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FDA wants more generic drug competition; ACA repeal eyed for summer

* U.S. President Donald Trump is meeting with House and Senate Republican leaders at the White House this afternoon to discuss his legislative priorities, including passing the Republicans' bill to repeal the Affordable Care Act this summer, White House Director of Legislative Affairs Marc Short told reporters last night.

* New York Gov. Andrew Cuomo yesterday issued emergency regulations for its state health department to prevent insurers from withdrawing from the state's ACA exchange market, The Wall Street Journal wrote.

* In a bid to increase competition and lower the prices of medicines, the U.S. Food and Drug Administration is considering prioritizing the approval of additional competing generic drugs. The agency aims to have three manufacturers for each generic drug, FDA Commissioner Scott Gottlieb told Bloomberg News.

* Nevada Gov. Brian Sandoval vetoed a price transparency bill that would have required manufacturers to provide advance notification to the state's health department about planned price increases for drugs such as insulin, and would also oblige Nevada to compile a list of prescription medicines deemed "essential" for treating diabetes, BioCentury noted.

* According to the Economist Intelligence Unit, the U.K.'s annual healthcare budget would drop by about £7.5 billion by 2021 and the country may need to allocate £600 million more on imported drugs if it chooses a "hard Brexit," or a sharp break in ties with the EU, over a "soft Brexit," wherein it will keep some existing arrangements with the bloc, Bloomberg News reported.

* STAT News carries a feature on Actemra, a rheumatoid arthritis drug manufactured by Roche Holding Ltd. unit Genentech, highlighting the drug's lack of a label warning on life-threatening side-effects despite evidence on risks of heart failure and other conditions for patients taking the treatment.

M&A and capital markets

* WuXi Biologics (Cayman) Inc., a Chinese contract drug manufacturer, priced its Hong Kong IPO of 193 million shares at HK$20.60 apiece, insiders told Reuters. The IPO is expected to raise HK$3.98 billion, Bloomberg News noted.

* AstraZeneca PLC priced a $2 billion bond, which will be offered in three tranches. The offering is expected to close June 12.

Drug and product pipeline

* A study presented at the American Society of Clinical Oncology questioned the benefit of cancer drugs as pharma companies, including Merck & Co. Inc. and AstraZeneca PLC, test whether new combinations of multiple pricey drugs can improve results compared to single-drug therapy or older treatments, the Journal reported. Genentech's combination therapy to treat HER2-positive early breast cancer showed only slightly better results than the already existing therapy.

* Chugai Pharmaceutical Co. Ltd. said a global phase 3 study showed Alecensa, or alectinib, demonstrated statistically significant improvement in progression-free survival and reduced risk of central nervous system progression or death in patients with lung cancer.

* Acorda Therapeutics Inc.'s phase 3 trial of CVT-301 in people with Parkinson's experiencing re-emergence of symptoms of the disease met its primary and multiple secondary endpoints.

* Starpharma Holdings Ltd.'s DEP irinotecan showed significantly better anti-tumor activity and increased survival rates in a variety of human colon cancer models, compared to conventional irinotecan — sold under the Camptosar brand name — in a preclinical study.

* TRACON Pharmaceuticals Inc. reported positive results from multiple studies of TRC105 and TRC102. The company evaluated TRC105 with Votrient for the treatment of advanced soft tissue sarcoma and with Inlyta to treat advanced renal cell carcinoma, while TRC102 with Temodar was tested in patients with refractory solid tumors.

* The European Commission approved the inclusion of treatment-free remission data on the product label of Novartis AG's Tasigna, which is used to treat Philadelphia chromosome-positive chronic myeloid leukemia.

Operational activity

* AbbVie Inc. is facing the first of more than 4,100 lawsuits alleging that the company's testosterone-replacement medicine, AndroGel, caused various side effects, including blood clots and heart attacks, Bloomberg News reported.

* Novartis entered into a clinical collaboration with Bristol-Myers Squibb Co. to evaluate Mekinist in combination with Opdivo and the Opdivo+Yervoy regimen as potential treatments for metastatic colorectal cancer patients with microsatellite stable tumors where the tumors are proficient in mismatch repair.

* Perrigo Co. PLC CEO John Hendrickson will retire and will also step down from the company's board upon the appointment of a new CEO. He joined the company in April 2016.

The day ahead

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

In Asia, the Hang Seng rose 0.52% to 25,997.14, while the Nikkei 225 fell 0.95% to 19,979.90.

In Europe, around midday, the FTSE 100 was down 0.8% at 7,520.78 and the Euronext 100 was 0.32% lower at 1,021.88.

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