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Bayer/Monsanto deal held up in Brazil; Puerto Rico could imperil drug supply

Top news

* Regulatory approval for Bayer AG's $66 billion takeover of Monsanto Co. is being held up in Brazil, Reuters reported. The country's competition regulator said structural changes are needed and that the efficiencies to be gained from the combination of the companies would not be sufficient to lessen competition concerns.

* Gilead Sciences Inc. acquired Kite Pharma Inc. after completing a tender offer that commenced in September. A total of 38,324,617 shares were tendered at a price of $180 per share.

* U.S. FDA Commissioner Scott Gottlieb warned of drug shortages if biopharmaceutical and medical device manufacturing facilities in Puerto Rico are not restored to their full capacity soon. Drugmakers like Amgen Inc., AstraZeneca PLC, Bristol-Myers Squibb Co., Eli Lilly and Co., GlaxoSmithKline plc, Johnson & Johnson, Merck & Co. Inc., Novartis AG and Pfizer Inc. all have plants in Puerto Rico.

On the policy front

* Gottlieb said Congress needs to ensure it is not making the eligibility criteria too broad in legislation that seeks to expand access to experimental treatments for patients who have exhausted other options. The FDA head said the broader the legislation's criteria, the more people may be exposed unnecessarily to potentially dangerous side effects.

* A U.S. House of Representatives committee is seeking information on Allergan plc's patent deal with the St. Regis Mohawk Tribe over its dry eye disease treatment Restasis. The bipartisan group of four representatives from the House Oversight and Government Reform Committee said the deal could "impair competition" across the industry.

Meanwhile, Allergan CEO Brent Saunders defended the deal and criticized the review process, stating that in certain cases patents that have already have been upheld in the federal court system can be "held hostage" by entities such as hedge funds with no involvement in biopharmaceutical development.

M&A and capital markets

* Medicure Inc. sold its interests in Apicore to an unnamed pharmaceutical company in an arm's length transaction for $105 million.

* Ultragenyx Pharmaceutical Inc. agreed to acquire Dimension Therapeutics Inc. for $6 per share, or $151 million, in cash. The deal comes a day after Dimension said it would terminate its merger agreement with Regenxbio Inc.

* Karo Pharma AB (publ) said its offer to acquire all shares of Weifa ASA reached an acceptance level of about 97.1%.

* Ablynx NV filed for a potential IPO on the Nasdaq Global Select market. The company plans to sell American depositary shares under the symbol ABLX.

* Deciphera Pharmaceuticals Inc. closed its IPO of 7.5 million common shares at $17 apiece.

* OptiNose Inc. is planning to offer 6,250,000 common shares priced between $15 to $17 per share in its IPO.

Drug and product pipeline

* The U.S. FDA approved Mylan NV's generic version of Teva Pharmaceutical Industries Ltd.'s Copaxone to treat relapsing forms of multiple sclerosis.

* Motif Bio plc's iclaprim met its main goal in a phase 3 study for treating acute bacterial skin and skin structure infections. The treatment worked as well as the current standard of care vancomycin in treating the disease.

Operational activity

* Mylan will pay $20.3 million to the Massachusetts Medicaid program to settle charges that it underpaid rebates on EpiPens for MassHealth members.

* French authorities searched Merck KGaA's Lyon plant where the drugmaker's thyroid drug Levothyrox is produced. The investigation is related to the new formulation of the drug that replaced lactose with citric acid and mannitol to make it easier for patients to tolerate.

* Amgen Inc. and CytomX Therapeutics Inc. entered into a collaboration to jointly develop a CytomX Probody T-cell engaging bispecific against the epidermal growth factor receptor, an oncology target expressed on multiple human cancer types.

Our features

Movement disorder drugs from Teva, rivals too costly, price group says: New options to treat the difficult side effects of antipsychotic medicines from Teva Pharmaceutical Industries and Neurocrine are too costly, price advisory group the Institute for Clinical and Economic Review said.

Express Scripts warns of rising per-person drug expenditure in US: The number of people in the U.S. with more than $50,000 in 2016 in prescription drug costs has gone up 35% in two years, according to a new report from pharmacy benefit manager Express Scripts Holding Co.

Trump tax plan could unlock pharma's record offshore cash pile: Big Pharma could have a chance to bring record-high foreign cash holdings back to the U.S. at a significant discount under the Trump administration's tax reform proposal.

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The day ahead

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

In Asia, the Hang Seng rose 0.73% to 28,379.18, and the Nikkei 225 was up 0.06% to 20,626.66.

In Europe, as of midday, the FTSE 100 dropped 0.07% to 7,462.69, and the Euronext 100 had fallen 0.30% to 1,041.48.

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