Top news
* The U.S. Supreme Court is weighing whether a patent review system established under a 2011 law violates patent holders' rights to a jury trial under the U.S. Constitution, in another case that has pitted brand-name drugmakers against their generic competitors and some of the biggest players in the high-tech industry.
* GlaxoSmithKline plc submitted a new drug application to the U.S. FDA seeking approval for its malaria treatment tafenoquine. The therapy is for the radical cure of Plasmodium vivax malaria in patients over 16 years of age, preventing the disease from relapsing or coming back.
M&A and capital markets
* BioMarin Pharmaceutical Inc. is selling a rare pediatric disease priority review voucher it received in April from the U.S. Food and Drug Administration for a lump sum payment of $125 million. The company received the voucher after the approval of Brineura, a new biological product for treating late infantile neuronal ceroid lipofuscinosis type 2, a form of Batten disease.
* The Canadian Competition Bureau cleared the proposed €46 billion merger between Essilor International SA and Luxottica Group SpA.
* Sinopharm Group Co. Ltd. agreed to buy drug retailer Shanghai Pudong New Area Medicines and Herbs Co. Ltd. from China National Pharmaceutical Group Corp. for 217.5 million Chinese yuan in cash.
* Temasek Holdings (Pte.) Ltd. is looking to sell its 20% stake in Zuellig Pharma Asia Pacific, Bloomberg News reported, citing people familiar with the matter. The sale could draw interest from strategic buyers including Mitsui & Co. Ltd. and private equity firms.
Drug and product pipeline
* Bristol-Myers Squibb Co. said the European Medicines Agency validated its type II variation application seeking to expand the indications of cancer drug combination Opdivo plus Yervoy, to include the treatment of intermediate- and poor-risk patients with advanced renal cell carcinoma, a type of kidney cancer.
* GlaxoSmithKline said it will use Owlstone Medical's breathalyzer device to develop an experimental compound called danirixin for respiratory disease. GSK will use the Breath Biopsy to assess whether the right patients can be identified, as well as the treatment effects of a novel drug that is currently in phase 2 trials for chronic obstructive pulmonary disease.
* The European Medicines Agency accepted for review Aeterna Zentaris Inc.'s Macrilen for the evaluation of adult growth hormone deficiency. Macimorelin has received orphan drug designation from the U.S. FDA for diagnosis of AGHD.
Operational activity
* Kyowa Hakko Kirin Co. Ltd. secured exclusive rights to develop and commercialize Ardelyx Inc.'s tenapanor for treating heart and kidney diseases in Japan. Ardelyx will receive $30 million up front and could receive up to $130 million in milestone payments.
* Alkermes plc licensed the development and commercial rights of its multiple sclerosis treatment, ALKS 8700, to Biogen Inc. Biogen will reimburse Alkermes for 50% of the 2017 ALKS 8700 development costs, with an up-front payment of $28 million.
* Teva Pharmaceutical Industries Ltd. said it will restructure its business units by combining the global groups for generics and specialty medicines into one commercial organization. The company also made several executive moves, including the appointment of Michael McClellan as CFO.
Our features
Long road ahead for shift to online drug sales in China: China has in recent years made attempts to decouple drug sales from the hospital business and move that market to an online platform, but significant hurdles remain, according to analysts that spoke to S&P Global Market Intelligence.
Regeneron's eye drug revenues uncertain after combo therapy failure: The days of dominance for Regeneron's blindness medicine Eylea may be numbered, as its latest attempt to protect market share through a combination therapy fails to produce results.
ViiV's 2-drug HIV pill beats Gilead to market, but may not win on long-term use: The approval of a daily HIV treatment that combines two medicines in one pill makes ViiV Healthcare, majority-owned by GlaxoSmithKline, the first to market with a reduced-drug regimen — yet safety concerns could give an opening to an incoming competitor.

Other features
* A growing number of hospitals and other medical companies will likely restructure their debt or file for bankruptcy in 2018 due to regulatory changes and technological advances, restructuring professionals told Bloomberg.
* Regulatory actions to increase drug pricing pressure in an aim to widen healthcare access will not hinder pharmaceutical companies from expanding in emerging markets, Olivier Charmeil, executive vice president, general medicines and emerging markets at Sanofi, said in an interview with The Economic Times of India.
* Bloomberg features DBV Technologies SA's efforts to bring its Viaskin peanut allergy patch to the market by 2019 despite recently having failed in a major study.
The day ahead
Early morning futures indicators pointed to a higher opening for the U.S. market.
In Asia, the Hang Seng slid 0.02% to 29680.85. The Nikkei 225 lost 0.04% to 22,486.24.
In Europe as of midday, the FTSE 100 added 0.62% to 7,429.76, and the Euronext 100 was up 0.71% to 1,044.21.
The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.
