Cara misses primary endpoint in Phase 2 dermatitis trial

 Study did not meet Primary Endpoint of worst-itch NRS change from baseline at

week 12 or Secondary Endpoint of 4-point responder analysis in the ITT patient population

– Study achieved Primary Endpoint of worst-itch NRS change and Secondary Endpoint of 4-point responder analysis in pre-specified analyses of mild-to-moderate AD patients (64% of ITT patient population) –

– Statistically significant improvement in 4-point responder analysis in
mild-to-moderate (BSA <10%) AD patients with 32% of KORSUVA-treated patients achieving a > 4-point reduction vs. 19% in placebo group (p=0.03) –

– KORSUVA was well tolerated at all dose levels –

– Company to host conference call today at 8:00 a.m. ET –

To participate in the conference call, please dial (800) 708-4539 (domestic) or (847) 619-6396 (international) and refer to conference ID 50157934. A live webcast of the call can be accessed under "Events & Presentations" in the News & Investors section of the Company's website at www.CaraTherapeutics.com.

An archived webcast recording will be available on the Cara website beginning approximately two hours after the call.

https://finance.yahoo.com/news/cara-therapeutics-announces-topline-results-110000707.html

Bristol Myers Q1 earnings miss as cancer drugs underperform

 Bristol Myers Squibb Co reported lower-than-expected first-quarter profit on Thursday as sales of its high margin cancer drugs Revlimid and Opdivo fell short of Wall Street estimates.

The underperformance of the cancer drugs was partially offset by better-than-expected sales of the blood thinner Eliquis that Bristol Myers shares with Pfizer Inc.

Excluding one-time items, the New York-based drugmaker said it earned $3.95 billion in the quarter, or $1.74 a share, compared with $3.96 billion, or $1.72 a share, a year ago.

Analysts on average expected $1.82 a share, according to IBES data from Refinitiv.

Chief Financial Officer David Elkins said in an interview that the sales mix - in particular, the outperformance in lower margin Eliquis versus higher margin Revlimid - accounts for most of the gap between the results and analysts' expectations.

Bristol Myers still expects full-year earnings in the range of $7.35 to $7.55 a share, Elkins said.

Revenue in the quarter of $11.07 billion was basically in line with analysts' projections.

Eliquis sales were $2.89 billion, beating analyst expectations by about $300 million. Revlimid had sales of $2.94 billion, around $150 million lower than Wall Street projections.

Sales of cancer immunotherapy Opdivo fell 3% to $1.72 billion, also around $150 million shy of analysts' estimates.

"Overall, I think we're in a good place," Elkins said, adding that he expects Eliquis' growth to continue and Opdivo to return to growth in the second half of the year due to approvals in new tumor types and its increasing use as an initial treatment for advanced lung cancer.

The company reported net earnings of $2.02 billion, or 89 cents per share, for the quarter, versus a net loss of $775 million a year ago, due in part to costs associated with the Celgene acquisition.

Bristol Myers shares closed at $66.03 on the New York Stock Exchange on Wednesday. The company's shares are up around 7.6% this year, underperforming the Standard and Poor's 500 index, which is up around 13% over the same period.

https://finance.yahoo.com/news/bristol-myers-first-quarter-earnings-110118305.html

Waivers for vaccine production 'not a solution' - BioNTech

 The granting of intellectual property waivers is not the right way to increase output of COVID-19 vaccines, the founder of German vaccine maker BioNTech said on Wednesday, advocating instead the award of production licences.

Such waivers are among the options being considered by the Biden administration for maximising the production and supply of vaccines, though no decision has been made, White House press secretary Jen Psaki said on Tuesday.

"This is not a solution," BioNTech CEO Ugur Sahin said.

BioNTech, which makes and markets its messenger RNA-based shot in partnership with U.S. drugmaker Pfizer, considers close cooperation with selected production partners to be the right approach because its vaccine is hard to make.

"We are considering ways to issue special licences to competent producers," Sahin told an online briefing hosted by the German foreign correspondents' association.

This would ensure that the quality of vaccines delivered to different regions of the world is consistent, Sahin said, adding that production by licensees could make a contribution towards the end of this year at the earliest.

The BioNTech/Pfizer shot has been widely administered in countries including Israel, the United States and Britain, and is also the lead vaccine in the European Union's inoculation campaign.

Sahin said it was important that shots produced in the EU could be exported to other parts of the world. The region could expect to achieve herd immunity by late summer, but it would be of little use if Europe were safe but the virus continued to rampage elsewhere, he added.

BioNTech expects Chinese health authorities to approve its vaccine "by July at the latest", Sahin told the briefing, adding it should be possible to start distributing it there that month.

"I am optimistic that we can help the people of China," said Sahin, describing its local partner, Shanghai Fosun Pharmaceutical Group Co Ltd, as "a great company".

https://finance.yahoo.com/news/1-waivers-vaccine-production-not-110203916.html

U.S. trade negotiator discusses COVID-19 IP waiver with Moderna CEO

 U.S. Trade Representative Katherine Tai on Wednesday met virtually with the top executive of drugmaker Moderna to discuss a proposed waiver of certain intellectual property rights in response to the COVID-19 pandemic, Tai's office said.

Tai and Moderna Chief Executive Stephane Bancel also discussed increasing vaccine production and global health issues, Tai's office said in a statement.

https://finance.yahoo.com/news/u-trade-negotiator-discusses-covid-003000435.html

Survey casts doubt on utility of wearable devices in healthcare

 

• A new report by Forrester Research on wearables in healthcare concludes such devices assist consumers rather than clinicians, and that their shortcomings are numerous. The report was based on interviews with more than 40 patients and physicians.
• "These products neither promise nor deliver healthcare. Why? They offer data, not answers to consumer questions, diagnoses, or treatment suggestions to help restore one's health," the report said. The issue with wearables is compounded by an issue that has been the demise of many technological advances in healthcare: Physicians are uninterested in monitoring information obtained remotely.
• The bearish report concludes that "consumer technology and data may never play a leading role in helping physicians provide healthcare. "The wearables market is diverse, ranging from high hopes for devices to control diabetes to reimbursement doubts for long-term cardiac monitoring to fitness trackers like the Apple Watch.

The report is hardly the first to question the ultimate usefulness of wearables in the practice of medicine, or to raise issues of physician participation and payment hurdles.

Forrester cited huge data gaps, a doubtful reimbursement landscape and numerous other factors that hinder their usefulness today. "Looking at the big picture, consumer data is a proverbial knife in a gun fight today," the report observed.

Along with the fact they are designed more with consumers in mind, it appears based on the dozens of interviews Forrest conducted that physicians are highly skeptical of such devices and the information they provide.

"I didn't get into healthcare to look at data. My passion is helping people," one physician in the Midwest told Forrester researchers. Other doctors expressed concern that the data they receive from wearables is not accurate. "I need to be able to trust the accuracy of the data. Companies would need to publish large studies documenting the accuracy of wearables across populations," said another physician who practices in Northern California.

The report did cite some potentially promising wearable applications under development, such as an app that gamifies physical therapy for patients with strokes, Alzheimer's disease and other neurological disorders, and another that tracks a patient's keystrokes to determine their state of mental health. And it did observe that "consumers who use technology to improve their wellness or health can still move the needle in the right direction."

However, the report concluded that unless physicians buy into the regular use of wearables and the devices are better designed to not only make them more "Apple-like" but easily accessible for those with health and physical disabilities, there may be little promise long-term for such devices.

The report suggested that focusing on what smartphones can do in terms of compiling and transmitting data may be the best route to making wearables acceptable to both patients and doctors.

https://www.healthcaredive.com/news/survey-casts-doubt-on-utility-of-wearable-devices-in-healthcare/598846/

Science groups urge providers not to use certain COVID-19 test data for care decisions

 

• The Association for Molecular Pathology and the Infectious Diseases Society of America are cautioning healthcare providers against using certain data generated by some COVID-19 PCR tests to make patient care decisions.
• Some tests generate data known as cycle threshold (Ct) values that have the potential to help determine a patient's prognosis and risk of transmission. But the wide variety of testing procedures in use and lack of a universal threshold are barriers that could result in misinterpretation of results and mismanagement of patients, the groups warned in a blog post.
• Separately, the American Clinical Laboratory Association issued a white paper on Thursday recommending that molecular tests that detect SARS-CoV-2 nucleic acid, such as PCR tests, should be prioritized for diagnosing COVID-19 in symptomatic patients.

Demand for COVID-19 testing wavered in the first quarter of this year as vaccination efforts began to ramp up, according to companies making the tests and laboratories that process them. Still, executives expect testing to continue to play an important role in public health efforts alongside vaccine rollouts for the foreseeable future. Schools, workplaces and other venues welcoming people back will rely on screening procedures to prevent virus resurgence.

The ACLA, whose members include LabCorp and Quest Diagnostics, advised in its white paper that screening programs using tests on a frequent basis that provide quick results can help contain community spread of the virus. Nucleic acid amplification tests, which include PCR assays, should be the "tests of choice" for symptomatic patients because they provide a definitive diagnosis. However, about 33% to 45% of people infected with SARS-CoV-2 are asymptomatic, ACLA said.

Antigen tests, which have lower analytic sensitivity, can be used if nucleic tests are not available, ACLA said. But the group noted that "there are many businesses, airlines and even countries that will only accept PCR tests based upon a belief that only PCR test results can be used to diagnose COVID-19. This misconception places an unnecessary burden on labs and resources."

ACLA recommended that federal agencies such as the Centers for Disease Control and Prevention and FDA provide more education on the appropriate use of NAAT tests. The group said data show that the reliability of antigen testing increases the more frequently a person is tested. Those who test positive with an antigen test should have the results confirmed with a NAAT.

Meanwhile, growing interest in using Ct values to measure the amount of SARS-CoV-2 in clinical specimens prompted AMP and IDSA in March to issue a joint statement on the use of Ct values in clinical decisions. In a follow-up blog post, the groups recommended that providers avoid routine use of Ct values to make clinical decisions because currently available data is limited.

Expanded development and standardization of test methods and more rigorous clinical data is needed, the groups said. For now, use of all qualitative tests currently on the market, including those that do not generate a Ct value, avoids potential bottlenecks that could result from demand for tests reporting Ct value.

According to CDC, the correlation between Ct values and the amount of virus in an original specimen is imperfect, for both qualitative and quantitative PCR assays. "It is therefore problematic to infer any relationship between an individual patient's Ct value and their viral load," the agency said. Ct values also can be affected if a specimen is not collected or stored properly or was collected early during the infection, CDC said.

https://www.healthcaredive.com/news/science-groups-urge-caution-against-using-certain-covid-19-test-data-providers/598947/

Primary care plays bigger role in vaccine rollout as burnout persists

 

• Primary care practices are playing a significant role in vaccinating people in the U.S. for COVID-19, according to a new survey from the Primary Care Collaborative and the Larry A. Green Center.
• The PCC surveyed more than 650 primary care physicians, nurse practitioners and pharmacists in 48 states, the District of Columbia and Guam. Altogether, nearly four out of 10 practices are administering the COVID-19 vaccines, "a marked increase" compared to just a few weeks prior, while 47% are partnering with local vaccination administration sites. "Primary care is now beginning to be leveraged to target the vaccine to hard-to-reach populations," the survey's authors concluded.
• The news comes as practices are financially stabilizing more than a year after the pandemic began. However, primary care practices are facing enormous challenges in the near term, including pent-up demand for medical and mental health services and a growing feeling of exhaustion among physicians.

The nation's primary care physicians have been battered by the COVID-19 pandemic, as patients put off elective care and practices had to cope with ramping up telehealth operations in just a matter of days. But they appear to be rebounding.

According to the PCC/Green survey, 38% of primary care practices say they are administering vaccines. Just a few weeks before, nearly half of practices said they wanted to administer vaccines but could not find a steady supply. The report shows that 42% of those administering vaccines are partnering with local health departments, while 34% are partnering with local healthcare systems.

However, just 19% of those surveyed say they have been able to obtain a steady supply of vaccines.

Meanwhile, the financial and work pressures that stemmed from the pandemic are continuing to take their toll, with data suggesting that practices are experiencing emotional whiplash. About 70% of those surveyed said their level of burnout and mental exhaustion has reached an all-time high. However, 38% say they are experiencing severe strain, compared to 85% last May. Yet nearly 40% say they require some form of mental health services or support, while four out of five say they have fielded calls from colleagues (and patients) in the midst of mental health crises.

Nevertheless, practices are forging what the survey called "new pandemic-era partnerships" to address social determinants of health and inequities. More than three-quarters of the practices surveyed say they are entering into such partnerships, including 42% with public health systems, 28% with community organizations and 18% with food banks or food pantries.

The survey suggests that as control of the pandemic takes place in the U.S., such services will be sorely needed. Health screening activities are double what they were in May 2020. Patients are being screened for substance use, social determinants of health, violence and abuse, post-traumatic stress disorder and depression, among other issues.

https://www.healthcaredive.com/news/primary-care-plays-bigger-role-in-vaccine-rollout-as-burnout-persists/599003/