Lupin Pharmaceuticals Inc. (LUPIN, 500257) on Monday announced positive top-line results from its pivotal Phase 3 clinical trial to assess the efficacy and safety of single-dose Solosec or secnidazole 2g oral granules in 147 female patients with trichomoniasis.

In the span of just a few short months, the ramifications and impact of COVID-19 have been vast. Virtually every aspect of public health has been affected by this pandemic, and the fight against antibiotic-resistant bacteria is no exception.

In this INSIDER Q&A, experts in contract manufacturing discuss aspects a brand owner should evaluate, what should be outlined in an agreement and what ongoing QA checks to conduct during the partnership.

It is "inconceivable" that immunity will not remain high on the list of health priorities when this pandemic ends and now is the time to create more "convincing experiences" to ensure trial turns into adoption, according to food and drink research and branding experts.

The nation’s largest pharmacy serving elder care facilities will pay Massachusetts nearly half a million dollars to settle allegations that it got kickbacks more than eight years ago from Abbott Laboratories to promote the anti-seizure drug, Depakote. The settlement was signed by Omnicare, a pharmacy services company that was acquired by CVS Health Corporation (NYSE: CVS) in August 2015. The $476,216 payment to Massachusetts is part of a $28 million multi-state settlement that included 47 states…

by Annie Waldman

Last September, over pancakes at a diner in central Massachusetts, Molly Baldwin told her husband, Jonathan, they were going to have a baby. He cried into his coffee mug, elated and a little surprised. They had only been trying for about a week, and they had yearned for a summer baby, ideally in June, which would enable their parents to spend more time with their first grandchild.

“We thought we had the best timing,” she said.

But as the novel coronavirus began to spread through the country this year, Baldwin realized in early March that it was only a matter of time before the virus hit her town, Fitchburg, and the nursing home where she’s a social worker. Her patients would be among the most vulnerable: Some had battled addiction, many had experienced homelessness and most were elderly. Flu seasons were always hard on her patients, and she dreaded the havoc a more lethal disease would wreak.

Baldwin also worried about her baby. She spent hours looking up the prenatal effects of COVID-19, and the lack of evidence-based research concerned her. She called her obstetrician, who cautioned that because of the unknowns, she should consider working from home to limit her exposure to the virus.

So Baldwin made a plan for when COVID-19 arrived at her nursing home: She would swap shifts with a colleague to work fewer hours and request to work from home, as many of her duties are paperwork or computer-based.

She would work from the comfort of her kitchen table. She would avoid catching the virus. She would keep visiting her doctor until it was time to deliver, her belly swelling with a baby girl she knew was healthy and safe.

None of it, not a single thing, would go according to plan.

Baldwin said her supervisor and the human resources representative from the facility verbally agreed in mid-March to let her work from home. (Baldwin spoke with ProPublica on the condition that her workplace not be named; ProPublica contacted her employers with questions for this story.)

Then, on April 16, one of the residents at her facility tested positive for the virus. Baldwin sought testing at a walk-in clinic, and the results came back negative. But when she called her obstetrician’s office, she got a warning: If she continued to work at the facility, potentially exposing herself to the virus, they would not allow her to enter their office for prenatal appointments unless she could prove with a test, before each visit, that she was negative for COVID-19.

She understood their caution; her job was beginning to feel at odds with her pregnancy. It was time for her work-from-home plan to go into action.

She called her employer and asked to start the accommodations she had requested the month before. But they told her that now the plan would not be feasible, she said. Other pregnant employees were continuing to work at the facilities, and she would have to as well, she said she was told.

“The services provided at a nursing home do not typically allow for remote working,” a company spokesperson told ProPublica. “However, we have made changes to accommodate our staff whenever possible, provided there is no impact on patient care.”

After finding out her request to work from home would not be granted, Baldwin panicked. “I’m not even a mom yet,” she said. “This is my first baby, and I already feel like I’m doing everything wrong.”

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Baldwin is one of dozens of pregnant workers who ProPublica has heard from who are navigating the risks of COVID-19 while in the field of health care.

“There are plenty of pregnant women across the country who are trying to figure out what to do to protect themselves, given the uncertainty,” said Emily Martin, vice president for education and workplace justice at the National Women’s Law Center. “If you feel like you can’t do your job because there aren’t certain accommodations and you feel like you’re at risk, it’s difficult to see where to go next.”

About half of the states have laws that allow pregnant women to request reasonable accommodations, including Massachusetts, Martin said.

According to the Massachusetts Pregnant Workers Fairness Act, signed into state law in July 2017, employers must grant reasonable accommodations to their pregnant employees that allow them to continue to do their job, “unless doing so would impose an ’undue hardship’ on the employer.” An employer also “cannot make an employee accept a particular accommodation if another reasonable accommodation would allow the employee to perform the essential functions of the job.”

Both the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists have stated that based on the data available, pregnant women do not face a higher risk of infection or severe morbidity related to COVID-19. That said, both the CDC and ACOG have suggested that health care facilities may want to consider reducing the exposure of pregnant health care workers to patients with confirmed or suspected COVID-19, if staffing permits.

“In the overwhelming majority of pregnancies, the person who is pregnant recovered well with mild illness,” said Dr. Neel Shah, an obstetrician and assistant professor at Harvard Medical School, echoing the current guidance. But, he cautioned, there is a lot we still don’t know about how the virus impacts bodies, let alone those that are pregnant. “We can’t say that it’s completely safe — we don’t know.”

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Baldwin and her husband went through their options.

She couldn’t quit because they needed her paycheck. They had a mortgage, student loans and a new baby on the way. She also loved her job and cared deeply for her patients, whom she wanted to continue to serve. Her employer, trying to manage understaffing, had discouraged employees from taking time off, she said. She didn’t want to take any additional sick days, because she needed to save them for her maternity leave.

They decided that she would have to return to work.

Her employer told her to wear a mask and gloves, use hand sanitizer and remain in her small, boxy office, which has three desks for four people. Though she didn’t have contact with the residents, her office mates still did.

Even though she was scared, she tried to stay optimistic. “I was grateful for what I had because I have friends that are out of work right now,” she said. But she remained perplexed about why her requests had been denied. “I was sitting in my office doing work that would have easily been done from a laptop on my kitchen table.”

The company spokesperson did not respond to a question about whether it had originally given Baldwin verbal approval to work from home. When asked why she couldn’t have done the same work remotely, he said, “Based on your questions, our HR and Risk Management are anticipating action and would prefer to not comment at all.”

The next day, the Massachusetts National Guard delivered testing kits to the nursing home, and every resident was checked for the virus. When the results came back, at least 22 residents and 20 other staff members tested positive.

“We are conducting cleanings and infection control measures multiple times per day, with extra focus on high touch areas,” the company spokesperson said. “We screen and take the temperature of anyone entering our building, and we have increased monitoring of our residents.”

Public data shows the facility has more than 30 cases among residents and staff, the maximum number that the state reports publicly.

“I thought if I just keep working, stay in my office, use hand sanitizer, wear my mask, go home and shower right away, disinfect my clothes, then I will be fine, and I can keep my baby safe, and I can shed all this guilt,” she said.

Then on April 24, two of her office mates texted to tell her they had the virus.

And that morning, she’d felt a tickle in her throat.

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“I know I’m positive,” she thought to herself, as she left work midday and drove to a CVS drugstore testing site an hour away that was offering free rapid tests for front-line and health care workers. Hundreds of cars were already lined up.

She waited alone in her Jeep Wrangler for three hours, wearing her mask as required, which muffled her nagging cough. She shifted around constantly, to keep blood from pooling in her swelling feet. At the front of the line, she received a 6-inch cotton swab, wedged it deep in her nasal cavity, and returned it to the technicians. They directed her into a side parking lot, and 30 minutes later, she got a phone call with her results.

“We’re sorry to tell you that you’re positive,” the voice on the line told her. Baldwin’s mind stalled, engulfed in a wave of anxiety, which gave way to seething frustration.

“This was so preventable,” she said. “Now here I am, 33 weeks pregnant and positive. My most important job is to keep the baby safe, and my actual job wasn’t making that happen.”

When she called her co-workers and supervisor to tell them she tested positive, she said they were “all very caring and compassionate.” They told her to stay home for at least a week, or until her symptoms subsided. The Families First Coronavirus Response Act requires most employers to provide their workers with two weeks of paid leave if the employee is quarantined or experiencing COVID-19 symptoms. Baldwin said she would have to exhaust her sick days first; she’d been saving them for her maternity leave. Her husband, who works as a correctional officer at a county jail, was allowed to take 14 days of paid leave to tend to his wife, without using his own sick days.

She could no longer go to her normal obstetrician for in-person appointments, and instead, she would have to rely on telemedicine. Her doctor connected her with an obstetrician specializing in COVID-19 cases, with whom she planned to meet this week.

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Last Saturday, Baldwin’s mother had planned to throw her daughter a baby shower. She had invited 50 of their closest friends to celebrate at a new restaurant and had ordered dozens of pink favors from Etsy.

Because of the stay-at-home order, her shower morphed into a drive-by celebration, where her friends and family passed by her house, honking their horns and holding celebratory signs, balloons and streamers. They dropped gifts in front of her house, including first aid kits and a handsewn pink mask for an infant.

Her symptoms have, so far, been relatively mild, similar to a normal flu: headaches, a stuffy nose, a sore throat and muscle pains. She’s spent most of the past week resting in bed and taking baths to soothe her body aches. While taking care of Baldwin, her husband has also contracted the virus and is experiencing severe body aches as well.

In addition to her disappointment that the hypnobirthing and breastfeeding classes she had signed up for are canceled, her time in quarantine is now filled with anxious questions about how the disease may impact her baby.

Will the stress of this experience damage her baby neurologically? Will her baby be born early? Will she have to deliver by cesarean section to relieve pressure on her body and lungs, like so many stories she had read? Will she have to be secluded from her baby for days or weeks after birth? And what if her own symptoms worsen?

“This is our first baby, and it was so planned and wanted,” she said. “But had we known this awful thing would happen, would we have tried when we did?”

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by Charles Ornstein and Lena V. Groeger

Nursing home residents have been among those hardest hit by the new coronavirus. In some states, more than half of the recorded deaths have been long-term care residents. Some of the homes have been cited for putting residents at “immediate jeopardy” of harm or death, our analysis showed.

And many of the affected homes have been previously written up for violating federal standards. That’s true in California, New Jersey and New York.

We’re updating Nursing Home Inspect to include more information about nursing homes across the country, including past problems with infection control practices, and which ones have had cases of COVID-19 among residents or staff.

We introduced this resource in 2012 as a way to search through tens of thousands of nursing home inspection reports to find problems and trends.

You can easily compare the nursing homes in your state based on how many times they have been cited for violating infection control protocols in the past three inspection cycles (roughly three years). We’ve also added data from The Washington Post on homes with COVID-19 cases. Nursing Home Inspect also allows you to sort by the number of health deficiencies cited by regulators; the number of serious deficiencies per home (that is, deficiencies in which patients were put in immediate jeopardy of harm); the amount of fines imposed; and how often the government has suspended payments to the home for new patients, another type of penalty.

Our data is from the U.S. Centers for Medicare and Medicaid Services (CMS), which has its own website called Nursing Home Compare. We’ve taken the information and organized it into an easy-to-use resource for families and residents, as well as researchers and other journalists.

Our site includes:

• State pages: Every state has its own section that allows you to compare all of the homes in a state on a variety of indicators.

• Individual nursing home pages: Every home has a section listing all of the health deficiencies identified within the past three survey cycles (roughly three years). The full text of these deficiency reports, if available, can be accessed via links from this page to CMS. Each home’s page also has ownership status — whether for-profit, government-run or nonprofit — and whether the home has been labeled by the government as a Special Focus Facility, meaning that it has many more problems than other homes. We’ve also labeled Special Focus Facility candidates, which meet the criteria to be a special focus facility but haven’t yet been designated as one. (We only include health deficiencies, not fire and safety violations, in this database.)

• State-by-state maps: The main page of the app shows how states compare in terms of the percentage of homes with at least one serious deficiency, the average fine paid by homes in the state, and the percentage of homes in each state with at least one infection-related deficiency.

• Top 20 Lists: We’ve listed the homes that have paid the most in fines in the nation and those with the highest number of serious deficiencies.

If homes violate federal standards, CMS may impose fines or suspend Medicare/Medicaid payments to the nursing home for new residents until the facility corrects the deficiency.

If problems persist or are not fixed, CMS can end its agreement with the nursing home. Additional details about CMS’ approach to enforcement can be found here.

Nursing Home Inspect continues to allow you to search through nearly 80,000 inspection reports by keywords, such as “choke” or “maggots,” to look for issues you care about. These search results can be sorted by date, city, state or severity of the deficiency.

Nursing homes are inspected on both a regular schedule and when there is a complaint. Inspectors typically work for state agencies paid by Medicare. If they find problems, known as deficiencies, they rank them on a scale of A to L, the most severe. The vast majority are either labeled D or E.

What you won’t find on these pages are self-reported quality measures for each home. Those can be found on Nursing Home Compare. We also don’t list the state sanctions imposed against homes because those are not centrally collected. For information on penalties within a given state, you should consult the state agency that regulates nursing homes. The federal government has a list of contacts available here.

When reading through inspection reports, it is a good idea to keep in mind the caveats we’ve outlined previously.

How We Combined Data Sources

To compile our app, we used different datasets: a listing of all Medicare-certified nursing homes, inspection violations and penalties, and deficiency report narratives.

We merged spreadsheets containing findings from routine inspections and those identified during complaint visits and kept only health violations, not fire safety violations.

We used each home’s unique identification code to match penalties imposed to the dates of their corresponding inspections so we could display that data together for each home. (We also noted some cases in which a penalty date did not have a corresponding inspection in the database.)

You can find the data we used on these sites:

• For a list of nursing homes: https://data.medicare.gov/Nursing-Home-Compare/Provider-Info/4pq5-n9py

• For penalties: https://data.medicare.gov/Nursing-Home-Compare/Penalties/g6vv-u9sr

• For health deficiency information: https://data.medicare.gov/Nursing-Home-Compare/Health-Deficiencies/r5ix-sfxw

• For deficiency report narratives (updated in April 2020): http://downloads.cms.gov/files/Full-Statement-of-Deficiencies-April-2020.zip

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It was just confirmed that I'll be teaching in Temple University's RA/QA MS program this spring. Specifically, I'll be teaching the ad-promo course.

If you or anyone you know is interested, please reach out to me for information. The course will be taught out of the Fort Washington campus, but online enrollment is permitted.

Here's the complete schedule of classes for the spring.

I live in Pennsylvania, just outside Philadelphia, in Montgomery County. Currently, Montco is the worst hit county in Pennsylvania for the COVID-19 outbreak. Consequently, the governor ordered all non-essential businesses to close more than a week ago in Montco, and yesterday expanded that order statewide.

Because most of my work is from home, the outbreak has not yet affected my ability to provide client service; however, for the foreseeable future all live speaking engagements are cancelled.

I was scheduled to deliver the device workshop at DIA advertising conference last week and also had some workshops scheduled with FDAnews for May and June. DIA's conference was been delayed with a decision about how to proceed still to be determined. I'll post an update here when I know more.

The May FDAnews workshop has been cancelled, and the June workshop is on hold. When I know more, I'll post an update.

In addition, I am part of the leadership committee for the Philadelphia RAPS chapter. We held our last event on March 5 at Temple University, and the next day, RAPS HQ sent out a notice asking chapters to hold off on live meetings for March and April. Currently, the chapter leadership is discussing other options, such as webinars to continue getting information to our membership during the outbreak.

While we adjust to life during a pandemic, I'll provide updates as I can. Stay safe and wash your hands!

Pharmacies dispensed approximately 35% more prescriptions in March 2020, compared with the previous month, according to a survey by the National Pharmacy Association.

To read the whole article click on the headline

March 12, 2020 —[Note: Due to the coronavirus epidemic, the Conference has been rescheduled from May.] Healthcare was already the top issue for voters—and the coronavirus pandemic only intensifies the focus heading into a hotly-contested election. Both parties want to “do something” about the cost of healthcare and especially drug prices, and what happens when […]

April 6, 2020 – The Coalition for Healthcare Communication last week endorsed an urgent request to Maryland Governor Larry Hogan (R) to veto HB 732, which would put in place the nation’s first tax on digital advertising. The request, sent March 31 by national media and advertising trade associations and members of The Advertising Coalition, […]

Venture capital firm Frazier Healthcare has grabbed Scott Byrd, Ian Mills, and Gordon McMurray as its new Entrepreneur-in-Residence consultants.

Last week, the New York Times had a nice piece “A Faster Way to Try Many Drugs on Many Cancers” on basket clinical trials, which matches patients to a therapy based on the genetics of their tumor as opposed to the site of their primary tumor. This type of trial feeds into the current excitement about precision

Call them victory anthems. Every time a patient with COVID-19 is well enough to be discharged, hospitals in New York and elsewhere play songs of celebration over the intercom. A doctor explains.

The U.N. triples its fundraising target for fighting the coronavirus, even as President Trump plans to freeze U.S. aid to its principal health agency.

Souplantation's owner says there was no way the restaurants' longtime self-serve model could survive in the era of COVID-19

Nursing facilities account for a large percentage of COVID-19 deaths. Better protection and testing can change that.

If nursing homes will remain closed until a COVID-19 vaccine is available, there will be no family visits for more than a year. That's intolerable.

Yokogawa Electric Corporation (TOKYO: 6841) announced today that its subsidiary, Yokogawa Engineering Asia, has been awarded a contract from PUB, Singapore's National Water Agency, to develop a plant simulation system for the Lower Seletar Waterworks, a 60 million gallons per day (mgd) water treatment facility in Singapore. This is part of PUB's continual investments in innovation and R&D to ensure a safe and sustainable water supply for Singapore.

Yokogawa Electric Corporation (TOKYO: 6841) and MetaMoJi Corporation announce that they have jointly developed SensPlus Note, a low cost and easy to implement solution for the digitization of plant data on mobile devices. SensPlus Note, a solution in Yokogawa's OpreX Operation and Maintenance Improvement family, improves the efficiency and quality of maintenance work and the precision of post-maintenance analyses by enabling data from plant field work to be used more efficiently. This solution will be released in all markets worldwide on January 31.

Yokogawa Electric Corporation (TOKYO: 6841) announces that it has developed the SU10 Single Cellome Unit, a device that uses a nanopipette to inject substances such as genes and drugs and aspirate intracellular materials at target locations in individual cells.

The Global Mega Trial by WHO named Solidarity will include the study and testing of 4 promising drugs in order to develop an antidote of Coronavirus.

The startup is refocusing on Asia and emerging markets.

The post Fashion platform Zilingo trims workforce, lays off 30 in Singapore appeared first on DealStreetAsia.

A Grab-Singtel joint venture has roped in former Citigroup executive Charles Wong as its senior managing director while AIA Singapore has named Wong Sze Keed as its new CEO. Grab-Singtel joint venture hires Citigroup’s former retail banking head A Grab–Singtel joint venture, which is in the fray for a digital

The post People Digest: Grab-Singtel JV hires former Citi exec; AIA names new SG CEO appeared first on DealStreetAsia.

It's SG growth & marketing director, Sarah Tan, will take over the reins as interim general manager.

The post Deliveroo’s Singapore GM departs, one quarter of employees in city-state laid off appeared first on DealStreetAsia.

Ninja Van becomes one of the few startups to score new funding since Covid-19 chilled deal activity.

The post Singapore’s Ninja Van raises $279m after pandemic drives e-commerce surge appeared first on DealStreetAsia.

npj Microgravity, Published online: 16 March 2020; doi:10.1038/s41526-020-0099-7

MHD surrogate model for convection in electromagnetically levitated molten metal droplets processed using the ISS-EML facility