First Edition: April 20, 2022

KHN: Heartbeat-Tracking Technology Raises Patients’ And Doctors’ Worries
If someone’s heart skips a beat, tech companies want to let them know about it. Gadget firms — starting with Apple and now Fitbit, which is owned by Google — are selling wearable devices that check heartbeat rhythms and alert users when something is out of sync. ... Still, although the gadgets are a technical achievement, some cardiologists say the information the devices produce isn’t always useful. Notifications from the devices aren’t definitive diagnoses. (Tahir, 4/20)

KHN: Abortion Clinic On Texas-Mexico Border Faces Unique Legal And Cultural Challenges 
Veronica Hernandez, manager of Whole Woman’s Health of McAllen, has long worried about the patients she sees walk in through the front door. Now, though, her concern is focused on those she doesn’t see. A Texas law that went into effect in September outlaws abortions after cardiac activity is detected in an embryo, usually at six weeks of pregnancy, and is considered the nation’s most restrictive abortion law. The law, which the Supreme Court has so far refused to block, makes no exception for victims of rape or incest and does not call on public officials to enforce it. Instead, it allows private citizens and groups to sue anyone who has provided an abortion or aided someone seeking an abortion in Texas. If the private citizens win the case, they are entitled to damages of at least $10,000. (DeGuzman, 4/20)

NPR: Moderna Says Its New 'Bivalent' Vaccine Shows Promise
The pharmaceutical company Moderna announced Tuesday that a new version of the company's COVID-19 vaccine appears to provide stronger, longer-lasting protection against variants of the virus than the original vaccine. Preliminary results from a study testing a vaccine that targets both the original strain of the virus and the beta variant — a so-called "bivalent" vaccine — appears to produce high levels of antibodies for months that can neutralize the virus. "We believe that these results validate our bivalent strategy," said Stéphane Bancel, Moderna's chief executive officer, in a news release. (Stein, 4/19)

Stat: Moderna Data Yield Hope For Better Covid Boosters, But Highlight Complexity Of Figuring Out How To Give Them
New data from Moderna offer hope that booster shots against Covid-19 could become at least somewhat more effective than they already are. But the data also point to how difficult it could be to determine exactly which Covid shots to give as annual boosters. On Tuesday Moderna released data testing a booster shot that is bivalent, meaning it contains equal amounts of vaccine from two different strains of the virus. This booster, currently known by the code number mRNA-1273.211, contains equal mRNA amounts of ancestral SARS-CoV-2 and spike proteins from the Beta variant of SARS-CoV-2, which originally emerged in South Africa. It does not contain vaccine targeted specifically against the Delta or Omicron variants that caused the most recent waves of Covid-19. (Herper, 4/19)

NBC News: CDC Launches Forecasting Center To Warn About Disease Threats
"How do we actually know that we need to start using and developing vaccines? How do we know that we need to deploy different antivirals? How do we know that we need to change our personal behavior when going out to dinner or to a movie? This kind of information that we’re trying to develop in the forecast would be very much similar to that," Dr. Dylan George, the CFA’s director for operations, said in a press call. During the first omicron wave, George added, the CFA gave government leaders "several weeks of advanced notice of the timing of the surge." That influenced policies on boosters, travel restrictions, and Covid testing in schools. (Bendix, 4/19)

AP: CDC Launches New Forecasting Center For Infectious Diseases 
The center is housed at CDC. Its initial $200 million in funding came from the 2021 coronavirus relief package. The center has awarded $21 million to academic institutions to develop modeling and forecasting methods. (Johnson, 4/19)

AP: Feds Will Appeal Mask Ruling Only If Mandate Still Needed 
The Justice Department said Tuesday it will not appeal a federal district judge’s ruling that ended the nation’s federal mask mandate on public transit unless the Centers for Disease Control and Prevention believes the requirement is still necessary. In a statement released a day after a Florida judge ended the sweeping mandate, which required face coverings on planes and trains and in transit hubs, Justice Department spokesman Anthony Coley said officials believe that the federal mask order was “a valid exercise of the authority Congress has given CDC to protect the public health.” He said it was “an important authority the Department will continue to work to preserve.” (Hollingsworth and Crawford, 4/19)

The Hill: Biden On Whether People Should Mask On Planes: ‘That’s Up To Them’
President Biden on Tuesday said whether to wear a mask on an airplane should be an individual choice after a federal judge blocked a requirement for passengers on public transportation to be masked. “Should people continue to wear masks on planes?” a reporter asked Biden during a trip to New Hampshire to promote infrastructure projects. "That’s up to them,” the president responded. (Samuels, 4/19)

The New York Times: Concerns Rise As Passenger Masks Fall 
Public health experts reacted with dismay to a federal judge’s ruling on Monday that struck down a mask requirement for plane, bus and train passengers, expressing concern that the case would set a precedent that erodes the authority of public health agencies and hampers their ability to respond to health emergencies. ... “If this ruling stands, it could put the American public at great risk,” said Dr. Richard Besser, president and chief executive of the Robert Wood Johnson Foundation and a former acting director of the C.D.C. He added that his concerns were less to do with the immediate consequences for mask mandates than with “the implications for future crises, of the ability to put in place simple public health measures to keep people safe.” (Rabin, 4/19)

Modern Healthcare: Mask Mandate Ruling Was 'Irresponsibly Abrupt,' Hospital Exec Says
Most health systems and physician groups are not adjusting their mask mandates after a federal judge struck down the law for airlines and public transportation. ... Trinity Health's chief clinical officer, Dr. Daniel Roth, said it jeopardizes the immunocompromised and those who can't be vaccinated. "Trinity Health has followed guidelines from the CDC to ensure the safety of our colleagues, clinicians and patients. Yesterday's court decision removing the requirement for face coverings on public transportation was irresponsibly abrupt and increases risk," he said in an emailed statement. Northwell Health will not change its masking rules in clinical settings, said Dr. David Battinelli, physician-in-chief of the New York City health system. "As a clinical facility, we're not public transportation. We're not the airlines. To me, there's almost no connection." (Kacik, Christ and Abrams, 4/19)

The Washington Post: Keep Wearing Your Mask On Planes, Health Experts Say 
The federal requirement to mask up on planes and other forms of transportation was tossed Monday by a federal judge in Florida. But health experts say those who want to protect themselves from the coronavirus as cases rise again should continue to cover their faces — with the best possible mask. “You can quote me on this: I’m going to continue to wear an N95 mask,” said David Freedman, professor emeritus of infectious diseases at the University of Alabama at Birmingham. “No question. You have no idea who’s on a plane.” He added: “I think everyone should.” (Sampson, 4/19)

USA Today: Are HEPA Filters On Airplanes Enough?
Weeks before a federal judge’s ruling led U.S. airlines to drop mask mandates, airline executives argued masks no longer should be required – in part because air filtration systems on planes create “hospital-grade cabin air.” Now that masks are optional on every major U.S. airline, experts said the filters that remove 99% of particles, including viruses, will help keep transmission on flights low but won't eliminate the risk of spreading COVID-19 that masks helped mitigate. (Kenning and Rodriguez, 4/20)

The New York Times: For Airlines, The Mask Mandate Couldn’t End Soon Enough
For flight attendants, pilots and others in the business, the mask mandate had become a source of frustration even as they acknowledged that it protected them during their extensive exposure to strangers. Flight crews had to enforce proper face coverings — a dangerous job in polarizing times. Some passengers refused to comply and became belligerent; in extreme cases, they even punched, kicked and bloodied flight attendants. “They don’t like being policemen on airplanes,” said David Neeleman, the founder of JetBlue Airways and now chief executive of a new company, Breeze Airways. “It’s not something that they signed up for, and I think it creates more agitation with customers.” (Chokshi and Murphy, 4/19)

The Washington Post: Delta Air Lines Initially Called Covid-19 An ‘Ordinary Seasonal Virus’ As Mask Mandate Was Lifted 
After backlash on social media, Delta Air Lines has walked back a comment falsely claiming that the coronavirus, which continues to account for more than 35,000 new cases per day, has become “an ordinary seasonal virus.” The airline made the comment Monday in an announcement stating that it will no longer require masks — a move several U.S. airlines have made after a federal judge struck down mask mandates in public transportation settings. (Bever, 4/19)

NPR: Judge Who Tossed The Mask Mandate Misunderstood 'Sanitation,' Legal Experts Say
When U.S. District Judge Kathryn Kimball Mizelle tossed out the federal government's transportation mask mandate on Monday, she relied in part on her interpretation of the term "sanitation." The 10-letter word can be found in the Public Health Service Act, a sprawling 1944 law that gave the federal government certain powers to respond to public health emergencies. The Biden administration relied on a piece of the Public Health Service Act to defend its COVID-19 mask mandate on airplanes and other forms of mass transit. (Hernandez and Simmons-Duffin, 4/19)

AP: Disney World: Face Masks Optional For All Areas Of Resort
Walt Disney World has lifted the last of its mask requirements, meaning face coverings will be optional for visitors at all locations on the central Florida Disney property. The rule change was posted Tuesday on Disney’s website. Masks are still recommended, though not required, for guests who are not fully vaccinated in indoor locations and enclosed transportation. (4/19)

Stat: Omicron Coronavirus Variant Splinters Into Fast-Spreading Lineages
Scientists around the world are discovering and tracking newer forms of the Omicron coronavirus variant, showing how even when a strain becomes globally dominant, it continues to evolve and can splinter into different lineages. Case in point: Updated data released Tuesday showed that a burgeoning form of Omicron, called BA.2.12.1 —  itself a sublineage of the BA.2 branch of Omicron — now accounts for nearly one in five infections in the United States. It’s eating into the prevalence of the ancestral BA.2, highlighting the emergent virus’s transmission advantage over its parent. BA.2 now accounts for about 74% of cases, while the remaining 6% or so are from the BA.1 branch of Omicron, the first form of the variant that took over globally and whose prevalence has been falling as BA.2 became dominant. (Joseph, 4/19)

NBC News: New Omicron BA.2 Subvariant Is Gaining A Foothold In The U.S., CDC Finds
Another omicron subvariant is gaining traction in the United States, the Centers for Disease Control and Prevention reported Tuesday. The subvariant, called BA.2.12.1, is an offshoot of the BA.2 version of omicron. While BA.2 remains the dominant variant in the U.S., BA.2.12.1 now accounts for roughly 1 in 5 new cases nationwide. The majority of cases in the U.S. — around 75 percent — are still caused by BA.2., which has been the country's dominant variant since late March. But BA.2.12.1, along with another version of omicron, called BA.2.12, is said to be responsible for the recent spike in Covid cases seen in upstate New York, the State Department of Health said last week. (Lovelace Jr., 4/19)

The Boston Globe: CDC Estimates New Omicron Version Accounts For 20 Percent Of New England COVID-19 Cases
A new version of the Omicron coronavirus variant now accounts for 20 percent of COVID-19 cases in New England, the Centers for Disease Control and Prevention estimated Tuesday. But experts say it’s too soon to tell what the impact will be. The new subvariant, BA.2.12.1, was in the news after it was spotted along with another new subvariant in New York and blamed last week by officials there for pushing up cases in the central part of the state. The original Omicron variant BA.1 caused a terrifying surge that peaked early this year in the United States. Cases have plummeted since then, though they recently turned up again as the more contagious BA.2 subvariant has arrived. (Finucane, 4/19)

Axios: CDC: 87% Of Children Hospitalized During U.S. Omicron Surge Unvaccinated
Most children from 5 to 11 years old hospitalized with COVID-19 during the U.S. surge driven by the Omicron variant were unvaccinated, per a Centers for Disease Control and Prevention study published Tuesday. The study of children hospitalized in the U.S. from Dec. 19 to Feb. 28 found the hospitalization rate was 2.1 times higher for those unvaccinated than their vaccinated peers. (Falconer, 4/19)

Bloomberg: Omicron Covid Wave Hit Unvaccinated Children Hardest: CDC
Almost 90% of U.S. children hospitalized for Covid during the omicron wave this winter were unvaccinated, according to a government study. Omicron caused a record-breaking number of pediatric hospitalizations from December to February, and national data on hundreds of kids aged 5 to 11 highlight the importance of vaccinating them, the Centers for Disease Control and Prevention said in the report. “Increasing vaccination coverage among children, particularly among racial and ethnic minority groups disproportionately affected by Covid-19, is critical to preventing Covid-19-associated hospitalization and severe outcomes,” the CDC said. (Muller, 4/19)

The Washington Post: Getting Covid-19 Over 50 Increases The Risk Of Getting Shingles 
People 50 and older who have had a mild case of covid-19 are 15 percent more likely to develop shingles (herpes zoster) within six month than are those who have not been infected by the coronavirus, according to research published in the journal Open Forum Infectious Diseases. The risk, however, was found to be even greater for older people who were hospitalized because of a more severe covid case, making them 21 percent more likely to develop shingles than those who did not have covid. (Searing, 4/19)

Columbus Dispatch: COVID Rising In Ohio: What You Need To Know About The State Of The Pandemic
Ohioans have enjoyed something of a COVID-19 lull for the last few months, but cases are already on the rise again throughout the state. Cases reported to the Ohio Department of Health have increased nearly 55% in the last three weeks from 3,103 the week of March 31 to 4,808 last week. While that's far lower than the 32,487 reported at the height of the winter surge Jan. 3, it's still something people "need to watch," said Dr. Joe Gastaldo, medical director of infectious diseases at OhioHealth. (Filby, 4/19)

CIDRAP: Drugs For Chronic Conditions Tied To Lower Risk Of COVID-19, Poor Outcomes
Use of the common maintenance drugs angiotensin-converting enzyme inhibitors (ACEIs), angiotensin-receptor blockers (ARBs), warfarin, statins, direct-factor Xa inhibitors, and P2Y12 inhibitors was tied to lower risk of COVID-19 infection, hospitalization, and death, a large US National Institutes of Health (NIH) study suggests. (4/19)

Milwaukee Journal Sentinel: MPS Reinstates Mask Requirement After Two Days Of Optional Policy
Milwaukee Public Schools announced Tuesday night that masks would again be required beginning Wednesday, after just one school-day of a mask-optional policy in the district. MPS Superintendent Keith Posley had announced in March that masks would no longer be required for staff and students beginning Monday. Students had the day off Monday but had a day of mask-optional school Tuesday. In a message to families Tuesday night, the district noted the mask requirement would be back in place Wednesday due to COVID spread in the city. (Linnane, 4/19)

Stateline: Parents Say Mask-Optional Policies Leave Out High-Risk Students
After South Carolina banned schools last spring from mandating masks, Amanda McDougald Scott removed her immunocompromised 5-year-old son from the Greenville County School District and enrolled him in a private eschool. But McDougald Scott felt strongly that public schools should be able to require masks to protect children with disabilities. So she joined eight other parents and two advocacy organizations in August in suing GOP Gov. Henry McMaster, state officials and seven other school districts over a state budget provision that prevented school districts from using state funds to impose mask mandates. After a legal battle, a federal appeals court in January allowed the provision to stand, in a victory for the state officials. (Wright, 4/19)

AP: Lawsuit: Hospital Director Fired After Virus Patient Concern 
A former director at a West Virginia hospital has filed a lawsuit alleging that he was fired after he raised concerns about the safety of patients who were on ventilators and receiving other respiratory care services during a surge of COVID-19 cases. Mark Mustard was fired as director of cardiopulmonary and therapy services at Princeton Community Hospital in September 2021. His departure from the West Virginia University Medicine affiliate came amid the surging delta COVID-9 variant “at a time when respiratory care was crucial to the community,” according to a lawsuit filed last week in Mercer County Circuit Court. (Willingham, 4/19)

ABC News: Americans Suffer Deadly Fentanyl Overdoses In Record Numbers 
In the first 18 months of the COVID-19 pandemic, a record number of Americans died from drug overdoses. Although months of data is still incomplete, statistics show that most of the deaths involve the potent drug fentanyl. According to the National Institute of Drug Abuse, fentanyl is 50 to 100 times more potent than morphine. In the new series “Poisoned,” which explores the devastation caused by fentanyl, ABC News Live examines how many parents are learning the deadly reality of the drug only after their children have suffered a fatal overdose. (Tienabeso, Delawala, Luna and Yamada, 4/19)

The Hill: Alabama Reaches $276M Settlement In Opioid Cases 
Alabama reached a $276 million settlement agreement with Johnson & Johnson, McKesson and Endo Pharmaceutical for their role in the opioid epidemic, the state’s attorney general announced on Tuesday. Under the agreement, Johnson & Johnson will pay $70.3 million to the state this year, while McKesson will pay out $141 million over nine years. Endo will pay $25 million this year. A settlement agreement does not mean an admission of guilt. (Dress, 4/19)

AP: Puzzling Outbreak Of Liver Disease In Kids Spreads To EU, US 
Health officials say they have detected more cases of a mysterious liver disease in children that was first identified in Britain, with new infections spreading to Europe and the U.S. ... U.S. officials have spotted nine cases in Alabama in children aged 1 to 6. (Cheng, 4/19)

NBC New York: Cancer Cluster Probe at NJ HS Underway After 100+ Diagnosed With Brain Tumors
There are growing concerns over a medical mystery at a New Jersey high school following dozens of diagnoses of brain tumors dating back decades. Every inch of Colonia High School -- from buildings to fields -- is being tested for radiation to determine if there is a link between the school and the number of cancer cases diagnosed amongst former students and staff. Al Lupiano, a graduate of the high school, believes there's a link between the school and brain tumors diagnosed in 108 people over a period of three decades, ending in the early 2000s. (Thompson, 4/18)

AP: Ohio Judge Again Blocks Abortion Law That Threatened Clinics 
A judge has blocked early enforcement of an Ohio abortion law signed in December that included additional licensing requirements challenged by the ACLU and Planned Parenthood as unnecessarily onerous. Hamilton County Common Pleas Judge Alison Hatheway’s ruling Friday blocked restrictions imposed on two southwest Ohio clinics by the Ohio Department of Health. (4/19)

The Texas Tribune: Former State Sen. Wendy Davis Challenges Texas Abortion Law In Court
Former Texas State Sen. Wendy Davis, best known for her 13-hour filibuster of a 2013 abortion bill, has filed a federal lawsuit challenging Texas’ recent abortion law. The suit claims the law is “blatantly unconstitutional” and written to “make a mockery of the federal courts.” The law, which went into effect in September and empowers private citizens to bring civil lawsuits against anyone who “aids or abets” in an abortion after fetal cardiac activity is detected, has led abortion clinics to stop providing the procedure after about six weeks of pregnancy. (Klibanoff, 4/19)

AP: Connecticut House Passes Bill To Protect Abortion Providers
Connecticut lawmakers advanced legislation Tuesday evening that abortion rights advocates say is needed to protect in-state medical providers from legal action, as well as patients who travel to Connecticut to terminate a pregnancy and those who help them. It comes amid new abortion restrictions being enacted in a growing number of conservative states. The bill cleared the House of Representatives by a bipartisan vote of 87-60. It now awaits action in the Senate. (Haigh, 4/19)

AP: California Bill Aims To Stop Pregnancy Loss Prosecutions
Adora Perez spent four years in prison for the death of her stillborn child after prosecutors in California’s Central Valley charged her with murder for using drugs during her pregnancy. Tuesday, California lawmakers advanced a bill that would let people like Perez sue prosecutors for charging them with those crimes — crimes that the state’s Attorney General has said do not exist under state law. (Beam, 4/20)

AP: 'You Inhaled It': Man Inhales Drill Bit During Dental Visit 
A routine trip to the dentist was anything but normal — after an Illinois man inhaled the dentist's drill bit and had to go to the hospital to get it removed last month. Tom Jozsi, 60, told WISN-TV that he was at the dentist getting his tooth filled when he was told he swallowed a tool. ... Dr. Abdul Alraiyes, at Aurora Medical Center-Kenosha in Wisconsin, said the bit was so deep that normal scopes couldn’t reach it. Jozsi said he was told that if it couldn't be taken out, part of his lung would have to be removed. Alraiyes and his medical team decided to try a newer device to remove the object — one that's designed for early detection of cancer. (4/19)

Fox News: COVID-19 Scared Patients Out Of Hospitals, Bringing On Health Neglect And Extreme Backlogs
Doctors across the country are now seeing more patients who chose to avoid hospitals during the height of the COVID-19 pandemic. They say this is causing a backlog of patients, many of whom are showing more serious health issues due to the lack of care during that period. Among them is Nalinthip Fetters, who recently found out she had a hole in her heart. She was supposed to get regular checkups but she, like many others, had steered clear of the hospital. "The pandemic happened and I just stopped. I didn’t want to deal with it because it was, like, COVID was going around," Fetters said. "I was so scared." (Addison, 4/19)

San Francisco Chronicle: Sutter Hospital Chain Locking Out Nurses Who Staged One-Day Strike
Sutter Health has locked out thousands of nurses across Northern California who staged a one-day strike at 18 facilities this week, and said it will bar them from returning to work until Saturday morning. The action came a day after 8,000 Sutter health care workers walked off the job Monday amid stalled contract negotiations, prompting Sutter to postpone some patient procedures and hire temporary replacement workers. The hospital chain said Tuesday that it had guaranteed five days of work for the replacement workers “amid the uncertainty of a widespread work stoppage.” (Asimov, 4/19)

Modern Healthcare: Kaiser Permanente, Cigna Ink Network, Pharmacy Services Agreement
Kaiser Permanente has negotiated its first partnership to use a rival insurer's commercial network, beginning in August. Under the five-year agreement announced Tuesday, Kaiser's more than 9 million members seeking emergency care while traveling outside the eight states served by the Oakland, California-based system can visit providers contracted with Cigna. Kaiser members will be responsible for the standard cost-sharing associated with their plan rather than paying out-of-network benefits. When Kaiser patients visit Cigna providers, their bills will be routed through Cigna's Evernorth healthcare services division, a spokesperson said. The deal is intended to lower patient costs, streamline administrative services and increase healthcare access. (Tepper, 4/19)

Modern Healthcare: Healthcare Industry Hit With Growing Number Of Retirement Plan Suits
Health insurance and hospital employees are filing more lawsuits against their employers over alleged failures to effectively manage their retirement accounts. Workers have filed 25 complaints against their employers this year, with at least 11 targeting the healthcare industry, including companies like Centene Corp., DaVita Inc. and Boston Children's Hospital, according to the U.S. Chamber of Commerce. The total has already exceeded the nine retirement benefits cases workers filed against healthcare companies in 2021, and is poised to beat 2020's record of 33 cases filed against healthcare industry employers, said Chantel Sheaks, the chamber's vice president of retirement policy. "It's not if, it's when," she said. (Tepper, 4/19)

Modern Healthcare: 5 Ways COVID-19 Shows Up In CMS' Proposed Hospital Pay Rule
After more than two years of living with the COVID-19 pandemic and with cases on the rise again, the virus continues to dictate hospital payment proposals for fiscal 2023. Here's a look at how at how four ideas in the proposed Medicare Hospital Inpatient Prospective Payment System rule were shaped by the pandemic, and one that hospital trade groups think ought to be: 1. CMS proposed returning to its typical practice of using the most recent available data to set hospital rates. CMS used 2019 data for 2022 rates when 2020 data was significantly impacted by the virus, believing that cases would decrease in 2022 to the point where pre-COVID-19 data would be more useful for rate-setting. But COVID-19 still hasn't gone away, and CMS said using 2021 claims and 2020 cost data with some modifications seems appropriate since Medicare patients will likely continue to be hospitalized with COVID-19 in 2023. (Goldman, 4/19)

Crain's Detroit Business: Trinity Health To Buy Out Partner In MercyOne Health System
Trinity Health said Tuesday it acquired the remaining shares of one of Iowa's largest health systems, MercyOne. Terms of the deal were not disclosed. Trinity created MercyOne in 1998 as a joint venture with Colorado-based Catholic Health Initiatives. In 2019, Catholic Health Initiaties merged with Dignity Health in Chicago to become CommonSpirit. (Walsh, 4/19)

Bloomberg: Alzheimer’s Trials Exclude Black Patients At ‘Astonishing’ Rate
Black people are about twice as likely to develop Alzheimer’s disease as White people, but for years the pharmaceutical industry has mostly left them out of trials intended to prove new drugs are safe and effective. Brian Van Buren, a 71-year-old retired flight attendant, knows what that feels like. He’s been living with Alzheimer’s since 2015. Over the years he has tried to join numerous trials, but he says he’s been turned down every time. In some cases he’s been told his other health issues—he suffers from diabetes, hypertension, and sleep apnea—rule him out. At other times, he says, he was turned away for not having a nearby partner or caregiver. (Langreth and Campbell, 4/19)

Stat: What Counts As A Breakthrough? 8 Insights On The FDA’s Approach To Medical Devices 
The word breakthrough carries a kind of weight: It’s a dramatic step forward, a critical advance in science or technology. But in the context of the Food and Drug Administration’s breakthrough devices program, the definition is far fuzzier. The agency doesn’t release the names of breakthrough-designated devices before they’ve reached the market, nor does it spell out why products earn the status. But STAT has gleaned new insights into how the agency determines what makes the cut as part of an investigation built on hundreds of public documents and interviews with dozens of companies, regulatory experts, and researchers. (Palmer and Aguilar, 4/20)

The Boston Globe: In Nation's Biotech Hub, Layoffs, Closures, And Mergers Are Expected
Based on the unrelenting demand for more lab space in the Boston area, a boom in the region’s massive biotech cluster continues unabated. But the stock market paints a different picture of an industry that is a linchpin of the Massachusetts economy. For more than a year, U.S. biotech stocks have been down overall, some by up to 80% or 90%. Pressure from investors has been especially intense for small- and medium-size companies that don’t yet have products on the market and are burning through cash in a race to commercialize their discoveries. Some, including local firms, have resorted to layoffs as they run low on funding, and industry leaders say more job cuts are likely, along with mergers and bankruptcies. (Cross, 4/19)