Top news
* President Donald Trump is ordering his administration to take new actions to boost access to Medicare and speed the payment of drugs covered by the program, but his directive is not calling for any new efforts to lower the costs of medicines.
The Oct. 3 executive order seeks to drive Medicare beneficiaries toward purchasing private insurance plans — Medicare Advantage — over getting their health coverage under the government's traditional program for seniors and Americans with disabilities.
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* President Trump, who suggested that the drug industry may be behind Democrats' impeachment inquiry of him, also said Florida's proposal to import medicines into the U.S. from Canada and other foreign nations would soon be approved.
Florida Gov. Ron DeSantis, a Republican, submitted the plan to the U.S. Department of Health and Human Services in late August after the agency a month earlier outlined two pathways as potential courses of action for importing prescription medicines into the U.S. — primarily from Canada — as a way to lower Americans' drug costs.
* Cambridge, U.K.-based AstraZeneca PLC's asthma medicine Fasenra won the U.S. Food and Drug Administration's approval for self-administration through the Fasenra Pen, a pre-filled, single-use auto-injector. The company said Fasenra is the only respiratory drug that can be administered, at home or in a doctor's office, every eight weeks after the initial loading-dose period.
* The FDA approved Gilead Sciences Inc.'s HIV medicine Descovy to prevent sexually acquired HIV infections, making it the second pre-exposure prophylaxis, or PrEP, drug after the company's Truvada. The U.S. health regulator approved the treatment for use in adults and adolescents who weigh at least 77 pounds, do not already have HIV and are at risk for sexual infection.
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* CVS Health Corp.'s health plan launched in 2018 based on analyses by the Institute for Clinical and Economic Review, or ICER, was slow to gain ground among customers and has attracted criticisms from patient advocacy groups, Reuters reported, citing a top medical executive from the pharmacy chain operator. Under the drug coverage initiative, CVS uses ICER's cost effectiveness assessment to determine whether to add second or third medicines entering the market if there are already similar treatments available in its pharmacy benefit plan.
On the policy front
* The European Medicines Agency said Brexit-related staffing losses will create challenges in delivering on its plans for the fourth quarter. The agency, which recently relocated to Amsterdam in the EU as part of the Brexit arrangements, said in its October board update the telework program for London employees had ended and that they have 730 employees, a 6% reduction since June. The agency employed 900 people before it left its Canary Wharf location in London.
Construction of the new EMA building in Amsterdam will be finalized in November, and staff will begin to move in starting in January 2020.
* The Medicare Payment Advisory Commission, or MedPAC, is exploring a complete restructuring of the program's Part D prescription drug coverage, with plans to make official recommendations in its June report to Congress. The changes include eliminating manufacturers' coverage-gap discount and capping beneficiaries' out-of-pocket spending.
* Hospital market concentration in U.S. metro areas increased by 5 percentage points from 2012 to 2016, according to a recent report from the Health Care Cost Institute, stoking the debate about industry consolidation and its impact on healthcare costs. The report examined 112 metro areas in 43 states and showed that 81 metro areas, or 72%, in 2016 were considered highly concentrated according to the standards used by the U.S. Department of Justice.
M&A and capital markets
* Organovo Holdings Inc., which initiated a strategic review of options in August, said it received a merger offer from privately held Viscient Biosciences. The company plans to evaluate Viscient's offer in due course and advised its shareholders to not take any action at this time.
* Heron Therapeutics Inc. priced its public offering of 8,571,429 common shares at $17.50 each to raise gross proceeds of about $150 million.
* Q BioMed Inc. has acquired generic non-opioid cancer bone pain drug strontium-89 chloride USP after entering a settlement deal with Bio-Nucleonics Inc.
Drug and product pipeline
* Arbutus Biopharma Corp. is discontinuing the development of its experimental drug AB-506 for treating chronic hepatitis B after disappointing results in an early-stage study.
* Aptevo Therapeutics Inc. is also dropping its experimental drug APVO210 for autoimmune diseases after failing in an early-stage study. The Seattle-based biotechnology company will implement an expense reduction strategy to cut down its annual expenditures.
* Theratechnologies Inc. said follow-up data from the TMB-311 study showed that Trogarzo, or ibalizumab, continued to suppress viral suppression in HIV-1 patients even after 48 weeks, preventing the virus from being transmitted. TMB-311 was a 24-week study, the Montreal-based company noted.
Operational activity
* Former Bayer AG technology executive Jim Swanson was named Johnson & Johnson's chief information officer, The Wall Street Journal reported. Swanson is replacing Stuart McGuigan, who was appointed as chief information officer at the State Department in March.
* Juan Ramón Alaix is retiring
* Indianapolis-based Eli Lilly and Co. is voluntary delisting its shares from Euronext Paris due to very low trading volume and to avoid the associated costs and administrative requirements for the secondary listing.
* Tocagen Inc. decided to lay off 30 full-time employees, representing 65% of its workforce, by the end of the year as part of a restructuring to focus resources on the clinical development of its brain cancer therapy Toca 511 and Toca FC.
The day ahead
Early morning futures indicators pointed to a lower opening for the U.S. market.
In Asia, the Hang Seng fell 1.11% to 25,821.03, while the Nikkei 225 rose 0.32% to 21,410.20.
In Europe, around midday, the FTSE 100 was up 0.35% to 7,102.21, and the Euronext 100 increased 0.27% to 1,057.94.
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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