AMAG Pharmaceuticals (NASDAQ:AMAG) jumps 41% after hours in apparent response to rumors that Apollo Global (NYSE:APO) portfolio company Covis Pharma is about to acquire the company.
Covis is a Netherlands-based specialty pharmaceutical company that only months ago was purchased by Apollo for an undisclosed sum.
It's been a rough few years for AMAG, which was a $70 stock in 2015, and closed below $10 today, with a market cap of about $320M. Earlier in 2020, its COO and CFO both exited the company.
https://seekingalpha.com/news/3618628-amag-pharma-up-41-on-takeover-rumor
For years, researchers have called out a glaring gap in many clinical trials: Despite having far higher rates of many diseases, older adults are largely excluded from studies testing new therapies that might help them.
For how extensively experts have studied the issue of age disparities, though, it remains a significant problem — and one that has grown all the more pressing during the Covid-19 pandemic, given that the virus has hit older adults particularly hard. An analysis published this week found that older adults are likely to be excluded from more than half of Phase 3 Covid-19 trials on Clinicaltrials.gov — which could make it more difficult for researchers to evaluate doses, efficacy, and safety across all age groups.
“It is important we have a trial population that reflects the real-world population,” said Ethan Ludmir, a clinician-researcher at the University of Texas MD Anderson Cancer Center who has studied age disparities in clinical trials. “We don’t know if an 18-year-old and a 55-year-old will tolerate [a] treatment differently or respond to it differently.”
That analysis, along with several other recent studies, suggest there’s a need for a course-correction — not just for Covid-19 studies, but for a wide range of research.
Another paper, published this month in JAMA Internal Medicine, looked at the inclusion of older adults in cardiovascular clinical trials before and after the National Institutes of Health rolled out what’s known as the Inclusion Across the Lifespan Policy in January 2019. The policy requires anyone applying for NIH funding for studies involving human participants to include a plan for including people of all ages — or explain the scientific or ethical reason why they’re not doing so.
Researchers looked at 97 cardiovascular trials listed on Clinicaltrials.gov and found that before the policy went into effect, one-third of trials had age limits. In the year after the policy went into effect, one-third of trials still had age limits.
Age limits weren’t the only factor that could limit enrollment of older adults. Two-thirds of the trials also used exclusion criteria that weren’t specific to age, but which would disproportionately winnow out older adults, such as having preexisting conditions. Most of the studies also didn’t include endpoints focused specifically on a treatment’s effects on older adults, such as whether older adults were less likely to adhere to the treatment regimen or more likely to experience problems with their mobility.
“Older adults bear a lot of the burden of cardiovascular disease in our country and yet are not always included in the study to see whether the drugs are safe for older adults or effective for older adults or have side effects,” said Colette DeJong, chief medical resident at University of California, San Francisco. DeJong was not involved in the study, but co-authored an editorial on its findings.
Experts said the NIH plan is the type of policy that will take time to pay off, given how far in advance studies are designed and how early funding — including the NIH grants that would come with policy stipulations — for studies is allocated.
“It’s going to be a few years before we know the effects of the policy… because they only looked at the first year, so time is going to tell us more,” said Kenneth Covinsky, a clinician and researcher who specializes in geriatrics at UCSF. Covinsky co-authored the editorial on the study with DeJong.
In another study, published in October 2019 in JAMA Oncology, Ludmir and his colleagues analyzed the average age of participants in 302 trials for breast, prostate, colorectal, or lung cancer, and compared it with the average age of patients worldwide with those diseases.
“We wanted to assess over the last 20 years or so, whether our cancer clinical trials effectively represent the patients that we see every day in our clinics,” said Ludmir.
affected by a disease. The biggest age disparities were seen in industry-funded studies and trials testing a targeted therapy. Another troubling finding: Those age gaps seemed to be widening over time.
“Age disparities among cancer trial participants are pervasive, worsening, and associated with industry sponsorship,” Ludmir and his co-authors wrote.
Experts are quick to note that in some cases, the exclusion of older adults from a participant pool is justified. In some cases, there are concerns about comorbidities or patient consent. In other scenarios, there might be risk involved with delivering experimental treatment in combination with other drugs commonly used among older adults.
In the analysis of Covid-19 trials, concerns about compliance — and specifically, the ability to consent to a study — were the most common age-related exclusion. Older participants were also often at risk of exclusion because of other disease diagnoses or technology requirements.
Taken together, experts said the recent findings underscore how often trials exclude older adults, whether directly or indirectly.
And fixing the problems won’t be as simple as changing the inclusion criteria for trials. There are a number of other barriers that affect whether older adults, including enrollment outreach and transportation concerns. Going forward, experts agree clinical trial sponsors will need to think creatively — and carefully — about the best ways to recruit and enroll older adults in a trial.
“It’s imperative that we let patients across all ages have the opportunity to participate in trials and use thoughtful decision-making in who we include and exclude,” Ludmir said.
And he and other experts say that should be a conversation that happens early in planning a study.
“The fundamental question is, if this drug were to be approved, who would it be used [for]?” asked Covinsky.
https://www.statnews.com/2020/09/30/age-disparities-clinical-trials-covid19/
The Justice Department is investigating whether acquisitions by Medtronic PLC limited competition in ventilator manufacturing, according to people familiar with the matter, an antitrust probe that emerged from complaints about device shortages during the coronavirus pandemic.
Medtronic has received a civil subpoena from the Justice Department formally requesting more information, the people said.
The probe is centered on two related acquisitions that date to 2012, when Covidien PLC, a device maker that sold ventilators, bought Newport Medical Instruments, a small California-based manufacturer of ventilator systems, for $108 million.
Newport had secured a contract with the federal government in 2010 to develop and supply low-cost ventilators, but the project stalled after Covidien bought Newport, and the two sides eventually agreed to end the contract before any ventilators were delivered.
Nearly three years after Covidien bought Newport, Medtronic bought Covidien in a roughly $50 billion deal, inheriting Newport in the process. Both deals received antitrust clearance from the Federal Trade Commission.
"Medtronic is cooperating fully with DOJ's review of the 2012 Covidien-Newport transaction," Medtronic spokesman Ben Petok said, adding that the deal was appropriately assessed and approved by the FTC.
Mr. Petok said the ventilator market remains competitive, "with at least 10 major players in which the top five account for approximately 50% market share. Indeed, Covidien purchased Newport to expand its ventilator portfolio in a highly competitive and fractured market, and, rather than discontinue the Newport family of ventilators, Medtronic continues to market Newport ventilators today."
A Justice Department spokeswoman didn't respond to requests for comment.
Fears of a ventilator shortage in the spring sent states and hospitals scrambling for whatever supplies they could secure to treat patients suffering the most severe symptoms of Covid-19. The demand also threatened to exhaust a federal stockpile of the lifesaving machines, spurring the Trump administration to sign contracts with manufacturers, including Medtronic, to ramp up supplies quickly. Some of the new ventilators came from nontraditional sources such as auto makers Ford Motor Co. and General Motors Co., which shifted some of their manufacturing capabilities to ventilators in the spring.
Medtronic boosted production of new ventilators in response to a surge in demand from the pandemic, including a partnership to produce some at a Foxconn Technology Group plant in Wisconsin. Medtronic said sales of its ventilators more than doubled in the quarter ended July 31 to meet higher global demand.
Insurers are rolling back the terms of telehealth coverage they launched this spring, with some UnitedHealth Group Inc. and Anthem Inc. customers set to face out-of-pocket charges on certain virtual visits starting October 1.
Major insurers are taking different approaches to covering remote care, which is typically done by phone or video. The companies are offering an array of deadlines, reimbursement strategies and charges, depending on factors like the type of plan or the purpose of the medical visit.
Doctors and hospital officials say the complex rules are leading to confusion -- and the cost-sharing charges create concern that patients, faced with an increased financial burden for telehealth, might delay or avoid visits.
"It's really very complicated," said Ted Okon, executive director of the Community Oncology Alliance. "It should be simplified and unified so that you don't have to constantly go back to this grid."
The new Anthem and UnitedHealth changes, for instance, only apply to certain plans and don't include virtual visits related to Covid-19, which will generally continue to be free for patients. Some other insurers had ended cost-sharing waivers for telehealth visits earlier in the year.
"Shifting the copayment back to patients now presents a risk that patients will cancel telehealth appointments or in-person visits that heighten the threat of infections," said Thomas Owens, senior vice president of Duke University Health System. Though many people with insurance would be charged only a flat copay for virtual visits, others might owe the full cost or a share of it, depending on their plan.
Telemedicine grew rapidly this spring and summer as the coronavirus pandemic shut down swaths of the U.S. health-care system. Doctors and hospitals around the country canceled much of their routine, in-person care and patients stayed home, nervous about the risk of infection.
Insurers and the federal Medicare program rushed out expanded coverage for virtual visits, often including reimbursement for doctors on-par with what they previously received for seeing patients in their offices.
Consumer surveys by the Deloitte Center for Health Solutions, a research unit of Deloitte LLP, found 28% of respondents this April said they had used a virtual visit in 2020. At the start of the year, just 19% said they had had one in the previous 12 months.
For Karen Smith, a family physician in Raeford, N.C., about a third of her patient visits in a typical week is now virtual, she said. The expanded coverage provided a financial lifeline to her practice and enabled her to stay in touch with patients who were afraid to come to the office because they feared viral infection, she said.
Patients might be less likely to use the remote visits if there is a charge, Dr. Smith said: "If they do have to pay, our patients are not going to accept the service."
Indeed, Linda Robertson, 71, who is Dr. Smith's patient, says that despite the convenience of telemedicine, a charge for digital visits would mean she and her husband would do fewer of them. Ms. Robertson, a retired teacher from Shannon, N.C. who has diabetes and rheumatoid arthritis, is nervous about the risk of infection with the coronavirus. With her current coverage, it is unlikely that Ms. Robertson would owe copays for doctor visits, either virtual or in-person.
"I can't afford to be paying copays every time I go to the hospital," Ms. Robertson said. "I don't pay the copays, and if I did, I would probably miss most of those meetings, I just couldn't afford it."
Doctors and hospitals say they are also struggling with uncertainty about future coverage of telehealth, since many insurers have said their current policies are guaranteed only until the end of the year.
Christi Siedlecki, chief executive of Grants Pass Clinic, which provides primary care in Grants Pass, Ore., said she is worried that the clinic will lose telehealth payments when the federal public-health emergency tied to the pandemic lapses, currently set to happen in late October. "It's not certain what the future holds," she said. "Everything right now is based on the state of emergency."
UnitedHealth is tweaking its cost-sharing policy as "the health-care system is returning to normal levels," a spokesman said. The Oct. 1 change affects in-network non-Covid-19 visits for people with Medicare Advantage and fully-insured employer and individual plans, the company said.
Anthem said that starting Oct. 1, patients enrolled in fully-insured employer and individual plans will generally face cost-sharing for non-Covid-19 virtual video visits with network providers. But telephone visits -- with no video -- will remain free of charge at least until the end of the year. The insurer's Medicare Advantage enrollees will also have no cost-sharing on video or phone visits at least until next year.
"As offices have been able to reopen, we have aligned our cost-sharing for telehealth and in-person care for non-Covid cases," an Anthem spokesman said.
Other major national insurers are taking varying approaches. CVS Health Corp.'s Aetna said it is waiving cost-sharing for virtual doctor visits, both specialists and primary care, in its Medicare plans at least through the end of the year. For those enrolled in fully-insured employer plans, there are no out-of-pocket charges for virtual visits for Covid-19 or behavioral and mental-health counseling. However, in early June, the insurer restored cost-sharing for other types of telehealth visits for those plans.
Cigna Corp. said it has waived cost-sharing for virtual visits related to Covid-19 through the end of October for its commercial plans. Out-of-pocket charges apply for telehealth not related to Covid-19, the insurer said. Cost-sharing is still waived for virtual visits by Medicare Advantage members, including those not for Covid-19.
