Neurocrine Biosciences (NASDAQ:NBIX) will present new data as part of 30 abstracts accepted from its movement disorder programs for tardive dyskinesia (TD) and Parkinson’s disease at the virtual scientific meetings, 2020 Psych Congress on September 10–13 and the MDS Virtual Congress 2020 on September 12–16.
Key highlights include data analyses from long-term Phase III studies of INGREZZA (valbenazine) capsules in adult patients with TD demonstrating sustained clinical benefit, safety and tolerability;
New Phase III data analyses of ONGENTYS (opicapone) capsules in patients with Parkinson’s disease, and;
Phase Ib data of an investigational gene therapy, NBIb-1817 (VY-AADC), evaluating outcomes of patients with advanced Parkinson’s disease.
Tardive dyskinesia is a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face and other body parts.
During a corporate presentation at the LD 500 investor conference yesterday, NanoViricides (NYSEMKT:NNVC) President & Executive Chairman Anil Diwan, Ph.D., stated that the company is close to selecting a top clinical candidate for the treatment of COVID-19.
He said that preclinical testing in an animal model showed that the company’s candidates were highly effective against a related coronavirus that uses the same ACE2 receptor as SARS-CoV-2 to infect healthy cells.
The FDA accepts for review Ascendis Pharma A/S’s (NASDAQ:ASND) marketing application seeking approval of TransCon hGH (lonapegsomatropin) for the treatment of pediatric growth hormone deficiency (GHD) (dwarfism), an Orphan Drug-tagged indication.
TransCon hGH is a long-acting prodrug of somatropin (human growth hormone).
The agency’s action date is June 25, 2021.
The company expects to file its application in Europe this month.
CureVac (NASDAQ:CVAC) jumps 5% premarket after being notified by the German Federal Ministry of Education and Research that the Company is expected receive up to €252M to support the development of its COVID-19 vaccine candidate.
In July 2020, CureVac had applied to a grant as part of a special program to accelerate the R&D of vaccines against SARS-CoV-2.
The grant is also expected to be used for rapid expansion of the COVID-19 vaccine production along with vaccine development.
Payments are contingent on reaching predefined milestones. CureVac expects funding of up to €103M in 2020 and up to €149M in 2021.
The independent Data Safety Monitoring Board has completed its first interim analysis of data from a Phase 3 clinical trial evaluating Mesoblast Limited’s (MESO -0.3%) remestemcel-L, an allogeneic mesenchymal stem cell product derived from bone marrow, in COVID-19 patients with moderate-to-severe acute respiratory distress syndrome (ARDS).
Based on preliminary results from 30% of targeted enrollment, the Board recommends that the study continue unchanged.
A total of three interim analyses for stopping accrual early for efficacy or futility will be done (30%, 45% and 60% of total target of randomized patients). Enrollment should be completed in Q4.
The primary endpoint is all-cause mortality within 30 days of randomization. A key secondary endpoint is days alive off mechanical ventilation within 60 days of randomization.
According to the company, remestemcel-L is believed to have immunomodulatory properties to counteract the cytokine storms that are implicated in various inflammatory conditions by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.
Gilead Sciences (NASDAQ:GILD) unit Kite has filed a supplemental marketing application to the FDA seeking approval of Yescarta (axicabtagene ciloleucel) for the treatment of relapsed/refractory follicular lymphoma and marginal zone lymphoma after two or more prior lines of systemic therapy, both Breakthrough Therapy-tagged indications.
The CAR T therapy was approved in the U.S. almost three years ago for certain types of non-Hodgkin lymphoma.
After slamming President Trump for acting “like a king”, NY Gov Andrew Cuomo has mercifully allowed more businesses in the Empire State to finally reopen, even though COVID-19 cases haven’t seen anything approaching the kind of resurgences that officials have warned about.
Unlike pretty much every other state at this point (even neighboring New Jersey finally caved), New York hasn’t allowed the return of indoor dining. The issue is prompting an outpouring of rage directed at Cuomo and NYC Mayor Bill de Blasio, who have allowed protesters to gather night after night, while crushing the city’s small businesses. Adding insult to injury, de Blasio caved to the teachers union and spared more than 20,000 city employees who had been set for layoffs.
Gyms finally reopened in NYC Wednesday after city officials forced businesses to get cleared by the health department. Gyms around the state were allowed to reopen Aug. 24, but the delay until Sept. 2 was unique to New York City.
Most of NY state allows limited indoor dining. NYC is the only city in the state that hasn’t authorized any form of indoor dining, despite the fact that it has consistently reported positivity rates below 1% for weeks.
On Thursday, with the country focused on vaccine news, Cuomo announced that the state would allow casinos and malls to reopen on a limited capacity on Sept. 9. But restaurants in NYC would remain closed for the foreseeable future.
While de Blasio pushes for Cuomo and him to cooperatively develop a timeline for the return of indoor dining in NYC, Cuomo responded with a thinly veiled taunt, again reminding NYC leaders that “they have no legal authority to make that decision” on fully reopening restaurants. While he suggested that he’s “amenable” to reopening restaurants, he insisted that the city needs to have a well-thought-out plan that must be approved by the governor.
After all, Cuomo is the one who has the final say.
” … We have major problems in New York City with the compliance on the bars. I have beseeched New York City to do a better job on compliance and enforcement,” Cuomo said during a telephonic briefing with reporters. “We put together a task force to do the enforcement on Long Island and New York City … We have taken state police resources from many places to do that enforcement.”
“My opinion is restaurants should open. The question is how?” Cuomo said Thursday.
He then went on to promise that a “timetable” for reopening would be hashed out by the end of the month, though the answer might be “good news or bad news.”
“I think it’s our responsibility to give them as clear an answer in the month of September as possible, of where we are going,” the mayor said Wednesday. “If there can be a timeline, if there can be a set of standards for reopening, we need to decide that in the next few weeks and announce it, whether it is good news or bad news.”
But restaurant owners, facing the destruction of their livelihood, are refusing to wait. A frustrated group of restaurant owners slapped Cuomo with a class action lawsuit urging a judge to over rule the governor and allow NYC restaurants to start reopening their dining rooms.
The suit is seeking $2 billion in damages and alleges that the state is violating the constitutional rights of the owners of more than 150,000 New York City restaurants, many of which have already closed permanently. One study published Thursday claims that 60% of NYC restaurants will likely be forced to close if indoor dining doesn’t return soon. More than 350 city restaurants have signed on.
One restaurant, Il Bacco in Queens, joined the suit to argue that customers can simply walk a few blocks away into Nassau County if they want to eat indoors.
NY State has reported nearly 470k cases, roughly half of those were confirmed in NYC.
We imagine the state’s liberal judges will side with the government. But as time goes on, more people are starting to doubt that the indoor dining ban is a safety issue. Instead, might this be another attempt by Cuomo to politically hamstring his most hated Democratic rival, de Blasio?
