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FDA reauthorization bill passes House committee; Novartis faces fresh fine


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FDA reauthorization bill passes House committee; Novartis faces fresh fine

* The House Energy and Commerce Committee voted unanimously to advance the Food and Drug Administration Reauthorization Act of 2017, a must-pass bill to renew four user-fee programs that the agency relies on for more than half of its funding. The bill, which would renew the FDA's authority to collect user fees from makers of prescription brand-name drugs, medical devices, generic medicines and biosimilars, has yet to be scheduled for a full Senate vote.

* Senate Majority Leader Mitch McConnell, R-Ky., is proposing to retain the provision of the Affordable Care Act that protects individuals with pre-existing conditions from being charged higher premiums when they sign up for individual insurance, an insider told Bloomberg News. McConnell told reporters that a Senate ACA repeal bill is set to be brought forward "in the near future."

* Health insurers in New York are seeking to raise premiums in their ACA insurance plans by an average of 16.6% next year, only slightly lower than the 18% hike that they requested in 2016 and equivalent to what was approved. New York received requests for rate hikes of between 4.4% and 47.3% from 16 insurers, as uncertainty clouds the future of the ACA amid efforts to repeal the law.

* Meanwhile, U.S. District Judge Joan Lefkow stopped short of ordering Illinois to pay $2 billion in unpaid Medicaid bills after ruling that the state failed to comply with court orders to pay healthcare bills for low-income and other vulnerable groups, the Associated Press reported. Instead, Lefkow asked that the state and Medicaid recipients negotiate an agreement.

Drug and product pipeline

* Novartis AG reported positive data from an interim analysis of its phase 2 trial evaluating CTL019 to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma, a cancer of B cells.

* AbbVie Inc. also achieved positive results in a phase 3 trial evaluating investigational drug upadacitinib in patients with moderate to severe rheumatoid arthritis who did not adequately respond to prior therapy.

* The U.S. FDA approved Strides Shasun Ltd.'s amantadine hydrochloride capsules to treat Parkinson's disease and as a pain reliever in the treatment of shingles.

Operational activity

* Novartis AG's South Korean unit is facing another fine for alleged unfair drug promotion practices in the country. Earlier this year, South Korea's Ministry of Health and Welfare imposed a 55.1 billion won fine on Novartis Korea Ltd. for paying doctors kickbacks. South Korea's Fair Trade Commission is now planning to fine the company 500 million South Korean won for funding overseas trips by medical practitioners to attend academic conferences from 2011 to 2016.

* Mathai Mammen will become Johnson & Johnson's head of pharma research and development at the start of 2018, replacing Bill Hait, who will become the company's global head of external innovation, Endpoints News reported. Mammen will join the company from Merck & Co. Inc.

Now featured on S&P Global Market Intelligence:

AstraZeneca impresses, Roche disappoints in breast-cancer trials at conference: AstraZeneca and Merck presented results that supported wider use of their medicines, while Roche's data for a combination therapy of two of its medicines failed to impress investors or clinicians, analysts said.

Roche's Perjeta shows negligible distinction in late-stage breast cancer trials: Roche's Perjeta showed a benefit of less than 1% to survival in a long-awaited late stage breast cancer trial, calling into question its combination with the blockbuster Herceptin medicine to bolster sales as the latter succumbs to generic rivals.

The day ahead

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

In Asia, the Hang Seng rose 0.34% to 26,063.06, while the Nikkei 225 was down 0.38% to 19,909.26.

In Europe, around midday, the FTSE 100 was down 0.07% to 7,473.06, and the Euronext 100 rose 0.23% to 1,021.94.

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