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Pfizer, Merck get FDA approval for diabetes drug; tax bill delivers blow to ACA

Top news

* The U.S. Food and Drug Administration approved Merck & Co. Inc. and Pfizer's Steglatro to treat type 2 diabetes. Steglatro, or ertugliflozin, will compete with AstraZeneca PLC's Farxiga, Johnson & Johnson's Invokana, and Eli Lilly and Co. and Boehringer Ingelheim Pharmaceuticals Inc.'s Jardiance.

* The U.S. House of Representatives held a second vote on the Republican tax plan and passed an updated version of the bill from the Senate 224-201.

Reuters noted that the tax bill is so far the largest blow to hit the Affordable Care Act, as it includes a provision that would repeal the ACA's individual mandate, which penalizes Americans who fail to obtain health insurance.

Sens. Lamar Alexander, R-Tenn., and Susan Collins, R-Maine, said they are dropping their request to include an ACA stabilization bill in a year-end spending deal to keep the government afloat, Reuters reported. The GOP lawmakers would instead ask Senate Majority Leader Mitch McConnell, R-Ky., to bring up two bills intended to fund individual insurance under the ACA in January 2018.

The pharmaceutical sector will be a big beneficiary of the tax overhaul as drugmakers and biotech companies will be able to repatriate cash overseas at a lower rate, Bloomberg News wrote. However, these companies will get a smaller tax credit for developing therapies for rare diseases.

On the policy front

* A new analysis by the Georgetown University Health Policy Institute found that more than 1.9 million children in 23 U.S. states could lose health coverage at the start of next year if Congress fails to renew federal funding for the Children's Health Insurance Program, or CHIP, The New York Times wrote.

* India is developing bulk medicines to lessen dependence on imports, especially from China, Drug Controller General of India G. N. Singh told the Press Trust of India.

M&A and capital markets

* Pfizer Inc. has been speculated to have tapped advisers to work on a potential offer for Shire plc at a price near £50 per share, the Financial Times reported. Shire declined to comment on the rumors.

* Valeant Pharmaceuticals International Inc.'s affiliate completed the sale of its Sprout Pharmaceuticals unit to Sprout2 Inc. in exchange for a 6% royalty on global sales of Addyi — which is used by premenopausal women to treat hypoactive sexual desire disorder — starting in May 2019.

Drug and product pipeline

* The European Commission granted marketing authorization for Chugai Pharmaceutical Co. Ltd.'s Alecensa, or alectinib, as a first-line treatment for ALK-positive, metastatic non-small cell lung cancer.

* The U.S. FDA approved Bristol-Myers Squibb Co.'s Opdivo as a post-surgical treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

* Meanwhile, Bristol-Myers and Taris BioMedical LLC will collaborate to evaluate Taris' TAR-200, in combination with Bristol-Myers' Opdivo, in patients with bladder cancer.

* The FDA approved Roche Holding AG's Perjeta, in combination with Herceptin and chemotherapy, for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence.

* GlaxoSmithKline plc said the FDA allowed the removal of the black box warning in the labeling of inhaler combo medicines used in asthma treatment, following the review of safety data from four studies submitted by GSK and two other companies.

* The FDA granted regenerative medicine advanced therapy designation to Mesoblast Ltd.'s mesenchymal precursor cell therapy, intended to treat heart failure patients with left ventricular systolic dysfunction and left ventricular assist devices.

* AbbVie Inc.'s upadacitinib met all primary and key secondary goals in a phase 3 trial studying the medication in patients with moderate to severe rheumatoid arthritis who did not adequately respond to treatment with methotrexate, an older medication.

* The FDA accepted Allergan plc and Paratek Pharmaceuticals Inc.'s new drug application for Seysara to treat moderate to severe acne vulgaris in patients aged nine years or older.

* The FDA granted marketing approval to Aeterna Zentaris Inc.'s Macrilen, or macimorelin, for the evaluation of adult growth hormone deficiency.

Operational activity

* Jacobson Pharma Corp. Ltd entered into a licensing framework agreement and a capital increase agreement with a unit of Chinese drugmaker Shanghai Fosun Pharmaceutical (Group) Co. Ltd. in an aim to tap into the biosimilar market in Hong Kong and certain emerging ASEAN markets.

* New Mexico Attorney General Hector Balderas added claims against drugmakers INSYS Therapeutics Inc. and Mallinckrodt PLC in a lawsuit seeking economic damages from opioid manufacturers and wholesale distributors for their alleged role in fueling the state's opioid epidemic.

* United Therapeutics Corp. reached a $210 million settlement with the U.S. government to resolve claims that the company violated the False Claims Act by paying kickbacks to Medicare patients using a charity as a conduit.

Other features

* Bloomberg talks about Hal Barron's imminent arrival at GlaxoSmithKline as research and development head and how his appointment signals a revival of the company's venture into cancer therapies, after it sold its cancer portfolio almost three years ago.

* Bloomberg also discusses the tactics drugmakers use to ward off market competition and continue to keep the price of medicines high.

* The U.S. Government Accountability Office looked into how much pharma and biotech companies spend on drug R&D and its correlation to sales, Endpoints News notes.

The day ahead

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

In Asia, the Hang Seng rose 0.45% to 29,367.06, and the Nikkei 225 was down 0.11% to 22,866.10.

In Europe, as of midday, the FTSE 100 was up 0.37% to 7,553.33, and the Euronext 100 fell 0.03% to 1,038.96.

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