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FDA asks Endo to drop opioid painkiller; lawmakers ask about future of Medicaid


Essential IR Insights Newsletter Fall - 2023

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FDA asks Endo to drop opioid painkiller; lawmakers ask about future of Medicaid

* Lawmakers yesterday threw questions at U.S. Department of Health and Human Services Secretary Tom Price about cuts to the Medicaid program and uncertainty over whether the Trump administration would continue making cost-sharing reduction payments to insurers. Some Republican senators also raised concerns about the impact to Medicaid, which could lose $834 billion under the House bill passed May 4, according to the Congressional Budget Office estimates.

* HHS Secretary Tom Price told the Senate Finance Committee yesterday that bringing down the price of prescription medicines is still "an absolute priority" of the Trump administration, Bloomberg News reported. Price has asked the Centers for Medicare and Medicaid Services, the U.S. Food and Drug Administration and the Health Resources and Services Administration to draft proposals to lower drug costs.

* The U.S. National Institutes of Health will refunnel about $210 million in research grant money every year to encourage younger researchers to stay in science and in the country, The Wall Street Journal wrote. The announcement comes at a time when the Trump administration is looking to cut over 20% of the NIH's budget.

* The U.K.'s Conservatives lost their parliamentary majority in sensational upset elections yesterday, potentially leaving them scrambling for support from a small regional party to remain in power at a time when negotiations on the country's departure from the EU are about to commence. The future headquarters of the European Medicines Agency, which is based in London, depends on whether the U.K. will choose a so-called hard Brexit, which could force the EMA to relocate its headquarters, or a soft Brexit, in which the U.K. could retain some arrangements with the bloc.

M&A and capital markets

* Valeant Pharmaceuticals International Inc. agreed to sell its iNova Pharmaceuticals business for $930 million in cash to private equity firms Pacific Equity Partners and The Carlyle Group. CEO Joseph Papa said Valeant is considering more asset sales and that processes are underway.

* Immuron Ltd. priced its U.S. IPO, raising $6.1 million in gross proceeds. The company issued 610,000 American depositary shares plus warrants to purchase another 610,000 ADSs for a combined price of $10 apiece.

Drug and product pipeline

* The U.S. FDA asked Endo International PLC to withdraw the reformulated Opana ER from the market. The regulator's request is based on concerns that the opioid painkiller's benefits no longer outweigh its risks and marks a shift in policy, specifically, by accounting for the impact of opioids not only in patients but also drug abusers.

* Adamas Pharmaceuticals Inc. reported positive data from the ongoing phase 3 trial of ADS-5102, or amantadine, extended-release capsules for the treatment of levodopa-induced dyskinesia in patients with Parkinson's disease.

* Regeneron Pharmaceuticals Inc. and Sanofi's eczema drug, Dupixent, is a good value for the money, price advisory group the Institute for Clinical and Economic Review said in a final review of two eczema options. Meanwhile, Pfizer Inc.'s Eucrisa, which targets mild to moderate eczema in both adults and children, was not assessed for cost-effectiveness due to data availability challenges and anticipated clinical uptake.

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Merck's lung cancer edge over Bristol-Myers grows at cancer conference: The ongoing rivalry between drugmakers Bristol-Myers Squibb Co. and Merck & Co. Inc. was yet again in focus at the world's biggest gathering of oncologists, where Merck sharpened its edge in lung cancer treatment with new data on its Keytruda immunotherapy.

The day ahead

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

In Asia, the Hang Seng fell 0.13% to 26,030.29, while the Nikkei 225 was up 0.52% to 20,013.26.

In Europe, around midday, the FTSE 100 was up 0.46% to 7,484.35, and the Euronext 100 had risen 0.19% to 1,019.55.

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