A Type B meeting with the FDA was held onJanuary 11, 2023.
Minutes of the meeting are expected to be available in approximately 30 days.
"We appreciate the FDA's ongoing guidance and support under the Breakthrough Therapy Designation associated with NRX-101 as well the previously issued Special Protocol Agreement for the treatment of Bipolar Depression in Patients with Acute Suicidal Ideation and Behavior. Our quest is to develop the first medicine to treat patients with suicidal depression and aim to develop a new drug therapy for post-traumatic stress disorder (PTSD)", said Stephen Willard, chief executive officer of NRx Pharmaceuticals. "We look forward to continued discussions addressing our mutual goal to treat bipolar depression and suicidality at a time when someone in the United States attempts suicide every 27 seconds."
NDA is supported by robust NASH clinical development program, including two positive interim analyses from the Phase 3 REGENERATE study demonstrating OCA’s improvement in liver fibrosis without worsening of NASH
PDUFA target action date set for June 22, 2023
Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted Intercept’s New Drug Application (NDA) for obeticholic acid (OCA) seeking accelerated approval for the treatment of patients with pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH).
FDA indicated that it considers this a complete, Class 2 resubmission and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 22, 2023,for the NDA. The timeline for the review of the NDA by FDA remains subject to change.
Company focusing on innovative technology and exit of pharmacy services
Restructuring to further extend capital resources
Annual cash burn expected to be reduced by greater than 65% in 2023
Company exploring financing options in connection with business transition
MedAvail Holdings, Inc. (Nasdaq: MDVL) (“MedAvail”), an innovative technology-enabled pharmacy company, today announced the execution of a strategic restructuring and reprioritization of its business targeted to deliver profitability.
Following an extensive review of the market landscape, growth strategy and structure of the business, the company is taking actions and restructuring its organization to focus on its pharmacy technology business and exit its pharmacy services and SpotRx business. With respect to the pharmacy services and SpotRx business, the company has hired a broker and is in active negotiations regarding the sale of its pharmacy assets.
An astounding 1,400 shops have popped up around New York City that areillegally selling cannabis products — a situation that alarmed lawmakers decried as the “Wild, Wild West” during a City City Council hearing Wednesday.
City Sheriff Anthony Miranda and representatives of the NYPD testified that existing laws make it difficult to immediately close illicit shops and often can issue only measly $250 fines for selling pot without a license — hardly a deterrent even after seizing illegal weed and edibles.
Miranda said illegal smoke shops are “rampant throughout the city” — noting 1,400 stores are being targeted and inspected by authorities for suspected illegal activity.
Just one legal weed shop is currently open in New York City with a second expected to open next week. But all the legal and illicit sales — combined with use of pot products being legalized — has left city streets smelling decidedly skunky.
Mayor Eric Adams last year created a cannabis task force to crack down on the illegal pot market, corralling a hodgepodge of agencies with enforcement powers including the sheriff’s office, the NYPD and Department of Consumer Affairs.
Only one legal weed shop is currently open in New York City.New York PostExisting laws make it difficult to immediately close illicit shops and often only measly $250 fines can be issued for selling pot without a license.New York Post
More alarming than the proliferation itself, one council member after another told horror stories regarding the ease with which teenaged high school students were able to access cannabis on the black market.
Councilwoman Carlina Rivera, who represents the Lower East Side, said high school students were using credit cards to buy cannabis.
“We have a lot of work to do,” said Councilwoman Gale Brewer, who chairs the oversight and investigations committee.
“There’s a lot of marketing that’s going to children. There’s a lot of public health issues, danger to the community. We want to make sure they’re in compliance,” Miranda said during the hearing, conducted jointly by the Council Committees on Oversight and Investigation, Consumer Affairs and Health.
NYC Sheriff Anthony Miranda said illegal smoke shops are “rampant throughout the city.”William FarringtonOver 1,000 stores are being targeted and inspected by authorities for suspected illegal activity.New York Post
The NYPD’s 311 data system received 951 complaints about illicit cannabis shops, said chief of patrol John Chell.
Chell said the illegal pot shops — with large amounts of cash on the premises — have also been a bonanza for crooks.
Robberies at smoke shops have more than doubled. A total of $1.5 million was stolen — or an average of $2,500 for the 593 reported robberies, he said.
Chell said nearly a third of the robberies of smoke shops were committed by teenagers between the ages of 15 and 19.
He said robbers are hitting several smoke shops in different boroughs in one night, adding that three shops were robbed Tuesday night.
“The same group of people. It’s a challenge for us,” Chell said.
The NYPD’s 311 data system received 951 complaints about illicit cannabis shops, according to NYPD Chief of Patrol John Chell.Lev Radin/Pacific Press/Shutters
None other than state Sen. Liz Krueger (D-Manhattan), author of the law that legalized the recreational use of cannabis, called the number of illicit shops out there “the wild, wild west.”
“They’re busy breaking a whole series of our laws. What it is doing is harming the entire model we’ve been trying so hard to build and get established throughout the state,” Krueger said, testifying remotely at the Council investigative hearing from Albany.
Krueger said she’s in negotiations with Gov. Katy Hochul’s office to craft a new state law to beef up enforcement, making it easier for authorities to financially punish and close illegal shops.
The new legislation would stiffen fines and tax violations, make it easier to seize illegal pot and also penalize landlords for allowing illegal shops to operate on their property.
Sheriff Miranda said notices are being sent to landlords of a tenant that has been illegally selling cannabis.
“If you’re running one of these illegal shops, you’re not going to get a license. Period. Because you know you’re breaking the law and it’s not OK,” Sen. Krueger said.
Hochul spokeswoman Hazel Crampton-Hays said, “We continue to work with our partners to enforce the law and to explore every possible mechanism available to protect New Yorkers and shut down illicit operators.”
Customers buying cannabis at the only legal dispensary open — at Housing Works on Broadway in Greenwich Village — supported a crackdown in illegal shops.
Sen. Liz Krueger said she’s in negotiations with Gov. Katy Hochul’s office to draft a new state law to increase enforcement.Getty Images for Housing Works
“I’ve been to other shops — you know, the fake ones. The ones that advertise CBD but also sell edibles and regular weed. But you don’t know what you’re getting at those places. You know what’s going into the weed at dispensaries,” said Jason Brown, a 47-year-old construction worker from Babylon, Long Island.
“It’s regulated and safer. You get a full layout of what’s in it..”
Brown supported a crackdown on the illegal shops with hefty fines because “would you want to pay a million dollars for a permit to open up a business here and then they’re going to let everyone else open up a business on every other corner, and sell it without a permit?”
Hannah, a 21-year-old from Crown Heights, said the illegal shops in Brooklyn are “very Ok.” “They don’t check your IDs and there’s no security like here,” she said of the state-licensed Housing Works dispensary.
” It’s very surprising. Honestly, I feel like I’m not smoking weed when I go there.”
She said she expects better quality weed at the licensed shops but added, “If these illegal places are not selling products that you’re tripping on and end up in the hospital, OK — go for it.”
Surrounding unlicensed shops selling weed seemed unconcerned by the state-licensed dispensary nearby.
At Lush Smoke Shop on MacDougal Street, a worker there said that people prefer their cannabis products because they’re stronger and not “mid” like Housing Works weed.
The store sells popular black market products like Punch Bars (edibles) and prerolls.
One customer said, “I prefer their pre-rolls because the flavor tastes better and they get you higher.”
A controversial new evidence lawhas led to big surges in the number of cases that prosecutors are being forced to drop across the Big Apple —fueling crimeby putting suspected bad guys back on the streets without ever having to face justice, a new study obtained by The Post reveals.
The rate at which cases were dismissed citywide rose from 44% in 2019 — the year new “discovery” rules were adopted by state lawmakers — to 69% by mid-October 2021, the Manhattan Institute finds in the report, set for release Thursday.
For misdemeanor cases, the increase was even more dramatic, jumping from 49% to 82% during the same period, according to official data cited by the conservative think tank.
“The statute, therefore, has correlated with a devastating rise in crime and a drop in arrests,” author and former NYPD analyst Hannah Meyers wrote.
“In New York City, adult felony arrests fell by 14% between 2019 and 2021, while NYC shootings rose by 102% and murders rose by over 51%.”
The study blamed the alarming situation on the “clerical burden” imposed on prosecutors who must “assemble and redact limitless…documents and videos” for defense lawyers as part of the legal process called “discovery.”
When combined with the state’s “speedy trial” laws, Meyers said, assistant district attorneys simply “run out of time to try cases or file motions to extend defendants’ detention.”
The study also found that while prosecutors were busy “chasing paper” to meet discovery deadlines as short as 20 days for defendants in jail, a “staggering” number of defense lawyers didn’t even bother to review the evidence to which they were entitled.
“According to sources with firsthand knowledge of this data, during at least the first year after… implementation, in many jurisdictions defense attorneys were failing to download discovery packages within their 30-day windows in over half of cases,” Meyers wrote.
The discovery law — part of a package that also included bail reform — even allows sleazy defense lawyers to “sabotage” prosecutors by taking advantage of the “speedy-trial window,” Meyers said.
Meyers pointed to a leaked, internal guide prepared by the Legal Aid Society that reportedly noted how the new rules “are especially important in misdemeanor cases.”
“An unscrupulous defense attorney could delay filing motions to suppress evidence until the last possible moment, all while the window before the ADA must dismiss the case keeps closing,” Meyers wrote.
“Defense attorneys can easily take advantage of this new leverage, contributing to the vastly increased dismissal rates, especially on low-level offenses.”
Manhattan District Attorney Alvin Bragg puts the blame on the discovery law for allowing criminals back on the streets.Stefan Jeremiah
In addition, what was once a “steady stream of qualified applicants” has been reportedly reduced to “months with no applicants at all.”
“Most attorneys are drawn to the low-paying, intrinsically high-stress role of prosecutor by a passion for making a difference for crime victims,” Meyers wrote. “But the soaring rates of case dismissals and inability of ADAs to devote sufficient time to case development as they scramble to collect discovery documents had meant that the central gratification of the role itself — representing the people and seeking justice — has been monumentally removed.”
Embattled Manhattan DA Alvin Bragg, whose soft-on-crime policiesled to a flurry of resignationsafter he took office last year, has since blamed the discovery law for his office’s “record attrition.”
In March, he told the City Council that “our ADAs burned out and sought less demanding jobs for more money.”
On Monday, Bragg also told WNYC radio that in 2021, before he took office, “1,800 or so more misdemeanor cases that timed out, they were dismissed because discovery wasn’t turned over on time.”
In a statement Wednesday, Bragg said there were “technical changes we can make to the discovery legislation” that would protect public safety “while also preserving the intent of the law.”
“We look forward to sharing more about our proposal in the coming days and will continue to collaborate with law enforcement partners, elected officials and the defense bar on this important issue,” he added.
Queens DA Melinda Katz said that while discovery reform was “overdue,” some aspects “impose burdens on the criminal justice system not seen anywhere else in the country.”
District Attorney Melinda Katz believes the discovery law needs to be revised in order to benefit the criminal justice system.BRIGITTE STELZER
“Tens of thousands of cases were needlessly dismissed across the city last year because of the reform’s requirement that prosecutors share mounds of inconsequential information. Revisions to the reform are urgently needed,” she said.
Staten Island DA Michael McMahon also said that “onerous discovery rules have had a dramatic and negative impact on the ability of my office to secure justice for victims of crime, hold lawbreakers accountable, and prevent crime by steering people in need to meaningful programs.”
“In the last three to four years, we have lost scores of staff to the private sector and dispiritingly, to other roles in government because of the unreasonable and unnecessary demands placed on them by Albany,” he said.
Staten Island DA Michael McMahon claims the discovery rules have a negative impact on providing justice for victims of crime.Kevin C. Downs for The New York Post
“The system as currently constructed by Albany is an abject failure, and we are seeing the impacts on our streets and in our courtrooms every day.”
The incoming president of the New York State Association of Criminal Defense Lawyers, Yung-Mi Lee of the Brooklyn Defender Services, didn’t challenge the report’s finding that discovery evidence didn’t get reviewed in 60% of cases.
“It was maybe an unforeseen technological challenge,” she said.
Lee also said that adapting to the new law “required an adjustment. And we’re still in the process of really working out the kinks at this point.”
“But I have to say, discovery reform has been incredibly eye-opening and extremely helpful,” she added.
The Legal Aid Society didn’t dispute the authenticity of the internal document Meyers said she obtained but blasted her study as “premised on a lie.”
“In fact, our team downloads discovery and disseminates evidence typically within 24 to 48 hours. The report’s author is either a liar or is so credulous and unconcerned with verifying facts that she should not be taken seriously,” a spokesperson said.
If China wants to reverse a decline in population, more should be done to help families raise their children, according to Wei Chao, a 31-year-old mother of twin girls living in Shanghai, and many more parents interviewed by Reuters held the same view.
"Nowadays many people do not want to have children if they can't provide a good education for them," Wei told Reuters on Wednesday as she sat in a park with her husband and daughters.
"When we have good income, of course we would be able to invest more in our children."
The government has already rolled out measures to encourage people to have more babies, including through tax deductions, longer maternity leave and housing subsidies, but so far they have done little to reverse the long-term trend.
China's statistics bureau released a report a day earlier that showed the population fell for the first time since 1961, the last year of China's Great Famine. With more than 1.41 billion people, China still has the world's largest population.
But the drop of roughly 850,000 in 2022 alarmed demographers and analysts who foresaw problems ahead for the economy if the trend continues, though the head of the statistics bureau said "overall labour supply still exceeds demand".
Sky-high education costs and dimming economic prospects have put many Chinese off having more than one child or even having any at all, despite the government scrapping its one-child policy in 2015.
Many Chinese who were born during the two decades after the policy was imposed in 1980 are particularly put off having children as they are already solely responsible for their parents and grandparents without the help of siblings.
"People born in the 1980s or 1990s are not as keen to have children as our parents’ generation," said Ding Ding, the 37-year-old father of a three-year-old girl.
"Our parents think if they have more children, they can get more care when they grow old. But the younger generation don't think the same anymore, they have a different mentality. They think raising one child is already very tiring."
China’s stringent zero-COVID policies that were in place for three years have caused further damage to the country’s demographic outlook, population experts said.
China is one of the most expensive places to raise a child, beaten only by South Korea, according to the Beijing-based YuWa Population Research.
In a study published last year, the think tank compared the cost of raising a child to the age of 18 years relative to the multiples of GDP per capita for different countries.
In Australia it was 2.08 times, 2.24 times in France, 2.91 times in Sweden, 3.64 times in Germany, and 4.11 times in the US.
By comparison, north Asian countries were the costliest, with Japan 4.26 times, China 6.9 times and South Korea 7.79 times. They were also ranked far lower for gender equality by the World Economic Forum versus countries such as Finland and Norway where birth rates were rising. A key root cause of low birth rates is gender inequality, demographers said.
The governments in South Korea and Japan have also introduced measures aimed at encouraging people to have children, but there is still plenty of resistance to starting a family.
“The biggest reason is people don't seem to be able to afford the cost or time spent giving birth and raising children,” Yu Hyun-su, a 23-year-old South Korean college student, told Reuters in Seoul.
India may have already overtaken China to become the world's most populous nation. U.N. experts predicted last year that India would have a population of 1.412 billion in 2022, and had been expecting the South Asian nation to overtake China this year.
On the streets of the Indian capital, some people felt that the government needed to take steps to tame the population growth, though it is already slowing.
"They should bring out some rules and regulations," said New Delhi resident Azhar Khan. “When the country’s population is in control, then only we can develop further.”
