After months awaiting federal approval and years developing a system to become a domestic supplier of medical molybdenum-99, Beloit company NorthStar Medical Radioisotopes is clear to hit the market.
A company insider said NorthStar received approval Thursday from the U.S. Food and Drug Administration to sell and supply moly-99 it produces using a government nuclear reactor in Missouri.
Jon Coulter, managing director of Hendricks Holdings in Beloit and a member of NorthStar’s board of managers, said the FDA approval letter, which he said was dated Thursday, means NorthStar can begin ramping up for its entry into the domestic moly-99 market.
That makes NorthStar the first company in the U.S. in a quarter century to be a domestic seller and supplier of moly-99.
“Now, as of today, we’re able to sell it. That’s really what this (approval) means today,” Coulter said.
NorthStar and a Janesville company, SHINE Medical Technologies, have been vying for years to be the first private companies in the U.S. to produce and supply moly-99 and other radioactive compounds for use in medical tests.
The moly-99 produced by NorthStar would be metered into doses at specialty pharmacies using NorthStar-designed equipment that operates without the use of radioactive, high-enriched uranium, the company has said.
Moly-99 is used to light up bone and other tissue in thousands of medical tests a day.
Coulter said NorthStar on Thursday had teleconferences planned with the FDA and the U.S. Department of Energy. Both of those agencies have played major roles in moving NorthStar through the processes of planning and approval of domestically produced moly-99.
Hendricks Holdings has a financial stake in NorthStar, company officials have said.
In a news release Thursday morning, NorthStar CEO George Messina called NorthStar “the first and thus far only company to achieve the objective of being the first U.S. producer of Mo-99 in more than 25 years.”
He said the company was “extremely proud to pioneer domestic production of Mo-99 that is independent of uranium-based product.”
NorthStar has made no public announcements on how soon it could enter the market, but company sources have indicated NorthStar has been producing moly-99 for some time but not selling it.
The Gazette on Thursday could not immediately reach NorthStar officials for comment.
Moly-99 is produced mainly in foreign government laboratories using nuclear reactors, many of which operate off highly enriched uranium also used to make nuclear weapons. Moly-99 is projected to be in critically short supply as foreign governments phase out aging reactors.
The U.S. Energy Department issued a news release Thursday morning trumpeting the FDA’s approval of NorthStar’s technology, calling it a “win-win” for “national security and health care.”
The agency said NorthStar’s processes move moly-99 production away from processes that use weapons-grade uranium.
“The domestic production of this critical medical isotope without highly enriched uranium reduces global proliferation threats while also providing a more reliable supply to health care providers that need moly-99 for diagnostic medical procedures every single day,” said Steven C. Erhart, Department of Energy acting under secretary for nuclear security and National Nuclear Security Administration administrator, in a statement.
In 2012, Congress passed the American Medical Isotopes Production Act, a law that directed the Department of Energy to start a program to support projects that produced medical moly-99 without highly enriched uranium.
The federal government has awarded both NorthStar and SHINE millions of dollars in matching grants.
NorthStar has worked with the federal government on development of its own processes for seven years, the Department of Energy said.
NorthStar uses a government-owned research reactor in Missouri to produce its moly-99, and its Beloit headquarters is set up as a distribution hub for moly-99 that will be shipped to radiopharmacy laboratories nationwide.
SHINE seeks to build a moly-99 production facility in Janesville and use particle accelerators. SHINE has said it could be more than a year before it ramps up its own production facility.
SHINE is building a test and demonstration facility in Janesville that’s expected to be operational sometime in 2018, the company has said. The test site would be used to set up and demonstrate SHINE’s proprietary accelerator technology, which the company said will allow it to produce moly-99 in Janesville without using highly enriched uranium.
The test facility is being built on land next to a Janesville tax increment financing district where SHINE plans to eventually build its 55,000-square-foot production facility. That facility is on track to be built and operating by 2020, SHINE has said, and will break ground this year.
So far, Janesville has committed $10.5 million in tax incentives to SHINE’s project, according to city records.
Asked Thursday for comment on NorthStar’s FDA approval, SHINE Vice President Katrina Pitas responded to The Gazette in an email.
In the email, Pitas wrote that the type of moly-99 that NorthStar produces and the type SHINE plans to produce in Janesville are different.
Pitas wrote that SHINE plans to produce what is known as “high-specific-activity” moly-99, which Pitas said is the type many major medical operators, including SHINE clients GE Healthcare, are equipped to handle through current “distribution” methods.
Pitas wrote that NorthStar produces what’s known as “low-specific-activity” moly-99, a type that would require clients to adjust to “new and complex distribution equipment.”
“Now that it has FDA approval, we will find out whether or not the (medical) market wants to change behavior,” Pitas wrote.
Pitas wrote that SHINE does not view NorthStar’s FDA approval as a “first-to-market situation” because the market has “long been served” by high-specific-activity moly-99, rather than the type NorthStar produces.
“They (NorthStar) will need to take significant share from existing sources of supply before it would have an impact on SHINE,” Pitas wrote.
Think ice hockey with the addition of tag. Or bobsledding with a side of hula-hooping.
This week, Washington Elementary School third-graders celebrated the opening of the Winter Olympics by creating and playing games of their own.
Here’s what they learned: When everybody is having fun, the scoring doesn’t matter.
Also, things don’t always work out like you expect.
The first game was based on ice hockey. When students made goals, they had to run over to a soft plastic dome called a blaster and step on it, shooting a ball at a target.
However, if a student from the other team was able to tag the first student, the first student lost the chance to earn extra points.
Confused? We were, but the kids were not. They got up and started to play immediately, the syncopated sounds of plastic hockey sticks cracking against each other drowning out any doubts about the rules.
Delaney King, 8, naturally took to the sport, deftly performing the quick-stop-and-reverse moves for which hockey players are known. She also held the hockey stick like an Olympian—as opposed to an enthusiastic third-grader.
It turns out she’s in gymnastics and plays summer hockey.
We can’t all be stars.
Brecken Combs, 9, one of the game’s inventors, watched the melee with a bemused expression.
“This isn’t how I imagined it,” Combs said to himself.
Combs and his fellow game designers—Brandon Saltz and Lexi Walker, both 9—wanted everybody to have a chance to play, so they created teams of four people.
But having four people on each team meant that each hockey/tag/blaster court had to be fairly small.
Combs and Saltz worried that somebody might get hurt. Players were getting too close to the goalies. With a larger court, they could create creases in front of each goal just like in regular ice hockey.
But nobody got hurt—no blood, no foul—and they could always make changes. Baseball wasn’t created in a day, either.
The next game had elements of bobsledding—sort of.
Students started by rolling across the gym floor on a scooter, which is like a four-wheeled sled. With a running start, a scooter will carry a grown woman across the gym.
The kids launched themselves via scooter to a jump rope in the center of a hula hoop. They then jumped 10 times, hula-hooped for five seconds, stepped up and down on hard foam blocks and then returned to the start.
Points were awarded for the fastest time.
Once the kids got started, they ran through the course over and over again, and nobody kept track of the score.
It was a big hit.
“It gets your heart pumping, and you use your muscles,” Issac Tearman, 8, said during feedback time.
Hailey Williamson, 8, liked it because “you got to do a lot of stuff.”
All that fun couldn’t happen without a equal dose of learning. Modern educational standards require every activity to be infused with academic rigor. A kid can’t launch a spitball without considering that force equals mass times acceleration.
Before they could have fun, students had to research and write about the different countries and sports involved in the Winter Olympics. The library media specialist created marble ramps to help them through the basic physics concepts of motion and momentum.
Physical education teacher Sherry Hintz was at the center of game creation.
Again, modern educational standards being what they are, she had to talk about the benefits of such an exercise, such as working together as a team, learning to accept feedback and empowering learning choices.
Hintz also participated in games when an extra player was needed and—this should be kept secret—she looked like she was having a lot of fun.
City staffers brought in extra chairs Thursday night for the nearly 100 people who packed City Hall to hear eight Milton School Board candidates discuss a proposed new high school and public trust.
The event was a precursor to the Feb. 20 primary, which will eliminate two candidates before the April 3 general election.
Incumbents Shelly Crull-Hanke and Brian Kvapil are running for re-election. Tony Astin, Joe Martin, Diamond McKenna, Brent Miller, Harvey Smith and Gabriel Szerlong are seeking their first terms on the board.
WCLO radio anchor Stan Stricker asked candidates submitted questions as moderator. The Milton Area Chamber of Commerce organized the forum.
Candidates echoed each other on several questions, applauding the district for quality academics, strong teachers and supportive parents. They said they would be willing to miss work for school board matters and encouraged the audience to attend games, graduations and other school events.
But questions about a new high school and public communication yielded the most passionate answers.
District voters have rejected two facilities referendums in the past two years. Some have complained that the district and school board have lost their trust while pushing for a new high school.
Martin said he disagreed with those who said trust was an issue. He said he thought the board was transparent when it explained the terms of both referendums.
“Just because you don’t like the message doesn’t mean they didn’t communicate,” Martin said.
Astin and Crull-Hanke agreed, saying the board has been as open as possible during regular meetings and other public listening sessions.
But Smith said district residents didn’t believe the board was listening to them. It was a common theme he heard while collecting signatures to get his name on the ballot, he said.
Kvapil, who has been the lone dissenting vote multiple times during his year on the school board, said he saw significant distrust. As a current board member, Kvapil put blame on himself and said everyone needed to work harder to regain public confidence.
Others said the board needed to make more of an effort to actually hear constituents.
Szerlong suggested asking teachers what they need. McKenna said some residents didn’t feel their input was validated, and Miller said an open line of communication between the board and the public doesn’t currently exist.
The trust question provided the most disparate answers until the end of the night, when Stricker asked candidates for their positions on a new high school.
Szerlong said he was not for or against a new building and stressed the district needed to work within its means.
Kvapil gave a similar answer, saying the idea of needs was subjective and that the board could not ask people to support something they couldn’t afford.
Continuing the earlier theme of sowing trust, Smith said the board needed to revisit public feedback in whatever solution it chose.
McKenna wanted the board to recognize the public has already rejected two referendums, but she wanted a balance between community input and what students needed.
The rest expressed outright support for a new high school.
Astin said he voted for both referendums, and he still believed a new school was likely the best solution.
Miller wanted something that would reduce overcrowding and improve safety, issues that could be solved with a new building.
Martin agreed and believed a new high school was the most cost-effective way to solve the district’s space problems.
Crull-Hanke has often talked about her time on a design team a decade ago. The needs then are still the same, she said, and an addition at the high school wouldn’t solve issues at other district buildings.
Despite opposing views in the community, the candidates said they believed district residents overall were supportive of Milton schools.
The crowd that squeezed into the city council chambers on a wintry night was evidence of that.
The government stumbled into a midnight shutdown Thursday as a rogue Senate Republican blocked a speedy vote on a massive, bipartisan, budget-busting spending deal, protesting the return of trillion-dollar deficits on the watch of Republicans controlling Washington.
A shutdown—technically a lapse in agency appropriations—became inevitable as GOP Sen. Rand Paul repeatedly held up votes on the budget plan, which is married to a six-week government-wide spending measure. The Senate recessed around 11 p.m. with plans to reconvene just after The Gazette’s press deadline.
Paul was seeking a vote on reversing spending increases and refused to speed things up when he was denied.
“I ran for office because I was very critical of President Obama’s trillion-dollar deficits,” the Kentucky senator said. “Now we have Republicans hand in hand with Democrats offering us trillion-dollar deficits. I can’t in all honesty look the other way.”
While the government’s authority to spend some money would expire at midnight, there weren’t likely to be many clear immediate effects. Essential personnel would remain on the job regardless, and it appeared possible—if not likely—that the measure could pass both the Senate and House before most federal employees were due to report for work.
If the measure passes in the wee hours of the morning, the government would open in the morning on schedule, said John Czwartacki, spokesman for the Office of Management and Budget, the agency responsible for coordinating any shutdown.
At the White House, there appeared to be little sense of concern. Aides closed shop early in the night, with no comment on the display on the Hill. The president did not tweet.
But frustrations were clear in both sides of the Capitol, where just hours earlier leaders had been optimistic that the budget deal was a sign they had left behind some of their chronic dysfunction. Senate Democrats sparked a three-day partial government shutdown last month by filibustering a spending bill, seeking relief for “Dreamer” immigrants who’ve lived in the country illegally since they were children. This time it was a Republican’s turn to throw a wrench in the works.
Paul brushed off pleas from his fellow Republicans, who billed the budget plan as an “emergency” measure needed for a depleted military.
“We will effectively shut down the federal government for no good reason,” said Sen. John Cornyn, as his requests to move to a vote were repeatedly rejected by Paul.
Paul was unfazed.
“I didn’t come up here to be part of somebody’s club. I didn’t come up here to be liked,” he said.
Approval of the measure in the Senate seemed assured—eventually—but the situation in the House remained dicey. In that chamber, progressive Democrats and tea party Republicans opposed the measure, which contains roughly $400 billion in new spending for the Pentagon, domestic agencies, disaster relief and extending a host of health care provisions.
However, House GOP leaders said they were confident they had shored up support among conservatives for the measure, which would shower the Pentagon with money but add hundreds of billions of dollars to the nation’s $20 trillion-plus debt.
House Democratic leaders opposed the measure—arguing it should resolve the plight of Dreamers—but not with all their might.
The legislation doesn’t address immigration, though Speaker Paul Ryan said again Thursday he was determined to bring an immigration bill to the floor this year—albeit only one that has President Donald Trump’s blessing.
At a late afternoon meeting, House Democratic Leader Nancy Pelosi of California made it plain she wasn’t pressuring fellow Democrats to kill the bill, which is packed with money for party priorities like infrastructure, combating opioid abuse and helping college students.
Still, it represented a bitter defeat for Democrats who followed a risky strategy to use the party’s leverage on the budget to address immigration and ended up scalded by last month’s three-day government shutdown. Protection for the Dreamers under former President Barack Obama’s Deferred Action for Childhood Arrivals program, or DACA, expires next month.
Republicans were sheepish about the bushels of dollars for Democratic priorities and the return next year of $1 trillion-plus deficits. But they pointed to money they have long sought for the Pentagon, which they say needs huge sums for readiness, training and weapons modernization.
“It provides what the Pentagon needs to restore our military’s edge for years to come,” said Ryan.
Beyond $300 billion worth of record increases for the military and domestic programs, the agreement adds $89 billion in overdue disaster aid for hurricane-slammed Texas, Florida and Puerto Rico, a politically charged increase in the government’s borrowing cap and a grab bag of health and tax provisions. There’s also $16 billion to renew a slew of expired tax breaks that Congress seems unable to kill.
“I love bipartisanship, as you know,” said Sen. Jeff Flake, R-Ariz. “But the problem is the only time we discover bipartisanship is when we spend more money.”
The deal contains far more money demanded by Democrats than had seemed possible only weeks ago.
“We’re not going to get DACA as part of this,” said Rep. John Yarmuth of Kentucky, the top Democrat on the Budget Committee. “So if we can negotiate a deal like I think we’ve gotten that essentially meets every other one of our priorities then I think that’s where a lot of the Democrats are.”
Added conservative Democrat Henry Cuellar of Texas, “It’s an easy ‘yes.’”
Combined with the Republicans’ December tax cut bill, the burst in spending would put the GOP-controlled government on track for the first $1 trillion-plus deficits since Obama’s first term and the aftermath of the most recent recession nine years ago.
“This budget deal shows just how broken the budget process is, that Congress thinks the only way to agree to a budget is to put hundreds of billions of dollars on the nation’s credit card,” said Maya MacGuineas, president of the Center for a Responsible Federal Budget, a Washington-based group.
The agreement would increase the government’s borrowing limit to prevent a first-ever default on U.S. obligations that looms in just a few weeks. The debt limit would be suspended through March 2019, putting the next vote on it safely past this year’s midterm elections.
local • 3A, 6A
Council alters review process
The Janesville City Council voted Thursday to changed how it evaluates the city manager in the hope the process will be more organized than in the past. The council will use the eight essential duties listed in the city manager’s job description to evaluate his performance. Since City Manager Mark Freitag started in December 2013, the council has lacked an established process to review his performance.
state • 2A
GOP offers two tax proposals
Wisconsin families with school-aged children would receive a one-time $100 tax rebate this summer and state sales tax would be waived on certain purchases the first weekend in August under a deal Gov. Scott Walker and Assembly Republicans announced Thursday. Democrats said Walker of trying to buy his re-election.
nation/world • 6B
Dow drops 1,000 points again
The Dow Jones industrials plunged more than 1,000 points Thursday, deepening a weeklong sell-off and dragging the financial markets past a 10 percent loss and into an official “correction” for the first time in two years. Thursday’s decline marked a stark turnabout in investors’ mood from just two weeks ago, when indexes set their latest record highs. The market began falling in the first few minutes of trading, and the pace of the declines worsened as the day wore on.