Morgan Stanley’s analyst Mark Purcell has upgraded his rating from Neutral to Buy. The target price has been lifted and is now set at CHF 101 compared to CHF 93 before.
Tuesday, September 1, 2020
Humana Boosts Full Year EPS Guidance
Humana Inc. said it is boosting its guidance for full year earnings per share.
The provider of health insurance services said in a Securities and Exchange Commission filing that it intends to revise its GAAP earnings per share guidance for the year to between $23.74 and $24.24, from the previous range of $17.36 to $17.86. The company said this reflects the current impact of the change in the fair market value of publicly-traded equity securities, as well as the receipt of payments associated with the commercial risk corridor receivables previously written off.
Humana said in the filing that its senior management is scheduled to meet with investors during September. During the meetings the company intends to revise the EPS guidance, while continuing to acknowledge the inherent uncertainty surrounding the ongoing coronavirus crisis and reiterating that it has withdrawn its additional detailed financial guidance given the likelihood of significant variability of results by financial statement line item.
Humana said it intends to affirm its expectation of $18.25 to $18.75 in adjusted EPS for fiscal 2020, reflecting certain measures taken to date and expected to be taken during the rest of the year.
Bristol Myers Squibb Gets FDA Approval for Onureg Tablets
Bristol Myers Squibb said Tuesday the U.S. Food and Drug Administration has approved Onureg azacitidine 300 mg tablets, CC-486, for the continued treatment of adult patients with acute myeloid leukemia.
The pharmaceutical company said the approval is based on results from a Phase 3 AML-001 study in which treatment with Onureg resulted in a statistically significant and clinically meaningful improvement in overall survival, the study’s primary endpoint, of nearly 10 months compared with placebo.
Median overall survival from time of randomization was greater than two years, it said. Onureg was continued until disease progression or unacceptable toxicity.
Onureg has warnings and precautions for risks of substitution with other azacitidine products, myelosuppression, increased early mortality in patients with myelodysplastic syndromes and embryo-fetal toxicity. Bristol Myers Squibb said that due to substantial differences in the pharmacokinetic parameters, Onureg shouldn’t be substituted for intravenous or subcutaneous azacitidine as it may result in a fatal adverse reaction.
The new drug application was granted priority review designation by the FDA, and a marketing authorization application for this indication was validated by the European Medicines Agency in May 2020.
The study enrolled 472 patients, randomized 1:1 to receive either Onureg 300 mg or placebo orally, once daily, for 14 days of a 28-day cycle, plus best supportive care.
Serious adverse reactions occurred in 15% of patients who received Onureg. The most common adverse reactions with Onureg versus placebo were nausea, vomiting, and diarrhea, the company said. Of patients who received Onureg, permanent discontinuation due to an adverse reaction occurred in 8% of patients.
US advisors detail how to prioritize Covid-19 vaccine
A new report that aims to prioritize groups to receive Covid-19 vaccine lays out detailed recommendations on who should be at the front of the line, starting with health care workers in high-risk settings, followed by adults of any age who have medical conditions that put them at significantly higher risk of having severe disease.
Also toward the front of the line would be older adults living in long-term care homes or other crowded settings.
The draft report, which runs 114 pages, was released Tuesday by the National Academies of Sciences, Engineering, and Medicine, which was tasked with the work by Francis Collins, director of the National Institutes of Health, and Robert Redfield, director of the Centers for Disease Control and Prevention.
A virtual public meeting on the recommendations will be held Wednesday afternoon, and the committee’s final report will be submitted later in September.
When Covid-19 vaccines are approved for use, initial supplies will be tight — potentially in the tens of millions of doses. Most of the vaccines under development will require two doses per person: a priming dose followed by a booster either three or four weeks later.
A new report that aims to prioritize groups to receive Covid-19 vaccine lays out detailed recommendations on who should be at the front of the line, starting with health care workers in high-risk settings, followed by adults of any age who have medical conditions that put them at significantly higher risk of having severe disease.
Also toward the front of the line would be older adults living in long-term care homes or other crowded settings.
The draft report, which runs 114 pages, was released Tuesday by the National Academies of Sciences, Engineering, and Medicine, which was tasked with the work by Francis Collins, director of the National Institutes of Health, and Robert Redfield, director of the Centers for Disease Control and Prevention.
A virtual public meeting on the recommendations will be held Wednesday afternoon, and the committee’s final report will be submitted later in September.
When Covid-19 vaccines are approved for use, initial supplies will be tight — potentially in the tens of millions of doses. Most of the vaccines under development will require two doses per person: a priming dose followed by a booster either three or four weeks later.
The report suggests that a second phase of vaccinations should involve critical risk workers — people in industries essential to the functioning of society — as well as teachers and school staff; people of all ages with an underlying health problem that increases the risk of severe Covid-19; all older adults not vaccinated in the first phase; people in homeless shelters and group homes, and prisons; and staff working in these facilities.
Young adults, children, and workers in essential industries not vaccinated previously would make up the third priority group. Remaining Americans who were not vaccinated in the first three groups would be offered vaccine during a fourth and final phase.
The report is meant to serve as a guide for more detailed prioritization plans on the order in which Americans will be offered vaccine. That more granular work is already being conducted by the Advisory Committee on Immunization Practices, an expert panel that crafts vaccination guidance for the CDC, and by state, local, and tribal health authorities, who must identify the actual people in their regions who fall into the priority groups.
There has been discussion of prioritizing people of color, who have been disproportionately badly hit in this pandemic. But the report does not recommend that Black, Hispanic, Latinx people, or American Indians or Alaskan Natives be treated as a distinct priority group.
The committee suggested that there does not appear to be a biological reason for why these communities are more seriously affected by the pandemic. Instead, it argues, the high rates of infections and deaths in these communities are due to systemic racism that leads to higher levels of poor health and socioeconomic factors such as working in jobs that cannot be done from home or living in crowded settings.
The report therefore prioritized other factors — people with underlying medical problems, people living in crowded environments, for instance — rather than creating priority categories for racial or ethnic groups.
The ACIP’s recommendations will go to the CDC. It remains unclear, however, whether the CDC, Operation Warp Speed — the task force set up to fast-track development of Covid-19 vaccines, drugs, and diagnostics — or the White House will make the final determinations on who will be vaccinated first.
The task of determining who should be at the front of the vaccines line is not an easy one, and must be made without key pieces of information. It’s not yet known how many vaccines will prove to be successful, when they will be approved for use, and in what quantities. Critically, some vaccines may prove to be more effective in key groups — the elderly, for instance — than others. Knowing that in advance could influence the recommendations, but people working on the priority groups cannot wait for that information to become available.
Initial discussions suggest large numbers of Americans would qualify as members of priority groups, a reality that will likely require additional tough decisions to be made.
The CDC estimates that there are between 17 million and 20 million health care workers in the country, and roughly 100 million people with medical conditions that put them at increased risk of severe illness if they contract Covid-19. There are roughly 53 million Americans aged 65 and older, and 100 million people in jobs designated as essential services. There is some overlap among these groups — health workers, for instance, are also essential workers.
A report released last month by the Johns Hopkins Center for Health Security recommended dividing priority groups into two tiers, with health workers and others essential to the Covid-19 response in the first tier and other health workers in the second.
In that report, people at greatest risk and their caregivers, and workers most essential to maintaining core societal functions would also be designated to be in the first tier.
NYC lowers speed limits on major roads amid COVID-19 speeding surge
New York City will lower the speed limit on nine major roads amid a surge in speeding during the COVID-19 pandemic, the Department of Transportation announced on Tuesday.
Speeding spiked in the initial weeks of the pandemic as drivers took advantage of near-empty roads, and has continued to outpace pre-pandemic levels over the summer.
The result has been deadly. The number of motor vehicle occupants killed in car crashes was 22 percent higher this June compared to last year, the New York Times reported.
Over the next six weeks, eight 30 mile-per-hour strips will be cut down to the standard 25 mph city limit: Riverside Drive in Manhattan; Northern Boulevard in Queens; Flatbush Avenue, Short Parkway Service Road and Dahlgren Place in Brooklyn; Bruckner Boulevard and Webster Avenue in the Bronx; and Targee Street in Staten Island.
Rockaway Boulevard in Queens will go from 40 mph to 35.
On Tuesday transportation officials also celebrated the final rollout of nearly 1,000 automated speed cameras in school zones across the five boroughs.
DOT had been installing the cameras at a rate of 60 per month since the beginning of the year, the city said.
Abbott set to dominate US testing for Covid-19
No sooner was Abbott’s cheap, rapid antigen test for Covid-19 authorised by the FDA last week than the US government snapped up almost all of those that will be produced this year. The Department of Health and Human Services is to pay Abbott $760m for 150 million of the BinaxNow assays in an effort to sidestep the backlog reported by many diagnostics firms caused by the sheer number of tests that need to be processed. Abbott says it can make 50 million of the tests per month starting in October, plus around half that figure this month as it ramps up. The US is currently performing around 24 million tests a month – of all kinds, from all manufacturers – far too few, experts say, to have a hope of controlling the spread of the virus. Doubtless other groups are working on similar technologies, but the Covid-19 tests authorised in the past week mainly work on viral RNA. The most recent comes from T2 Biosystems, better known for its diagnostics for sepsis-causing pathogens. T2 claims sensitivity of 95% and specificity of 100% for the T2Sars-CoV-2 panel.
U.S. to send millions of rapid COVID-19 tests to states to support school reopenings
The U.S. government will send an “overwhelming majority” of the rapid COVID-19 tests it purchased from Abbott Laboratories last week to governors of U.S. states and territories to support school reopening and other critical tasks, an administration official said at a press briefing.
Other top priorities for the newly purchased tests include day care centers, first-responders, and ‘critical infrastructure,’ said Admiral Brett Giroir, the assistant secretary for health at the U.S. Department of Health and Human Services.
The U.S. government purchased 150 million rapid antigen tests for COVID-19 from Abbott in a roughly $750 million deal.
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