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US Senate revs up FDA user fee bill; Daiichi Sankyo in $300M settlement


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US Senate revs up FDA user fee bill; Daiichi Sankyo in $300M settlement

* U.S. Senate Majority Leader Mitch McConnell, R-Ky., filed cloture on the Food and Drug Administration Reauthorization Act of 2017 to allow the agency to continue collecting user fees from drug makers. The Senate could vote on the legislation as early as Aug. 3.

* The Senate Republicans' failure to pass a bill to repeal and replace the Affordable Care Act, was not the fault of the Democrats, McConnell admitted.

* Meanwhile, the U.S. Court of Appeals for the District of Columbia Circuit allowed Democratic state attorneys general to defend government payments to insurers under the Affordable Care Act. U.S. President Donald Trump had warned that he could end the ACA's cost-sharing reduction payments unless Congress passes a new healthcare bill.

* The U.S. government could end up saving over $6.8 billion if the Affordable and Safe Prescription Drug Importation Act is enacted into law, STAT News wrote citing a preliminary estimate from the U.S. Congressional Budget Office. The bill would allow Americans to import prescription medicines from Canada and certain other countries; opponents argue that it could expose them to counterfeits.

* The European Medicines Agency launched a business continuity plan to address uncertainty and workload implications resulting from the relocation of the agency's headquarters following the departure of the U.K. from the EU. The EMA also cut the number of audits as well as some corporate governance and support activities to channel resources into core activities.

M&A and capital markets

* Bayer AG reportedly submitted commitments to European regulators in light of competition concerns over its $66 billion acquisition of agricultural company Monsanto Co. Bayer, which did not comment on what commitments it offered to regulators, expects to close the deal by year-end.

* Zealand Pharma A/S plans to offer up to 3.9 million American depositary shares in an IPO on the Nasdaq Global Select Market. Pricing of the offering is expected to take place Aug. 8 after U.S. market close.

* Clementia Pharmaceuticals Inc. priced an IPO of 8 million common shares at $15 apiece. The shares are expected to commence trading on the Nasdaq Global Select Market on Aug. 2 under the ticker CMTA, with the offering set to close Aug. 7.

Drug and product pipeline

* The U.S. FDA accepted and granted priority review to AstraZeneca PLC's new drug application for acalabrutinib to treat patients with mantle cell lymphoma, a rare type of blood cancer. This follows the FDA's breakthrough therapy designation for the treatment.

* The FDA said Bristol-Myers Squibb Co.'s Opdivo can now be used to fight a certain type of metastatic colorectal cancer that progressed after receiving fluoropyrimidine, oxaliplatin and irinotecan. Opdivo is already approved as therapy for a number of cancers, including lung cancer.

* The FDA approved Celgene Corp. and Agios Pharmaceuticals Inc.'s Idhifa to treat blood cancer with a specific genetic mutation. Idhifa was cleared for use with RealTime IDH2 Assay, a companion diagnostic from Abbott Laboratories.

* Pfizer Inc. has shelved four phase 1 clinical trials, including a stem cell therapy for a leading cause of blindness, FierceBiotech reported, citing the drugmaker's pipeline update as of Aug. 1. Pfizer also discontinued the development of its potential treatments for acute coronary syndrome, diabetes mellitus-type 2 and intracerebral hemorrhage.

Operational activity

* Daiichi Sankyo Co. Ltd. agreed to settle some 2,300 U.S. cases alleging that the company's blood pressure drugs Benicar, Benicar HCT, Azor and Tribenzor did not carry labels that warned of gastrointestinal side effects. The company will pay $300 million if at least 95% of all eligible claimants opt for the settlement.

* Eisai Co. Ltd. saw a 50.3% year-over-year decline in its fiscal first-quarter 2017 attributable profit to ¥9.81 billion, or ¥34.24 per share, from ¥19.74 billion, or ¥68.92 per share. The company affirmed its fiscal 2017 outlook and anticipates a 1.1% growth in attributable profit to ¥39.80 billion, or ¥139.17 a share.

* Ono Pharmaceutical Co. Ltd. reported fiscal first-quarter 2017 consolidated profit attributable to shareholders of ¥11.77 billion, or ¥22.31 per share, down from ¥13.68 billion, or ¥25.81 per share, a year earlier. The drugmaker also confirmed its outlook for fiscal 2017: attributable profit of ¥29.0 billion, or ¥54.72 per share.

* Illumina Inc.'s second-quarter non-GAAP net attributable income fell on a yearly basis to $121 million, or 82 cents per share, from $127 million, or 86 cents per share. The company raised its outlook for GAAP attributable EPS to between $5.36 and $5.46 from the previous forecast of $5.26 to $5.36.

The day ahead

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

In Asia, the Hang Seng climbed 0.24% to 27,607.38, while the Nikkei 225 rose 0.47% to 20,080.04.

In Europe, around midday, the FTSE 100 fell 0.31% to 7,401.32 and the Euronext 100 dropped 0.11% to 999.49.

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