a rare disease.

* Anonymous whistleblowers claiming to be employees of Chongqing Pharma Research Institute wrote to the drug regulator in Chongqing, China accusing Shanghai Fosun Pharmaceutical (Group) Co. Ltd. of illegally changing production processes for its active pharmaceutical ingredients, fabricating data to achieve passing results and bribing local officials to get approvals for production changes, FiercePharma reported. Chongqing Pharma Research Institute is a unit of Fosun Pharma.

Fosun Pharma responded by saying its products are made using approved production processes and any adjustments have been approved by authorities.

Other features

* Reuters has a feature about medicines in low- and middle-income countries containing dangerous or ineffective mixes of ingredients, and another about how cataract surgery has no link to a longer life in older women.

* A study published in JAMA Network Open showed that a larger number of children and adolescents were diagnosed with the attention-deficit/hyperactivity disorder in 2016 than in 1997. The study showed the estimated prevalence of diagnosed attention-deficit/hyperactivity disorder in US children and adolescents increased from 6.1% in 1997-1998 to 10.2% in 2015-2016.

* The New York Times has a feature on U.S. cable giant Comcast and other large employers in the country who are revamping healthcare for their employees in an attempt to manage their costs.

* The Financial Times has a feature on the European Research Council's Developing Human Connectome Project which is using magnetic resonance imaging to map brain function of developing fetuses.

The day ahead

U.S. markets are closed due to Labor Day.

In Asia, the Hang Seng was down 0.63% to 27,712.54. The Nikkei 225 retreated 0.69% to 22,707.38.

In Europe as of midday, the FTSE 100 was up 0.71% to 7,485.98 and the Euronext 100 was up 0.04% to 1,059.17.

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