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EU suggests pharma guideline post-Brexit; drugmakers fail surprise inspections

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EU suggests pharma guideline post-Brexit; drugmakers fail surprise inspections

* The U.S. Senate is unlikely to produce a comprehensive healthcare plan this year or a deal to repeal and replace the Affordable Care Act after returning from a recess next week, Sen. Richard Burr, R-N.C., told a North Carolina news station, The Wall Street Journal reports.

* Meanwhile, Senate Republicans are considering taxing employer-sponsored health insurance plans as they draft their own version of a healthcare revamp bill, the Journal wrote.

* The European Commission and the European Medicines Agency published a document, suggesting guidelines on medicinal products in relation to the U.K.'s decision to leave the EU. The regulators said drugs manufactured in Britain will be considered imported and that U.K. companies may need to adjust their operation sites to comply with European requirements for drug safety.

* Biogen Inc. received marketing authorization approval from the European Commission for Spinraza, a drug to treat 5q spinal muscular atrophy, a genetic neuromuscular disorder. The drug is the first approved treatment in the EU for spinal muscular atrophy.

M&A and capital markets

* Sources tell Bloomberg News that Jamieson Wellness Inc. plans to price its IPO at C$300 million. The Toronto-based vitamin and natural health products company filed for an IPO last week.

* Ontario-based medical marijuana producer MedReleaf Corp. raised C$100.7 million in an initial public offering.

* Manhattan Scientifics Inc. affiliate Imagion Biosystems Ltd. filed for an initial public offering to raise up to A$12 million from Australian investors.

* United Therapeutics Corp. entered an agreement with Citibank NA relating to its $250 million accelerated share repurchase program. United expects to borrow $250 million under its revolving credit facility and use the proceeds of the revolving loans to pay the initial purchase price of its common stock to Citibank under the program.

Drug and product pipeline

* Cadila Healthcare Ltd.'s Zydus Cadila secured the U.S. Food and Drug Administration's approval to market Levofloxacin for the treatment of bacterial infections.

* XBiotech Inc.'s Hutruo antibody therapy passed a phase 3 study to potentially treat advanced colorectal cancer, also known as bowel cancer and colon cancer.

* ViiV Healthcare made regulatory submissions to the European Medicines Agency and the U.S. FDA, seeking approval for an HIV-1 treatment involving its drug Tivicay in combination with Janssen Sciences Ireland UC's Edurant. ViiV shareholders include GlaxoSmithKline PLC, Pfizer Inc. and Shionogi & Co. Ltd.

Operational activity

* OBI Pharma Inc. agreed to acquire Threshold Pharmaceuticals Inc.'s TH-3424, a pro-drug that selectively targets cancers overexpressing the enzyme aldo-keto reductase 1c3. OBI Pharma intends to accelerate the treatment's development and plans to submit an investigational new-drug application with the U.S. FDA in early 2018.

* Minerva Neurosciences Inc. is set to receive $30 million in upfront and up to $40 million in milestone-related payment from Johnson & Johnson's Janssen Pharmaceutica NV under an amendment to its co-development and license agreement for MIN-202. Minerva will gain global strategic control of the development of MIN-202 and Janssen will give up its right to royalties on sales of the product in Minerva territories.

Now featured on S&P Global Market Intelligence:

* Almost 80% of drugmakers failed surprise inspections, China FDA report reveals: In 2016, the China Food and Drug Administration carried out 434 onsite local and overseas manufacturing inspections, good manufacturing practice certification inspections, unannounced inspections and distribution chain inspections.

* In pricing debate, rare disease drugs pose unique challenge: The number of rare-disease drugs on the market has ballooned in recent years, bringing a bevy of often high-priced drugs to the U.S. at a time when healthcare costs are increasingly a top concern.

The day ahead

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

In Asia, the Hang Seng increased 0.44% to 25,924.05, and the Nikkei 225 climbed 1.60% to 20,177.28.

In Europe around midday, the FTSE 100 was up 0.34% to 7,569.70, and the Euronext 100 was up 0.86% to 1,035.45.

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