* A spokesperson for the U.S. Centers for Medicare and Medicaid Services told S&P Global Market Intelligence that the Trump administration's new policy for Medicare Part D that would limit coverage of a drug to only certain uses "would not lead to an effective drug being replaced with an ineffective one." Excluding certain indications may lead to some plans adding more drugs to their formularies they otherwise may have left off because of the expense of treating those eliminated conditions, the spokesperson said.
But it is unclear whether those added drugs would make much of a difference to patients' lives, health policy expert Rachel Sachs, an associate professor of law at Washington University in St. Louis, told S&P Global Market Intelligence.
Former CMS Administrator Tom Scully told reporters last week that it was highly unlikely that healthcare legislation would move on Capitol Hill any time soon, given the partisan environment. If any changes to the U.S. system were going to happen, they likely will be driven by CMS' Center for Medicare and Medicaid Innovation, Scully said during an Aug. 31 forum hosted by the Alliance for Health Policy and APCO Worldwide.
* Pfizer Inc. said it anticipates costs of $100 million resulting from the U.K.'s upcoming departure from the EU, as the British drugmaker prepares for a hard Brexit, a worst-case scenario in which the U.K. would not have access to the bloc's single market, Bloomberg News reported. The company said costs come from transferring product testing and licenses to other countries, changing clinical trial management procedures and other preventive measures.
* Dechra Pharmaceuticals PLC said it has implemented a hard Brexit mitigation plan that includes setting up an EU-based laboratory testing facility and transferring product registrations to an EU-domiciled unit. The U.K.-based manufacturer of veterinary products expects Brexit costs of up to £2 million but anticipates the financial impact to be immaterial.
* Bayer AG is looking at cutting jobs and outsourcing staff as part of management's wide-ranging review of drug research and development to be completed in November, Reuters reported, citing a person familiar with the company. The German agrochemical and pharmaceutical company is set to announce its second-quarter earnings tomorrow.
Drug and product pipeline
* Redx Pharma PLC said it reached an agreement with regulators in the U.K. to resume enrollment in an early stage clinical trial of its cancer drug RXC004. The U.K.-based pharmaceutical company expects to resume the trial during the first half of 2019, having sorted out the terms of a repurposed study with the U.K.'s Medicines and Healthcare products Regulatory Agency.
* Abivax SA said its drug ABX464 was shown to be effective in treating a type of inflammatory bowel disease under a midstage study. Under the phase 2a trial, called ABX464-101, the therapy showed statistically significant efficacy in treating patients with moderate to severe ulcerative colitis whose diseases did not respond to anti-tumor necrosis factor monoclonal antibodies or corticosteroids — treatments that alleviate inflammation.
* Merck & Co. Inc. said the U.S. Food and Drug Administration accepted and granted priority review for a new supplemental biologics license application seeking accelerated approval for the blockbuster drug Keytruda to treat certain patients with Merkel cell carcinoma, a rare, aggressive form of skin cancer.
* The New York Times featured a study on bacteria engineered to treat phenylketonuria, a rare genetic condition that can lead to intellectual disability, seizures, behavioral problems and mental disorders.
The day ahead
Early morning futures indicators pointed to a mixed opening for the U.S. market.
In Asia, Hang Seng gained 0.94% to 27,973.34, while the Nikkei 225 fell 0.05% to 22,696.90.
In Europe, around midday, the FTSE 100 dropped 0.30% to 7,481.73, and the Euronext 100 shed 0.94% to 1,049.48.
Click here to read about today's financial markets, setting out the factors driving stocks, bonds and currencies around the world ahead of the New York open.
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